Managed Entry Decisions
| Drug | Decision | Link To guidance | Status | Date Added to website |
|---|---|---|---|---|
| Belumosudil (Rezurock®) | In Northern Ireland, belumosudil mesilate (Rezurock®) is accepted for use, within its marketing authorisation, for treating chronic graft-versus-host disease in people 12 years and over after 2 or more systemic treatments. The company has a commercial arrangement. This makes belumosudil available to the NHS with a discount. The size of the discount is commercial in confidence. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA949 | NICE TA949 | Accepted | 15/05/2024 |
| Nivolumab + relatlimab (Opdualag®) | In Northern Ireland, nivolumab + relatlimab (Opdualag®) is accepted for use as an option for untreated advanced (unresectable or metastatic) melanoma in people 12 years and over, only if: • nivolumab–relatlimab is stopped after 2 years of treatment, or earlier if the cancer progresses, and • the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA950 | NICE TA950 | Accepted | 15/05/2024 |
| Olaparib (Lynparza®) | In Northern Ireland, olaparib (Lynparza®) is accepted for use, within its marketing authorisation, as an option for maintenance treatment of BRCA mutation-positive, advanced (FIGO stages 3 and 4), high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to first-line platinum-based chemotherapy in adults. It is only accepted for use if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA962 | NICE TA962 | Accepted | 15/05/2024 |
| Sebelipase alfa (Kanuma®) | In Northern Ireland, sebelipase alfa (Kanuma®) is not accepted for use in treating lysosomal lipase deficiency that is not Wolman disease in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop For further information see SMC2437 | SMC2437 | Not accepted | 15/05/2024 |
| Satralizumab (Enspryng®) | In Northern Ireland, satralizumab (Enspryng®) is not accepted for use as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2663 | SMC2663 | Not accepted | 15/05/2024 |
| Etrasimod (Velsipity®) | In Northern Ireland, etrasimod (Velsipity®) is accepted for use within its marketing authorisation, as an option for moderately to severely active ulcerative colitis in people aged 16 years and over when: • conventional or biological treatments cannot be tolerated or • the condition has not responded well enough, or lost response to treatment. Etrasimod is only accepted for use if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA956 | NICE TA956 | Accepted | 15/05/2024 |
| Cabozantinib (Cabometyx®) | In Northern Ireland, cabozantinib (Cabometyx®) is accepted for use with nivolumab as an option for untreated advanced renal cell carcinoma in adults, only if: • their disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria, and • nivolumab with ipilimumab or lenvatinib with pembrolizumab would otherwise be offered, and • the companies provide cabozantinib and nivolumab according to their commercial arrangements. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA964 | NICE TA964 | Accepted | 07/05/2024 |
| Dostarlimab (Jemperli®) | In Northern Ireland, dostarlimab (Jemperli®) is accepted for use platinum-based chemotherapy is recommended with managed access as an option for treating primary advanced or recurrent endometrial cancer with high microsatellite instability or mismatch repair deficiency in adults who are candidates for systemic therapy. It is only accepted for use if the conditions in the managed access agreement for dostarlimab are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA963 | NICE TA963 | Accepted | 07/05/2024 |
| Formoterol + glycopyrrolate (Bevespi Aerosphere®) | In Northern Ireland, glycopyrronium/formoterol fumarate (Bevespi Aerosphere®) is accepted for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). For further information see SMC2652 | SMC2652 | Accepted | 07/05/2024 |
| Atogepant (Aquipta®) | In Northern Ireland, atogepant (Aquipta®) is accepted for use as an option for preventing migraine in adults who have at least 4 migraine days per month, only if at least 3 preventive medicines have failed. Stop atogepant after 12 weeks if the frequency of migraines does not reduce by: • at least 50% in episodic migraine (defined as fewer than 15 headache days per month) • at least 30% in chronic migraine (defined as 15 or more headache days per month, with at least 8 of those having features of migraine). If people with the condition and their healthcare professional consider atogepant to be one of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see NICE TA973 | NICE TA973 | Accepted | 17/05/2024 |
| Ravulizumab (Ultomiris®) | In Northern Ireland, ravulizumab (Ultomiris®) is not accepted for use as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop For further information see SMC 2657 | SMC 2657 | Not accepted | 10/04/2024 |
| Ravulizumab (Ultomiris®) | In Northern Ireland, ravulizumab (Ultomiris®) is not accepted for use for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin 4 (AQP4) antibody-positive. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop For further information see SMC2658 | SMC2658 | Not accepted | 10/04/2024 |
| Daratumumab - subcutaneous (Darzalex® 1,800mg solution for injection) | In Northern Ireland, daratumumab - subcutaneous (Darzalex® 1,800mg solution for injection) is accepted for use, with bortezomib, cyclophosphamide and dexamethasone as an option for treating newly diagnosed systemic amyloid light-chain (AL) amyloidosis in adults. It is accepted for use only if: • daratumumab is stopped after 24 cycles of treatment, or earlier if the condition progresses, and • the company provides daratumumab according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA959 | NICE TA959 | Accepted | 10/04/2024 |
| Ritlecitinib (Litfulo®) | In Northern Ireland, ritlecitinib (Litfulo®) is accepted for use within its marketing authorisation, as an option for treating severe alopecia areata in people 12 years and over. The company has a commercial arrangement (simple discount patient access scheme). This makes ritlecitinib available to the NHS with a discount. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA958 | NICE TA958 | Accepted | 10/04/2024 |
| Momelotinib (Omjjara®) | In Northern Ireland, momelotinib (Omjjara®) is accepted for use as an option for treating myelofibrosis-related splenomegaly or symptoms in adults with moderate to severe anaemia who have not had a JAK inhibitor or have had ruxolitinib, only if: • they have intermediate-2 or high-risk myelofibrosis, and • the company provides momelotinib according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA957 | NICE TA957 | Accepted | 10/04/2024 |
| Fluocinolone acetonide (Iluvien®) | In Northern Ireland, fluocinolone acetonide intravitreal implant (Iluvien®) is accepted for use as an option for treating visual impairment caused by chronic diabetic macular oedema in adults, only if: • their condition has not responded well enough to available treatments, and • the implant will be used in an eye with a natural lens (phakic eye), and • the company provides it according to the commercial arrangement If people with the condition and their clinicians consider fluocinolone acetonide intravitreal implant to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA953 | NICE TA953 | Accepted | 10/04/2024 |
| Dupilumab (Dupixent®) | In Northern Ireland, dupilumab (Dupixent®) is not accepted for use, within its marketing authorisation, for treating moderate to severe prurigo nodularis in adults when systemic treatment is suitable. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA 955 | NICE TA955 | Not accepted | 10/04/2024 |
| Epcoritamab (Tepkinly®) | In Northern Ireland, epcoritamab (Tepkinly®) is accepted for use as an option for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults after 2 or more systemic treatments, only if: • they have had polatuzumab vedotin, or if polatuzumab vedotin is contraindicated or not tolerated, and • the company provides epcoritamab according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA954 | NICE TA954 | Accepted | 10/04/2024 |
| Nirmatrelvir plus ritonavir, sotrovimab and tocilizumab | • Nirmatrelvir plus ritonavir (Paxlovid®) is accepted for use as an option for treating COVID‑19 in adults, only if they: - do not need supplemental oxygen for COVID‑19 and - they have any of the following: • an increased risk for progression to severe COVID‑19, as defined in section 5 of NICE TA878 • age 70 years and over • a body mass index (BMI) of 35kg/m2 or more • diabetes • heart failure. • Sotrovimab (Xevudy®) is accepted for use as an option for treating COVID‑19 in adults and young people aged 12 years and over and weighing at least 40kg, only if: - they do not need supplemental oxygen for COVID‑19 and - they have an increased risk for progression to severe COVID‑19, as defined in section 5 of NICE TA878 and - nirmatrelvir plus ritonavir is contraindicated or unsuitable. Sotrovimab is only accepted for use if the company provides it according to the commercial arrangement. • Tocilizumab (RoActemra®) is accepted for use, within its marketing authorisation, as an option for treating COVID‑19 in adults who: - are having systemic corticosteroids and - need supplemental oxygen or mechanical ventilation. Tocilizumab is only accepted for use if the company provides it according to the commercial arrangement. For further information see NICE TA878 | NICE TA878 | Accepted | 10/04/2024 |
| Lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) | In Northern Ireland, lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) is NOT accepted for use, within its marketing authorisation, for treating prostate-specific membrane antigen (PSMA)-positive hormone-relapsed metastatic prostate cancer in adults: • after taxane-based chemotherapy and an anti-androgen or • when taxanes are 'medically unsuitable'. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA930 | NICE TA930 | Not accepted | 08/03/2024 |
| Belantamab mafodotin (Blenrep®) | In Northern Ireland, belantamab mafodotin (Blenrep®) is not accepted for use as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2597 | SMC2597 | Not accepted | 08/03/2024 |
| Loncastuximab tesirine (Zynlonta®) | In Northern Ireland, loncastuximab tesirine (Zynlonta®) is accepted for use as an option for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) after 2 or more systemic treatments in adults, only if: • they have previously had polatuzumab vedotin and • the company provides it according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA 947 | NICE TA 947 | Accepted | 08/03/2024 |
| Talazoparib (Talzenna®) | In Northern Ireland, Talazoparib (Talzenna®) is accepted for use within its marketing authorisation, for treating HER2-negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations in adults who have had: • an anthracycline or a taxane, or both, unless these treatments are not suitable, and • endocrine therapy if they have hormone receptor (HR)-positive breast cancer, unless this is not suitable. Talazoparib is only accepted for use if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA952 | NICE TA 952 | Accepted | 08/03/2024 |
| Olaparib (Lynparza®) | In Northern Ireland, olaparib (Lynparza®) is accepted for use, with bevacizumab within its marketing authorisation, for maintenance treatment of high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose cancer: • has completely or partially responded after first-line platinum-based chemotherapy with bevacizumab • is advanced (International Federation of Gynecology and Obstetrics [FIGO] stages 3 and 4) and • is homologous recombination deficiency (HRD) positive (defined as having either a BRCA1 or BRCA2 mutation, or genomic instability). The company has a commercial arrangement. This makes olaparib with bevacizumab available to the NHS with a discount. The size of the discount is commercial in confidence. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA946 | NICE TA 946 | Accepted | 08/03/2024 |
| Durvalumab (Imfinzi®) | In Northern Ireland, durvalumab (Imfinzi®) plus gemcitabine and cisplatin is accepted for use, within its marketing authorisation, as an option for treating locally advanced, unresectable, or metastatic biliary tract cancer in adults. It is only accepted for use if the company provides durvalumab according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA944 | NICE TA 944 | Accepted | 08/03/2024 |
| Budesonide (Kinpeygo®) | In Northern Ireland, targeted-release budesonide (Kinpeygo®) is accepted for use as an option for treating primary immunoglobulin A nephropathy (IgAN) when there is a risk of rapid disease progression in adults with a urine protein-to-creatinine ratio of 1.5g/g or more. Targeted-release budesonide is recommended only if: • it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated • the company provides it according to the commercial arrangement Until such times as a Primary Care Price Parity Scheme (Primary Care PAS) is agreed, prescribing and dispensing of this medicine should remain in Secondary Care in Northern Ireland. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA937 | NICE TA 937 | Accepted | 08/03/2024 |
| Tirzepatide (Mounjaro®) | In Northern Ireland, tirzepatide (Mounjaro®) is accepted for use for treating type 2 diabetes alongside diet and exercise in adults when it is insufficiently controlled only if: • triple therapy with metformin and 2 other oral antidiabetic drugs is ineffective, not tolerated or contraindicated, and • they have a body mass index (BMI) of 35 kg/m2 or more, and specific psychological or other medical problems associated with obesity, or • they have a BMI of less than 35 kg/m2, and: - insulin therapy would have significant occupational implications, or - weight loss would benefit other significant obesity-related complications. Use lower BMI thresholds (usually reduced by 2.5 kg/m2) for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see NICE TA924 | NICE TA 924 | Accepted | 08/03/2024 |
| Trastuzumab deruxtecan (Enhertu®) | In Northern Ireland, trastuzumab deruxtecan (Enhertu®) is accepted for use as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. This advice applies only in the context of an approved Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis | SMC2608 | Accepted | 07/03/2024 |
| Efgartigimod | In Northern Ireland, efgartigimod alfa (Vyvgart®) is not accepted for use as an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2561 | SMC2561 | Not accepted | 28/02/2024 |
| Degarelix (Firmagon®) | In Northern Ireland, degarelix (Firmagon®) is accepted for use: • for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. • as neoadjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer. This advice applies only in the context of an approved Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see SMC2625 | SMC2625 | Accepted | 28/02/2024 |
| Olaparib (Lynparza®) | In Northern Ireland, olaparib (Lynparza®) with abiraterone and prednisone or prednisolone is accepted for use, within its marketing authorisation, as an option for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy. It is only accepted for use if the company provides it according to the commercial arrangements Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA951 | NICE TA951 | Accepted | 28/02/2024 |
| Ivosidenib (Tibsovo®) | In Northern Ireland, ivosidenib (Tibsovo®) is accepted for use, within its marketing authorisation, as an option for treating locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation in adults after 1 or more systemic treatments. The company has a commercial arrangement (simple discount patient access scheme). This makes ivosidenib available to the NHS with a discount. The size of the discount is commercial in confidence. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA948 | NICE TA948 | Accepted | 28/02/2024 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) plus chemotherapy with or without bevacizumab is accepted for use as an option for treating persistent, recurrent or metastatic cervical cancer in adults whose tumours express PD‑L1 with a combined positive score of at least 1. It is accepted for use only if: • pembrolizumab is stopped at 2 years of uninterrupted treatment, or earlier if the cancer progresses, and • the company provides it according to the commercial arrangements. For further information see NICE TA939 Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis | NICE TA939 | Accepted | 28/02/2024 |
| Mercaptamine bitartrate (Procysbi®) | In Northern Ireland, mercaptamine (Procysbi®) is not accepted for use for the treatment of proven nephropathic cystinosis. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2571 | SMC2571 | Not accepted | 28/02/2024 |
| Sebelipase alfa (Kanuma®) | In Northern Ireland, sebelipase alfa (Kanuma®) is accepted for use as an option for long-term enzyme replacement therapy in Wolman disease (rapidly progressive lysosomal acid lipase deficiency [LAL-D]), only if people are 2 years or younger when treatment starts. It is accepted for use only if the company provides sebelipase alfa according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE HST30 | NICE HST30 | Accepted | 28/02/2024 |
| Velmanase alfa (Lamzede®) | In Northern Ireland, velmanase alfa (Lamzede®) is accepted for use as an option for treating the non-neurological signs and symptoms of mild to moderate alpha-mannosidosis, only if: • treatment is started in people under 18 years (it can be continued in people who turn 18 while on treatment) • the company provides it according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE HST29 | NICE HST29 | Accepted | 28/02/2024 |
| Cabozantinib (Cabometyx®) | In Northern Ireland, cabozantinib (Cabometyx®) is not accepted for use, within its marketing authorisation, for treating locally advanced or metastatic differentiated thyroid cancer (DTC) that is unsuitable for or refractory to radioactive iodine, and that has progressed after systemic treatment, in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA928 | NICE TA928 | Not accepted | 28/02/2024 |
| Foslevodopa + foscarbidopa (Produodopa®) | In Northern Ireland, foslevodopa + foscarbidopa (Produodopa®) is accepted for use as an option for treating advanced levodopa-responsive Parkinson's in adults whose symptoms include severe motor fluctuations and hyperkinesia or dyskinesia, when available medicines are not working well enough, only if: • they cannot have apomorphine or deep brain stimulation, or these treatments no longer control symptoms, and • the company provides foslevodopa–foscarbidopa according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA934 | NICE TA934 | Accepted | 28/02/2024 |
| Osilodrostat (Isturisa®) Cushing’s disease | In Northern Ireland, osilodrostat (Isturisa®) is not accepted for use. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2640 | SMC2640 | Not accepted | 28/02/2024 |
| Empagliflozin (Jardiance®) | In Northern Ireland, empagliflozin (Jardiance®) is accepted for use as an option for treating chronic kidney disease (CKD) in adults, only if: • it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated, and • people have an estimated glomerular filtration rate of: - 20ml/min/1.73 m2 to less than 45ml/min/1.73 m2 or: - 45ml/min/1.73 m2 to 90ml/min/1.73 m2 and either: • a urine albumin-to-creatinine ratio of 22.6mg/mmol or more, or • type 2 diabetes. If people with the condition and their clinicians consider empagliflozin to be 1 of a range of suitable treatments (including dapagliflozin), after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements. For further information see NICE TA942 | NICE TA942 | Accepted | 28/02/2024 |
| Indacaterol (as acetate), glycopyrronium bromide and mometasone furoate (Enerzair Breezhaler ®) | In Northern Ireland, indacaterol (as acetate), glycopyrronium bromide and mometasone furoate (Enerzair Breezhaler ®) is accepted for use as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. | SMC2355 | Accepted | 12/12/2023 |
| Secukinumab (Cosentyx®) | In Northern Ireland, secukinumab (Cosentyx®) is accepted for use as an option for treating active moderate to severe hidradenitis suppurativa (acne inversa) in adults when it has not responded well enough to conventional systemic treatment, only if: • adalimumab is not suitable, did not work or has stopped working • the company provides secukinumab according to the commercial arrangements. Assess response to secukinumab after the first 16 weeks of treatment, and only continue if there is clear evidence of a response, defined as: • a reduction of 25% or more in the total abscess and inflammatory nodule count, and • no increase in abscesses and draining fistulas. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA935 | NICE TA935 | Accepted | 12/12/2023 |
| Baricitinib (Olumiant®) | In Northern Ireland, baricitinib (Olumiant®) is not accepted for use, within its marketing authorisation, for treating severe alopecia areata in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA926 | NICE TA926: | Not accepted | 12/12/2023 |
| Zanubrutinib (Brukinsa®) | In Northern Ireland, zanubrutinib (Brukinsa®) is accepted for use as an option for treating chronic lymphocytic leukaemia (CLL) in adults. It is only accepted for use if the CLL is: • untreated and - there is a 17p deletion or tumour protein 53 (TP53) mutation or - there is no 17p deletion or TP53 mutation, and fludarabine plus cyclophosphamide and rituximab (FCR), or bendamustine plus rituximab (BR) is unsuitable, or • relapsed or refractory. Zanubrutinib is accepted for use only if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA931 | NICE TA931 | Accepted | 12/12/2023 |
| Glofitamab (Columvi®) | In Northern Ireland, glofitamab (Columvi®) is accepted for use within its marketing authorisation, as an option for treating relapsed or refractory diffuse large B‑cell lymphoma in adults after 2 or more systemic treatments. Glofitamab is only recommended if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA927 | NICE TA927 | Accepted | 12/12/2023 |
| Crizotinib (Xalkori®) | In Northern Ireland, crizotinib (Xalkori®) is not accepted for use as monotherapy for the treatment of paediatric patients (age ≥6 to <18 years) with: • relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL) • recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT). People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2621 | SMC2621 | Not accepted | 05/12/2023 |
| Mirikizumab (Omvoh®) | In Northern Ireland, mirikizumab (Omvoh®) is accepted for use as an option for treating moderately to severely active ulcerative colitis in adults when conventional or biological treatment cannot be tolerated, or the condition has not responded well enough or lost response to treatment, only if: • a tumour necrosis factor (TNF)‑alpha inhibitor has not worked (that is the condition has not responded well enough or has lost response to treatment) or • a TNF-alpha inhibitor cannot be tolerated or is not suitable and • the company provides it according to the commercial arrangement If people with the condition and their clinicians consider mirikizumab to be 1 of a range of suitable treatments (including vedolizumab and ustekinumab), after discussing the advantages and disadvantages of all the options, use the least expensive. Take into account the administration costs, dosage, price per dose and commercial arrangements. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA925 | TA925 | Accepted | 05/12/2023 |
| Daratumumab (Darzalex®) | In Northern Ireland, daratumumab (Darzalex®) is accepted for use, with lenalidomide and dexamethasone, within its marketing authorisation, as an option for untreated multiple myeloma in adults, when an autologous stem cell transplant is unsuitable. The company has a commercial arrangement. This makes daratumumab available to the NHS with a discount. The size of the discount is commercial in confidence. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA917 | TA917 | Accepted | 04/12/2023 |
| Tofacitinib (Xeljanz®) | In Northern Ireland tofacitinib (Xeljanz®) is accepted for use as an option for treating active ankylosing spondylitis that is not controlled well enough with conventional therapy in adults, only if: • tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough and • the company provides tofacitinib according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA920 | TA920 | Accepted | 04/12/2023 |
| Ruxolitinib (Jakavi®) | In Northern Ireland, ruxolitinib (Jakavi®) is accepted for use, within its marketing authorisation, for treating polycythaemia vera in adults who cannot tolerate hydroxycarbamide (also called hydroxyurea) or when the condition is resistant to it. It is only accepted for use if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA921 | TA921 | Accepted | 04/12/2023 |
| Bimekizumab (Bimzelx®) | In Northern Ireland, bimekizumab (Bimzelx®) is accepted for use as an option in adults for treating active ankylosing spondylitis (AS) when conventional therapy has not worked well enough or is not tolerated, or active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation (shown by elevated C-reactive protein or MRI) when non-steroidal anti-inflammatory drugs (NSAIDs), have not worked well enough or are not tolerated. It is recommended only if: • tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough, and • the company provides it according to the commercial arrangement Assess response to bimekizumab after 16 weeks of treatment. Continue treatment only if there is clear evidence of response, defined as: • a reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to 50% of the pre-treatment value or by 2 or more units and • a reduction in the spinal pain visual analogue scale (VAS) by 2 cm or more. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information please see NICE TA918 | TA918 | Accepted | 04/12/2023 |
| Bimekizumab (Bimzelx®) | In Northern Ireland, bimekizumab (Bimzelx®) alone or with methotrexate, is accepted for use as an option for treating active psoriatic arthritis (defined as peripheral arthritis with 3 or more tender joints and 3 or more swollen joints) in adults whose condition has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is accepted for use only if they have had 2 conventional DMARDs and: • at least 1 biological DMARD or • tumour necrosis factor (TNF)-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE TA199) Bimekizumab is accepted for use only if the company provides it according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA916 | TA916 | Accepted | 04/12/2023 |
| Pegunigalsidase alfa (Elfabrio®) | In Northern Ireland, pegunigalsidase alfa (Elfabrio®) is accepted for use, within its marketing authorisation, as an option for treating Fabry disease in adults (also known as alphagalactosidase deficiency). It is recommended only if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA915 | TA915 | Accepted | 04/12/2023 |
| Rimegepant (Vydura®) | In Northern Ireland, rimegepant (Vydura®) is accepted for use as an option for the acute treatment of migraine with or without aura in adults, only if for previous migraines: • at least 2 triptans were tried and they did not work well enough or • triptans were contraindicated or not tolerated, and nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol were tried but did not work well enough *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see NICE TA919 | TA919 | Accepted | 04/12/2023 |
| Daridorexant (Quviviq®) | In Northern Ireland, daridorexant (QUVIVIQ®) is accepted for use for treating insomnia in adults with symptoms lasting for 3 nights or more per week for at least 3 months, and whose daytime functioning is considerably affected, only if: • cognitive behavioural therapy for insomnia (CBTi) has been tried but not worked, or • CBTi is not available or is unsuitable. The length of treatment should be as short as possible. Treatment with daridorexant should be assessed within 3 months of starting and should be stopped in people whose long-term insomnia has not responded adequately. If treatment is continued, assess whether it is still working at regular intervals. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see NICE TA922 | TA922 | Accepted | 04/12/2023 |
| Empagliflozin (Jardiance®) | In Northern Ireland, empagliflozin (Jardiance®) is accepted for use within its marketing authorisation, as an option for treating symptomatic chronic heart failure with preserved or mildly reduced ejection fraction in adults. For further information see NICE TA929 | TA929 | Accepted | 04/12/2023 |
| Darolutamide (Nubeqa®) | In Northern Ireland, darolutamide (Nubeqa®) is accepted for use, within its marketing authorisation, as an option for treating hormone-sensitive metastatic prostate cancer in adults. Darolutamide is only accepted for use if the company provides it according to the commercial arrangement. For further information see NICE TA903 | TA903 | Accepted | 09/10/2023 |
| Mavacamten (Camzyos®) | In Northern Ireland, mavacamten (Camzyos®) is accepted for use as an option for treating symptomatic obstructive hypertrophic cardiomyopathy in adults who have a New York Heart Association class of 2 to 3. It is recommended only if: - it is an add-on to individually optimised standard care that includes beta-blockers, non-dihydropyridine calcium-channel blockers or disopyramide, unless these are contraindicated, and - the company provides it according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA913 | TA913 | Accepted | 09/10/2023 |
| Aflibercept (Eylea®) | In Northern Ireland aflibercept (Eylea®) is not accepted for use in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2612 | SMC2612 | Not accepted | 09/10/2023 |
| Dermatophagoides pteronyssinus and Dermatophagoides farina (Acarizax®) | In Northern Ireland, standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae 12 SQ-HDM* per oral lyophilisate (Acarizax®), is not accepted for use in: • Adult patients (18-65 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with at least one of the following conditions: - persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication - house dust mite allergic asthma not well controlled by inhaled corticosteroids and associated with mild to severe house dust mite allergic rhinitis. Patients' asthma status should be carefully evaluated before the initiation of treatment • Adolescents (12-17 years) diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE) with persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2613 | SMC2613 | Not accepted | 09/10/2023 |
| Tebentafusp (Kimmtrak®) | In Northern Ireland, tebentafusp (Kimmtrak®) is not accepted for use, within its marketing authorisation, for treating HLA-A*02:01-positive unresectable or metastatic uveal melanoma in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE FAD ID1441 | NICE FAD ID1441 | Not accepted | 09/10/2023 |
| Birch bark extract (Filsuvez®) | In Northern Ireland, birch bark extract (Filsuvez®) is accepted for use, within its marketing authorisation, as an option for treating partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa in people aged 6 months and over. It is only recommended if the company provide it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. Until such times as a Primary Care Price Parity Scheme (Primary Care PAS) is agreed, prescribing and dispensing of this medicine should remain in Secondary Care in Northern Ireland. For further information see NICE HST28 | NICE HST28 | Accepted | 09/10/2023 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is accepted for use as an option for treating tumours with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency in adults with: • advanced or recurrent endometrial cancer that has progressed during or after a platinum-based therapy, who cannot have curative surgery or radiotherapy • unresectable or metastatic gastric, small intestine or biliary cancer that has progressed during or after 1 therapy • colorectal cancer after fluoropyrimidine combination therapy, only if they cannot have nivolumab with ipilimumab. It is only recommended if: • pembrolizumab is stopped at 2 years of uninterrupted treatment, or earlier if the cancer progresses, and • the company provides it according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA914 | NICE TA914 | Accepted | 09/10/2023 |
| C1-esterase inhibitor (human) (Cinryze®) | In Northern Ireland, human C1-esterase inhibitor (Cinryze®) is accepted for use as an option for the treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (HAE). It is also accepted for the routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of HAE, who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see AWMSG 2117 | AWMSG 2117 | Accepted | 18/09/2023 |
| Ropeginterferon alfa-2b (Besremi) | In Northern Ireland, ropeginterferon alfa-2b (Besremi®) is not accepted to use as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC 2563 | SMC2563 | Not Accepted | 18/09/2023 |
| Voxelotor (Oxbryta®) | In Northern Ireland, voxelotor (Oxbryta®) is not accepted for use with or without hydroxycarbamide is not recommended, within its marketing authorisation, for treating haemolytic anaemia caused by sickle cell disease in people 12 years and over. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE FDG ID1403 | NICE FDG ID1403 | Not Accepted | 18/09/2023 |
| Afamelanotide (Scenesse®) | In Northern Ireland, afamelanotide (Scenesse®) is not accepted for use, within its marketing authorisation, for preventing phototoxicity in adults with erythropoietic protoporphyria (EPP). People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE HST27 | NICE HST27 | Not Accepted | 18/09/2023 |
| Cipaglucosidase alfa (Pombiliti®) | In Northern Ireland, cipaglucosidase alfa (Pombiliti®) is accepted for use as an option for treating late-onset Pompe disease in adults. It is accepted for use only if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA912 | NICE TA912 | Accepted | 18/09/2023 |
| Olaparib (Lynparza®) | In Northern Ireland, olaparib (Lynparza®) is accepted for use as an option for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults whose cancer has responded to platinum-based chemotherapy, only if: - they have a BRCA1 or BRCA2 mutation - they have had 2 or more courses of platinum-based chemotherapy - the company provides olaparib according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA908 | NICE TA908 | Accepted | 18/09/2023 |
| Axicabtagene ciloleucel (Yescarta®) | In Northern Ireland, axicabtagene ciloleucel (Yescarta®) is not accepted for use, within its marketing authorisation, for treating relapsed or refractory follicular lymphoma after 3 or more systemic treatments in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA894 | NICE TA894 | Not Accepted | 08/08/2023 |
| Daratumumab (Darzalex®) | In Northern Ireland, daratumumab (Darzalex®) with bortezomib and dexamethasone is accepted for use as an option for treating multiple myeloma in adults, only if they have had just 1 previous line of treatment and: • it included lenalidomide or • lenalidomide is unsuitable as a second-line treatment and • the company provides it according to the commercial arrangement. For further information see NICE TA897 | NICE TA897 | Accepted | 08/08/2023 |
| Deucravacitinib (Sotyktu®) | In Northern Ireland, deucravacitinib (Sotyktu®) is accepted for use as an option for treating moderate to severe plaque psoriasis in adults, only if: • the Psoriasis Area and Severity Index (PASI) is 10 or more and the Dermatology Life Quality Index (DLQI) is more than 10 • the condition has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated • the company provides deucravacitinib according to the commercial arrangement Consider stopping deucravacitinib between 16 weeks and 24 weeks if there has not been at least a 50% reduction in the PASI score (PASI 50) from when treatment started. Consider stopping deucravacitinib at 24 weeks if the psoriasis has not responded adequately. An adequate response is defined as: • a 75% reduction in the PASI score (PASI 75) from when treatment started or • a 50% reduction in the PASI score (PASI 50) and a 5-point reduction in DLQI from when treatment started. If people with the condition and their clinicians consider deucravacitinib to be one of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA907 | NICE TA907 | Accepted | 08/08/2023 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) is accepted for use with chemotherapy, within its marketing authorisation, as an option for the neoadjuvant treatment of resectable (tumours at least 4 cm or node positive) non-small-cell lung cancer (NSCLC) in adults. It is only recommended if the company provides it according to the commercial arrangement. The recommendations contained within this guidance represent off-label use of a medicine in Northern Ireland, and as such clinicians prescribing this treatment should ensure that they abide by extant HSC Trust governance procedures in relation to the prescribing of off-label medicines. For further information see NICE TA876 | NICE TA876 | Accepted | 08/08/2023 |
| Selpercatinib (Retsevmo®) | In Northern Ireland, selpercatinib (Retsevmo®) is accepted for use as an option for treating RET fusion-positive advanced non-small-cell lung cancer (NSCLC) in adults, only if: • it is untreated • the conditions in the managed access agreement for selpercatinib are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA911 | NICE TA911 | Accepted | 08/08/2023 |
| Risankizumab (Skyrizi®) | In Northern Ireland, risankizumab (Skyrizi®) is accepted for use as an option for treating moderately to severely active Crohn's disease in people 16 years and over, only if: • the disease has not responded well enough or lost response to a previous biological treatment or • a previous biological treatment was not tolerated or • tumour necrosis factor (TNF)-alpha inhibitors are not suitable. Risankizumab is only recommended if the company provides it according to the commercial arrangement PLEASE NOTE: Part of the recommendation contained within this guidance technically represents off-label use of a medicine in Northern Ireland, and as such clinicians prescribing this treatment in 16- and 17-year-olds should ensure that they abide by extant HSC Trust governance procedures in relation to the prescribing of off-label medicines. For further information see NICE TA888 | NICE TA888 | Accepted | 12/07/2023 |
| Pembrolizumab (Keytruda®) | In Northern Ireland pembrolizumab (Keytruda®) plus lenvatinib is accepted for use, within its marketing authorisation, for treating advanced or recurrent endometrial cancer in adults: • whose cancer has progressed on or after platinum-based chemotherapy and • who cannot have curative surgery or radiotherapy. Pembrolizumab plus lenvatinib is accepted for use only if the companies provide them according to the commercial arrangements For further information see NICE TA904 | NICE TA904 | Accepted | 12/07/2023 |
| Upadacitinib (Rinvoq®) | In Northern Ireland, upadacitinib (Rinvoq®) is accepted for use as an option for treating moderately to severely active Crohn’s disease in adults, only if: • the disease has not responded well enough or lost response to a previous biological treatment or • a previous biological treatment was not tolerated or • tumour necrosis factor (TNF)-alpha inhibitors are contraindicated. Upadacitinib is only accepted for use if the company provides it according to the commercial arrangement. For further information see NICE TA905 | NICE TA905 | Accepted | 12/07/2023 |
| Tixagevimab + cilgavimab (Evusheld®) | In Northern Ireland, tixagevimab plus cilgavimab (Evusheld®) is not accepted for use, within its marketing authorisation, for the pre-exposure prophylaxis of COVID-19 in adults who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to someone infected with SARS-CoV-2, and: • who are unlikely to have an adequate immune response to COVID-19 vaccination, or • for whom COVID-19 vaccination is not recommended. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA900 | NICE TA900 | Not Accepted | 12/07/2023 |
| Mosunetuzumab (Lunsumio®) | In Northern Ireland, mosunetuzumab (Lunsumio®) is not accepted for use, within its marketing authorisation, for treating relapsed or refractory follicular lymphoma in adults who have had 2 or more systemic therapies. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA892 | NICE TA892 | Not Accepted | 12/07/2023 |
| Lorlatinib (Lorviqua®) | In Northern Ireland, lorlatinib (Lorviqua®) is not accepted for use, within its marketing authorisation, for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) in adults who have not had an ALK inhibitor. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA909 | NICE TA909 | Not Accepted | 12/07/2023 |
| Dabrafenib (Tafinlar®) | In Northern Ireland, dabrafenib plus trametinib is accepted for use as an option for treating BRAF V600 mutation-positive advanced non-small-cell lung cancer (NSCLC) in adults, only if: • it is used as first-line treatment of advanced stage cancer and • the company provides it according to the commercial arrangement For further information see NICE TA898 | NICE TA898 | Accepted | 11/07/2023 |
| Bulevirtide (Hepcludex®) | In Northern Ireland, bulevirtide (Hepcludex®) is accepted for use as an option for treating chronic hepatitis D in adults with compensated liver disease only if: • there is evidence of significant fibrosis (METAVIR stage F2 or above or Ishak stage 3 or above) and • their hepatitis has not responded to peginterferon alfa-2a (PEG-IFN) or they cannot have interferon-based therapy. Bulevirtide is only accepted for use if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA896 | NICE TA896 | Accepted | 11/07/2023 |
| Brexucabtagene autoleucel (Tecartus®) | In Northern Ireland, brexucabtagene autoleucel (Tecartus®) is accepted for use as an option for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people 26 years and over. It is accepted for use only if the conditions in the managed access agreement for brexucabtagene autoleucel are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA893 | NICE TA893 | Accepted | 11/07/2023 |
| Axicabtagene ciloleucel (Yescarta®) | In Northern Ireland, axicabtagene ciloleucel (Yescarta®) is accepted for use as an option for treating diffuse large B-cell lymphoma in adults when an autologous stem cell transplant is suitable if it: • has relapsed within 12 months after first-line chemoimmunotherapy or • is refractory to first-line chemoimmunotherapy. It is accepted for use only if the conditions in the managed access agreement for axicabtagene ciloleucel are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further informaton see NICE TA895 | NICE TA895 | Accepted | 11/07/2023 |
| Ibrutinib (Imbruvica®) | In Northern Ireland, ibrutinib (Imbruvica®) plus venetoclax is accepted for use, within its marketing authorisation, as an option for untreated chronic lymphocytic leukaemia (CLL) in adults. This is only if the companies provide both drugs according to the commercial arrangements. For further information see NICE TA891 | NICE TA891 | Accepted | 11/07/2023 |
| Eladocagene exuparvovec (Upstaza®) | In Northern Ireland, eladocagene exuparvovec (Upstaza®) is accepted for use, within its marketing authorisation, as an option for treating aromatic L‑amino acid decarboxylase (AADC) deficiency in people 18 months and over with a clinical, molecular and genetically confirmed diagnosis of AADC deficiency with a severe phenotype. Eladocagene exuparvovec is only accepted for use if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE HST26 | NICE HST26 | Accepted | 11/07/2023 |
| Lumasiran (Oxlumo®) | In Northern Ireland, lumasiran (Oxlumo®) is accepted for use, within its marketing authorisation, as an option for treating primary hyperoxaluria type 1 (PH1) in people of all ages. It is accepted for use only if the company provides lumasiran according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE HST25 | NICE HST25 | Accepted | 11/07/2023 |
| Onasemnogene abeparvovec (Zolgensma®) | In Northern Ireland, onasemnogene abeparvovec (Zolgensma®) is accepted for use as an option for treating presymptomatic 5q spinal muscular atrophy (SMA) with a biallelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene in babies aged 12 months and under. It is only accepted for use if the company provides it according to the commercial arrangement. This guidance is a partial review of NICE HST15. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE HST24 | NICE HST24 | Accepted | 11/07/2023 |
| Ravulizumab (Ultomiris®) | Reflect AWMSG Advice No: 0322: In Northern Ireland, ravulizumab (Ultomiris®) is accepted for use as an option for the treatment of paroxysmal nocturnal haemoglobinuria in paediatric patients with a body weight of 10kg or above: • in patients with haemolysis with clinical symptom(s) indicative of high disease activity • in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS price. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see AWMSG 0322 | AWMSG 0322 | Accepted | 11/07/2023 |
| Olaparib (Lynparza®) | In Northern Ireland, olaparib (Lynparza®) is accepted for use, within its marketing authorisation, as an option for the adjuvant treatment of HER2-negative high-risk early breast cancer that has been treated with neoadjuvant or adjuvant chemotherapy in adults with germline BRCA1 or 2 mutations. It is only accepted for use if the company provides it according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA886 | NICE TA886 | Accepted | 11/07/2023 |
| Olaparib (Lynparza®) | In Northern Ireland, olaparib (Lynparza®) is accepted for use, within its marketing authorisation, as an option for treating hormone-relapsed metastatic prostate cancer with BRCA1 or BRCA2 mutations that has progressed after a newer hormonal treatment (such as abiraterone or enzalutamide) in adults. Olaparib is only accepted for use if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA887 | NICE TA887 | Accepted | 11/07/2023 |
| Dapagliflozin (Forxiga®) | In Northern Ireland, dapagliflozin (Forxiga®) is accepted for use, within its marketing authorisation, as an option for treating symptomatic chronic heart failure with preserved or mildly reduced ejection fraction in adults. For further information see NICE TA902 | NICE TA902 | Accepted | 11/07/2023 |
| Rimegepant (Vydura®) | In Northern Ireland, rimegepant (Vydura®) is accepted for use as an option for preventing episodic migraine in adults who have at least 4 and fewer than 15 migraine attacks per month, only if at least 3 preventative treatments have not worked. Stop rimegepant after 12 weeks of treatment if the frequency of migraine attacks does not reduce by at least 50%. If people with the condition and their clinicians consider rimegepant to be one of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see NICE TA906 | NICE TA906 | Accepted | 11/07/2023 |
| Difelikefalin (Kapruvia®) | In Northern Ireland, difelikefalin (Kapruvia®) is accepted for use within its marketing authorisation, for treating moderate to severe pruritus in adults with chronic kidney disease having in-centre haemodialysis. Difelikefalin is only recommended if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA890 | NICE TA890 | Accepted | 11/07/2023 |
| Casirivimab/imdevimab (Ronapreve®), nirmatrelvir/ritonavir (Paxlovid®), sotrovimab (Xevudy®) and tocilizumab (RoActemra®) | In Northern Ireland: Nirmatrelvir plus ritonavir (Paxlovid®) is accepted for use as an option for treating COVID‑19 in adults, only if they: - do not need supplemental oxygen for COVID‑19 and - have an increased risk for progression to severe COVID‑19, as defined in the independent advisory group report commissioned by the Department of Health and Social Care (https://www.gov.uk/government/publications/higher-risk-patients-eligible-for-covid-19-treatments-independent-advisory-group-report ) Sotrovimab (Xevudy®) is accepted for use as an option for treating COVID‑19 in adults and young people aged 12 years and over and weighing at least 40 kg, only if: - they do not need supplemental oxygen for COVID‑19 and - they have an increased risk for progression to severe COVID‑19, as defined in the independent advisory group report commissioned by the Department of Health and Social Care and - nirmatrelvir plus ritonavir is contraindicated or unsuitable. Sotrovimab is only recommended if the company provides it according to the commercial arrangement. Tocilizumab (RoActemra®) is accepted for use, within its marketing authorisation, as an option for treating COVID‑19 in adults who: - are having systemic corticosteroids and - need supplemental oxygen or mechanical ventilation. Tocilizumab is only recommended if the company provides it according to the commercial arrangement. Casirivimab plus imdevimab (Ronapreve®) is not accepted for use, within its marketing authorisation, for treating acute COVID‑19 in adults. For further information see NICE TA878 | NICE TA878 | Accepted | 12/05/2023 |
| Tezepelumab (Tezspire®) | In Northern Ireland tezepelumab (Tezspire®), as an add-on maintenance treatment, is accepted for use as an option, for severe asthma in people 12 years and over, when treatment with high-dose inhaled corticosteroids plus another maintenance treatment has not worked well enough. It is accepted for use only if people: - have had 3 or more exacerbations in the previous year, or - are having maintenance oral corticosteroids. Tezepelumab is accepted for use only if the company provides it according to the commercial arrangement Stop tezepelumab if the rate of severe asthma exacerbations, or the maintenance oral corticosteroid dose, have not been reduced by at least 50% at 12 months. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA880 | NICE TA880 | Accepted | 12/05/2023 |
| Voclosporin (Lupkynis®) | In Northern Ireland voclosporin (Lupkynis®) is accepted for use, with mycophenolate mofetil, within its marketing authorisation, as an option for treating active class 3 to 5 (including mixed class 3 and 5, and 4 and 5) lupus nephritis in adults. It is only accepted for use if the company provides voclosporin with mycophenolate mofetil according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA882 | NICE TA882 | Accepted | 12/05/2023 |
| Fampridine (Fampyra®) | In Northern Ireland, fampridine (Fampyra®) is accepted for use to improve walking in adult patients with multiple sclerosis with walking disability (EDSS [expanded disability status scale] 4-7). This advice applies only in the context of an approved Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see SMC2253 | SMC 2253 | Accepted | 12/05/2023 |
| Tafasitamab (Minjuvi®) | In Northern Ireland, tafasitamab (Minjuvi®) with lenalidomide is not accepted for use, within its marketing authorisation, for treating relapsed or refractory diffuse large B-cell lymphoma in adults who cannot have an autologous stem cell transplant. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA883 | NICE TA883 | Not Accepted | 12/05/2023 |
| Ripretinib (Quinlock®) | In Northern Ireland, ripretinib (Quinlock®) is not accepted for use, within its marketing authorisation, for treating advanced gastrointestinal stromal tumour (GIST) in adults after 3 or more kinase inhibitors, including imatinib. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA881 | NICE TA881 | Not Accepted | 12/05/2023 |
| Asfotase alfa (Strensiq®) | In Northern Ireland, asfotase alfa (Strensiq®) is accepted for use as an option for treating paediatric‑onset hypophosphatasia if the person's symptoms started before or at birth (perinatal onset) or between the ages of 0 and 6 months (infantile onset). It is also accepted for use for people whose symptoms started between the ages of 6 months and 17 years (juvenile onset) only if: • they are aged 1 year to 4 years and have: - not reached expected developmental gross motor milestones for their age or - continuing or recurring significant musculoskeletal pain that affects daily activities and quality of life, and has not improved after 2 different types of painkiller recommended by a national pain specialist • they are aged 5 years to 18 years and have: - limited mobility assessed by a specialist using the modified Bleck Ambulation Efficiency Score and a Bleck score between 1 and 6 or - continuing or recurring significant musculoskeletal pain that affects daily activities and quality of life, and has not improved after 2 different types of painkiller recommended by a national pain specialist. • they are over 18 years and have 2 or more of the following: - current fractures with a history of non-traumatic, recurring or non- or poorly healing fractures - limited mobility assessed by a specialist using the modified Bleck Ambulation Efficiency Score and a Bleck score between 1 and 6 - continuing or recurring significant musculoskeletal pain that affects daily activities and quality of life, and has not improved after 2 different types of painkiller recommended by a national pain specialist. Asfotase alfa is only accepted for use if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE HST23 | NICE HST23 | Accepted | 12/05/2023 |
| Axicabtagene ciloleucel (Yescarta®) | In Northern Ireland axicabtagene ciloleucel (Yescarta®) is accepted for use, within its marketing authorisation, as an option for treating relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma in adults after 2 or more systemic therapies. It is recommended only if the company provides axicabtagene ciloleucel according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information please see NICE TA872 | NICE TA872 | Accepted | 17/04/2023 |
| Ixazomib (Ninlaro®) | In Northern Ireland, ixazomib (Ninlaro®), with lenalidomide and dexamethasone, is accepted for use as an option for treating multiple myeloma in adults, only if: - they have had 2 or 3 lines of therapy and - the company provides ixazomib according to the commercial arrangement. For further information please see NICE TA870 | NICE TA870 | Accepted | 17/04/2023 |
| Ataluren (Translarna®) | In Northern Ireland, ataluren (Translarna®) is accepted for use within its marketing authorisation, as an option for treating Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene in people 2 years and over who can walk. This is only if the company provides ataluren according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE HST22 | NICE HST22 | Accepted | 17/04/2023 |
| Macitentan (Opsumit®) | In Northern Ireland, macitentan (Opsumit®) is accepted for use, as monotherapy or in combination, for the long-term treatment of pulmonary arterial hypertension in adult patients of World Health Organisation Functional Class II to III. Use is restricted to initiation and prescribing by specialists. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see SMC95214 | SMC95214 | Accepted | 10/03/2023 |
| Tisagenlecleucel (Kymriah®) | In Northern Ireland, tisagenlecleucel (Kymriah®) is not accepted for use in the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. People currently receiving this drug for this indication should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2566 | SMC2566 | Not Accepted | 10/03/2023 |
| Cannabidiol (Epidyolex®) | In Northern Ireland, cannabidiol (Epidyolex®) is accepted for use as an add-on treatment option for seizures caused by tuberous sclerosis complex in people aged 2 years and over, only if: • their seizures are not controlled well enough by 2 or more antiseizure medications (either used alone or in combination) or these treatments were not tolerated • seizure frequency is checked every 6 months, and cannabidiol is stopped if the frequency has not fallen by at least 30% compared with the 6 months before starting treatment • the company provides cannabidiol according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA873 | NICE TA873 | Accepted | 10/03/2023 |
| Polatuzumab (Polivy®) | In Northern Ireland, polatuzumab (Polivy®), with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP), is accepted for use for untreated diffuse large B-cell lymphoma (DLBCL) in adults, only if • they have an International Prognostic Index (IPI) score of 2 to 5 • the company provides it according to the commercial arrangement For further information see NICE TA874 | NICE TA874 | Accepted | 10/03/2023 |
| Eptinezumab (Vyepti®) | In Northern Ireland, eptinezumab (Vyepti®) is accepted for use as an option for preventing migraine in adults, only if: • they have 4 or more migraine days a month • at least 3 preventive drug treatments have failed and • the company provides it according to the commercial arrangement Stop eptinezumab after 12 weeks of treatment if: • in episodic migraine (fewer than 15 headache days a month), the frequency does not reduce by at least 50% • in chronic migraine (15 headache days a month or more with at least 8 of those having features of migraine), the frequency does not reduce by at least 30%. If people with the condition and their clinicians consider eptinezumab to be 1 of a range of suitable treatments (including erenumab, fremanezumab and galcanezumab), discuss the advantages and disadvantages of the available treatments. After that discussion, if more than 1 treatment is suitable, choose the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA871 | NICE TA871 | Accepted | 10/03/2023 |
| Vutrisiran (Amvuttra®) | In Northern Ireland, vutrisiran (Amvuttra®) is accepted for use, within its marketing authorisation, as an option for treating hereditary transthyretin-related amyloidosis in adults with stage 1 or stage 2 polyneuropathy. It is only accepted for use if the company provides vutrisiran according to the commercial arrangement. For further information see NICE TA868 | NICE TA868 | Accepted | 10/03/2023 |
| Finerenone (Kerendia®) | In Northern Ireland, finerenone (Kerendia®) is accepted for use as an option for treating stage 3 and 4 chronic kidney disease (with albuminuria) associated with type 2 diabetes in adults. It is recommended only if: • It is an add-on to optimised standard care. This should include, unless they are unsuitable, the highest tolerated licensed doses of: - angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), and - sodium–glucose cotransporter-2 (SGLT2) inhibitors, and • people have an estimated glomerular filtration rate (eGFR) of 25ml/min/1.73 m2 or more. For further information see NICE TA877 | NICE TA877 | Accepted | 10/03/2023 |
| Venetoclax (Venclyxto®) | In Northern Ireland, venetoclax (Venclyxto®) with low dose cytarabine is accepted for use as an option for untreated acute myeloid leukaemia in adults when intensive chemotherapy is unsuitable, only if: • they have over 30% bone marrow blasts • the company provides venetoclax according to the commercial arrangement The recommendations contained within this guidance represent off-label use of a medicine in Northern Ireland, and as such clinicians prescribing this treatment should ensure that they abide by extant HSC Trust governance procedures in relation to the prescribing of off-label medicines. For further information see NICE TA787 | NICE TA787 | Accepted | 27/02/2023 |
| Alpelisib (Piqray®) | In Northern Ireland, alpelisib (Piqray®) with fulvestrant is accepted for use as an option for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated, locally advanced or metastatic breast cancer in adults, only if: • their cancer has progressed after a CDK4/6 inhibitor plus an aromatase inhibitor and • the company provides alpelisib according to the commercial arrangement The recommendations contained within this guidance represent off-label use of a medicine in Northern Ireland, and as such clinicians prescribing this treatment should ensure that they abide by extant HSC Trust governance procedures in relation to the prescribing of off-label medicines For further information see NICE TA816 | NICE TA816 | Accepted | 27/02/2023 |
| Teriflunomide - 7mg tablet formulation (Aubagio®) | In Northern Ireland, teriflunomide (Aubagio®) is accepted for use as an option for the treatment of paediatric patients aged 10 years and older with relapsing-remitting multiple sclerosis. Teriflunomide use is restricted to the treatment of active relapsing–remitting multiple sclerosis (normally defined as 2 clinically significant relapses in the previous 2 years) in paediatric patients aged 10 years and older, who do not have highly active or rapidly evolving severe relapsing–remitting multiple sclerosis. This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS price. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see AWMSG | AWMSG 1022 | Accepted | 27/02/2023 |
| Everolimus (Votubia®) | In Northern Ireland, everolimus (Votubia®) is accepted for use for the treatment of patients with subependymal giant cell astrocytoma associated with tuberous sclerosis complex who require therapeutic intervention but are not amenable to surgery This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent to or lower than the PAS price. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see AWMSG | AWMSG 2322 | Accepted | 27/02/2023 |
| Everolimus (Votubia®) | In Northern Ireland, everolimus (Votubia®) is accepted for use for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery. This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent to or lower than the PAS price. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see AWMSG | AWMSG 2322 | Accepted | 27/02/2023 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) with fluoropyrimidine-based and platinum-based combination chemotherapy is accepted for use as an option for untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma in adults whose tumours express PD-L1 at a level of 1% or more. It is accepted for use only if: • pembrolizumab plus chemotherapy is not suitable • the company provides nivolumab according to the commercial arrangement For further information see NICE TA865 | NICE TA865 | Accepted | 27/02/2023 |
| Regorafenib (Stivarga®) | In Northern Ireland, regorafenib (Stivarga®) is accepted for use within its marketing authorisation, as an option for metastatic colorectal cancer in adults who have had previous treatment (including fluoropyrimidine-based chemotherapy, anti-VEGF therapy and anti-EGFR therapy) or when these treatments are unsuitable. Regorafenib is only recommended if the company provides it according to the commercial arrangement. For further information see NICE TA866 | NICE TA866 | Accepted | 27/02/2023 |
| Trastuzumab deruxtecan (Enhertu®) | In Northern Ireland, trastuzumab deruxtecan (Enhertu®) is accepted for use with managed access as an option for treating HER2-positive unresectable or metastatic breast cancer after 1 or more anti-HER2 treatments in adults. It is accepted for use only if the conditions in the managed access agreement for trastuzumab deruxtecan are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA862 | NICE TA862 | Accepted | 27/02/2023 |
| Maribavir (Livtencity®) | In Northern Ireland, maribavir (Livtencity®) is accepted for use within its marketing authorisation, as an option for treating cytomegalovirus (CMV) infection that is refractory to treatment including cidofovir, foscarnet, ganciclovir or valganciclovir in adults who have had a haematopoietic stem cell transplant or solid organ transplant. It is recommended only if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA860 | NICE TA860 | Accepted | 27/02/2023 |
| Nintedanib (Ofev®) | In Northern Ireland, nintedanib (Ofev®) is accepted as an option for treating idiopathic pulmonary fibrosis in adults, only if: - they have a forced vital capacity of above 80% predicted - the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA864. | NICE TA864 | Accepted | 27/02/2023 |
| Esketamine nasal spray (Spravato®) | In Northern Ireland, esketamine nasal spray (Spravato®) is not accepted for use, with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI), within its marketing authorisation, for treatment-resistant depression that has not responded to at least 2 different antidepressants in the current moderate to severe depressive episode in adults People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For furthern information see NICE TA854 | NICE TA854 | Not Accepted | 27/02/2023 |
| Upadacitinib (Rinvoq®) | In Northern Ireland, upadacitinib is accepted for use as an option for treating active non-radiographic axial spondyloarthritis with objective signs of inflammation (shown by elevated C-reactive protein or MRI) that is not controlled well enough with non-steroidal anti-inflammatory drugs (NSAIDs) in adults. It is accepted for use only if: - tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough and - the company provides upadacitinib according to the commercial arrangement. Assess response to upadacitinib after 16 weeks of treatment. Continue treatment only if there is clear evidence of response, defined as a reduction in: - the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to 50% of the pre-treatment value or by 2 or more units and - the spinal pain visual analogue scale (VAS) by 2 cm or more. For further information see NICE TA861 | NICE TA861 | Accepted | 27/02/2023 |
| Lenvatinib (Kisplyx®) | In Northern Ireland, lenvatinib (Kisplyx®) is accepted for use with pembrolizumab as an option for untreated advanced renal cell carcinoma in adults, only if: • their disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria and • nivolumab with ipilimumab would otherwise be offered and • the companies provide lenvatinib and pembrolizumab according to the commercial arrangements. For further information see NICE TA858 | NICE TA858 | Accepted | 24/02/2023 |
| Upadacitinib (Rinvoq®) | In Northern Ireland, upadacitinib (Rinvoq®) is accepted to use, within its marketing authorisation, as an option for treating moderately to severely active ulcerative colitis in adults: • when conventional or biological treatment cannot be tolerated, or • if the condition has not responded well enough or has stopped responding to these treatments, and • if the company provides upadacitinib according to the commercial arrangement For further information see NICE TA856 | NICE TA856 | Accepted | 24/02/2023 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) with platinum- and fluoropyrimidine-based chemotherapy is accepted for use, within its marketing authorisation, as an option for untreated HER2‑negative, advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma in adults whose tumours express PD‑L1 with a combined positive score (CPS) of 5 or more. Nivolumab is only recommended if the company provides it according to the commercial arrangement. For further information see NICE TA857 | NICE TA857 | Accepted | 24/02/2023 |
| Avatrombopag tablets (Doptelet®) | In Northern Ireland, avatrombopag (Doptelet®) is accepted for use, within its marketing authorisation, as an option for treating primary chronic immune thrombocytopenia (ITP) refractory to other treatments (for example, corticosteroids, immunoglobulins) in adults. It is only recommended if the company provides it according to the commercial arrangement. For further information see NICE TA853 | NICE TA853 | Accepted | 24/02/2023 |
| Trifluridine + tipiracil (Lonsurf®) | In Northern Ireland, trifluridine-tipiracil (Lonsurf®) is accepted for use, within its marketing authorisation, as an option for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in adults who have had 2 or more treatment regimens. It is only recommended if the company provides trifluridine–tipiracil according to the commercial arrangement. For further information see NICE TA852 | NICE TA852 | Accepted | 24/02/2023 |
| Amivantamab (Rybrevant®) | In Northern Ireland, amivantamab (Rybrevant®) is not accepted for use, within its marketing authorisation, for treating locally advanced or metastatic non-small-cell lung cancer (NSCLC) after platinum-based chemotherapy in adults whose tumours have epidermal growth factor receptor (EGFR) exon 20 insertion mutations. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA850 | NICE TA850 | Not Accepted | 24/02/2023 |
| Cabozantinib (Cabometyx®) | In Northern Ireland, cabozantinib (Cabometyx®) is accepted for use as an option for treating advanced hepatocellular carcinoma (HCC) in adults who have had sorafenib, only if: • they have Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and • the company provides it according to the commercial arrangement For further information see NICE TA849 | NICE TA849 | Accepted | 24/02/2023 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is accepted for use, within its marketing authorisation, as an option with chemotherapy for neoadjuvant treatment and alone as adjuvant treatment after surgery for adults with triple-negative: • early breast cancer at high risk of recurrence or • locally advanced breast cancer It is recommended only if the company provides pembrolizumab according to the commercial arrangement. For further information see NICE TA851 | NICE TA851 | Accepted | 24/02/2023 |
| Angiotensin II (Giapreza®) | In Northern Ireland, angiotensin II (Giapreza®) is not accepted for use for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. For further information see AWMSG | AWMSG 3500 | Not Accepted | 24/02/2023 |
| Ferric maltol (Feraccru®) | In Northern Ireland, ferric maltol (Feraccru®) is not accepted for use in adults for the treatment of iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD). People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2500 | SMC2500 | Not Accepted | 24/02/2023 |
| Estetrol + drospirenone (Drovelis®) | In Northern Ireland, estetrol + drospirenone (Drovelis®) is not accepted for use as oral contraception. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2564 | SMC2564 | Not Accepted | 24/02/2023 |
| Bedaquiline (Sirturo®) | In Northern Ireland, bedaquiline (Sirturo®) is accepted as an option as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adults and paediatric patients (5 years to less than 18 years of age and weighing at least 15kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see AWMSG2222 | AWMSG2222 | Accepted | 23/02/2023 |
| Micronised progesterone (Utrogestan®) | In Northern Ireland, micronised progesterone (Utrogestan®) is accepted for adjunctive use with oestrogen in post-menopausal women with an intact uterus, as hormone replacement therapy (HRT). Micronised progesterone provides an additional treatment choice in the therapeutic class of progestogens. For further information see SMC2529 | SMC2529 | Accepted | 22/02/2023 |
| Somatrogon (long-acting formulation of somatotropin) (Ngenla®) | In Northern Ireland, somatrogon (Ngenla®) is accepted for use within its marketing authorisation, as an option for treating growth disturbance caused by growth hormone deficiency in children and young people aged 3 years and over. If people with the condition and their clinicians consider somatrogon to be 1 of a range of suitable treatments (including any preparation of somatropin) discuss the advantages and disadvantages of the available treatments. After that discussion, if more than 1 treatment is suitable, choose the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements. For further information see NICE TA863 | NICE TA863 | Accepted | 15/02/2023 |
| Atezolizumab (Tecentriq®) | In Northern Ireland, atezolizumab (Tecentriq®) is accepted for use as an option for adjuvant treatment after complete tumour resection in adults with stage 2 to 3a non-small-cell lung cancer (NSCLC) whose: - tumours have the programmed cell death ligand-1 (PD-L1) biomarker expression on 50% or more of their tumour cells and - whose disease has not progressed after platinum-based adjuvant chemotherapy. It is recommended only if the company provides atezolizumab according to the managed access agreement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA823 | NICE TA823 | Accepted | 8/12/2022 |
| Faricimab (Vabysmo®) | In Northern Ireland, faricimab (Vabysmo®) is accepted for use as an option for treating wet age-related macular degeneration in adults, only if: - the eye has a best-corrected visual acuity between 6/12 and 6/96 - there is no permanent structural damage to the central fovea - the lesion size is 12-disc areas or less in greatest linear dimension - there are signs of recent disease progression (for example, blood vessel growth as shown by fluorescein angiography, or recent visual acuity changes) - the company provides faricimab according to the commercial arrangement. If patients and their clinicians consider faricimab to be one of a range of suitable treatments (including aflibercept and ranibizumab), choose the least expensive treatment. Take account of administration costs, dosage, price per dose and commercial arrangements. Only continue faricimab if an adequate response to treatment is maintained. Criteria for stopping should include persistent deterioration in visual acuity and anatomical changes in the retina. For further information see NICE TA800 | NICE TA800 | Accepted | 8/12/2022 |
| Faricimab (Vabysmo®) | In Northern Ireland, faricimab (Vabysmo®) is accepted for use as an option for treating visual impairment due to diabetic macular oedema in adults, only if: - the eye has a central retinal thickness of 400 micrometres or more at the start of treatment - the company provides faricimab according to the commercial arrangement. If patients and their clinicians consider faricimab to be one of a range of suitable treatments (including aflibercept and ranibizumab), choose the least expensive treatment. Take account of administration costs, dosage, price per dose and commercial arrangements. For further information see NICE TA799 | NICE TA799 | Accepted | 8/12/2022 |
| Palbociclib (Ibrance®) | In Northern Ireland, palbociclib (Ibrance®) is accepted for use as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults who have had endocrine therapy only if: - exemestane plus everolimus is the most appropriate alternative to a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor and - the company provides it according to the commercial arrangement. For further information see NICE TA836 | NICE TA836 | Accepted | 8/12/2022 |
| Fostamatinib disodium (Tavlesse®) | In Northern Ireland, fostamatinib disodium (Tavlesse®) is accepted for use as an option for treating refractory chronic immune thrombocytopenia in adults, only if: • they have previously had a thrombopoietin receptor agonist (TPO-RA), or a TPO-RA is unsuitable • the company provides fostamatinib according to the commercial arrangement For further information see NICE TA835 | NICE TA835 | Accepted | 8/12/2022 |
| Esketamine (Spravato®) | In Northern Ireland, esketamine (Spravato®) is not accepted for use when co-administered with oral antidepressant therapy, in adults with a moderate to severe episode of Major Depressive Disorder, as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2539 | SMC2539 | Not Accepted | 8/12/2022 |
| Dexamethasone + levofloxacin (Ducressa®) eye drops | In Northern Ireland, Dexamethasone + levofloxacin (Ducressa®) eye drops solution is accepted for use for prevention and treatment of inflammation, and prevention of infection associated with cataract surgery in adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents. For further information see SMC2511 | SMC2511 | Accepted | 8/12/2022 |
| Dupilumab (Dupixent®) | In Northern Ireland, dupilumab (Dupixent®) is accepted for use as an option for restricted use. Dupilumab is licensed in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Dupilumab is restricted to use in a subpopulation of the licensed indication in line with the NICE recommendation for the use of dupilumab for treating severe asthma with type 2 inflammation that is inadequately controlled in people 12 years and over (TA751). Dupilumab is not accepted for use within NI outside of this subpopulation. This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS price. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see AWMSG 1522 | AWMSG1522 | Accepted | 14/11/2022 |
| Cannabinoid (Sativex®) | In Northern Ireland, cannabinoid oromucosal spray (Sativex®) is accepted for use as a treatment option for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. The following restrictions apply: 1. Sativex® can only be prescribed within its marketing authorisation. This is, as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy 2. Sativex® is to be initiated and supervised by a physician with specialist expertise in treating spasticity due to MS, in line with its marketing authorisation 3. Sativex® is to be prescribed following peer review via the process agreed with SPPG commissioners 4. A 4-week trial of Sativex® to treat moderate to severe spasticity in adults with MS can be considered, if: - other pharmacological treatments for spasticity are not effective (see the recommendations on spasticity in NICE's guideline on multiple sclerosis in adults) - the company provides Sativex® according to its pay-for-responders scheme (it funds the first 3 x10ml vials if there is agreement for continued funding for people with at least a 20% reduction in spasticity-related symptoms on a 0 to 10 patient-reported numeric rating scale after 4 weeks). See NICE NG144 https://www.nice.org.uk/guidance/ng144 5. After the 4-week trial, Sativex® can only be continued if the person has had at least a 20% reduction in spasticity-related symptoms on a 0 to 10 patient-reported numeric rating scale. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see SMC2473 | SMC2473 | Accepted | 14/11/2022 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is accepted for use within its marketing authorisation, as an option for the adjuvant treatment of completely resected stage 2B or 2C melanoma in people 12 years and over. It is recommended only if the company provides pembrolizumab according to the commercial arrangement. For further information see NICE TA837 | NICE TA837 | Accepted | 14/11/2022 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is accepted for use, within its marketing authorisation, as an option for the adjuvant treatment of renal cell carcinoma at increased risk of recurrence after nephrectomy, with or without metastatic lesion resection, in adults. It is recommended only if the company provides it according to the commercial arrangement. For further information see NICE TA830 | NICE TA830 | Accepted | 14/11/2022 |
| Zanubrutinib (Brukinsa®) | In Northern Ireland, zanubrutinib (Brukinsa®) is accepted for use as an option for treating Waldenström’s macroglobulinaemia in adults who have had at least 1 treatment, only if: • bendamustine plus rituximab is also suitable and • the company provides it according to the commercial arrangement For further information see NICE TA833 | NICE TA833 | Accepted | 14/11/2022 |
| Tafasitamab (Minjuvi®) | In Northern Ireland, tafasitamab (Minjuvi®) with lenalidomide is not accepted for use, within its marketing authorisation, for treating relapsed or refractory diffuse large B-cell lymphoma in adults who cannot have an autologous stem cell transplant. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE FAD ID3795 | NICE FAD ID3795 | Not Accepted | 14/11/2022 |
| Ozanimod (Zeposia®) | In Northern Ireland, ozanimod (Zeposia®) is accepted for use as an option for treating moderately to severely active ulcerative colitis in adults, only if: • conventional treatment cannot be tolerated or is not working well enough and infliximab is not suitable, or • biological treatment cannot be tolerated or is not working well enough, and • the company provides it according to the commercial arrangement For further information see NICE TA828 | NICE TA828 | Accepted | 14/11/2022 |
| Azacitadine (Onureg®) | In Northern Ireland, oral azacitidine (Onureg®) is accepted for use within its marketing authorisation, as an option for maintenance treatment for acute myeloid leukaemia (AML) in adults who: • are in complete remission, or complete remission with incomplete blood count recovery, after induction therapy with or without consolidation treatment, and • cannot have or do not want a haematopoietic stem cell transplant. It is recommended only if the company provides oral azacitidine according to the commercial arrangement. For further information see NICE TA827 | NICE TA827 | Accepted | 14/11/2022 |
| Potassium bicarbonate + potassium citrate (Sibnayal®) | In Northern Ireland, potassium citrate + potassium hydrogen carbonate (Sibnayal®) is accepted for use for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older. This advice applies only in the context of an approved Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Until such times as a Primary Care Price Parity Scheme (Primary Care PAS) is agreed, prescribing and dispensing of this medicine should remain in Secondary Care in Northern Ireland. For further information see SMC2409 | SMC2409 | Accepted | 14/11/2022 |
| Relugolix + estradiol + norethisterone (Ryeqo®) | In Northern Ireland, relugolix-estradiol-norethisterone (Ryeqo®) is accepted for use, within its marketing authorisation, as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age. For further information see NICE TA832 | NICE TA832 | Accepted | 14/11/2022 |
| Avacopan (Tavneos®) | In Northern Ireland, avacopan (Tavneos®) is accepted for use, with a cyclophosphamide or rituximab regimen, within its marketing authorisation, as an option for treating severe active granulomatosis with polyangiitis or microscopic polyangiitis in adults. It is recommended only if the company provides it according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA825 | NICE TA825 | Accepted | 12/10/2022 |
| Upadacitinib (Rinvoq®) | In Northern Ireland, upadacitinib is accepted for use as an option for treating active ankylosing spondylitis that is not controlled well enough with conventional therapy in adults, only if: • tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough, and • the company provides upadacitinib according to the commercial arrangement Assess response to upadacitinib after 16 weeks of treatment. Continue treatment only if there is clear evidence of response, defined as: • a reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to 50% of the pre-treatment value or by 2 or more units and • a reduction in the spinal pain visual analogue scale (VAS) by 2 cm or more. For further information see NICE TA829 | NICE TA829 | Accepted | 12/10/2022 |
| Dexamethasone intravitreal implant (Ozurdex®) | In Northern Ireland, dexamethasone intravitreal implant (Ozurdex®) is accepted for use as an option for treating diabetic macular oedema in adults only if their condition has not responded well enough to, or who cannot have non-corticosteroid therapy. For further information see NICE824 | NICE TA824 | Accepted | 12/10/2022 |
| Abrocitinib (Cibinqo®) | In Northern Ireland, abrocitinib (Cibinqo®) is accepted for use as an option for treating moderate to severe atopic dermatitis that is suitable for systemic treatment in adults and young people 12 years and over, only if: - the disease has not responded to at least 1 systemic immunosuppressant, or these are not suitable. - the company provides abrocitinib according to the commercial arrangement Stop abrocitinib at 16 weeks if the atopic dermatitis has not responded adequately. An adequate response is: - at least a 50% reduction in the Eczema Area and Severity Index score (EASI 50) from when treatment started and - at least a 4‐point reduction in the Dermatology Life Quality Index (DLQI) from when treatment started. For further information see NICE TA814 | NICE TA814 | Accepted | 12/10/2022 |
| Asciminib (Scemblix®) | In Northern Ireland, asciminib (Scemblix®) is accepted for use, within its marketing authorisation*, as an option for treating chronic-phase Philadelphia chromosome-positive chronic myeloid leukaemia without a T315I mutation after 2 or more tyrosine kinase inhibitors in adults. It is recommended only if the company provides asciminib according to the commercial arrangement. * The licenced indication in Northern Ireland is broader compared to the Marketing Authorisation granted in Great Britain. In Northern Ireland asciminib (Scemblix) is indicated for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (Ph+ CML CP) previously treated with two or more tyrosine kinase inhibitors. The NICE recommended indication for asciminib (Scemblix) is included within the licenced indication in Northern Ireland. For further information see NICE813 | NICE TA813 | Accepted | 12/10/2022 |
| Opicapone (Ongentys®) | In Northern Ireland, opicapone (Ongentys®) is accepted for use as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations. Opicapone provides an additional treatment choice in the therapeutic class of catechol-O-methyl transferase inhibitors. This advice applies only in the context of an approved Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. A price parity scheme (primary care patient access scheme) for opicapone is currently in place in Northern Ireland. This allows opicapone to be prescribed in Primary Care in NI. For further information see SMC2430 | SMC2430 | Accepted | 12/10/2022 |
| Trifarotene (Aklief®) | In Northern Ireland, trifarotene (Aklief®) is accepted for use for the cutaneous treatment of acne vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present. Trifarotene provides an additional treatment choice in the therapeutic class of topical retinoids. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see SMC2441 | SMC2441 | Accepted | 12/10/2022 |
| Estradiol / micronised progesterone (Bijuve®) | In Northern Ireland, Bijuve® (1mg estradiol (as estradiol hemihydrate) and 100mg progesterone) is accepted for use as continuous combined hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women with intact uterus and with at least 12 months since last menses. The experience in treating women older than 65 years is limited. Estradiol / micronised progesterone (Bijuve®) offers an additional treatment choice of continuous combined hormone replacement therapy. For further information see SMC2502 | SMC2502 | Accepted | 12/10/2022 |
| Mepolizumab (Nucala®) | In Northern Ireland, mepolizumab (Nucala®) is not accepted for use as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2491 | SMC2491 | Not Accepted | 12/9/2022 |
| Grazoprevir + elbasvir (Zepatier®) | In Northern Ireland, grazoprevir + elbasvir (Zepatier®) is accepted for use for the treatment of genotype 1 or 4 chronic hepatitis C in paediatric patients 12 years of age and older who weigh at least 30 kg. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see AWMSG 1222 | AWMSG1222 | Accepted | 12/9/2022 |
| Enfortumab vedotin (Padcev®) | In Northern Ireland, enfortumab vedotin (Padcev®) is not accepted for use as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2505 | SMC2505 | Not Accepted | 12/9/2022 |
| Vedolizumab (Entyvio®) | In Northern Ireland, vedolizumab (Entyvio®) is not accepted for use for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy. People currently receiving this drug for this indication should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2506 | SMC2506 | Not Accepted | 12/9/2022 |
| Brolucizumab (Beovu®) | In Northern Ireland, brolucizumab (Beovu®) is accepted for use as an option for treating visual impairment due to diabetic macular oedema in adults, only if: • the eye has a central retinal thickness of 400 micrometres or more at the start of treatment • the company provides brolucizumab according to the commercial arrangement For further information see NICE TA820 | NICE TA820 | Accepted | 12/9/2022 |
| Avalglucosidase alfa (Nexviadyme®) | In Northern Ireland, avalglucosidase alfa (Nexviadyme®) is accepted for use within its marketing authorisation, as an option for treating Pompe disease in babies, children, young people and adults, only if the company provides avalglucosidase alfa according to the commercial arrangement. For further information see NICE TA821 | NICE TA821 | Accepted | 12/9/2022 |
| Sacituzumab govitecan (Trodelvy®) | In Northern Ireland, sacituzumab govitecan (Trodelvy®) is accepted for use within its marketing authorisation*, as an option for treating unresectable triple-negative locally advanced or metastatic breast cancer in adults after 2 or more systemic therapies, at least one of which was for advanced disease. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis *The licenced indication in Northern Ireland is broader compared to the Marketing Authorisation granted in Great Britain. In Northern Ireland sacituzumab govitecan (Trodelvy) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease. The NICE recommendation for sacituzumab govitecan (Trodelvy) is included within the licenced indication in Northern Ireland. For further information see NICE TA819 | NICE TA819 | Accepted | 12/9/2022 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) is accepted for use, with ipilimumab, as an option for untreated unresectable malignant pleural mesothelioma in adults, only if: • they have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 • the company provides it according to the commercial arrangement For further information see NICE TA818 | NICE TA818 | Accepted | 12/9/2022 |
| Setmelanotide (Imcivree®) | In Northern Ireland, setmelanotide (Imcivree®) is accepted for use, within its marketing authorisation, as an option for treating obesity and controlling hunger caused by pro-opiomelanocortin (POMC) deficiency, including proprotein convertase subtilisin/kexin type 1 or leptin receptor (LEPR) deficiency in people 6 years and over. It is only recommended if the company provides setmelanotide according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST21 | NICE HST21 | Accepted | 12/9/2022 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) is accepted for use as an option for the adjuvant treatment of muscle-invasive urothelial cancer that is at high risk of recurrence after radical resection in adults whose tumours express PD-L1 at a level of 1% or more. It is recommended only if: • adjuvant treatment with platinum-based chemotherapy is unsuitable, and • the company provides nivolumab according to the commercial arrangement For further information see NICE TA817 | NICE TA817 | Accepted | 12/9/2022 |
| Guselkumab (Tremfya®) | In Northern Ireland, guselkumab (Tremfya®) is accepted for use, alone or with methotrexate, as an option for treating active psoriatic arthritis in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is accepted for use only if they have had 2 conventional DMARDs and: • have had at least 1 biological DMARD, or • tumour necrosis factor (TNF)-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE TA199) Guselkumab is recommended only if the company provides it according to the commercial arrangement. Active psoriatic arthritis is defined as peripheral arthritis with 3 or more tender joints and 3 or more swollen joints. Assess the response to guselkumab from 16 weeks. Stop guselkumab at 24 weeks if the psoriatic arthritis has not responded adequately using the Psoriatic Arthritis Response Criteria (PsARC; an adequate response is an improvement in at least 2 of the 4 criteria, 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria). If the PsARC response is not adequate but there is a Psoriasis Area and Severity Index (PASI) 75 response, a dermatologist should decide whether continuing treatment is appropriate based on skin response. For further information see NICE TA815 | NICE TA815 | Accepted | 12/9/2022 |
| Inclisiran (Leqvio®) | In Northern Ireland, inclisiran (Leqvio®) is accepted for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: • in combination with a statin or statin with other lipid lowering therapies in patients who are unable to reach LDL-C goals with the maximum tolerated dose of a statin, or • alone or in combination with other lipid lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated. Prescribing of inclisiran is RESTRICTED TO SPECIALIST USE and only in patients at high cardiovascular risk as follows: • patients with heterozygous familial hypercholesterolaemia (HeFH) and LDL-C ≥5.0mmol/L, for primary prevention of cardiovascular events or, • patients with HeFH and LDL-C≥3.5mmol/L, for secondary prevention of cardiovascular events or, • patients with high risk due to previous cardiovascular events and LDL-C≥4.0mmol/L or, • patients with recurrent/polyvascular disease and LDL-C≥3.5mmol/L. This advice applies only in the context of an approved Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. For further information see SMC2358 | SMC2358 | Accepted | 12/9/2022 |
| Remimazolam (Byfavo®) | In Northern Ireland, remimazolam (Byfavo®) is not accepted for use in adults for procedural sedation. For further information see SMC2454 | SMC2454 | Not Accepted | 12/9/2022 |
| Beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium (Trimbow® pMDI 172 micrograms/5 micrograms/9 micrograms) | In Northern Ireland, Trimbow® pMDI (beclometasone dipropionate 172micrograms/ formoterol fumarate dihydrate 5micrograms/ glycopyrronium 9 micrograms) is accepted for use in the maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see SMC2334 | SMC2334 | Accepted | 12/9/2022 |
| Tepotinib (Tepmetko®) | In Northern Ireland, tepotinib (Tepmetko®) is accepted for use, within its marketing authorisation*, as an option for treating advanced non-small-cell lung cancer (NSCLC) with METex14 skipping alterations in adults, only if the company provides tepotinib according to the commercial arrangement. * Please note: the licenced indication in Northern Ireland is at a different line of treatment compared to the Marketing Authorisation granted in Great Britain. In Northern Ireland tepotinib is indicated as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to METex14 skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. For further information see NICE TA789 | NICE TA789 | Accepted | 10/8/2022 |
| Pralsetinib (Gavreto®) | In Northern Ireland, pralsetinib (Gavreto®) is not accepted for use, within its marketing authorisation, as an option for treating RET fusion-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had a RET inhibitor before. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA812 | NICE TA812 | Not Accepted | 4/8/2022 |
| Ruxolitinib (Jakavi®) | In Northern Ireland, ruxolitinib (Jakavi®) is not accepted for use for the treatment of: - patients aged 12 years and older with acute graft versus host disease who have inadequate response to corticosteroids - patients aged 12 years and older with chronic graft versus host disease who have inadequate response to corticosteroids People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2498 | SMC2498 | Not Accepted | 4/8/2022 |
| Cemiplimab (Libtayo®) | In Northern Ireland, cemiplimab (Libtayo®) is accepted for use as an option for treating metastatic or locally advanced cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not suitable, only if: - it is stopped at 24 months, or earlier if their disease progresses, and - the company provides cemiplimab according to the commercial arrangement. For further information see NICE TA802 | NICE TA802 | Accepted | 4/8/2022 |
| Upadacitinib (Rinvoq®) | In Northern Ireland, upadacitinib (Rinvoq®) is accepted for use as an option for treating moderate to severe atopic dermatitis that is suitable for systemic treatment in adults and young people 12 years and over, only if: - the disease has not responded to at least 1 systemic immunosuppressant, or these are not suitable. - the company provides upadacitinib according to the commercial arrangement Stop upadacitinib at 16 weeks if the atopic dermatitis has not responded adequately. An adequate response is: - at least a 50% reduction in the Eczema Area and Severity Index score (EASI 50) from when treatment started and - at least a 4‐point reduction in the Dermatology Life Quality Index (DLQI) from when treatment started. For further information see NICE TA814 | NICE TA814 | Accepted | 4/8/2022 |
| Tralokinumab (Adtralza®) | In Northern Ireland, tralokinumab (Adtralza®) is accepted for use as an option, for treating moderate to severe atopic dermatitis that is suitable for systemic treatment in adults, only if: - the disease has not responded to at least 1 systemic immunosuppressant, or these are not suitable. - the company provides tralokinumab according to the commercial arrangement. Stop tralokinumab at 16 weeks if the atopic dermatitis has not responded adequately. An adequate response is: - at least a 50% reduction in the Eczema Area and Severity Index score (EASI 50) from when treatment started and - at least a 4‐point reduction in the Dermatology Life Quality Index (DLQI) from when treatment started. For further information see NICE TA814 | NICE TA814 | Accepted | 4/8/2022 |
| Durvalumab (Imfinzi®) | In Northern Ireland, durvalumab (Imfinzi®) is accepted for use as an option for treating locally advanced unresectable non-small-cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed after platinum-based chemoradiation only if: - they have had concurrent platinum-based chemoradiation - the company provides durvalumab according to the commercial arrangement For further information see NICE TA798 | NICE TA798 | Accepted | 4/8/2022 |
| Abemaciclib (Verzenios®) | In Northern Ireland, abemaciclib (Verzenios®) is accepted for use, with endocrine therapy, within its marketing authorisation, as an option for adjuvant treatment of hormone receptor positive, HER2-negative, node-positive early breast cancer in adults whose disease is at high risk of recurrence, defined as pathological tumour involvement in: • at least 4 positive axillary lymph nodes, or • 1 to 3 positive axillary lymph nodes, and at least one of the following criteria: - grade 3 disease (defined as at least 8 points on the modified Bloom-Richardson grading system or equivalent), or - primary tumour size of at least 5 cm. It is recommended only if the company provides it according to the commercial arrangement For further information see NICE TA810 | NICE TA810 | Accepted | 4/8/2022 |
| Roxadustat (Evrenzo®) | In Northern Ireland, roxadustat (Evrenzo®) is accepted for use as an option for treating symptomatic anaemia associated with chronic kidney disease (CKD) in adults only if: - they have stage 3 to 5 CKD with no iron deficiency and - they are not on dialysis at the start of treatment and - the company provides roxadustat according to the commercial arrangement For further information see NICE TA807 | NICE TA807 | Accepted | 4/8/2022 |
| Imlifidase (Idefirix®) | In Northern Ireland, imlifidase (Idefirix®) is accepted for use as a desensitisation treatment option for adults who: - are waiting for a kidney transplant from a deceased donor - are highly sensitised to human leukocyte antigens (HLA) - have a positive crossmatch with the donor and are unlikely to have a transplant under the available kidney allocation system (including prioritisation programmes for highly sensitised people). It is accepted for use only if: - a maximum of 1 dose is given - it is given in a specialist centre with experience of treating high sensitisation to HLA - the company provides imlifidase according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA809 | NICE TA809 | Accepted | 4/8/2022 |
| Risankizumab (Skyrizi®) | In Northern Ireland, risankizumab (Skyrizi®), alone or in combination with methotrexate, is accepted for use as an option for treating active psoriatic arthritis in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is recommended only if they have: - peripheral arthritis with 3 or more tender joints and 3 or more swollen joints - moderate to severe psoriasis (a body surface area of at least 3% affected by plaque psoriasis and a Psoriasis Area and Severity Index [PASI] score greater than 10) - had 2 conventional DMARDs and at least 1 biological DMARD. Risankizumab is accepted for use only if the company provides it according to the commercial arrangement For further information see NICE TA803 | NICE TA803 | Accepted | 4/8/2022 |
| Venetoclax (Venclyxto®) | In Northern Ireland, venetoclax (Venclyxto®) is accepted for use within its marketing authorisation, for treating chronic lymphocytic leukaemia (CLL) in adults: - with a 17p deletion or TP53 mutation and when a B‑cell receptor pathway inhibitor is unsuitable, or whose disease has progressed after a B‑cell receptor pathway inhibitor or - without a 17p deletion or TP53 mutation, and whose disease has progressed after both chemo‑immunotherapy and a B‑cell receptor pathway inhibitor. It is recommended only if the company provides venetoclax according to the commercial arrangement. For further information see NICE TA796 | NICE TA796 | Accepted | 4/8/2022 |
| Ibrutinib (Imbruvica®) | In Northern Ireland, ibrutinib (Imbruvica®) is not accepted for use, within its marketing authorisation, for treating Waldenström’s macroglobulinaemia in adults who have had at least 1 previous therapy. This recommendation is not intended to affect treatment with ibrutinib that was funded in line with NICE TA491 before NICETA795 was published. If this applies, when that funding ends ibrutinib will be funded by the company until the patient and their NHS clinician consider it appropriate to stop. For further information see NICE TA795 | NICE TA795 | Not Accepted | 4/8/2022 |
| Diroximel fumarate (Vumerity®) | In Northern Ireland, diroximel fumarate (Vumerity®) is accepted for use as an option for treating active relapsing–remitting multiple sclerosis (normally defined as 2 clinically significant relapses in the previous 2 years) in adults, only if: - they do not have highly active or rapidly evolving severe relapsing–remitting multiple sclerosis and - the company provides diroximel fumarate according to the commercial arrangement For further information see NICE TA794 | NICE TA794 | Accepted | 4/8/2022 |
| Teduglutide (Revestive®) | In Northern Ireland, teduglutide (Revestive®) is accepted for use, within its marketing authorisation, as an option for treating short bowel syndrome (SBS) in people 1 year and above. People should be stable following a period of intestinal adaptation after surgery before having teduglutide. Teduglutide is recommended only if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA804 | NICE TA804 | Accepted | 4/8/2022 |
| Brivaracetam (Briviact®) | In Northern Ireland, brivaracetam (Briviact®) is accepted for use as an option for adjunctive therapy of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. Use should be restricted for use in the treatment of patients with refractory epilepsy, who remain uncontrolled with, or are intolerant to, other adjunctive anti-epileptic medicines, within its licensed indication. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see AWMSG1322 | AWMSG1322 | Accepted | 4/8/2022 |
| Delafloxacin (Quofenix®) | In Northern Ireland, delafloxacin (Quofenix®) is accepted for use in the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of this infection. Use of delafloxacin is restricted to patients with suspected or confirmed polymicrobial infection following treatment failure or when standard antibacterial therapies are not suitable. Delafloxacin should be used on the advice of local microbiologists or specialists in infectious disease. ** This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. ** For further information see SMC2453 | SMC2453 | Accepted | 4/8/2022 |
| Mepolizumab (Nucala®) | In Northern Ireland, mepolizumab (Nucala®) is not accepted for use as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA). People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2490 | SMC2490 | Not Accepted | 20/7/2022 |
| Mepolizumab (Nucala®) | In Northern Ireland, mepolizumab (Nucala®) is not accepted for use as add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2488 | SMC2488 | Not Accepted | 20/7/2022 |
| Cemiplimab (Libtayo®) | In Northern Ireland, cemiplimab (Libtayo®) is not accepted for use as monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: - locally advanced NSCLC who are not candidates for definitive chemoradiation, or - metastatic NSCLC People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2489 | SMC2489 | Not Accepted | 20/7/2022 |
| Daratumumab (Daralex®) | In Northern Ireland, daratumumab (Daralex®) is not accepted for use in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. People currently receiving this drug for this indication should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2416 | SMC2416 | Not Accepted | 20/7/2022 |
| Fenfluramine (Fintepla®) | In Northern Ireland, fenfluramine (Fintepla®) is accepted for use as an add-on to other antiepileptic medicines for treating seizures associated with Dravet syndrome in people aged 2 years and older, only if: • it is an add-on to 2 other antiepileptic medicines • the frequency of convulsive seizures is checked every 6 months, and fenfluramine is stopped if it has not fallen by at least 30% compared with the 6 months before starting treatment • the company provides fenfluramine according to the commercial arrangement For further information see NICE TA808 | NICE TA808 | Accepted | 20/7/2022 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is accepted for use with chemotherapy (paclitaxel or nab-paclitaxel) as an option for treating triple-negative, locally recurrent unresectable or metastatic breast cancer in adults who have not had chemotherapy for metastatic disease. It is recommended only if: - the tumours express PD-L1 with a combined positive score (CPS) of 10 or more and an immune cell staining (IC) of less than 1%, and - the company provides pembrolizumab according to the commercial arrangement For further information see NICE TA801 | NICE TA801 | Accepted | 20/7/2022 |
| Selumetinib (Koselugo®) | In Northern Ireland, selumetinib (Koselugo®) is accepted for use, within its marketing authorisation, for treating symptomatic and inoperable plexiform neurofibromas (PN) associated with type 1 neurofibromatosis (NF1) in children aged 3 and over, only if the company provides selumetinib according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST20 | NICE HST20 | Accepted | 20/7/2022 |
| Icosapent ethyl (Vazkepa®) | In Northern Ireland, icosapent ethyl (Vazkepa®) is accepted for use as an option for reducing the risk of cardiovascular events in adults. It is recommended if they have a high risk of cardiovascular events and raised fasting triglycerides (1.7 mmol/litre or above) and are taking statins, but only if they have: • established cardiovascular disease (secondary prevention), defined as a history of any of the following: − acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation) − coronary or other arterial revascularisation procedures − coronary heart disease − ischaemic stroke − peripheral arterial disease, and • low-density lipoprotein cholesterol (LDL-C) levels above 1.04mmol/litre and below or equal to 2.60mmol/litre. ** This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. ** For further information see NICE TA805 | NICE TA805 | Accepted | 20/7/2022 |
| Filgotinib (Jyseleca®) | In Northern Ireland filgotinib (Jyseleca®) is accepted for use within its marketing authorisation, as an option for treating moderately to severely active ulcerative colitis in adults: • when conventional or biological treatment cannot be tolerated, or • if the disease has not responded well enough or has stopped responding to these treatments, and • if the company provides filgotinib according to the commercial arrangement For further information see NICE TA792 | NICE TA792 | Accepted | 6/6/2022 |
| Carfilzomib (Kyprolis®) | In Northern Ireland, carfilzomib (Kyprolis®) is not accepted for use, in combination with daratumumab and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2484 | SMC2484 | Not Accepted | 6/6/2022 |
| Belimumab (Benlysta®) | In Northern Ireland, belimumab (Benlysta®) is not accepted for use, in combination with background immunosuppressive therapies, for the treatment of adult patients with active lupus nephritis. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2483 | SMC2483 | Not Accepted | 6/6/2022 |
| Ibrutinib (Imbruvica®) | In Northern Ireland, ibrutinib (Imbruvica®) is not accepted for use, in combination with rituximab, for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2485 | SMC2485 | Not Accepted | 6/6/2022 |
| Niraparib (Zejula®) | In Northern Ireland, niraparib (Zejula®) is accepted for use as an option for treating relapsed, platinum-sensitive high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to the most recent course of platinum-based chemotherapy in adults. It is recommended only if: - they have a BRCA mutation and have had 2 courses of platinum-based chemotherapy, or - they do not have a BRCA mutation and have had 2 or more courses of platinum-based chemotherapy, and - the company provides it according to the commercial arrangement. For further information see NICE TA784 | NICE TA784 | Accepted | 6/6/2022 |
| Elosulfase alfa (Vimizim®) | In Northern Ireland, elosulfase alfa (Vimizim®) is accepted for use within its marketing authorisation, as an option for treating mucopolysaccharidosis type 4A (MPS 4A) for people of all ages. It is only recommended if the company provides elosulfase alfa according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST19 | NICE HST19 | Accepted | 6/6/2022 |
| Daratumumab (Daralex®) | In Northern Ireland, daratumumab (Daralex®) monotherapy is accepted for use as an option for treating relapsed and refractory multiple myeloma in adults who have had a proteasome inhibitor and an immunomodulator, and whose disease progressed on the last treatment, only if: - they have daratumumab after 3 treatments and - the company provides daratumumab according to the commercial arrangement. For further information see NICE TA783 | NICE TA783 | Accepted | 6/6/2022 |
| Avelumab (Bavenico®) | In Northern Ireland, avelumab (Bavencio®) is accepted for use, as an option for maintenance treatment of locally advanced or metastatic urothelial cancer that has not progressed after platinum-based chemotherapy in adults, only if: • avelumab is stopped at 5 years of uninterrupted treatment or earlier if the disease progresses and • the company provides avelumab according to the commercial arrangement For further information see NICE TA788 | NICE TA788 | Accepted | 6/6/2022 |
| Romosozumab (Evenity®) | In Northern Ireland, romosozumab (Evenity®) is accepted for use as an option for treating severe osteoporosis in people after menopause who are at high risk of fracture, only if: • they have had a major osteoporotic fracture within 24 months (so are at imminent risk of another fracture) and • the company provides romosozumab according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA791 | NICE TA791 | Accepted | 6/6/2022 |
| Oritavancin (Tenkasi®) | In Northern Ireland, oritavancin (Tenkasi®) is accepted for use in the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Use is restricted to patients with confirmed or suspected methicillin-resistant Staphylococcus aureus (MRSA) infection who are eligible for early discharge. Use should be on the advice of local microbiologists or specialists in infectious disease. For further information see SMC2285 | SMC2285 | Accepted | 6/6/2022 |
| Tucatinib (Tukysa®) | In Northern Ireland, tucatinib (Tukysa®) with trastuzumab and capecitabine is accepted for use as an option for treating HER2-positive locally advanced or metastatic breast cancer in adults after 2 or more anti-HER2 treatment therapies only if the company provides tucatinib according to the commercial arrangement For further information see NICE TA786 | NICE TA786 | Accepted | 12/5/2022 |
| Icatibant (Firazyr®) | In Northern Ireland, icatibant (Firazyr®) is accepted for use as an option for use for the symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1 esterase-inhibitor deficiency. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of icatibant. This advice is contingent upon the continuing availability of the Patient Access Scheme in Northern Ireland. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see AWMSG 0818 | AWMSG 0818 | Accepted | 12/5/2022 |
| Blinatumomab (Blincyto®) | In Northern Ireland, blinatumomab (Blincyto®) is not accepted for use as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2468 | SMC2468 | Not Accepted | 12/5/2022 |
| Daratumumab (Darzalex®) | In Northern Ireland, daratumumab (Darzalex®) is not accepted for use in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2469 | SMC2469 | Not Accepted | 12/5/2022 |
| Atidarsagene autotemcel (Libmeldy®) | In Northern Ireland, atidarsagene autotemcel (Libmeldy®) is accepted for use within its marketing authorisation, as an option for treating metachromatic leukodystrophy with mutations in the arylsulphatase A (ARSA) gene: - for children who have late infantile or early juvenile types, with no clinical signs or symptoms - for children who have the early juvenile type, with early clinical signs or symptoms, and who can still walk independently and have no cognitive decline. It is recommended only if the company provides atidarsagene autotemcel according to the commercial arrangement. Atidarsagene autotemcel should be delivered in a highly specialised service by a specialist multidisciplinary team. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST18 | NICE HST18 | Accepted | 12/5/2022 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab with ipilimumab is accepted for use, within its marketing authorisation, as an option for untreated advanced renal cell carcinoma in adults: - whose disease is intermediate or poor risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria and - only if the company provides nivolumab with ipilimumab according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA780 | NICE TA780 | Accepted | 12/5/2022 |
| Sotorasib (Lumakras®) | In Northern Ireland, sotorasib (Lumakras®) is accepted for use as an option for treating KRAS G12C mutation-positive locally advanced or metastatic non-small-cell lung cancer in adults whose disease has progressed on, or who cannot tolerate, platinum-based chemotherapy or anti-PD-1/PD-L1 immunotherapy. It is recommended only if the conditions in the managed access agreement for sotorasib are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA781 | NICE TA781 | Accepted | 12/5/2022 |
| Odevixibat (Bylvay®) | In Northern Ireland, odevixibat (Bylvay®) is accepted for use within its marketing authorisation, as an option for treating progressive familial intrahepatic cholestasis (PFIC) in people 6 months and older. It is recommended only if the company provides odevixibat according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST17 | NICE HST17 | Accepted | 7/4/2022 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®), with carboplatin and paclitaxel is accepted for use as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults, only if - their tumours express PD‑L1 with a tumour proportion score of 0% to 49% - their tumours express PD‑L1 with a tumour proportion score of 50% or more and they need urgent clinical intervention - it is stopped at 2 years of uninterrupted treatment or earlier if their disease progresses and - the company provides pembrolizumab according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA770 | NICE TA770 | Accepted | 7/4/2022 |
| Dostarlimab (Jemperli®) | In Northern Ireland, dostarlimab (Jemperli®) is accepted for use as an option for treating advanced or recurrent endometrial cancer with high microsatellite instability or mismatch repair deficiency in adults who have had platinum-based chemotherapy. It is recommended only if the conditions in the managed access agreement are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA779 | NICE TA779 | Accepted | 7/4/2022 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is accepted for use within its marketing authorisation, as an option for the adjuvant treatment of completely resected stage 3 melanoma with lymph node involvement in adults. It is recommended only if the company provides pembrolizumab according to the commercial arrangement. For further information see NICE TA766 | NICE TA766 | Accepted | 7/4/2022 |
| Fremanezumab (Ajovy®) | In Northern Ireland, fremanezumab (Ajovy®) is accepted for use as an option for preventing migraine in adults, only if: - they have 4 or more migraine days a month - at least 3 preventive drug treatments have failed and - the company provides it according to the commercial arrangement Stop fremanezumab after 12 weeks of treatment if: - in episodic migraine (fewer than 15 headache days a month), the frequency does not reduce by at least 50% - in chronic migraine (15 headache days a month or more with at least 8 of those having features of migraine), the frequency does not reduce by at least 30%. A price parity scheme (primary care patient access scheme) for fremanezumab is currently in place in Northern Ireland. This allows fremanezumab to be prescribed in a shared-care arrangement between Secondary and Primary Care in NI. Refer to the Interface Pharmacy website http://www.ipnsm.hscni.net for further information. For further information see NICE TA764 | NICE TA764 | Accepted | 7/4/2022 |
| Betula verrucosa (Itulazax®) | In Northern Ireland, standardised allergen extract of pollen from white birch betula verrucosa (Itulazax 12 SQ-Bet®) is not accepted for use in adult patients for the treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch homologous group. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2471 | SMC2471 | Not Accepted | 7/4/2022 |
| Hydrocortisone - extended release formulation (Efmody®) | In Northern Ireland, hydrocortisone modified-release (Efmody®) is not accepted for use in the treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2414 | SMC2414 | Not Accepted | 7/4/2022 |
| Pitolisant (Ozawade®) | In Northern Ireland, pitolisant (Ozawade®) is not accepted for use, within its marketing authorisation, to improve wakefulness and reduce excessive daytime sleepiness in adults with obstructive sleep apnoea whose sleepiness has not been satisfactorily treated by primary obstructive sleep apnoea therapy such as continuous positive airway pressure (CPAP), or who cannot tolerate it. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA776 | NICE TA776 | Not Accepted | 7/4/2022 |
| Solriamfetol (Sunosi®) | In Northern Ireland, solriamfetol (Sunosi®) is not accepted for use within its marketing authorisation, to improve wakefulness and reduce excessive daytime sleepiness in adults with obstructive sleep apnoea whose sleepiness has not been satisfactorily treated by primary obstructive sleep apnoea therapy, such as continuous positive airway pressure (CPAP). People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA777 | NICE TA777 | Not Accepted | 7/4/2022 |
| Eculizumab (Soliris®) | In Northern Ireland, eculizumab (Soliris®) is not accepted for use in the treatment of adults with neuromyelitis optica spectrum disorder in patients who are anti-aquaporin-4 antibody-positive with a relapsing course of the disease. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2456 | SMC2456 | Not Accepted | 8/3/2022 |
| Anakinra (Kineret®) | In Northern Ireland, anakinra (Kineret®) is not accepted for use in the treatment of Familial Mediterranean Fever (FMF). People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2449 | SMC2449 | Not Accepted | 8/3/2022 |
| Amikacin, liposomal nebuliser dispersion (Arikayce®) | In Northern Ireland, amikacin liposomal nebuliser dispersion (Arikayce®) is accepted for use in the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium Avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. This advice applies only in the context of an approved Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see SMC2432 | SMC2432 | Accepted | 8/3/2022 |
| Upadacitinib (Rinvoq®) | In Northern Ireland, upadacitinib (Rinvoq®) is accepted for use, alone or with methotrexate, as an option for treating active psoriatic arthritis in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is recommended only if they have peripheral arthritis with 3 or more tender joints and 3 or more swollen joints and: • they have had 2 conventional DMARDs and at least 1 biological DMARD or • TNF-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE's technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis). Upadacitinib is recommended only if the company provides it according to the commercial arrangement. For further information see NICE TA768 | NICE TA768 | Accepted | 8/3/2022 |
| Daratumumab (Darzalex®) | In Northern Ireland, daratumumab (Darzalex®) plus bortezomib, thalidomide and dexamethasone is accepted for use, within its marketing authorisation, as induction and consolidation treatment for untreated multiple myeloma in adults, when an autologous stem cell transplant is suitable. It is recommended only if the company provides daratumumab according to the commercial arrangement. For further information see NICE TA763 | NICE TA763 | Accepted | 8/3/2022 |
| Venetoclax (Venclyxto®) | In Northern Ireland, venetoclax (Venclyxto®) with azacitidine is accepted for use, within its marketing authorisation, as an option for untreated acute myeloid leukaemia in adults when intensive chemotherapy is unsuitable. It is recommended only if the company provides venetoclax according to the commercial arrangement. For further information see NICE TA765 | NICE TA765 | Accepted | 8/3/2022 |
| Pegcetacoplan (Aspaveli®) | In Northern Ireland, pegcetacoplan (Aspaveli®) is accepted for use, within its marketing authorisation, as an option for treating paroxysmal nocturnal haemoglobinuria (PNH) in adults who have anaemia after at least 3 months of treatment with a C5 inhibitor. It is recommended only if the company provides pegcetacoplan according to the commercial arrangement For further information see NICE TA778 | NICE TA778 | Accepted | 8/3/2022 |
| Arachis hypogaea (formerly known as AR101) (Palforzia®) | In Northern Ireland, Palforzia® is accepted for use, within its marketing authorisation, as an option for treating peanut allergy in children aged 4 to 17. Palforzia may be continued in patients aged 18 years or older. Palforzia should be used in conjunction with a peanut-avoidant diet. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA769 | NICE TA769 | Accepted | 8/3/2022 |
| Ponesimod (Ponvory®) | In Northern Ireland, ponesimod (Ponvory®) is accepted for use for treating relapsing-remitting multiple sclerosis with active disease defined by clinical or imaging features in adults, only if the company provides ponesimod according to the commercial arrangement For further information see NICE TA767 | NICE TA767 | Accepted | 8/3/2022 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is accepted for use as an option for treating relapsed or refractory classical Hodgkin lymphoma in people aged 3 and older. It is recommended if they have had an autologous stem cell transplant that has not worked or they have had at least 2 previous therapies and an autologous stem cell transplant is not an option, and only if: • they have not had brentuximab vedotin and • the company provides pembrolizumab according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA772 | NICE TA772 | Accepted | 8/3/2022 |
| Olaparib (Lynparza®) | In Northern Ireland, olaparib (Lynparza®) is NOT accepted for use as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2435 | SMC2435 | Not Accepted | 8/3/2022 |
| Olaparib (Lynparza®) | In Northern Ireland, olaparib (Lynparza®) is NOT accepted for use as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo) adjuvant or metastatic setting unless patients were not suitable for these treatments. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2436 | SMC2436 | Not Accepted | 8/3/2022 |
| Durvalumab (Imfinzi®) | In Northern Ireland, durvalumab (Imfinzi®) is NOT accepted for use, in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adults with extensive-stage small cell lung cancer. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2434 | SMC2434 | Not Accepted | 8/3/2022 |
| Osimertinib (Tagrisso®) | In Northern Ireland, osimertinib (Tagrisso®) is accepted for use as adjuvant treatment after complete tumour resection in adults with stage 1b to 3a non-small-cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. It is recommended only if: - osimertinib is stopped at 3 years, or earlier if there is disease recurrence or unacceptable toxicity and - the company provides osimertinib according to the managed access agreement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA761 | NICE TA761 | Accepted | 8/3/2022 |
| Selpercatinib (Retsevmo ®) | In Northern Ireland, selpercatinib (Retsevmo®) is accepted for use as an option for treating RET fusion-positive advanced non-small-cell lung cancer (NSCLC) in adults who need systemic therapy after immunotherapy, platinum-based chemotherapy or both. It is accepted for use only if the conditions in the managed access agreement are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA760 | NICE TA760 | Accepted | 8/3/2022 |
| Givosiran (Givlaari®) | In Northern Ireland, givosiran (Givlaari®) is accepted for use as an option for treating acute hepatic porphyria (AHP) in adults and young people aged 12 and older, only if: - they have clinically confirmed severe recurrent attacks (4 attacks or more within 12 months) and - the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST16 | NICE HST16 | Accepted | 8/3/2022 |
| Belimumab (Benlysta®) | In Northern Ireland, belimumab (Benlysta®) is accepted for use as an option as add-on treatment for active autoantibody-positive systemic lupus erythematosus in people with high disease activity despite standard treatment, only if: - high disease activity is defined as at least 1 serological biomarker (positive anti-double-stranded DNA or low complement) and a SELENA‑SLEDAI score of greater than or equal to 10 - treatment is continued beyond 24 weeks only if the SELENA‑SLEDAI score has improved by 4 points or more - the company provides belimumab according to the commercial arrangement. For further information see NICE TA752 | NICE TA752 | Accepted | 8/3/2022 |
| Fedratinib (Inrebic®) | In Northern Ireland, fedratinib (Inrebic®) is accepted for use as an option for treating disease-related splenomegaly or symptoms of primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis in adults. It is recommended only if: • they have previously had ruxolitinib and • the conditions in the managed access agreement for fedratinib are followed Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA756 | NICE TA756 | Accepted | 8/3/2022 |
| Risdiplam (Evrysdi®) | In Northern Ireland, risdiplam (Evrysdi®) is accepted for use as an option for treating 5q spinal muscular atrophy (SMA) in people of all ages with a clinical diagnosis of SMA types 1, 2 or 3 or with pre-symptomatic SMA and 1 to 4 SMN2 copies. It is accepted for use only if the conditions of the managed access agreement are followed. For further information see NICE TA755 | NICE TA755 | Accepted | 8/3/2022 |
| Cabotegravir (Vocabria®) | In Northern Ireland, cabotegravir (Vocabria®) with rilpivirine is accepted for use, within its marketing authorisation, as an option for treating HIV-1 infection in adults: - with virological suppression (HIV-1 RNA fewer than 50 copies/ml) on a stable antiretroviral regimen and - without any evidence of viral resistance to, and no previous virological failure with, any non-nucleoside reverse transcriptase inhibitors or integrase inhibitors. It is accepted for use only if the company provides it according to the commercial arrangement. For further information see NICE TA757 | NICE TA757 | Accepted | 8/3/2022 |
| Cenobamate (Ontozry®) | In Northern Ireland, cenobamate (Ontozry®) is accepted for use as an option for treating focal onset seizures with or without secondary generalised seizures in adults with drug-resistant epilepsy that has not been adequately controlled with at least 2 anti-seizure medicines. It is recommended only if: - it is used as an add-on treatment, after at least 1 other add-on treatment has not controlled seizures, and - treatment is started in a tertiary epilepsy service For further information see NICE TA753 | NICE TA753 | Accepted | 8/3/2022 |
| Mogamulizumab (Poteligeo®) | In Northern Ireland, Mogamulizumab (Poteligeo®) is accepted for use, within its marketing authorisation, as an option for treating Sézary syndrome in adults who have had at least 1 systemic treatment. It is recommended only if the company provides mogamulizumab according to the commercial arrangement. Mogamulizumab is accepted for use as an option for treating mycosis fungoides in adults, only if: - their condition is stage 2B or above and - they have had at least 2 systemic treatments and - the company provides mogamulizumab according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA754 | NICE TA754 | Accepted | 8/3/2022 |
| Mexiletine (Namuscula®) | In Northern Ireland, mexiletine (Namuscula®) is accepted for use within its marketing authorisation, as an option for treating the symptoms of myotonia in adults with non-dystrophic myotonic disorders. It is recommended only if the company provides mexiletine (Namuscla) according to the commercial arrangement For further information see NICE TA748 | NICE TA748 | Accepted | 8/3/2022 |
| Empagliflozin (Jardiance®) | In Northern Ireland, empagliflozin (Jardiance®) is accepted for use as an option for treating symptomatic chronic heart failure with reduced ejection fraction in adults, only if it is used as an add-on to optimised standard care with: - an angiotensin-converting enzyme (ACE) inhibitor or angiotensin 2 receptor blocker (ARB), with a beta blocker and, if tolerated, a mineralocorticoid receptor antagonist (MRA), or - sacubitril valsartan with a beta blocker and, if tolerated, an MRA. Start empagliflozin for treating symptomatic heart failure with reduced ejection fraction on the advice of a heart failure specialist. Monitoring should be done by the most appropriate healthcare professional. For further information see NICE TA773 | NICE TA773 | Accepted | 8/3/2022 |
| Dapagliflozin (Forxiga®) | In Northern Ireland, dapagliflozin (Forxiga®) is accepted for use as an option for treating chronic kidney disease (CKD) in adults. It is recommended only if: - it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated, and - people have an estimated glomerular filtration rate (eGFR) of 25ml/min/1.73m2 to 75ml/min/1.73 m2 at the start of treatment and: - have type 2 diabetes or - have a urine albumin-to-creatinine ratio (uACR) of 22.6mg/mmol or more. For further information see NICE TA775 | NICE TA775 | Accepted | 8/3/2022 |
| Budesonide prolonged release tablet (Cortiment®) | In Northern Ireland, Budesonide prolonged release tablet (Cortiment®) is accepted for use for the induction of remission in patients with active microscopic colitis. Cortiment® offers a prolonged release formulation of budesonide for this indication. Other oral budesonide formulations are available at lower cost. For further information see SMC | SMC | Accepted | 9/2/2022 |
| Tirbanibulin (Klisyri®) | In Northern Ireland, tirbanibulin (Klisyri®) is accepted for use in the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see SMC | SMC | Accepted | 9/2/2022 |
| Mometasone + olopatadine (Ryaltris®) | In Northern Ireland, olopatadine hydrochloride and mometasone furoate monohydrate (Ryaltris®) is accepted for use in the treatment of moderate to severe nasal symptoms associated with allergic rhinitis in adults and adolescents 12 years of age and older. Its use is restricted to patients in whom monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient. For patients in whom the combination of olopatadine hydrochloride plus mometasone furoate monohydrate is an appropriate choice of therapy, Ryaltris® provides the two ingredients in a single nasal spray. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see SMC | SMC | Accepted | 9/2/2022 |
| Solriamfetol (Sunosi®) | In Northern Ireland, solriamfetol (Sunosi®) is accepted for use as an option for treating excessive daytime sleepiness in adults with narcolepsy with or without cataplexy. This is only if modafinil and either dexamfetamine or methylphenidate have not worked well enough or are not suitable. For further information see NICE TA758 | NICE TA758 | Accepted | 9/2/2022 |
| Isatuximab (Sarclisa®) | In Northern Ireland, isatuximab (Sarclisa®) is not accepted for use, in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 7/12/2021 |
| Cabozantinib (Cabometyx®) | In Northern Ireland, cabozantinib (Cabometyx®) is accepted for use in combination with nivolumab for the first-line treatment of advanced renal cell carcinoma in adults. This advice applies only in the context of a Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see SMC | SMC | Accepted | 7/12/2021 |
| Atezolizumab (Tecentriq®) | In Northern Ireland, atezolizumab (Tecentriq®) is accepted for use, within its marketing authorisation, as an option for untreated locally advanced or metastatic urothelial cancer in adults whose tumours express PD‑L1 at a level of 5% or more and when cisplatin-containing chemotherapy is unsuitable. This is only if the company provides atezolizumab according to the commercial arrangement. This guidance updates and replaces NICE technology appraisal guidance 492 For further information see NICE TA739 | NICE TA739 | Accepted | 7/12/2021 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) is accepted for use as an option for treating recurrent or metastatic squamous cell carcinoma of the head and neck in adults whose disease has progressed on platinum‑based chemotherapy, only if: • the disease has progressed within 6 months of having chemotherapy and • the company provides it according to the commercial arrangement. For further information see NICE TA736 | NICE TA736 | Accepted | 7/12/2021 |
| Nintedanib (Ofev®) | In Northern Ireland, nintedanib (Ofev®) is accepted for use within its marketing authorisation, as an option for treating chronic progressive fibrosing interstitial lung diseases (PF-ILD) in adults. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA747 | NICE TA747 | Accepted | 7/12/2021 |
| Dupilumab (Dupixent®) | In Northern Ireland, dupilumab (Dupixent®) is accepted for use as add-on maintenance therapy as an option for treating severe asthma with type 2 inflammation that is inadequately controlled in people 12 years and over, despite maintenance therapy with high-dose inhaled corticosteroids and another maintenance treatment, only if: • the dosage used is 400mg initially and then 200mg subcutaneously every other week, • the person has agreed to and follows an optimised standard treatment plan, • the person has a blood eosinophil count of 150 cells per microlitre or more and fractional exhaled nitric oxide of 25 parts per billion or more, and has had at least 4 or more exacerbations in the previous 12 months, • the person is not eligible for biologicals or has asthma that has not responded adequately to biological therapy • the company provides dupilumab with the discount agreed in the patient access scheme Stop dupilumab if the rate of severe asthma exacerbations has not been reduced by at least a 50% after 12 months. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA751 | NICE TA751 | Accepted | 7/12/2021 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) is accepted for use, within its marketing authorisation, for adjuvant treatment of completely resected oesophageal or gastro-oesophageal junction cancer in adults who have residual disease after previous neoadjuvant chemoradiotherapy. It is recommended only if the company provides nivolumab according to the commercial arrangement. For further information see NICE TA746 | NICE TA746 | Accepted | 7/12/2021 |
| Avapritinib (Ayvakyt®) | In Northern Ireland, avapritinib (Ayvakyt®) is not accepted for use as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 7/12/2021 |
| Upadacitinib (Rinvoq®) | In Northern Ireland, upadacitinib (Rinvoq®) is accepted for use, with methotrexate, as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with 2 or more conventional disease modifying antirheumatic drugs (DMARDs), only if: • disease is moderate (a disease activity score [DAS28] of 3.2 to 5.1) and • the company provides upadacitinib according to the commercial arrangement. Upadacitinib can be used as monotherapy when methotrexate is contraindicated or if people cannot tolerate it, when the criteria above are met. If more than one treatment is suitable, start treatment with the least expensive drug (taking into account administration costs, dose needed and product price per dose). This may vary because of differences in how the drugs are used and treatment schedules. Continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. If this initial response is not maintained, stop treatment. Take into account any physical, psychological, sensory or learning disabilities, or communication difficulties that could affect the responses to the DAS28 and make any appropriate adjustments. For further information see NICE TA744 | NICE TA744 | Accepted | 7/12/2021 |
| Selpercatinib (Retsevmo®) | In Northern Ireland, selpercatinib (Retsevmo®) is accepted for use as an option for treating: • advanced RET fusion-positive thyroid cancer in adults who need systemic therapy after sorafenib or lenvatinib • advanced RET-mutant medullary thyroid cancer in people 12 years and older who need systemic therapy after cabozantinib or vandetanib It is recommended only if the conditions in the managed access agreement are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA742 | NICE TA742 | Accepted | 7/12/2021 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) with platinum- and fluoropyrimidine-based chemotherapy is accepted for use, within its marketing authorisation, as an option for untreated locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a combined positive score (CPS) of 10 or more. Pembrolizumab is only accepted for use if the company provides it according to the commercial arrangement For further information see NICE TA737 | NICE TA737 | Accepted | 8/11/2021 |
| Abemaciclib (Verzenios®) | In Northern Ireland, abemaciclib (Verzenios®) is accepted for use with fulvestrant as an option for treating hormone receptor‑positive, human epidermal growth factor receptor 2 (HER2)‑negative, locally advanced or metastatic breast cancer in adults who have had endocrine therapy only if: - exemestane plus everolimus is the most appropriate alternative to a cyclin‑dependent kinase 4 and 6 (CDK 4/6) inhibitor and - the company provides abemaciclib according to the commercial arrangement. For further information see NICE TA725 | NICE TA725 | Accepted | 8/11/2021 |
| Berotralstat (Orladeyo®) | In Northern Ireland, berotralstat (Orladeyo®) is accepted for use as an option for preventing recurrent attacks of hereditary angioedema in people 12 years and older, only if: • they have at least 2 attacks per month and • it is stopped if the number of attacks per month does not reduce by at least 50% after 3 months. It is only recommended if the company provides berotralstat according to the commercial arrangement. For further information see NICE TA738 | NICE TA738 | Accepted | 8/11/2021 |
| Tofacitinib (Xeljanz®) | In Northern Ireland, tofacitinib (Xeljanz®) is accepted for use as an option for treating active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive or negative polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis in people 2 years and older. This is if their condition has responded inadequately to previous treatment with disease-modifying antirheumatic drugs, and only if: • a tumour necrosis factor (TNF)-alpha inhibitor is not suitable or does not control the condition well enough, and • the company provides tofacitinib according to the commercial arrangement Tofacitinib can be used with methotrexate, or as monotherapy when methotrexate is not tolerated or if continued treatment with methotrexate is inappropriate If tofacitinib is one of a range of treatments considered suitable by patients, or their parents or carers, and their clinicians, choose the least expensive (taking into account administration costs and commercial arrangements). For further information see NICE TA735 | NICE TA735 | Accepted | 8/11/2021 |
| Apalutamide (Erleada®) | In Northern Ireland, apalutamide (Erleada®) plus androgen deprivation therapy (ADT) is accepted for use as an option for treating hormone-sensitive METASTATIC prostate cancer in adults, only if: • docetaxel is not suitable or cannot be tolerated • the company provides apalutamide according to the commercial arrangement For further information see NICE TA741 | NICE TA741 | Accepted | 8/11/2021 |
| Apalutamide (Erleada®) | In Northern Ireland, apalutamide (Erleada®) plus androgen deprivation therapy (ADT) is accepted for use, within its marketing authorisation, as an option for treating hormone relapsed NON-metastatic prostate cancer that is at high risk of metastasising in adults. High risk is defined as a blood prostate specific antigen (PSA) level that has doubled in 10 months or less on continuous ADT. It is accepted only if the company provides apalutamide according to the commercial arrangement. For further information see NICE TA740 | NICE TA740 | Accepted | 8/11/2021 |
| Secukinumab (Cosentyx®) | In Northern Ireland, secukinumab (Cosentyx®) is accepted for use as an option for treating plaque psoriasis in children and young people aged 6 to 17 years, only if: • the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and • the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and • the company provides the drug according to the commercial arrangement For further information see NICE TA734 | NICE TA734 | Accepted | 8/11/2021 |
| Chloroprocaine (Ampres®) | In Northern Ireland, chloroprocaine (Ampres®) is accepted for use as spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes. Use is restricted to day-case anaesthetic pathways. For further information see SMC | SMC | Accepted | 8/11/2021 |
| Midazolam 2mg/mL oral solution in single-dose container (Ozalin®) | In Northern Ireland, midazolam oral solution (Ozalin®) is accepted for use in children from 6 months to 17 years old, for moderate sedation before a therapeutic or diagnostic procedure or as premedication before anaesthesia. Ozalin® 2mg/mL oral solution is supplied in single-use glass ampoules and the dose must be measured using the oral applicator, which is graduated in kg of body weight, and the filter straw provided. The availability of midazolam oral solution (Ozalin®) provides a licensed alternative to an unlicensed preparation. For further information see SMC | SMC | Accepted | 8/11/2021 |
| Vericiguat (Verquvo®) | In Northern Ireland, vericiguat (Verquvo®) is not accepted for use for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 8/11/2021 |
| Natalizumab subcutaneous injection (Tysabri®) | In Northern Ireland, natalizumab for subcutaneous administration (Tysabri® 150mg solution for injection; pre-filled syringe) is accepted for use as an alternative formulation for those patients who would otherwise be deemed eligible for natalizumab solution for infusion (i.e. those who meet the criteria as laid out in NICE TA127). For further information see NICE TA127 | NICE TA127 | Accepted | 12/10/2021 |
| Luspatercept (Reblozyl®) | In Northern Ireland, luspatercept (Reblozyl®) is not accepted for treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy and for the treatment of adult patients with transfusion-dependent anaemia associated with beta-thalassaemia. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see AWMSG 2177 | AWMSG | Not Accepted | 12/10/2021 |
| Elotuzumab (Empliciti®) | In Northern Ireland, elotuzumab (Empliciti®) is NOT accepted for use, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 12/10/2021 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) plus ipilimumab and 2 cycles of platinum-doublet chemotherapy is NOT accepted within its marketing authorisation, for untreated metastatic non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA724 | NICE TA724 | Not Accepted | 12/10/2021 |
| Sapropterin (Kuvan®) | In Northern Ireland, sapropterin (Kuvan®) is accepted for use as an option for treating hyperphenylalaninaemia that responds to sapropterin (response as defined in the summary of product characteristics) in people with phenylketonuria (PKU), only if they are: • under 18 and a dose of 10mg/kg is used, only using a higher dose if target blood phenylalanine levels cannot be achieved at 10mg/kg • aged 18 to 21 inclusive, continuing the dose they were having before turning 18 or at a maximum dose of 10mg/kg • pregnant (from a positive pregnancy test until birth). Sapropterin is recommended only if the company provides it according to the commercial arrangement. For further information see NICE TA729 | NICE TA729 | Accepted | 12/10/2021 |
| Midostaurin (Rydapt®) | In Northern Ireland, midostaurin (Rydapt®) is accepted for use within its marketing authorisation, as an option for treating aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasms or mast cell leukaemia in adults. It is recommended only if the company provides midostaurin according to the commercial arrangement For further information see NICE TA728 | NICE TA728 | Accepted | 12/10/2021 |
| Pemigatinib (Pemazyre®) | In Northern Ireland, pemigatinib (Pemazyre®) is accepted for use within its marketing authorisation, as an option for treating locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after systemic therapy in adults. It is recommended only if the company provides pemigatinib according to the commercial arrangement For further information see NICE TA722 | NICE TA722 | Accepted | 12/10/2021 |
| Bimekizumab (Bimzelx®) | In Northern Ireland, bimekizumab is accepted for use as an option for treating plaque psoriasis in adults, only if: - the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and - the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and - the company provides the drug according to the commercial arrangement Stop bimekizumab treatment at 16 weeks if the psoriasis has not responded adequately. An adequate response is defined as: - a 75% reduction in the PASI score (PASI 75) from when treatment started or - a 50% reduction in the PASI score (PASI 50) and a 5-point reduction in DLQI from when treatment started. For further information see NICE TA723 | NICE TA723 | Accepted | 12/10/2021 |
| Adalimumab | In Northern Ireland, adalimumab is accepted for use as an option for the treatment of severely active Crohn’s Disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. The need to continue treatment should be reviewed at least every 12 months Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. | Accepted | 15/9/2021 | |
| Pertuzumab + trastuzumab (Phesgo®) | In Northern Ireland, pertuzumab + trastuzumab (Phesgo®) is accepted for use in line with previous NICE advice for pertuzumab and trastuzumab (see NICE TA509, TA424 and TA569) This advice applies only in the context of an approved Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see SMC | SMC | Accepted | 15/9/2021 |
| Fostemsavir (Rukobia®) | In Northern Ireland, fostemsavir (Rukobia®) is not accepted for use in combination with other antiretrovirals for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 15/9/2021 |
| Abiraterone (Zytiga®) | In Northern Ireland, abiraterone (Zytiga®) with prednisone or prednisolone plus androgen deprivation therapy (ADT) is not accepted for use, within its marketing authorisation, for treating newly diagnosed high-risk hormone-sensitive metastatic prostate cancer in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA721 | NICE TA721 | Not Accepted | 15/9/2021 |
| Chlormethine (Ledaga®) | In Northern Ireland, chlormethine gel (Ledaga®) is accepted for use as an option for treating early stage (stage 1A, 1B, and 2A) mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL)in adults, only if the company provides chlormethine gel according to the commercial arrangement For further information see NICE TA720 | NICE TA720 | Accepted | 15/9/2021 |
| Dasatinib (Sprycel®) | In Northern Ireland, dasatinib (Sprycel®) is not accepted for use in the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia in combination with chemotherapy. People currently receiving this drug for this indication should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 15/9/2021 |
| Adalimumab, etanercept, infliximab and abatacept | In Northern Ireland, adalimumab, etanercept and infliximab, all with methotrexate, are accepted for use as options for treating active rheumatoid arthritis in adults, only if: • intensive therapy with 2 or more conventional disease-modifying antirheumatic drugs (DMARDs) has not controlled the disease well enough and • disease is moderate (a disease activity score [DAS28] of 3.2 to 5.1) and • the companies provide adalimumab, etanercept and infliximab at the same or lower prices than those agreed with the Commercial Medicines Unit. Adalimumab and etanercept can be used as monotherapy when methotrexate is contraindicated or not tolerated, when the criteria above are met. Continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. If this initial response is not maintained at 6 months, stop treatment. If more than one treatment is suitable, start treatment with the least expensive drug (taking into account administration costs, dose needed and product price per dose). This may vary because of differences in how the drugs are used and treatment schedules. Take into account any physical, psychological, sensory or learning disabilities, or communication difficulties that could affect the responses to the DAS28 and make any appropriate adjustments. Abatacept with methotrexate is not accepted for use, within its marketing authorisation, for treating moderate active rheumatoid arthritis in adults when 1 or more DMARDs has not controlled the disease well enough. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA715 | NICE TA715 | Accepted | 15/9/2021 |
| Onasemnogene abeparvovec (Zolgensma®) | In Northern Ireland, onasemnogene abeparvovec (Zolgensma®) is accepted for use, as an option, for treating 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of type 1 SMA in babies, only if: - they are 6 months or younger, or - they are aged 7 to 12 months, and - their treatment is agreed by the national multidisciplinary team. It is only recommended for these groups if: - permanent ventilation for more than 16 hours per day or a tracheostomy is not needed - the company provides it according to the commercial arrangement. For babies aged 7 to 12 months, the national multidisciplinary team should develop auditable criteria to enable onasemnogene abeparvovec to be allocated to babies in whom treatment will give them at least a 70% chance of being able to sit independently. Onasemnogene abeparvovec is recommended as an option for treating presymptomatic 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene in babies. It is recommended only if the conditions in the managed access agreement are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see HST15 | NICE HST15 | Accepted | 15/9/2021 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) is accepted for use, as an option, for treating locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) in adults after chemotherapy, only if: - their tumours are PD-L1 positive, and - it is stopped at 2 years of uninterrupted treatment, or earlier if their disease progresses, and - they have not had a PD-1 or PD-L1 inhibitor before. It is accepted for use only if the company provides nivolumab according to the commercial arrangement. For further information see NICE TA713 | NICE TA713 | Accepted | 15/9/2021 |
| Enzalutamide (Xtandi®) | In Northern Ireland, enzalutamide (Xtandi®) plus androgen deprivation therapy, is accepted for use within its marketing authorisation, as an option for treating hormone-sensitive metastatic prostate cancer in adults. It is only accepted for use if the company provides enzalutamide according to the agreed commercial arrangement. For further information see NICE TA712 | NICE TA712 | Accepted | 15/9/2021 |
| Ramucirumab (Cyramza®) | In Northern Ireland, ramucirumab (Cyramza®) is not accepted for use in combination with erlotinib for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 15/9/2021 |
| Ravulizumab (Ultomiris®) | In Northern Ireland, ravulizumab (Ultomiris®) is accepted for use within its marketing authorisation, as an option for treating atypical haemolytic uraemic syndrome (aHUS) in people weighing 10kg or more: - who have not had a complement inhibitor before or - whose disease has responded to at least 3 months of eculizumab treatment. It is recommended only if the company provides ravulizumab according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA710 | NICE TA710 | Accepted | 15/9/2021 |
| Secukinumab (Cosentyx®) | In Northern Ireland, secukinumab (Cosentyx®) is accepted for use as an option for treating active non-radiographic axial spondyloarthritis with objective signs of inflammation (shown by elevated C-reactive protein or MRI) that is not controlled well enough with non-steroidal anti-inflammatory drugs (NSAIDs) in adults. It is accepted only if: - tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough and - the company provides secukinumab according to the commercial arrangement For further information see NICE TA719 | NICE TA719 | Accepted | 15/9/2021 |
| Ixekizumab (Taltz®) | In Northern Ireland, ixekizumab (Taltz®) is accepted for use as an option for treating active ankylosing spondylitis that is not controlled well enough with conventional therapy, or active non-radiographic axial spondyloarthritis with objective signs of inflammation (shown by elevated C-reactive protein or MRI) that is not controlled well enough with nonsteroidal anti-inflammatory drugs (NSAIDs), in adults. It is accepted only if: - tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough, and - the company provides ixekizumab according to the commercial arrangement. For further information see NICE TA718 | NICE TA718 | Accepted | 15/9/2021 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab with ipilimumab is accepted for use for previously treated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency after fluoropyrimidine-based combination chemotherapy. It is recommended only if the company provides nivolumab and ipilimumab according to the commercial arrangements. For further information see NICE TA716 | NICE TA716 | Accepted | 15/9/2021 |
| Atezolizumab (Tecentriq®) | In Northern Ireland, atezolizumab is accepted for use, within its marketing authorisation, as an option for untreated metastatic non-small-cell lung cancer (NSCLC) in adults if: - their tumours have PD-L1 expression on at least 50% of tumour cells or 10% of tumour-infiltrating immune cells - their tumours do not have epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations and - the company provides atezolizumab according to the commercial arrangement For further information see NICE TA705 | NICE TA705 | Accepted | 15/9/2021 |
| Dupilumab (Dupixent®) | In Northern Ireland, dupilumab (Dupixent®) is accepted for use for the treatment of severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy and where existing systemic therapies are not advisable. This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS price. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see AWMSG | AWMSG | Accepted | 4/8/2021 |
| Ozanimod (Zeposia®) | In Northern Ireland, ozanimod (Zeposia®) is not accepted for use, within its marketing authorisation, for treating relapsing–remitting multiple sclerosis in adults with clinical or imaging features of active disease. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA706 | NICE TA706 | Not Accepted | 4/8/2021 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) is accepted for use, within its marketing authorisation, for treating unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma in adults after fluoropyrimidine and platinum-based therapy. It is recommended only if the company provides nivolumab according to the commercial arrangement. For further information see NICE TA707 | NICE TA707 | Accepted | 4/8/2021 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is accepted for use as an option for untreated metastatic colorectal cancer with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency in adults, only if: • pembrolizumab is stopped after 2 years and no documented disease progression, and • the company provides pembrolizumab according to the commercial arrangement For further information see NICE TA709 | NICE TA709 | Accepted | 4/8/2021 |
| Tafamidis (Vyndaqel®) | In Northern Ireland, tafamidis (Vyndaqel®) is not accepted for use, within its marketing authorisation, for treating wild-type or hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM) in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA696 | NICE TA696 | Not Accepted | 4/8/2021 |
| Delafloxacin (Quofenix®) | In Northern Ireland, delafloxacin (Quofenix®) is not accepted for use in the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 4/8/2021 |
| Relebactam + cilastatin + imipenem (Recarbrio®) | In Northern Ireland, relebactam + cilastatin + imipenem (Recarbrio®), is not accepted for use in the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 4/8/2021 |
| Vigabatrin 100mg and 500mg soluble tablets (Kigabeq®) | In Northern Ireland, Vigabatrin 100mg and 500mg soluble tablets (Kigabeq®) is accepted for use in infants and children from 1 month to less than 7 years of age for: • Treatment in monotherapy of infantile spasms (West's syndrome). • Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated. For further information see SMC | SMC | Accepted | 4/8/2021 |
| 5-aminolevulinic acid medicated plaster (Alacare®) | In Northern Ireland, 5-aminolevulinic acid medicated plaster (Alacare®) is accepted for use as a single use treatment of mild actinic keratoses lesions with a maximum diameter of 1.8 cm on the face and scalp (hairless areas) Alacare medicated plasters should be used along with photodynamic therapy. Alacare should only be administered by a nurse or other healthcare professional trained with the use of photodynamic therapies under the supervision of a physician. See the Summary of Product Characteristics for further details. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see SMC | SMC | Accepted | 4/8/2021 |
| Lenalidomide (Revlimid®) | In Northern Ireland, lenalidomide (Revlimid®) is accepted for use as maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma in adults, only if: - the dosage schedule is 10 mg per day on days 1 to 21 of a 28‑day cycle and - the company provides lenalidomide according to the commercial arrangement. For further information see NICE TA680 | NICE TA680 | Accepted | 9/6/2021 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is not accepted for use, within its marketing authorisation, for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy. This recommendation is not intended to affect treatment with pembrolizumab that was started in line with NICE TA519 before this guidance was published. For those people, pembrolizumab will be funded by the company until they and their NHS clinician consider it appropriate to stop. For further information see NICE TA692 | NICE TA692 | Not Accepted | 9/6/2021 |
| Avelumab (Bavencio®) | In Northern Ireland, avelumab (Bavencio®) is accepted for use as an option for treating metastatic Merkel cell carcinoma in adults who have not had chemotherapy for metastatic disease. It is recommended only if the company provides avelumab according to the commercial arrangement. For further information see NICE TA691 | NICE TA691 | Accepted | 9/6/2021 |
| Trastuzumab deruxtecan (Enhertu®) | In Northern Ireland, trastuzumab deruxtecan (Enhertu®) is accepted for use as an option for treating HER2-positive unresectable or metastatic breast cancer in adults after 2 or more anti-HER2 therapies. It is recommended only if the conditions in the managed access agreement are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA704 | NICE TA704 | Accepted | 9/6/2021 |
| Ofatumumab (Kesimpta®) | In Northern Ireland, ofatumumab (Kesimpta®) is accepted for use as an option for treating relapsing–remitting multiple sclerosis in adults with active disease defined by clinical or imaging features. This is only if the company provides ofatumumab according to the commercial arrangement. For further information see NICE TA699 | NICE TA699 | Accepted | 9/6/2021 |
| Ravulizumab (Ultomiris®) | In Northern Ireland, ravulizumab (Ultomiris®) is accepted for use, within its marketing authorisation, as an option for treating paroxysmal nocturnal haemoglobinuria in adults: • with haemolysis with clinical symptoms suggesting high disease activity, or • whose disease is clinically stable after having eculizumab for at least 6 months, and • the company provides it according to the commercial arrangement For further information see NICE TA698 | NICE TA698 | Accepted | 9/6/2021 |
| Budesonide orodispersible tablet (Jorveza®) | In Northern Ireland, budesonide as an orodispersible tablet (Jorveza®) is accepted for use as an option for inducing remission of eosinophilic oesophagitis in adults. For further information see NICE TA708 | NICE TA708 | Accepted | 9/6/2021 |
| Indacaterol (as acetate) and mometasone furoate (Atectura Breezhaler®) | In Northern Ireland, indacaterol (as acetate) and mometasone furoate (Atectura Breezhaler®) is accepted for use as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short-acting beta2-agonists. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see SMC | SMC | Accepted | 9/6/2021 |
| Andexanet alfa (Ondexxya®) | In Northern Ireland, andexanet alfa (Ondexxya®) is accepted for use as an option for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding, only if: • the bleed is in the gastrointestinal tract, and • the company provides andexanet alfa according to the commercial arrangement Andexanet alfa is recommended only in research for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding in the skull (intracranial haemorrhage), in the form of an ongoing randomised trial mandated by the regulator. For further information see NICE TA697 | NICE TA697 | Accepted | 9/6/2021 |
| Doravirine + lamivudine + tenofovir disoproxil fumarate (Delstrigo®) | In Northern Ireland, doravirine + lamivudine + tenofovir disoproxil (Delstrigo®) is accepted for use for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, lamivudine, or tenofovir. Doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo®) offers an additional treatment choice of NNRTI-based single-tablet regimen for this indication. This advice applies only in the context of a Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see SMC | SMC | Accepted | 10/5/2021 |
| Doravirine (Pifeltro®) | In Northern Ireland, doravirine (Pifeltro®) is accepted for use, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class. Doravirine offers an additional treatment choice in the therapeutic class of NNRTIs for this indication. This advice applies only in the context of a Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see SMC | SMC | Accepted | 10/5/2021 |
| Ribociclib (Kisqali®) | In Northern Ireland, ribociclib (Kisqali®) with fulvestrant is accepted for use as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults who have had previous endocrine therapy only if: - exemestane plus everolimus is the most appropriate alternative to a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor, and - the company provides ribociclib according to the commercial arrangement For further information see NICE TA687 | NICE TA687 | Accepted | 10/5/2021 |
| Anakinra (Kineret®) | In Northern Ireland, anakinra (Kineret®) is accepted for use as an option for treating Still's disease with moderate to high disease activity, or continued disease activity after non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. It is only recommended for: - adult-onset Still's disease that has responded inadequately to 2 or more conventional disease‑modifying antirheumatic drugs (DMARDs) - systemic juvenile idiopathic arthritis in people 8 months and older with a body weight of 10kg or more that has not responded to at least 1 conventional DMARD. For further information see NICE TA685 | NICE TA685 | Accepted | 10/5/2021 |
| Carfilzomib (Kyprolis®) | In Northern Ireland, carfilzomib (Kyprolis®) is accepted for use, in combination with lenalidomide and dexamethasone, as an option for treating multiple myeloma in adults, only if: • they have had only 1 previous therapy, which included bortezomib, and • the company provides carfilzomib according to the commercial arrangement For further information see NICE TA695 | NICE TA695 | Accepted | 10/5/2021 |
| Acalabrutinib (Calquence®) | In Northern Ireland, acalabrutinib (Calquence®) is accepted for use as monotherapy, as an option for untreated chronic lymphocytic leukaemia (CLL) in adults, only if: • there is a 17p deletion or TP53 mutation, or • there is no 17p deletion or TP53 mutation, and fludarabine plus cyclophosphamide and rituximab (FCR), or bendamustine plus rituximab (BR) is unsuitable, and • the company provides the drug according to the commercial arrangement Acalabrutinib is also accepted for use as monotherapy, within its marketing authorisation, as an option for previously treated CLL in adults. It is recommended only if the company provides the drug according to the commercial arrangement For further information see NICE TA689 | NICE TA689 | Accepted | 10/5/2021 |
| Nivolumab (Opdivo®) | In Northern Ireland nivolumab (Opdivo®) is accepted for use within its marketing authorisation, as an option for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease. It is recommended only if the company provides nivolumab according to the commercial arrangement. For further information see NICE TA684 | NICE TA684 | Accepted | 10/5/2021 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is accepted for use, with pemetrexed and platinum chemotherapy, as an option for untreated, metastatic, non-squamous non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR)‑positive or anaplastic lymphoma kinase (ALK)‑positive mutations. This is only if: - it is stopped at 2 years of uninterrupted treatment, or earlier if the disease progresses and - the company provides pembrolizumab according to the commercial arrangement For further information see NICE TA683 | NICE TA683 | Accepted | 10/5/2021 |
| Leuprorelin (Prostap DCS) | In Northern Ireland, leuprorelin (Prostap DCS) is accepted for use as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in pre- and peri-menopausal women at higher risk of disease recurrence (young age, high grade tumour, lymph node involvement). In women who have received chemotherapy, premenopausal status must be confirmed after completion of chemotherapy. Leuprorelin offers an additional treatment choice in the therapeutic class of gonadotropin-releasing hormone (GnRH) analogues for this indication. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see SMC | SMC | Accepted | 12/4/2021 |
| Leuprorelin (Prostap DCS) | In Northern Ireland, leuprorelin (Prostap DCS) is accepted for use as treatment in pre- and peri-menopausal women with advanced breast cancer suitable for hormonal manipulation. Leuprorelin offers an additional treatment choice in the therapeutic class of gonadotropin-releasing hormone (GnRH) analogues for this indication. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see SMC | SMC | Accepted | 12/4/2021 |
| Mercaptamine eye drops (Cystadrops®) | In Northern Ireland, mercaptamine eye drops (Cystadrops®) are not accepted for use for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 12/4/2021 |
| Alpelisib (Piqray®) | In Northern Ireland, alpelisib (Piqray®) is not accepted for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 12/4/2021 |
| Glasdegib (Daurismo®) | In Northern Ireland, glasdegib (Daurismo®) is not accepted for use in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 12/4/2021 |
| Apremilast (Otezla®) | In Northern Ireland, apremilast (Otezla®) is not accepted for use in the treatment of adult patients with oral ulcers associated with Behçet’s disease who are candidates for systemic therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 12/4/2021 |
| Metreleptin (Myalepta®) | In Northern Ireland metreleptin (Myalepta®) is accepted for use: 1. As an option for treating the complications of leptin deficiency in lipodystrophy for people who are 2 years and over and have generalised lipodystrophy. 2. As an option for treating the complications of leptin deficiency in lipodystrophy for people who are 12 years and over, have partial lipodystrophy, and do not have adequate metabolic control despite having standard treatments. It is only recommended if they have an HbA1c level above 7.5%, or fasting triglycerides above 5.0mmol/litre, or both. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST14 | NICE HST14 | Accepted | 12/4/2021 |
| Omalizumab (Xolair®) | In Northern Ireland, omalizumab (Xolair®) is not accepted for use as add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe chronic rhinosinusitis with nasal polyps for whom therapy with INC does not provide adequate disease control. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 12/4/2021 |
| Baricitinib (Olumiant®) | In Northern Ireland, baricitinib (Olumiant®) is accepted for use as an option for treating moderate to severe atopic dermatitis in adults, only if: - the disease has not responded to at least 1 systemic immunosuppressant, such as ciclosporin, methotrexate, azathioprine and mycophenolate mofetil, or these are not suitable, and - the company provides it according to the commercial arrangement For further information see NICE TA681 | NICE TA681 | Accepted | 12/4/2021 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is not accepted for use as monotherapy, for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS)≥10. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC | SMC | Not Accepted | 12/4/2021 |
| Bempedoic acid (Nilemdo® or Nustendi®) | In Northern Ireland, bempedoic acid with ezetimibe is accepted for use as an option for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet in adults. It is recommended only if: • statins are contraindicated or not tolerated, • ezetimibe alone does not control low-density lipoprotein cholesterol well enough, and • the company provides bempedoic acid and bempedoic acid with ezetimibe according to the commercial arrangement. Bempedoic acid with ezetimibe can be used as separate tablets or a fixed-dose combination. A price parity scheme (primary care patient access scheme) for Nilemdo®/ Nustendi® is currently in place in Northern Ireland. This allows Nilemdo®/ Nustendi® to be prescribed in primary care in line with the criteria set out in NICE TA694 . For further information see NICE TA694 | NICE TA694 | Accepted | 10/5/2021 |
| Beclometasone + formoterol + glycopyrronium (Trimbow®) | In Northern Ireland, beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium (Trimbow®) is accepted for use as maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see SMC | SMC | Accepted | 12/4/2021 |
| Dupilumab (Dupixent®) | In Northern Ireland, dupilumab (Dupixent®) is not accepted for use as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 11/3/2021 |
| Brolucizumab (Beovu®) | In Northern Ireland, brolucizumab (Beovu®) is accepted for use as an option for treating wet age-related macular degeneration in adults, only if, in the eye to be treated: - the best-corrected visual acuity is between 6/12 and 6/96 - there is no permanent structural damage to the central fovea - the lesion size is less than or equal to 12 disc areas in greatest linear dimension and - there is recent presumed disease progression (for example, blood vessel growth, as shown by fluorescein angiography, or recent visual acuity changes). It is recommended only if the company provides brolucizumab according to the commercial arrangement For further information see NICE TA672 | NICE TA672 | Accepted | 11/3/2021 |
| Brigatinib (Alunbrig®) | In Northern Ireland, brigatinib (Alunbrig®) is accepted for use, within its marketing authorisation, as an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) that has not been previously treated with an ALK inhibitor in adults. It is recommended only if the company provides brigatinib according to the commercial arrangement. For further information see NICE TA670 | NICE TA670 | Accepted | 11/3/2021 |
| Filgotinib (Jyseleca®) | In Northern Ireland, filgotinib (Jyseleca®) is accepted for use, with methotrexate, as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with 2 or more conventional disease modifying antirheumatic drugs (DMARDs), only if: • disease is moderate or severe (a disease activity score [DAS28] of 3.2 or more) and • the company provides filgotinib according to the commercial arrangement. Filgotinib, with methotrexate, is accepted for use as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to or who cannot have other DMARDs, including at least 1 biological DMARD, only if: • disease is severe (a DAS28 of more than 5.1) and • they cannot have rituximab and • the company provides filgotinib according to the commercial arrangement Filgotinib, with methotrexate, is accepted for use as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to rituximab and at least 1 biological DMARD, only if: • disease is severe (a DAS28 of more than 5.1) and • the company provides filgotinib according to the commercial arrangement Filgotinib can be used as monotherapy when methotrexate is contraindicated or if people cannot tolerate it, when the criteria above are met. For further information see NICE TA676 | NICE TA676 | Accepted | 11/3/2021 |
| Mepolizumab (Nucala®) | In Northern Ireland, mepolizumab (Nucala®) is accepted for use as an option for treating severe refractory eosinophilic asthma, only if: - it is used for adults who have agreed to and followed the optimised standard treatment plan and - the blood eosinophil count has been recorded as 300 cells per microlitre or more and the person has had at least 4 exacerbations needing systemic corticosteroids in the previous 12 months, or has had continuous oral corticosteroids of at least the equivalent of prednisolone 5 mg per day over the previous 6 months or - the blood eosinophil count has been recorded as 400 cells per microlitre or more and the person has had at least 3 exacerbations needing systemic corticosteroids in the previous 12 months (so they are also eligible for either benralizumab or reslizumab). Mepolizumab is accepted only if the company provides it according to the commercial arrangement. If mepolizumab, benralizumab or reslizumab are equally suitable, start treatment with the least expensive option (taking into account drug and administration costs). At 12 months: - stop mepolizumab if the asthma has not responded adequately or - continue mepolizumab if the asthma has responded adequately and assess response each year. An adequate response is defined as: - a clinically meaningful reduction in the number of severe exacerbations needing systemic corticosteroids or - a clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma control. For further information see NICE TA671 | NICE TA671 | Accepted | 11/3/2021 |
| Autologous anti-CD19-transduced CD3+ cells (Tecartus®) | In Northern Ireland, treatment with autologous anti-CD19-transduced CD3+ cells (Tecartus®) is accepted as an option for treating relapsed or refractory mantle cell lymphoma in adults who have previously had a Bruton’s tyrosine kinase (BTK) inhibitor. It is only recommended if the conditions in the managed access agreement for autologous anti-CD19-transduced CD3+ cells treatment are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA677 | NICE TA677 | Accepted | 11/3/2021 |
| Niraparib (Zejula®) | In Northern Ireland, niraparib (Zejula®) is accepted for use as an option for maintenance treatment for advanced (FIGO stages 3 and 4) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer after response to first-line platinum-based chemotherapy in adults. It is recommended only if the conditions in the managed access agreement for niraparib are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA673 | NICE TA673 | Accepted | 11/3/2021 |
| Erenumab (Aimovig®) | In Northern Ireland, erenumab (Aimovig®) is accepted for use as an option for preventing migraine in adults, only if: • they have 4 or more migraine days a month • at least 3 preventive drug treatments have failed • the 140 mg dose of erenumab is used and • the company provides it according to the commercial arrangement Stop erenumab after 12 weeks of treatment if: • in episodic migraine (less than 15 headache days a month) the frequency does not reduce by at least 50% • in chronic migraine (15 headache days a month or more with at least 8 of those having features of migraine) the frequency does not reduce by at least 30% A price parity scheme (primary care patient access scheme) for erenumab is currently in place in Northern Ireland. This allows erenumab to be prescribed in a shared-care arrangement between Secondary and Primary Care in NI. Refer to the Interface Pharmacy website http://www.ipnsm.hscni.net for further information. For further information see NICE TA682 | NICE TA682 | Accepted | 11/3/2021 |
| Budesonide + formoterol + glycopyrronium (Trixeo Aerosphere®) | In Northern Ireland, budesonide + formoterol + glycopyrronium (Trixeo Aerosphere®) is accepted for use as maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist. Use is restricted to patients with severe COPD (forced expiratory volume in one second [FEV1] less than 50% predicted normal). *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium. | SMC | Accepted | 11/3/2021 |
| Relabactam + cilastatin + imipenem (Recarbrio®) | In Northern Ireland, relabactam/cilastatin/imipenem (Recarbrio®) is not accepted for use for the treatment of: - hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults - bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium. | SMC | Not Accepted | 11/3/2021 |
| Carfilzomib (Kyprolis®) | In Northern Ireland, carfilzomib (Kyprolis®) with dexamethasone is accepted for use as an option for treating multiple myeloma in adults, only if: - they have had only 1 previous therapy and - the company provides carfilzomib according to the commercial arrangement For further information see NICE TA657 | NICE TA657 | Accepted | 21/1/2021 |
| Encorafenib (Braftovi®) | In Northern Ireland, encorafenib (Braftovi®) is accepted for use with cetuximab, within its marketing authorisation, as an option for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment. It is recommended only if the company provides it according to the commercial arrangements For further information see NICE TA668 | NICE TA668 | Accepted | 21/1/2021 |
| Atezolizumab (Tecentriq®) | In Northern Ireland, atezolizumab (Tecentriq®) is accepted for use with bevacizumab as an option for treating advanced or unresectable hepatocellular carcinoma (HCC) in adults who have not had previous systemic treatment, only if: - they have Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and - the company provides it according to the commercial arrangements For further information see NICE TA666 | NICE TA666 | Accepted | 21/1/2021 |
| Caplacizumab (Cablivi®) | In Northern Ireland, caplacizumab (Cablivi®) is accepted for with plasma exchange and immunosuppression, within its marketing authorisation, as an option for treating an acute episode of acquired thrombotic thrombocytopenic purpura (TTP) in adults, and in young people aged 12 years and over who weigh at least 40 kg. Treatment should be started and supervised by physicians experienced in managing thrombotic microangiopathies. It is recommended only if the company provides caplacizumab according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further informatin see NICE TA667 | NICE TA667 | Accepted | 21/1/2021 |
| Venetoclax (Venclyxto®) | In Northern Ireland, venetoclax (Venclyxto®) is accepted for use with obinutuzumab as an option for untreated chronic lymphocytic leukaemia (CLL) in adults, only if: - there is a 17p deletion or TP53 mutation, or - there is no 17p deletion or TP53 mutation, and fludarabine plus cyclophosphamide and rituximab (FCR), or bendamustine plus rituximab (BR), is unsuitable, and - the company provides the drug according to the commercial arrangement. Venetoclax plus obinutuzumab is accepted for use as an option for untreated CLL in adults, only if: - there is no 17p deletion or TP53 mutation, and FCR or BR IS SUITABLE, and - the conditions in the managed access agreement for venetoclax plus obinutuzumab are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA663 | NICE TA663 | Accepted | 21/1/2021 |
| Upadacitinib (Rinvoq®) | In Northern Ireland, upadacitinib (Rinvoq®) is accepted for use in Northern Ireland as follows: Upadacitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs), only if: • disease is severe (a disease activity score [DAS28] of more than 5.1) and • the company provides upadacitinib according to the commercial arrangement - Upadacitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to or who cannot have other DMARDs, including at least 1 biological DMARD, only if: • disease is severe (a DAS28 of more than 5.1) and • they cannot have rituximab and • the company provides upadacitinib according to the commercial arrangement Upadacitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to rituximab and at least 1 biological DMARD, only if: • disease is severe (a DAS28 of more than 5.1) and • the company provides upadacitinib according to the commercial arrangement Upadacitinib can be used as monotherapy for people who cannot take methotrexate because it is contraindicated or because of intolerance, when the criteria in the above are met. Continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. After an initial response within 6 months, stop treatment if at least a moderate EULAR response is not maintained. For further information see NICE TA665 | NICE TA665 | Accepted | 21/1/2021 |
| Dapagliflozin (Forxiga®) | In Northern Ireland, dapagliflozin (Forxiga®) is accepted for use as an option for treating symptomatic chronic heart failure with reduced ejection fraction in adults, only if it is used as an add-on to optimised standard care. For further information see NICE TA679 | NICE TA679 | Accepted | 21/1/2021 |
| Darolutamide (Nubeqa®) | In Northern Ireland, darolutamide (Nubeqa®) is accepted for use within its marketing authorisation, as an option for treating hormone-relapsed prostate cancer in adults at high risk of developing metastatic disease. It is recommended only if the company provides darolutamide according to the commercial arrangement. For further information see NICE TA660 | NICE TA660 | Accepted | 8/12/2020 |
| Ibrutinib (Imbruvica®) | In Northern Ireland, ibrutinib (Imbruvica®) is accepted for use in combination with rituximab for the treatment of adult patients with Waldenström's macroglobulinaemia who have received at least one prior therapy. This advice applies only in the context of a Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see SMC | SMC | Accepted | 8/12/2020 |
| Daratumumab subcutaneous injection (Darzalex®) | In Northern Ireland, daratumumab subcutaneous injection (Darzalex®) is accepted for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. Use is restricted to use as a fourth-line treatment option This advice applies only in the context of a Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further informtion see SMC | SMC | Accepted | 8/12/2020 |
| Daratumumab subcutaneous injection (Darzalex®) | In Northern Ireland, daratumumab subcutaneous injection (Darzalex®) is accepted for use, in combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received one prior therapy only. This advice applies only in the context of a Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see SMC | SMC | Accepted | 8/12/2020 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is accepted for use as an option for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a combined positive score (CPS) of 1 or more. This is only if: • pembrolizumab is given as a monotherapy • pembrolizumab is stopped at 2 years of uninterrupted treatment, or earlier if disease progresses, and • the company provides pembrolizumab according to the commercial arrangement For further information see NICE TA661 | NICE TA661 | Accepted | 8/12/2020 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) is accepted for use as an option for treating locally advanced or metastatic squamous non-small-cell lung cancer (NSCLC) in adults after chemotherapy, only if: • it is stopped at 2 years of uninterrupted treatment, or earlier if their disease progresses, and • they have not had a PD-1 or PD-L1 inhibitor before. It is recommended only if the company provides nivolumab according to the commercial arrangement For further information see NICE TA655 | NICE TA655 | Accepted | 8/12/2020 |
| Volanesorsen (Waylivra®) | In Northern Ireland, volanesorsen (Waylivra®) is accepted for use, within its marketing authorisation, as an option for treating familial chylomicronaemia syndrome in adults with genetically confirmed familial chylomicronaemia syndrome who are at high risk of pancreatitis, and when response to diet and triglyceride-lowering therapy has been inadequate. It is recommended only if the company provides volanesorsen according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST13 | NICE HST13 | Accepted | 8/12/2020 |
| Isatuximab (Sarclisa®) | In Northern Ireland, isatuximab (Sarclisa®) is accepted for use, with pomalidomide and dexamethasone, as an option for treating relapsed and refractory multiple myeloma in adults who have had lenalidomide and a proteasome inhibitor, and whose disease has progressed on their last treatment, only if: • they have had 3 previous lines of treatment • the conditions in the managed access agreement for isatuximab with pomalidomide and dexamethasone are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA658 | NICE TA658 | Accepted | 8/12/2020 |
| Osimertinib (Tagrisso®) | In Northern Ireland, osimertinib (Tagrisso®) is accepted for use as an option for treating epidermal growth factor receptor (EGFR) T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults, only if: - their disease has progressed after first-line treatment with an EGFR tyrosine kinase inhibitor and - the company provides osimertinib according to the commercial arrangement. For further information see NICE TA653 | NICE TA653 | Accepted | 8/12/2020 |
| Galcanezumab (Emgality®) | In Northern Ireland, galcanezumab (Emgality®) is accepted for use as an option for preventing migraine in adults, only if: • they have 4 or more migraine days a month • at least 3 preventive drug treatments have failed and • the company provides it according to the commercial arrangement . Stop galcanezumab after 12 weeks of treatment if: • in episodic migraine (less than 15 headache days a month) the frequency does not reduce by at least 50% • in chronic migraine (15 headache days a month or more) the frequency does not reduce by at least 30%. A price parity scheme (primary care patient access scheme) for galcanezumab is currently in place in Northern Ireland. This allows galcanezumab to be prescribed in a shared-care arrangement between Secondary and Primary Care in NI. Refer to the Interface Pharmacy website http://www.ipnsm.hscni.net for further information. For further information see NICE TA659 | NICE TA659 | Accepted | 8/12/2020 |
| Siponimod (Mayzent®) | In Northern Ireland, siponimod (Mayzent®) is accepted for use, within its marketing authorisation, as an option for treating secondary progressive multiple sclerosis with evidence of active disease (that is, relapses or imaging features of inflammatory activity) in adults. It is recommended only if the company provides siponimod according to the commercial arrangement. For further information see NICE TA656 | NICE TA656 | Accepted | 8/12/2020 |
| Osimertinib (Tagrisso®) | In Northern Ireland, osimertinib (Tagrisso®) is accepted for use, within its marketing authorisation, for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults. It is recommended only if the company provides osimertinib according to the commercial arrangement For further information see NICE TA654 | NICE TA654 | Accepted | 9/11/2020 |
| Meropenem + vaborbactam (Vaborem®) | In Northern Ireland, meropenem/vaborbactam (Vaborem®) is accepted for use for the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections of the following infections in adults: • Complicated urinary tract infection (cUTI), including pyelonephritis • Complicated intra-abdominal infection (cIAI) • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Meropenem/vaborbactam is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. Use should be restricted to treatment in adults with confirmed carbapenem-resistant Enterobacteriaceae (CRE), which is involved in the production of Klebsiella pneumoniae carbapenemase (KPC) associated with cUTI (including acute pyelonephritis [AP]), cIAI, HAP (including VAP) and bacteraemia that occurs in association with, or is suspected to be associated with any of the infections previously mentioned. Use should be on the advice of local microbiologists or specialists in infectious disease. For further information see SMC | SMC | Accepted | 9/11/2020 |
| Naldemedine (Rizmoic®) | In Northern Ireland, naldemedine (Rizmoic®) is accepted for use, within its marketing authorisation, as an option for treating opioid-induced constipation in adults who have had laxative treatment. For further information see NICE TA651 | NICE TA651 | Accepted | 9/11/2020 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab with axitinib is not accepted within its marketing authorisation, for untreated advanced renal cell carcinoma in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA650 | NICE TA650 | Not Accepted | 12/10/2020 |
| Hydroxycarbamide (Xromi®) | In Northern Ireland, hydroxycarbamide oral solution (Xromi®) is accepted for use for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 2 years of age. Use is restricted to children who are too young to be able to swallow capsules / tablets and adults and adolescents who have difficulty in swallowing solid oral dosage forms. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 12/10/2020 |
| Vedolizumab (Entyvio®) | In Northern Ireland, vedolizumab subcutaneous injection in pre-filled syringe or pre-filled pen (Entyvio®) is accepted for use for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to a TNFα antagonist. This advice applies only in the context of an approved Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicine Consortium. | SMC | Accepted | 12/10/2020 |
| Vedolizumab (Entyvio®) | In Northern Ireland, vedolizumab subcutaneous injection in pre-filled syringe or pre-filled pen (Entyvio®) is accepted for use for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist. This advice applies only in the context of an approved Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 12/10/2020 |
| Entrectinib (Rozlytrek®) | In Northern Ireland, entrectinib (Rozlytrek®) is accepted for use, within its marketing authorisation, as an option for treating ROS1-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had ROS1 inhibitors. It is recommended only if the company provides entrectinib according to the commercial arrangement. For further information see NICE TA643 | NICE TA643 | Accepted | 12/10/2020 |
| Polatuzumab (Polivy®) | In Northern Ireland, polatuzumab vedotin with rituximab and bendamustine is accepted for use, within its marketing authorisation, as an option for treating relapsed or refractory diffuse large B-cell lymphoma in adults who cannot have a haematopoietic stem cell transplant. It is recommended only if the company provides polatuzumab vedotin according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA649 | NICE TA649 | Accepted | 12/10/2020 |
| Treosulfan (Trecondi®) | In Northern Ireland, treosulfan with fludarabine is accepted for use as an option for conditioning treatment before allogeneic haematopoietic stem cell transplant for people with malignant diseases for whom a reduced intensity regimen, such as low-dose busulfan with fludarabine, would be suitable. For further information see NICE TA640 | NICE TA640 | Accepted | 12/10/2020 |
| Avelumab (Bavencio®) | In Northern Ireland, avelumab (Bavencio®) with axitinib is accepted for use as an option for untreated advanced renal cell carcinoma in adults. It is recommended only if the conditions in the managed access agreement for avelumab with axitinib are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA645 | NICE TA645 | Accepted | 12/10/2020 |
| Lixisenatide + insulin glargine (Suliqua®) | In Northern Ireland, lixisenatide + insulin glargine (Suliqua®) is accepted for use in combination with metformin for the treatment of adults with type 2 diabetes mellitus, to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose-lowering medicinal product or with basal insulin. Use is restricted to patients who are uncontrolled on basal insulin (glycosylated haemoglobin [HbA1c] > 7.5% [59mmol/mol]) and for whom a GLP-1 receptor agonist is appropriate as an add-on intensification therapy to basal insulin analogues. This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 12/10/2020 |
| Gilteritinib (Xospata®) | In Northern Ireland, gilteritinib (Xospata®) monotherapy is accepted for use as an option for treating relapsed or refractory FLT3 mutation-positive acute myeloid leukaemia (AML) in adults only if the company provides gilteritinib according to the commercial arrangement. Gilteritinib should not be given as maintenance therapy after a haematopoietic stem cell transplant. For further information see NICE TA642 | NICE TA642 | Accepted | 16/9/2020 |
| Brentuximab (Adcetris®) | In Northern Ireland, brentuximab (Adcetris®) is accepted for use with cyclophosphamide, doxorubicin and prednisone (CHP), within its marketing authorisation, as an option for untreated systemic anaplastic large cell lymphoma in adults. It is only recommended if the company provides brentuximab vedotin according to the commercial arrangement. For further information see NICE TA641 | NICE TA641 | Accepted | 16/9/2020 |
| Atezolizumab (Tecentriq®) | In Northern Ireland, atezolizumab (Tecentriq®) with nab-paclitaxel is accepted for use for treating triple-negative, unresectable, locally advanced or metastatic breast cancer in adults whose tumours express PD-L1 at a level of 1% or more and who have not had previous chemotherapy for metastatic disease. It is recommended only if the company provides atezolizumab according to the commercial arrangement. For further information see NICE TA639 | NICE TA639 | Accepted | 16/9/2020 |
| Atezolizumab (Tecentriq®) | In Northern Ireland, atezolizumab (Tecentriq®) is accepted for use with carboplatin and etoposide is recommended as an option for untreated extensive-stage small-cell lung cancer in adults, only if: - they have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and - the company provides atezolizumab according to the commercial arrangement For further information see NICE TA638 | NICE TA638 | Accepted | 16/9/2020 |
| Entrectinib (Rozlytrek®) | In Northern Ireland, entrectinib (Rozlytrek®) is accepted for use as an option for treating neurotrophic tyrosine receptor kinase (NTRK) fusion positive solid tumours in adults and children 12 years and older if: - the disease is locally advanced or metastatic or surgery could cause severe health problems and - they have not had an NTRK-inhibitor before and - they have no satisfactory treatment options. It is recommended only if the conditions in the managed access agreement for entrectinib are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA644 | NICE TA644 | Accepted | 16/9/2020 |
| Ustekinumab (Stelara®) | In Northern Ireland, ustekinumab (Stelara®) is accepted for use as an option for treating moderately to severely active ulcerative colitis in adults when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment, only if: - a tumour necrosis factor‑alpha inhibitor has failed (that is the disease has responded inadequately or has lost response to treatment) or - a tumour necrosis factor‑alpha inhibitor cannot be tolerated or is not suitable, and - the company provides ustekinumab at the same price or lower than that agreed with the Commercials Medicines Unit. For further information see NICE TA633 | NICE TA633 | Accepted | 16/9/2020 |
| Trastuzumab emtansine (Kadcyla®) | In Northern Ireland, trastuzumab emtansine (Kadcyla®) is accepted for use as an option for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in adults who have residual invasive disease in the breast or lymph nodes after neoadjuvant taxane-based and HER2-targeted therapy. It is recommended only if the company provides trastuzumab emtansine according to the commercial arrangement. For further information see NICE TA632 | NICE TA632 | Accepted | 16/9/2020 |
| Obinutuzumab (Gazyvaro®) | In Northern Ireland, obinutuzumab (Gazyvaro®) with bendamustine followed by obinutuzumab maintenance is accepted for use, within its marketing authorisation, as an option for treating follicular lymphoma that did not respond or progressed up to 6 months after treatment with rituximab or a rituximab-containing regimen. It is recommended only if the company provides it according to the commercial arrangement. For further information see NICE TA629 | NICE TA629 | Accepted | 16/9/2020 |
| Larotrectinib (Vitrakvi®) | In Northern Ireland, larotrectinib (Vitrakvi®) is accepted for use as an option for treating neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in adults and children if: - the disease is locally advanced or metastatic or surgery could cause severe health problems and - they have no satisfactory treatment options. It is accepted for use only if the conditions in the managed access agreement for larotrectinib are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA630 | NICE TA630 | Accepted | 16/9/2020 |
| Lorlatinib (Lorviqua®) | In Northern Ireland, lorlatinib (Lorviqua®) is accepted for use, within its marketing authorisation, as an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults whose disease has progressed after: - alectinib or ceritinib as the first ALK tyrosine kinase inhibitor or - crizotinib and at least 1 other ALK tyrosine kinase inhibitor Lorlatinib is accepted for use only if the company provides lorlatinib according to the commercial arrangement. For further information see NICE TA628 | NICE TA628 | Accepted | 16/9/2020 |
| Ranibizumab (Lucentis®) | In Northern Ireland, ranibizumab (Lucentis®) is not accepted for use in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 16/9/2020 |
| Avatrombopag (Doptelet®) | In Northern Ireland, avatrombopag (Doptelet®) is accepted for use for the treatment of thrombocytopenia in people with chronic liver disease needing a planned invasive procedure. For further information see NICE TA626. | NICE TA626 | Accepted | 14/07/2020 |
| Ranibizumab (Lucentis®) | In Northern Ireland, ranibizumab (Lucentis®) is not accepted for use in the treatment of proliferative diabetic retinopathy in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium. | SMC | Not Accepted | 14/07/2020 |
| Plerixafor (Mozobil®) | In Northern Ireland, plerixafor (Mozobil®) is accepted for use in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children aged 1 year to <18 years with lymphoma or solid malignant tumours, either: - pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilisation with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or - who previously failed to collect sufficient haematopoietic stem cells. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium. | SMC | Accepted | 14/07/2020 |
| Lenalidomide (Revlimid®) | In Northern Ireland,lenalidomide (Revlimid®) is accepted for use with rituximab, within its marketing authorisation, as an option for previously treated follicular lymphoma (grade 1 to 3A) in adults. It is only recommended if the company provides lenalidomide according to the commercial arrangement. For further information see NICE TA627. | NICE TA627 | Accepted | 14/07/2020 |
| Cinacalcet hydrochloride granules 1mg, 2.5mg and 5mg (Mimpara® granules) | In Northern Ireland, cinacalcet granules (Mimpara® granules) are not accepted for use in the management of: 1. Secondary hyperparathyroidism (HPT) - Treatment of secondary HPT in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy - Treatment of secondary HPT in children aged 3 years and older with ESRD on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. 2. Parathyroid carcinoma and primary HPT in adults. Reduction of hypercalcaemia in adult patients with: - parathyroid carcinoma - primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated People currently receiving this formulation of cinacalcet should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium. | SMC | Not Accepted | 14/07/2020 |
| emtricitabine/tenofovir disoproxil (Truvada®) | In Northern Ireland, emtricitabine + tenofovir disoproxil fumarate (Truvada®) is accepted for use, in combination with safer sex practices, for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. For further information see Scottish Medicines Consortium. | SMC | Accepted | 14/07/2020 |
| Dupilumab (Dupixent®) | In Northern Ireland, dupilumab (Dupixent®) is accepted for use in the treatment of moderate-to-severe atopic dermatitis in adolescents who are greater than, or equal to, twelve or less than eighteen years of age who are candidates for systemic therapy. Use is restricted to patients who have had an inadequate response to existing systemic immunosuppressants such as ciclosporin, or in whom such treatment is considered unsuitable. This advice applies only in the context of a Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium. | SMC | Accepted | 10/03/2020 |
| Peginterferon beta-1a (Plegridy®) | In Northern Ireland, peginterferon beta-1a (Plegridy®) is accepted for use, within its marketing authorisation, as an option for treating relapsing–remitting multiple sclerosis in adults. For further information see NICE TA624. | NICE TA624 | Accepted | 10/03/2020 |
| Prasterone (Intarosa®) | In Northern Ireland, prasterone (Intarosa®) is not accepted for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 24/02/2020 |
| Ceftolozane + tazobactam (Zerbaxa®) | In Northern Ireland, ceftolozane + tazobactam (Zerbaxa®) is not accepted for use in adults for the treatment of hospital acquired pneumonia, including ventilator-associated pneumonia.People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. | SMC | Not Accepted | 24/02/2020 |
| Zanamivir (Dectova®) | In Northern Ireland, zanamivir (Dectova®) is accepted for use for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥ 6 months) when: - the patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or - other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient. | SMC | Accepted | 24/02/2020 |
| Patiromer (Veltassa®) | In Northern Ireland, patiromer (Veltassa®) is accepted for use as an option for treating hyperkalaemia in adults only if used: •in emergency care for acute life-threatening hyperkalaemia alongside standard care or •for people with persistent hyperkalaemia and stages 3b to 5 chronic kidney disease or heart failure, if they: - have a confirmed serum potassium level of at least 6.0mmol/litre and - are not taking, or are taking a reduced dosage of, a renin-angiotensin- aldosterone system (RAAS) inhibitor because of hyperkalaemia and - are not on dialysis. For further information see NICE TA623 | NICE TA623 | Accepted | 24/02/2020 |
| Sotagliflozin (Zynquista®) | In Northern Ireland, sotagliflozin (Zynquista®) is accepted for use as an option for treating type 1 diabetes in adults with a body mass index (BMI) of at least 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, only if all of the following apply: • sotagliflozin is given as one 200mg tablet daily • they are on insulin doses of more than 0.5 units/kg of body weight/day • they have completed a structured education programme that is evidence based, quality assured, delivered by trained educators and includes information about diabetic ketoacidosis, such as: − how to recognise its risk factors, signs and symptoms − how and when to monitor blood ketone levels − what actions to take for elevated blood ketones • treatment is started and supervised by a consultant physician specialising in endocrinology and diabetes.Assess haemoglobin A1c (HbA1c) levels after 6 months and regularly after this. Stop sotagliflozin if there has not been a sustained improvement in glycaemic control (that is, a fall in HbA1c level of at least 0.3%). *This drug is not on the NI Formulary for this indication and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices | NICE TA622 | Accepted | 24/02/2020 |
| Ibrutinib (Imbruvica®) | In Northern Ireland, ibrutinib (Imbruvica®) is not accepted for use, in combination with obinutuzumab, for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. | SMC | Not Accepted | 24/02/2020 |
| Ramucirumab (Cyramza®) | In Northern Ireland, ramucirumab (Cyramza®) is not accepted for use as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein of ≥ 400 ng/mL and who have been previously treated with sorafenib.People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. | SMC | Not Accepted | 24/02/2020 |
| Trientine tetrahydrochloride (new formulation) (Cuprior®) | In Northern Ireland, trientine tetrahydrochloride (Cuprior®) is accepted for use for the treatment of Wilson's disease in adults, adolescents and children ≥5 years intolerant to D-penicillamine therapy.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. | SMC | Accepted | 24/02/2020 |
| Glecaprevir + pibrentasvir (Maviret®) | In Northern Ireland, glecaprevir + pibrentasvir (Maviret®) is accepted for use in the treatment of chronic hepatitis C virus (HCV) infection in adolescents aged 12 to ‹ 18 years.This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of glecaprevir/pibrentasvir. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. | SMC | Accepted | 24/02/2020 |
| Cannabidiol with Clobazam (Epidyolex®) | In Northern Ireland, Cannabidiol with Clobazam (Epidyolex®) is accepted for use as an option for treating seizures associated with Lennox-Gastaut syndrome in people aged 2 years and older, only if: - the frequency of drop seizures is checked every 6 months and cannabidiol is stopped if the frequency has not fallen by at least 30% compared with the 6 months before starting treatment - the company provides cannabidiol according to the commercial arrangement. | NICE TA615 | Accepted | 24/02/2020 |
| Cannabidiol with Clobazam (Epidyolex®) | In Northern Ireland, Cannabidiol with Clobazam (Epidyolex®) is accepted for use with clobazam as an option for treating seizures associated with Dravet syndrome in people aged 2 years and older, only if: - the frequency of convulsive seizures is checked every 6 months and cannabidiol is stopped if the frequency has not fallen by at least 30% compared with the 6 months before starting treatment - the company provides cannabidiol according to the commercial arrangement. | NICE TA614 | Accepted | 24/02/2020 |
| Neratinib (Nerlynx®) | In Northern Ireland, neratinib (Nerlynx®) is accepted for use as an option for the extended adjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults who completed adjuvant trastuzumab-based therapy less than 1 year ago only if: - trastuzumab is the only HER2-directed adjuvant treatment they have had, and - if they had neoadjuvant chemotherapy-based regimens, they still had residual invasive disease in the breast or axilla following the neoadjuvant treatment, and - the company provides neratinib according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. | NICE TA612 | Accepted | 24/02/2020 |
| Lusutrombopag (Mulpleo®) | In Northern Ireland, lusutrombopag (Mulpleo®) is accepted for use, within its marketing authorisation, as an option for treating severe thrombocytopenia (that is, a platelet count of below 50,000 platelets per microlitre of blood) in adults with chronic liver disease having planned invasive procedures. For further information see NICE TA617 | NICE TA617 | Accepted | 24/02/2020 |
| Atezolizumab (Tecentriq®) | In Northern Ireland, atezolizumab (Tecentriq®) is not accepted for use, in combination with nab-paclitaxel and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR mutant or ALK-positive NSCLC. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. | SMC | Not Accepted | 24/02/2020 |
| Cerliponase alfa (Brineura®) | In Northern Ireland, cerliponase alfa (Brineura®) is accepted for use as an option for treating neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency, only if the conditions in the managed access agreement are followed.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. | NICE HST12 | Accepted | 24/02/2020 |
| Soliris® | In Northern Ireland, eculizumab (Soliris®) is not accepted for use in the treatment of adults with refractory generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive.People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.For further information seeSMC2236 | SMC | Not Accepted | 17/12/2019 |
| Pentosan polysulphate sodium (Elmiron®) | In Northern Ireland, pentosan polysulphate sodium (Elmiron®) is accepted for use as an option for treating bladder pain syndrome with glomerulations or Hunner’s lesions in adults with urinary urgency and frequency, and moderate to severe pain, only if: - their condition has not responded to an adequate trial of standard oral treatments - it is not offered in combination with bladder instillations - any previous treatment with bladder instillations was not stopped because of lack of response - it is used in secondary care and - the company provides pentosan polysulfate sodium according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.For further information see NICE TA610 | NICE TA610 | Accepted | 17/12/2019 |
| Voretigene neparvovec (Luxturna®) | In Northern Ireland, voretigene neparvovec (Luxturna®) is accepted for use, within its marketing authorisation, as an option for treating RPE65-mediated inherited retinal dystrophies in people with vision loss caused by inherited retinal dystrophy from confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. It is recommended only if the company provides voretigene neparvovec according to the commercial arrangement.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.For further information seeNICE HST11 | NICE HST11 | Accepted | 17/12/2019 |
| Rucaparib (Rubraca®) | In Northern Ireland, rucaparib (Rubraca®) is accepted for use as an option for maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults, only if the conditions in the managed access agreement for rucaparib are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information seeNICE TA611 | NICE TA611 | Accepted | 17/12/2019 |
| Imiquimod (Zyclara®) | In Northern Ireland, imiquimod (Zyclara®) is accepted for use for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate. Use is restricted to the treatment of large field actinic keratosis (>25cm2). For further information seeSMC2211 | SMC | Accepted | 17/12/2019 |
| Glibenclamide (Amglidia®) | In Northern Ireland, glibenclamide (Amglidia®) is not accepted for use in the treatment of neonatal diabetes mellitus, for use in newborns, infants and children. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeSMC2237 | SMC | Not Accepted | 20/11/2019 |
| Eribulin (Halaven®) | In Northern Ireland, eribulin (Halaven®) is not accepted for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeSMC2231 | SMC | Not Accepted | 20/11/2019 |
| Idelalisib (Zydelig®) | In Northern Ireland, idelalisib (Zydelig®) is not accepted for use, within its marketing authorisation, for treating follicular lymphoma that has not responded to 2 prior lines of treatment in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeNICE TA604 | NICE TA604 | Not Accepted | 20/11/2019 |
| Rivaroxaban (Xarelto®) | In Northern Ireland, rivaroxaban plus aspirin is accepted for use, within its marketing authorisation, as an option for preventing atherothrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease who are at high risk of ischaemic events. For further information seeNICE TA607 | NICE TA607 | Accepted | 20/11/2019 |
| Dolutegravir + lamivudine (Dovato®) | In Northern Ireland, dolutegravir + lamivudine (Dovato®) is accepted for use for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information seeSMC2205 | SMC | Accepted | 20/11/2019 |
| Lanadelumab (Takhzyro®) | In Northern Ireland, lanadelumab (Takhzyro®) is accepted for use as an option for preventing recurrent attacks of hereditary angioedema in people aged 12 and older, only if: · they are eligible for preventive C1-esterase inhibitor (C1-INH) treatment in line with NHS England’s commissioning policy, that is, they are having 2 or more clinically significant attacks (as defined in the policy) per week over 8 weeks despite oral preventive therapy, or oral therapy is contraindicated or not tolerated. · the lowest dosing frequency of lanadelumab is used in line with the summary of product characteristics, that is, when the condition is in a stable, attack-free phase, and · the company provides lanadelumab according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.For further information see NICE TA606 | NICE TA606 | Accepted | 20/11/2019 |
| Botulinum A toxin (Xeomin®) | In Northern Ireland, botulinum neurotoxin type A (Xeomin®) is accepted for use, within its marketing authorisation, as an option for treating chronic sialorrhoea caused by neurological conditions in adults. It is recommended only if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information seeNICE TA605 | NICE TA605 | Accepted | 20/11/2019 |
| Ivacaftor + lumacaftor (Orkambi®) | In Northern Ireland, ivacaftor + lumacaftor (Orkambi®) is not accepted for use in the treatment of cystic fibrosis in patients aged 6 years and older (tablets) and aged 2 to 5 years (granules) who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see SMC2182 | SMC | Not Accepted | 10/10/2019 |
| Ivacaftor + tezacaftor (Symkevi®) | In Northern Ireland, ivacaftor + tezacaftor (Symkevi®) is not accepted for use for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.For further information see SMC2183 | SMC | Not Accepted | 10/10/2019 |
| Pomalidomide (Imnovid®) | In Northern Ireland, pomalidomide (Imnovid®) is not accepted for use in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information seeSMC2219 | SMC | Not Accepted | 10/10/2019 |
| Lenalidomide (Revlimid®) | In Northern Ireland, lenalidomide (Revlimid®) is not accepted for use as combination therapy with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeSMC2217 | SMC | Not Accepted | 10/10/2019 |
| Rucaparib (Rubraca®) | In Northern Ireland, rucaparib (Rubraca®) is not accepted for use as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeSMC2221 | SMC | Not Accepted | 10/10/2019 |
| Degarelix (Firmagon®) | In Northern Ireland,degarelix (Firmagon®) is accepted for use as an option for treating advanced hormone-dependent prostate cancer in people with spinal metastases, only if the commissioner can achieve at least the same discounted drug cost as that available to the NHS in June 2016. A price parity scheme (primary care patient access scheme) for degarelix is currently in place in Northern Ireland. This allows degarelix to be prescribed in primary care. For further information seeNICE TA404 | NICE TA404 | Accepted | 10/10/2019 |
| Buprenorphine(Buvidal®) | In Northern Ireland buprenorphine (Buvidal®) is accepted for use for the treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over. Use is restricted to patients in whom methadone is not suitable and for whom the use of buprenorphine is considered appropriate. In Northern Ireland Buvidal® is accepted for use by specialist addiction services only. For further information see SMC2169 | SMC | Accepted | 10/10/2019 |
| Ospemifene (Senshio®) | In Northern Ireland, ospemifene (Senshio®) is accepted for use for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see SMC2170 | SMC | Accepted | 10/10/2019 |
| Patisiran (Onpattro®) | In Northern Ireland, patisiran (Onpattro®) is accepted for use, within its marketing authorisation, as an option for treating hereditary transthyretin amyloidosis in adults with stage 1 and stage 2 polyneuropathy. It is recommended only if the company provides patisiran according to the commercial arrangement.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.For further information seeNICE HST10 | NICE HST10 | Accepted | 10/10/2019 |
| Perampanel oral suspension (Fycompa®) | In Northern Ireland, perampanel (Fycompa®) is not accepted for use as adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeScottish Medicines Consortium | SMC | Not Accepted | 19/09/2019 |
| Golimumab (Simponi®) | In Northern Ireland, golimumab (Simponi®) is not accepted for use, in combination with methotrexate, for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older who have responded inadequately to previous therapy with methotrexate. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeScottish Medicines Consortium | SMC | Not Accepted | 19/09/2019 |
| Brentuximab vedotin (Adcetris®) | In Northern Ireland, brentuximab vedotin (Adcetris®) is not accepted for use as treatment of adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeScottish Medicines Consortium | SMC | Not Accepted | 19/09/2019 |
| Perampanel oral suspension (Fycompa®) | In Northern Ireland, perampanel oral suspension (Fycompa®) is accepted for use for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy. Use is restricted to second-line adjunctive treatment in patients with refractory partial onset epilepsy who are unable to swallow perampanel tablets. Treatment should be initiated only by physicians who have appropriate experience in the treatment of epilepsy. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices See Scottish Medicines Consortium | SMC | Accepted | 19/09/2019 |
| Sodium zirconium cyclosilicate (Lokelma®) | In Northern Ireland, sodium zirconium cyclosilicate (Lokelma®) is accepted for use as an option for treating hyperkalaemia in adults only if used: • in emergency care for acute life-threatening hyperkalaemia alongside standard care, or • for people with persistent hyperkalaemia and chronic kidney disease stage 3b to 5 or heart failure, if they: - have a confirmed serum potassium level of at least 6.0 mmol/litre and - because of hyperkalaemia, are not taking an optimised dosage of renin-angiotensin-aldosterone system (RAAS) inhibitor and - are not on dialysis. Stop sodium zirconium cyclosilicate if RAAS inhibitors are no longer suitable. Technology appraisal guidance [TA599]Published: 04 September 2019 Last updated: 24 January 2022. For further information see NICE TA599 | NICE TA599 | Accepted | 19/09/2019 |
| Rivaroxaban (Xarelto®) | In Northern Ireland, rivaroxaban (Xarelto®) plus aspirin is accepted for use within its marketing authorisation, as an option for preventing atherothrombotic events in adults with coronary artery disease or symptomatic peripheral artery disease who are at high risk of ischaemic events. For further information see NICE TA607 | NICE TA607 | Accepted | 19/09/2019 |
| Fingolimod (Gilenya®) | In Northern Ireland, fingolimod (Gilenya®) is accepted for use as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of patients aged 10 to <18 years: - Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy. or - Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by two or more disabling relapses in one year, and with one or more gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous MRI. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 19/09/2019 |
| Blinatumomab (Blincyto®) | In Northern Ireland, blinatumomab (Blincyto®) is accepted for use as an option for treating Philadelphia-chromosome-negative CD19-positive B-precursor acute lymphoblastic leukaemia in adults with minimal residual disease (MRD) of at least 0.1%, only if: - the disease is in first complete remission and - the company provides blinatumomab according to the commercial arrangement For further information see NICE TA589 | NICE TA589 | Accepted | 19/09/2019 |
| Fluocinolone acetonide (Iluvien®) | In Northern Ireland, fluocinolone acetonide intravitreal implant (Iluvien®) is accepted for use, within its marketing authorisation, as an option for preventing relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. It is recommended only if the company provides it according to the commercial arrangement Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA590 | SMC | Accepted | 19/09/2019 |
| Dacomitinib (Vizimpro®) | In Northern Ireland, dacomitinib (Vizimpro®) is accepted for use, within its marketing authorisation, as an option for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults. It is recommended only if the company provides it according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information seeNICE TA595 | NICE TA595 | Accepted | 19/09/2019 |
| Risankizumab (Skyrizi®) | In Northern Ireland, risankizumab (Skyrizi®) is accepted for use as an option for treating plaque psoriasis in adults, only if: - the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and - the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and - the company provides the drug according to the commercial arrangement. For further information see NICE TA596 | NICE TA596 | Accepted | 19/09/2019 |
| Alirocumab (Praluent®) | Alirocumab (Praluent®) is not accepted for use in Northern Ireland in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. Alirocumab is not accepted for use in adults with established atherosclerotic cardiovascular disease outside the criteria specified in NICE TA394. Alirocumab remains accepted for use in line with NICE TA393. For further information see SMC2201 | SMC | Not Accepted | 23/08/2019 |
| GLP-1 mimetics (for example dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide) | In Northern Ireland, glucagon-like peptide (GLP-1) mimetics (including dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide) are accepted for use in the management of type 2 diabetes in adults in line with the recommendations as laid out in NICE guideline NG28. https://niformulary.hscni.net/ Please refer to for preferred NI Forumulary choices | NICE NG28 | Accepted | 23/08/2019 |
| Rituximab (MabThera®) | In Northern Ireland, rituximab (MabThera®) is not accepted for use for the treatment of patients with moderate to severe pemphigus vulgaris. People currently receiving this drug for this indication should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.For further information see SMC2193 | SMC | Not Accepted | 23/08/2019 |
| Dasatinib (Sprycel®) | In Northern Ireland, dasatinib (Sprycel®) is not accepted for use in the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia in combination with chemotherapy. People currently receiving this drug for this indication should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.For further information see SMC2192 | SMC | Not Accepted | 23/08/2019 |
| Chenodeoxycholic acid Leadiant® | In Northern Ireland, chenodeoxycholic acid Leadiant® is not accepted for use for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis) in infants, children and adolescents aged 1 month to 18 years and adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.For further information see SMC2190 | SMC | Not Accepted | 23/08/2019 |
| Enzalutamide (Xtandi®) | In Northern Ireland, enzalutamide (Xtandi®) is not accepted for use for treating high-risk hormone-relapsed non-metastatic prostate cancer in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.For further information see NICE TA580 | NICE TA580 | Not Accepted | 23/08/2019 |
| Ertugliflozin (Steglatro®) | In Northern Ireland, ertugliflozin (Steglatro®) with metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor is accepted for use as an option for treating type 2 diabetes in adults when diet and exercise alone do not provide adequate glycaemic control, only if: • the disease is uncontrolled with metformin and a DPP-4 inhibitor, and • a sulfonylurea or pioglitazone is not appropriate. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices.For further information seeNICE TA583 | NICE TA583 | Accepted | 23/08/2019 |
| Hydrocortisone -granules in capsules for opening (Alkindi®) | In Northern Ireland, Hydrocortisone -granules in capsules for opening (Alkindi®) is accepted for use as replacement therapy of adrenal insufficiency in infants, and children. Use is restricted to the first-line treatment of infants and young children with adrenal insufficiency aged from birth to less than six years of age for whom hydrocortisone must otherwise be individually prepared by manipulation such as by compounding (or crushing) or by production of special solutions in order to produce age-appropriate doses, or hydrocortisone given as off-label buccal tablets. This advice takes account of the benefits of a patient access scheme that improves the cost-effectiveness of Alkindi®. A price parity scheme (primary care patient access scheme) for Alkindi® is currently in place in Northern Ireland. This allows Alkindi® to be prescribed in primary care.This advice is contingent upon the continuing availability of the price parity scheme in Northern Ireland or a list price that is equivalent or lower. For further information see SMC2088 | SMC | Accepted | 23/08/2019 |
| Atezolizumab (Tecentriq®) | In Northern Ireland, atezolizumab plus bevacizumab, carboplatin and paclitaxel is accepted as an option for metastatic non-squamous non-small-cell lung cancer (NSCLC) in adults: - who have not had treatment for their metastatic NSCLC before and whose PD-L1 tumour proportion score is between 0% and 49% or, - when targeted therapy for epidermal growth factor receptor (EGFR)- positive or anaplastic lymphoma kinase (ALK)-positive NSCLC has failed. It is accepted for use only if: - atezolizumab and bevacizumab are stopped at 2 years of uninterrupted treatment, or earlier if the disease progresses, and - the company provides atezolizumab and bevacizumab according to the commercial arrangements. For further information see NICE TA584 | NICE TA584 | Accepted | 23/08/2019 |
| Ocrelizumab (Ocrevus®) | In Northern Ireland, ocrelizumab (Ocrevus®) is accepted for use, within its marketing authorisation, as an option for treating early primary progressive multiple sclerosis with imaging features characteristic of inflammatory activity in adults. It is recommended only if the company provides it according to the commercial arrangement. For further information see NICE TA585 | NICE TA585 | Accepted | 23/08/2019 |
| Lenalidomide (Revlimid®) | In Northern Ireland, lenalidomide (Revlimid®) is accepted for use as an option for treating multiple myeloma in adults only if: - they have had only 1 previous therapy, which included bortezomib, and - the company provides it according to the commercial arrangement. For further information see NICE TA586 | NICE TA586 | Accepted | 23/08/2019 |
| Inotersen (Tegsedi®) | In Northern Ireland, inotersen (Tegsedi®) is accepted for use, within its marketing authorisation, as an option for treating stage 1 and stage 2 polyneuropathy in adults with hereditary transthyretin amyloidosis. It is accepted for use only if the company provides inotersen according to the commercial arrangement.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST9 | NICE HST9 | Accepted | 23/08/2019 |
| Nusinersen (Spinraza®) | In Northern Ireland, nusinersen (Spinraza®) is accepted for use as an option for treating 5q spinal muscular atrophy (SMA) only if: - people have pre-symptomatic SMA, or SMA types 1, 2 or 3 and - the conditions in the managed access agreement are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA588 | NICE TA588 | Accepted | 23/08/2019 |
| Lenalidomide (Revlimid®) | In Northern Ireland, lenalidomide (Revlimid®) is accepted for use with dexamethasone, as an option for previously untreated multiple myeloma in adults who are not eligible for a stem cell transplant, only if: - thalidomide is contraindicated (including for pre-existing conditions that it may aggravate) or - the person cannot tolerate thalidomide, and - the company provides lenalidomide according to the commercial arrangement. For further information see NICE TA587 | NICE TA587 | Accepted | 23/08/2019 |
| Letermovir (Prevymis®) | In Northern Ireland, letermovir (Prevymis®) is accepted for use, within its marketing authorisation, as an option for preventing cytomegalovirus (CMV) reactivation and disease after an allogeneic haematopoietic stem cell transplant (HSCT) in adults who are seropositive for CMV. It is recommended only if the company provides it according to the commercial arrangement. For further information see NICE TA591 | NICE TA591 | Accepted | 23/08/2019 |
| Doxylamine + pyridoxine (Xonvea®) | In Northern Ireland, doxylamine succinate and pyridoxine hydrochloride (Xonvea®) is not accepted for use in the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 25/06/2019 |
| Cariprazine (Reagila®) | In Northern Ireland, cariprazine (Reagila®) is accepted for use in the treatment of schizophrenia in adult patients. Use is restricted to second-line therapy in patients where predominantly negative symptoms have been identified as an important feature. For further information see Scottish Medicines Consortium | SMC | Accepted | 25/06/2019 |
| Latanoprost + timolol (Fixapost®) | In Northern Ireland, latanoprost + timolol (Fixapost®) is accepted for use for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. Use is restricted to use in patients who have proven sensitivity to preservatives. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices For further information see Scottish Medicines Consortium | SMC | Accepted | 25/06/2019 |
| Dasatinib (Sprycel®) | In Northern Ireland, dasatinib (Sprycel®) is accepted for use for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dasatinib. This advice is contingent upon the continuing availability of the patient access scheme or a list price that is equivalent or lower.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.For further information seeScottish Medicines Consortium | SMC | Accepted | 25/06/2019 |
| Blinatumomab (Blincyto®) | In Northern Ireland, blinatumomab (Blincyto®) is accepted for use as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukaemia which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of blinatumomab. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.For further information seeScottish Medicines Consortium | SMC | Accepted | 25/06/2019 |
| Mepolizumab (Nucala®) | In Northern Ireland, mepolizumab (Nucala®) is accepted for use as an add-on treatment for severe refractory eosinophilic asthma in adolescents and children aged 6 years and older. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of mepolizumab. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 25/06/2019 |
| Brentuximab (Adcetris®) | In Northern Ireland, brentuximab vedotin (Adcetris®) is accepted as an option for treating CD30-positive cutaneous T-cell lymphoma (CTCL) after at least 1 systemic therapy in adults, only if: - they have mycosis fungoides stage IIB or over, primary cutaneous anaplastic large cell lymphoma or Sézary syndrome and - the company provides brentuximab vedotin according to the commercial arrangement For further information see NICE TA577 | NICE TA577 | Accepted | 25/06/2019 |
| Rituximab (MabThera®) | In Northern Ireland, rituximab (MabThera®) is not accepted for use in combination with glucocorticoids, for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium. Please note – The use of rituximab, in combination with glucocorticoids, for the induction of remission in adult patients with anti-neutrophil cytoplasmic antibody [ANCA]-associated vasculitis (severely active granulomatosis with polyangiitis [Wegener's] and microscopic polyangiitis in line with NICE TA308 remains valid. Please refer to NICE TA308 for the conditions of use. | SMC | Not Accepted | 09/05/2019 |
| Epoetin alfa (Eprex®) | In Northern Ireland, epoetin alfa (Eprex®) is not accepted for use in the treatment of symptomatic anaemia (haemoglobin concentration of ≤10g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (<200 mU/mL). People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeScottish Medicines Consortium | SMC | Not Accepted | 09/05/2019 |
| Rufinamide (Inovelon®) | In Northern Ireland, rufinamide (Inovelon®) is accepted for use as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients 1 year to ≤4 years. Use is restricted to patients who have failed treatment with or are intolerant of other antiepileptic drugs. For further information seeScottish Medicines Consortium | SMC | Accepted | 09/05/2019 |
| Testosterone gel (Testavan®) | In Northern Ireland, testosterone gel (Testavan®) is accepted for use as testosterone replacement therapy for adult male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.Use is restricted to patients requiring a transdermal delivery system.For further information seeScottish Medicines Consortium | SMC | Accepted | 09/05/2019 |
| Romiplostim (Nplate®) | In Northern Ireland, romiplostim (Nplate®) is accepted for use in the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Use is restricted to patients with severe symptomatic ITP or patients with a high risk of bleeding.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.For further information seeScottish Medicines Consortium | SMC | Accepted | 09/05/2019 |
| Pertuzumab (Perjeta®) | In Northern Ireland, pertuzumab (Perjeta®) is accepted for use with intravenous trastuzumab and chemotherapy, for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults, only if: - they have lymph-node-positive disease - the company provides it according to the commercial arrangement. For further information see NICE TA569 | NICE TA569 | Accepted | 09/05/2019 |
| Brigatinib (Alunbrig®) | In Northern Ireland, brigatinib (Alunbrig®) is accepted for use, within its marketing authorisation, for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had crizotinib. It is recommended only if the company provides it according to the commercial arrangementFor further information see NICE TA571 | NICE TA571 | Accepted | 09/05/2019 |
| Tildrakizumab (Ilumetri®) | In Northern Ireland, tildrakizumab (Ilumetri®) is accepted for use as an option for treating plaque psoriasis in adults, only if: - the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and - the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and - the company provides the drug according to the commercial arrangement For further information see NICE TA575 | NICE TA575 | Accepted | 09/05/2019 |
| Certolizumab (Cimzia®) | In Northern Ireland, certolizumab (Cimzia®) is accepted for use as an option for treating plaque psoriasis in adults, only if: - the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and - the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and - the lowest maintenance dosage of certolizumab pegol is used (200 mg every 2 weeks) after the loading dosage and - the company provides the drug according to the commercial arrangement For further information see NICE TA574 | NICE TA574 | Accepted | 09/05/2019 |
| Migalastat (Galafold®) | In Northern Ireland, migalastat is accepted for use, within its marketing authorisation, as an option for treating Fabry disease in people over 16 years of age with an amenable mutation, only if migalastat is provided with the discount agreed in the patient access scheme, and only if enzyme replacement therapy (ERT) would otherwise be offered. Criteria for starting and stopping ERT for Fabry disease are described in the UK adult Fabry disease standard operating procedures (Hughes et al. 2013). With the discount provided in the patient access scheme, migalastat has a lower total cost than ERT, and potentially provides greater health benefits than ERT. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST4 | NICE HST4 | Accepted | 09/05/2019 |
| Eliglustat (Cerdelga®) | In Northern Ireland, eliglustat is accepted for use within its marketing authorisation for treating type 1 Gaucher disease, that is, for long-term treatment in adults who are cytochrome P450 2D6 poor, intermediate or extensive metabolisers. Eliglustat is only recommended when the company provides it with the discount agreed in the patient access scheme. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST5 | NICE HST5 | Accepted | 09/05/2019 |
| Strimvelis | In Northern Ireland, strimvelis is accepted for use, within its marketing authorisation, as an option for treating adenosine deaminase deficiency–severe combined immunodeficiency (ADA–SCID) when no suitable human leukocyte antigen-matched related stem cell donor is available.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.For further information see NICE HST7 | NICE HST7 | Accepted | 09/05/2019 |
| Burosumab (Crysvita®) | In Northern Ireland, Burosumab is accepted for use within its marketing authorisation, for treating X‑linked hypophosphataemia (XLH) with radiographic evidence of bone disease in children aged 1 year and over, and in young people with growing bones. It is recommended only if the company provides burosumab according to the commercial arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST8 | NICE HST8 | Accepted | 09/05/2019 |
| Darvadstrocel (Alofisel®) | In Northern Ireland, darvadstrocel (Alofisel®) is not accepted for use, within its marketing authorisation, for previously treated complex perianal fistulas in adults with non-active or mildly active luminal Crohn’s disease. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA556 | NICE TA556 | Not Accepted | 26/03/2019 |
| Dexmedetomidine (Dexdor®) | In Northern Ireland, dexmedetomidine (Dexdor®) is not accepted for use in the sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.For further information see Scottish Medicines Consortium | SMC | Not Accepted | 26/03/2019 |
| Ertugliflozin (Steglatro®) | In Northern Ireland, Ertugliflozin as monotherapy is accepted for use for treating type 2 diabetes in adults for whom metformin is contraindicated or not tolerated and when diet and exercise alone do not provideadequate glycaemic control, only if: • a dipeptidyl peptidase 4 (DPP 4) inhibitor would otherwise be prescribed and • a sulfonylurea or pioglitazone is not appropriate Ertugliflozin in a dual therapy regimen in combination with metformin is accepted for use as an option for treating type 2 diabetes, only if: • a sulfonylurea is contraindicated or not tolerated or • the person is at significant risk of hypoglycaemia or its consequences If patients and their clinicians consider ertugliflozin to be 1 of a range of suitable treatments including canagliflozin, dapagliflozin and empagliflozin, the least expensive should be chosen. Note: This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see NICE TA572 | NICE TA572 | Accepted | 26/03/2019 |
| Eslicarbazepine (Zebinix®) | In Northern Ireland, eslicarbazepine (Zebinix®) is accepted for use as adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation. Use is restricted to patients with highly refractory epilepsy who have been heavily pre-treated and remain uncontrolled with existing anti-epileptic drugs. For further information see Scottish Medicines Consortium | SMC | Accepted | 26/03/2019 |
| Benralizumab (Fasenra®) | In Northern Ireland, benralizumab (Fasenra®) is accepted for use as an add-on therapy as an option for treating severe eosinophilic asthma that is inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids and long-acting beta-agonists, only if: - the person has agreed to and followed the optimised standard treatment plan and - they have an eosinophil count of 300 cells per microlitre or more, and either are taking maintenance oral corticosteroids or have had 4 or more exacerbations in the past 12 months, or both (that is, are eligible for mepolizumab), or - they have an eosinophil count of 400 cells per microlitre or more with 3 or more exacerbations in the past 12 months (that is, are eligible for reslizumab). Benralizumab is recommended only if the company provides it according to the commercial arrangement. For further information see NICE TA565 | NICE TA565 | Accepted | 26/03/2019 |
| Abemaciclib (Verzenios®) | In Northern Ireland, abemaciclib (Verzenios®) with an aromatase inhibitor is accepted for use, within its marketing authorisation, as an option for treating locally advanced or metastatic, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer as first endocrine-based therapy in adults. Abemaciclib is recommended only if the company provides it according to the commercial arrangement.For further information see NICE TA563 | NICE TA563 | Accepted | 26/03/2019 |
| Venetoclax (Venclyxto®) | In Northern Ireland, venetoclax (Venclyxto®) with rituximab is accepted for use, within its marketing authorisation, as an option for treating chronic lymphocytic leukaemia in adults who have had at least 1 previous therapy. It is recommended only if the company provides it according to the commercial arrangement.For further information see NICE TA561 | NICE TA561 | Accepted | 26/03/2019 |
| Encorafenib (Braftovi®) | In Northern Ireland, encorafenib with binimetinib is accepted for use, within its marketing authorisation, as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma in adults. It is recommended only if the company provides encorafenib and binimetinib according to the commercial arrangements.For further information see NICE TA562 | NICE TA562 | Accepted | 26/03/2019 |
| Tisagenlecleucel (Kymriah®) | In Northern Ireland, tisagenlecleucel (Kymriah®) is accepted for use as an option for treating relapsed or refractory diffuse large B-cell lymphoma in adults after 2 or more systemic therapies, only if the conditions in the managed access agreement are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA567 | NICE TA567 | Accepted | 26/03/2019 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is not accepted as monotherapy for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a ≥50% TPS and progressing on or after platinum-containing chemotherapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 14/02/2019 |
| Tiotropium bromide (Spiriva® Respimat) | In Northern Ireland, tiotropium bromide (Spiriva® Respimat) is accepted for use as add-on maintenance bronchodilator treatment in patients aged 6 years and older with severe asthma who experienced one or more severe asthma exacerbations in the preceding year. For further information see Scottish Medicines Consortium | SMC | Accepted | 14/02/2019 |
| Evolocumab (Repatha) | In Northern Ireland, evolocumab (Repatha®) is not accepted for use in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: - in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium Evolocumab is not accepted for use in adults with established atherosclerotic cardiovascular disease outside the criteria specified in NICE TA394. Evolocumab remains accepted for use in line with NICE TA394 | SMC | Not Accepted | 25/01/2019 |
| Ciclosporin (Verkazia®) | In Northern Ireland, ciclosporin (Verkazia®) is accepted for use in the treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents. For further information seeScottish Medicines Consortium | SMC | Accepted | 25/01/2019 |
| Fosaprepitant (Ivemend®) | In Northern Ireland, fosaprepitant (Ivemend 150mg®) is accepted for use for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in paediatric patients aged 6 months to 17 years. Fosaprepitant is given as part of a combination therapy. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information seeScottish Medicines Consortium | SMC | Accepted | 25/01/2019 |
| Tisagenlecleucel-T (Kymriah®) | In Northern Ireland, Tisagenlecleucel-T (Kymriah®) is accepted for use as an option for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged up to 25 years, only if the conditions in the managed access agreement are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information seeNICE TA554 | NICE TA554 | Accepted | 25/01/2019 |
| Tofacitinib (Xeljanz®) | In Northern Ireland, tofacitinib (Xeljanz®) is accepted for use, within its marketing authorisation, as an option for treating moderately to severely active ulcerative colitis in adults when conventional therapy or a biological agent cannot be tolerated or the disease has responded inadequately or lost response to treatment. It is recommended only if the company provides tofacitinib with the discount agreed in the commercial arrangement. For further information seeNICE TA547 | NICE TA547 | Accepted | 25/01/2019 |
| Regorafenib (Stivarga®) | In Northern Ireland, regorafenib (Stivarga®) is accepted for use as an option for treating advanced unresectable hepatocellular carcinoma in adults who have had sorafenib, only if:they have Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 andthe company provides it according to the commercial arrangement.For further information see NICE TA555 | NICE TA555 | Accepted | 25/01/2019 |
| Lenalidomide (Revlimid®) | In Northern Ireland, lenalidomide (Revlimid®) is not accepted for use as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.For further information seeScottish Medicines Consortium | SMC | Not Accepted | 18/12/2018 |
| Sirolimus (Rapamune®) | In Northern Ireland, sirolimus (Rapamune®) is not accepted for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop For further information seeScottish Medicines Consortium | SMC | Not Accepted | 18/12/2018 |
| Vandetanib (Capresla®) | In Northern Ireland, vandetanib (Capresla®) is not accepted for use for treating aggressive and symptomatic medullary thyroid cancer in adults with unresectable, locally advanced or metastatic disease. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeNICE TA550 | NICE TA550 | Not Accepted | 18/12/2018 |
| Padeliporfin (Tookad®) | In Northern Ireland, padeliporfin (Tookad®) is not accepted for use, within its marketing authorisation, for untreated, unilateral, low-risk prostate cancer in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seeNICE TA546 | NICE TA546 | Not Accepted | 18/12/2018 |
| Ipilimumab (Yervoy®) | In Northern Ireland, ipilimumab (Yervoy®) is accepted for use as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adolescents 12 years of age and older. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ipilimumab. This advice is contingent upon the continuing availability of the patient access scheme or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information seeScottish Medicines Consortium | SMC | Accepted | 18/12/2018 |
| Lenvatinib (Lenvima®) | In Northern Ireland, lenvatinib (Lenvima®) is accepted for use as an option for untreated, advanced, unresectable hepatocellular carcinoma in adults, only if:they have Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 andthe company provides it according to the commercial arrangement.For further information see NICE TA551 | NICE TA551 | Accepted | 18/12/2018 |
| Liposomal cytarabine–daunorubicin (Vyxeos®) | In Northern Ireland, liposomal cytarabine–daunorubicin is accepted for use, within its marketing authorisation, as an option for untreated therapy-related acute myeloid leukaemia or acute myeloid leukaemia with myelodysplasia-related changes in adults. It is recommended only if the company provides it according to the commercial arrangement. For further information seeNICE TA552 | NICE TA552 | Accepted | 18/12/2018 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is • not accepted for use for treating relapsed or refractory classical Hodgkin lymphoma in adults who have had autologous stem cell transplant and brentuximab vedotin. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. In Northern Ireland, pembrolizumab (Keytruda®) is • accepted for use as an option for treating relapsed or refractory classical Hodgkin lymphoma in adults who have had brentuximab vedotin and cannot have autologous stem cell transplant, only if: - pembrolizumab is stopped after 2 years of treatment or earlier if the person has a stem cell transplant or the disease progresses and - the conditions in the managed access agreement for pembrolizumab are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis For further information see NICE TA540 | NICE TA540 | Not Accepted | 10/12/2018 |
| Crizotinib (Xalkori®) | In Northern Ireland, crizotinib (Xalkori®) is accepted for use as an option for treating ROS1‑positive advanced non-small-cell lung cancer (NSCLC) in adults, only if the conditions in the managed access agreement are followed. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see or further information see NICE TA529 | NICE TA529 | Accepted | 10/12/2018 |
| Denosumab (Prolia®) | In Northern Ireland, denosumab (Prolia®) is not accepted for use in the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 12/11/2018 |
| Bictegravir + emtricitabine + tenofovir alafenamide (Biktarvy®) | In Northern Ireland, bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy®) is accepted for use in the treatment of adults infected with human immunodeficiency virus 1 (HIV-1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of bictegravir / emtricitabine / tenofovir alafenamide. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 12/11/2018 |
| Dolutegravir + rilpivirine (Juluca®) | In Northern Ireland, dolutegravir / rilpivirine film-coated tablet (Juluca®) is accepted for use in the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase inhibitor. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dolutegravir/rilpivirine. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 12/11/2018 |
| Dabrafenib (Tafinlar®) with trametinib (Mekinist®) | In Northern Ireland, dabrafenib (Tafinlar®) with trametinib (Mekinist®) is accepted for use within its marketing authorisation, as an option for the adjuvant treatment of resected stage III BRAF V600 mutation-positive melanoma in adults. It is recommended only if the company provides dabrafenib and trametinib with the discounts agreed in the commercial arrangements. For further information see NICE TA544 | NICE TA544 | Accepted | 12/11/2018 |
| Tofacitinib (Xeljanz®) | In Northern Ireland, tofacitinib (Xeljanz®) is accepted for use, with methotrexate, as an option for treating active psoriatic arthritis in adults, only if: - it is used as described in NICE’s technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis, or - the person has had a tumour necrosis factor (TNF)-alpha inhibitor but their disease has not responded within the first 12 weeks or has stopped responding after 12 weeks, or - TNF-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE’s technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis). Tofacitinib is only recommended if the company provides it according to the commercial arrangement. For further information see NICE TA543 | NICE TA543 | Accepted | 12/11/2018 |
| Gemtuzumab ozogamicin (Mylotarg®) | In Northern Ireland, gemtuzumab ozogamicin (Mylotarg®), with daunorubicin and cytarabine, is accepted for use as an option for untreated CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia, in people 15 years and over, only if: - they start induction therapy when either the cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (that is because the test was unsuccessful) or when their cytogenetic test results are not yet available and - they start consolidation therapy when their cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (because the test was unsuccessful) and - the company provides gemtuzumab ozogamicin according to the commercial arrangement. For further information see NICE TA545 | NICE TA545 | Accepted | 12/11/2018 |
| Denosumab (Xgeva®) | In Northern Ireland, denosumab (Xgeva®) is not accepted for use for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with haematological malignancies involving bone. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 02/11/2018 |
| Bosutinib (Bosulif®) | In Northern Ireland, bosutinib (Bosulif®) is not accepted for use for the treatment of adult patients with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukaemia. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 02/11/2018 |
| Glycerol phenylbutyrate (Ravicti®) | In Northern Ireland, glycerol phenylbutyrate (Ravicti®) is accepted for use as adjunctive therapy for chronic management of adult and paediatric patients ≥2 months of age with urea cycle disorders (UCDs) including deficiencies of carbamoyl phosphate synthase I (CPS), ornithine carbamoyltransferase (OTC), argininosuccinate synthetase (ASS), argininosuccinate lyase (ASL), arginase I (ARG) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (HHH) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate must be used with dietary protein restriction and, in some cases, dietary supplements (e.g. essential amino acids, arginine, citrulline, protein-free calorie supplements). This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of glycerol phenylbutyrate. Ravicti can be purchased at the agreed price in Northern Ireland and can, therefore, be prescribed and dispensed in Primary Care. For further information see Scottish Medicines Consortium | SMC | Accepted | 02/11/2018 |
| Ixekizumab (Taltz®) | In Northern Ireland, ixekizumab (Taltz®) is accepted for use either alone, or with methotrexate, as an option for treating active psoriatic arthritis in adults, only if: - it is used as described in NICE’s technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis or - the person has had a tumour necrosis factor (TNF)-alpha inhibitor but their disease has stopped responding after the first 12 weeks or -TNF-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE's technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis). Ixekizumab is only accepted for use if the company provides it according to the commercial arrangement. For further information see NICE TA537 | NICE TA537 | Accepted | 02/11/2018 |
| Inotuzumab ozogamicin (Besponsa®) | In Northern Ireland, inotuzumab ozogamicin (Besponsa®) is accepted for use within its marketing authorisation, as an option for treating relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia in adults. People with relapsed or refractory Philadelphia chromosome positive disease should have had at least 1 tyrosine kinase inhibitor. Inotuzumab ozogamicin is recommended only if the company provides it according to the commercial arrangement. For further information see NICE TA541 | NICE TA541 | Accepted | 02/11/2018 |
| Cabozantinib (Cabometyx®) | In Northern Ireland, cabozantinib (Cabometyx®) is accepted, within its marketing authorisation, for adults with untreated advanced renal cell carcinoma that is intermediate- or poor-risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria. It is recommended only if the company provides cabozantinib according to the commercial arrangement. For further information see NICE TA542 | NICE TA542 | Accepted | 02/11/2018 |
| Conestat alfa (Ruconest®) | In Northern Ireland, conestat alfa (Ruconest®) is accepted for use for the treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of conestat alfa. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 02/11/2018 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) is not accepted for use as an option for treating locally advanced unresectable or metastatic urothelial carcinoma in adults who have had platinum-containing therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA530 | NICE TA530 | Not Accepted | 21/09/2018 |
| Raltegravir (Isentress®) | In Northern Ireland, raltegravir (Isentress®) is not accepted for use in combination with other anti-retroviral medicinal products in the treatment of human immunodeficiency virus in neonates. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 21/09/2018 |
| Cenegermin (Oxervate®) | In Northern Ireland, cenegermin (Oxervate®) is not accepted for use for treating moderate or severe neurotrophic keratitis in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA532 | NICE TA532 | Not Accepted | 21/09/2018 |
| Ledipasvir + sofosbuvir (Harvoni®) | In Northern Ireland, ledipasvir + sofosbuvir (Harvoni®) is accepted for use in the treatment of chronic hepatitis C (CHC) in adolescents aged 12 to <18 years. Use is restricted to patients with genotype 1 and 4 CHC only. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 21/09/2018 |
| Everolimus dispersible tablets (Votubia®) | In Northern Ireland, Everolimus dispersible tablets (Votubia®) are accepted for use as adjunctive treatment of patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex (TSC). This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of everolimus. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 21/09/2018 |
| Telotristat ethyl (Xermelo®) | In Northern Ireland, telotristat ethyl (Xermelo®) is accepted for use in the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue therapy in adults inadequately controlled by somatostatin analogue therapy. Use is restricted to patients with CS diarrhoea who experience an average of four or more bowel motions per day, despite receiving somatostatin analogue therapy. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of telotristat ethyl. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 21/09/2018 |
| 177 Lu-dotatate (lutetium) (Lutathera®) | In Northern Ireland, lutetium (177Lu) oxodotreotide (Lutathera®) is accepted for use as an option for treating unresectable or metastatic, progressive, well-differentiated (grade 1 or grade 2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (NETs) in adults. It is recommended only if the company provides it according to the commercial arrangement. For further information see NICE TA539 | NICE TA539 | Accepted | 21/09/2018 |
| Ocrelizumab (Ocrevus®) | In Northern Ireland, ocrelizumab (Ocrevus®) is accepted for use as an option for treating relapsing–remitting multiple sclerosis in adults with active disease defined by clinical or imaging features, only if: - alemtuzumab is contraindicated or otherwise unsuitable and - the company provides ocrelizumab according to the commercial arrangement. For further information see NICE TA533 | NICE TA533 | Accepted | 21/09/2018 |
| Dupilumab (Dupixent®) | In Northern Ireland, dupilumab (Dupixent®), in combination with topical corticosteroids, is accepted for use as an option for treating moderate to severe atopic dermatitis in adults, only if: - the disease has not responded to at least 1 other systemic therapy, such as ciclosporin, methotrexate, azathioprine and mycophenolate mofetil, or these are contraindicated or not tolerated - the company provides dupilumab according to the commercial arrangement. Stop dupilumab at 16 weeks if the atopic dermatitis has not responded adequately. An adequate response is: - at least a 50% reduction in the Eczema Area and Severity Index score (EASI 50) from when treatment started and - at least a 4-point reduction in the Dermatology Life Quality Index (DLQI) from when treatment started. For further information see NICE TA534 | NICE TA534 | Accepted | 21/09/2018 |
| Alectinib (Alecensa®) | In Northern Ireland, alectinib (Alecensa®) is accepted for use within its marketing authorisation, as an option for untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults. It is recommended only if the company provides alectinib according to the commercial arrangement. For further information see NICE TA536 | NICE TA536 | Accepted | 21/09/2018 |
| Dinutuximab beta (Qarziba®) | In Northern Ireland, dinutuximab beta (Qarziba®) is accepted for use as an option for treating high-risk neuroblastoma in people aged 12 months and over whose disease has at least partially responded to induction chemotherapy, followed by myeloablative therapy and stem cell transplant, only if: - they have not already had anti-GD2 immunotherapy and - the company provides dinutuximab beta according to the commercial arrangement. For further information see NICE TA538 | NICE TA538 | Accepted | 21/09/2018 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®) is accepted for use as an option for untreated PD-L1-positive metastatic non-small-cell lung cancer (NSCLC) in adults whose tumours express PD-L1 (with at least a 50% tumour proportion score) and have no epidermal growth factor receptor- or anaplastic lymphoma kinase-positive mutations, only if: - pembrolizumab is stopped at 2 years of uninterrupted treatment, or earlier in the event of disease progression and - the company provides pembrolizumab according to the commercial access agreement. For further information see NICE TA531 | NICE TA531 | Accepted | 21/09/2018 |
| Sorafenib (Nexavar®) and Lenvatinib (Lenvima®) | In Northern Ireland lenvatinib and sorafenib are accepted as options for treating progressive, locally advanced or metastatic differentiated thyroid cancer (papillary, follicular or Hürthle cell) in adults whose disease does not respond to radioactive iodine, only if: - they have not had a tyrosine kinase inhibitor before or - they have had to stop taking a tyrosine kinase inhibitor within 3 months of starting it because of toxicity (specifically, toxicity that cannot be managed by dose delay or dose modification). Lenvatinib and sorafenib are recommended only if the companies provide them according to the commercial arrangements. For further information see NICE TA535 | NICE TA535 | Accepted | 21/09/2018 |
| Eslicarbazepine (Zebinix®) | In Northern Ireland, eslicarbazepine (Zebinix®) is not accepted for use as monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 10/08/2018 |
| Brentuximab vedotin (Adcetris®) | In Northern Ireland, brentuximab vedotin (Adcetris®) is not accepted for use in the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 10/08/2018 |
| Interferon beta-1b (Betaferon) | In Northern Ireland, Interferon beta-1b (Betaferon) is not accepted for use within its marketing authorisation as an option for treating multiple sclerosis. For those medicines that have been accepted for use, where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For those patients on Betaferon®, people currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA527 | NICE TA527 | Not Accepted | 10/08/2018 |
| Fluticasone + formoterol (Flutiform K-Haler®) | In Northern Ireland, Fluticasone + formoterol (Flutiform K-Haler®) is accepted for use for the regular treatment of asthma where the use of a combination product [an inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA)] is appropriate: - For patients not adequately controlled with ICS as ‘as required’ inhaled short-acting β2-agonist or - For patients already adequately controlled on both ICS and a LABA. Flutiform k-haler is a breath-actuated inhaler that is bioequivalent to Flutiform metered-dose inhaler (pMDI) and costs the same. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 10/08/2018 |
| Progesterone (Lubion®) | In Northern Ireland, Progesterone (Lubion®) solution for injection is accepted for use in adults for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women who are unable to use or tolerate vaginal preparations. For further information see Scottish Medicines Consortium | SMC | Accepted | 10/08/2018 |
| Selexipag (Uptravi®) | In Northern Ireland, selexipag (Uptravi®) is accepted for use in Northern Ireland for the treatment of pulmonary arterial hypertension (PAH) in adult patients. Use is restricted to combination therapy in a sub-population of patients with PAH specifically those in WHO FC III who are insufficiently controlled with an ERA and a PDE-5 inhibitor and who would be considered for treatment with inhaled iloprost. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of selexipag. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 10/08/2018 |
| Icatibant (Firazyr®) | In Northern Ireland, icatibant (Firazyr®) is accepted for use in the symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of icatibant. This advice is contingent upon the continuing availability of the Patient Access Scheme in Northern Ireland. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 10/08/2018 |
| Brentuximab vedotin (Adcetris®) | In Northern Ireland, brentuximab vedotin (Adcetris®) is accepted as an option for treating CD30-positive Hodgkin lymphoma in adults with relapsed or refractory disease, only if: - they have already had autologous stem cell transplant or - they have already had at least 2 previous therapies when autologous stem cell transplant or multi-agent chemotherapy are not suitable and - the company provides brentuximab vedotin according to the commercial arrangement. For further information see NICE TA524 | NICE TA524 | Accepted | 10/08/2018 |
| Midostaurin (Rydapt®) | In Northern Ireland, midostuarin (Rydapt®) is accepted for use, within its marketing authorisation, as an option in adults for treating newly diagnosed acute FLT3-mutation-positive myeloid leukaemia with standard daunorubicin and cytarabine as induction therapy, with high-dose cytarabine as consolidation therapy, and alone after complete response as maintenance therapy. It is recommended only if the company provides midostaurin with the discount agreed in the patient access scheme. For further information see NICE TA523 | NICE TA523 | Accepted | 10/08/2018 |
| Arsenic (Trisenox®) | In Northern Ireland, arsenic trioxide (Trisenox®) is accepted for use within its marketing authorisation, as an option for inducing remission and consolidation in acute promyelocytic leukaemia (characterised by the presence of the t[15;17] translocation and/or the PML/RAR-alpha gene) in adults with: - untreated, low-to-intermediate risk disease (defined as a white blood cell count of 10x103 per microlitre or less), when given with all-trans-retinoic acid (ATRA) - relapsed or refractory disease, after a retinoid and chemotherapy. For further information see NICE TA526 | NICE TA526 | Accepted | 10/08/2018 |
| Interferon beta, glatiramer acetate | In Northern Ireland, beta interferons and glatiramer acetate for the treatment of multiple sclerosis are accepted for use as follows: Interferon beta-1a is accepted as an option for treating multiple sclerosis, only if: - the person has relapsing–remitting multiple sclerosis and - the companies provide it with the discounts agreed in the patient access schemes. Interferon beta-1b (Extavia®) is accepted as an option for treating multiple sclerosis, only if: - the person has relapsing–remitting multiple sclerosis and has had 2 or more relapses within the last 2 years or - the person has secondary progressive multiple sclerosis withcontinuing relapses and - the company provides it with the discount agreed in the patient access scheme. Glatiramer acetate is recommended as an option for treating multiple sclerosis, only if: - the person has relapsing–remitting multiple sclerosis and - the company provides it with the discount agreed in the patient access scheme. For further information see NICE TA527 | NICE TA527 | Accepted | 10/08/2018 |
| Guselkumab (Tremfya®) | In Northern Ireland, guselkumab (Tremfya®) is accepted for use as an option for treating plaque psoriasis in adults, only if: - the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and - the disease has not responded to other systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet A radiation), or these options are contraindicated or not tolerated and - the company provides the drug with the discount agreed in the patient access scheme. For further information see NICE TA521 | NICE TA521 | Accepted | 10/08/2018 |
| Atezolizumab (Tecentriq®) | In Northern Ireland, atezolizumab (Tecentriq®) is accepted for use as an option for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy, only if: - atezolizumab is stopped at 2 years of uninterrupted treatment or earlier if the disease progresses, and - the company provides atezolizumab with the discount agreed in the patient access scheme. For further information see NICE TA525 | NICE TA525 | Accepted | 10/08/2018 |
| Asparaginase recombinant (Spectrila®) | In Northern Ireland, asparaginase (Spectrila®) is accepted for use as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 14/06/2018 |
| Atezolizumab (Tecentriq®) | In Northern Ireland, atezolizumab (Tecentriq®) is accepted for use as an option for treating locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults who have had chemotherapy (and targeted treatment if they have an EGFR- or ALK-positive tumour), only if: - atezolizumab is stopped at 2 years of uninterrupted treatment or earlier if the disease progresses, and - the company provides atezolizumab with the discount agreed in the patient access scheme. For further information see NICE TA520 | NICE TA520 | Accepted | 14/06/2018 |
| Sofosbuvir (Sovaldi®) | In Northern Ireland, sofosbuvir (Sovaldi®) is not accepted for use for the treatment of chronic hepatitis C in adolescents aged 12 to <18 years. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 04/05/2018 |
| Nilotinib (Tasigna®) | In Northern Ireland, nilotinib (Tasigna®) is not accepted for use in: - paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase - paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 04/05/2018 |
| Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®) | In Northern Ireland, Genvoya® is not accepted for use in the treatment of HIV-1 infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 04/05/2018 |
| Dexamethasone (Neofordex®) | In Northern Ireland, dexamethasone (Neofordex®) is not accepted for use in adults for the treatment of symptomatic multiple myeloma in combination with other medicinal products. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 04/05/2018 |
| Botulinum A toxin (Dysport®) | In Northern Ireland, botulinum A toxin (Dysport®) is not accepted for use for the symptomatic treatment of focal spasticity of lower limbs in adults affecting the ankle joint due to stroke or traumatic brain injury. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 04/05/2018 |
| Ciprofloxacin ear drops (Cetraxal®) | In Northern Ireland, ciprofloxacin ear drops (Cetraxal®) are accepted for use in the treatment of acute otitis externa in adults and children older than 1 year with an intact tympanic membrane, caused by ciprofloxacin susceptible microorganisms. Use is restricted to situations when off-label or unlicensed ciprofloxacin formulations would otherwise be used. For further information see Scottish Medicines Consortium | SMC | Accepted | 04/05/2018 |
| Tocilizumab (RoActemra®) | In Northern Ireland, tocilizumab (RoActemra®) is accepted for use, when used with a tapering course of glucocorticoids (and when used alone after glucocorticoids), as an option for treating giant cell arteritis in adults, only if: - they have relapsing or refractory disease - they have not already had tocilizumab - tocilizumab is stopped after 1 year of uninterrupted treatment at most and - the company provides it with the discount agreed in the patient access scheme. For further information see NICE TA518 | NICE TA518 | Accepted | 04/05/2018 |
| Parathyroid hormone (Natpar®) | In Northern Ireland, parathyroid hormone (Natpar®) is not accepted for use in Northern Ireland as adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 03/05/2018 |
| lvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (Stribild®) | In Northern Ireland, Stribild® is not accepted for use in the treatment of HIV‑1 infection in adolescents aged 12 to <18 years weighing≥35kg who are infected with HIV‑1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild® and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil fumarate. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 20/04/2018 |
| Pasireotide (Signifor®) | In Northern Ireland, pasireotide (Signifor®) is not accepted for use in the treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 20/04/2018 |
| Peginterferon alfa-2a (Pegasys®) | In Northern Ireland, peginterferon alfa-2a (Pegasys®) is not accepted for use in the treatment of hepatitis B envelope antigen (HBeAg)-positive chronic hepatitis B in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 20/04/2018 |
| Eribulin (Halaven®) | In Northern Ireland, eribulin (Halaven®) is not accepted for use for treating locally advanced or metastatic breast cancer in adults who have had only 1 chemotherapy regimen. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA515 | NICE TA515 | Not Accepted | 20/04/2018 |
| 5-aminolaevulinic acid gel (Ameluz®) | In Northern Ireland, 5-aminolaevulinic acid (Ameluz®) gel is accepted for use in the treatment of adults with superficial and / or nodular basal cell carcinoma (BCC) unsuitable for surgical treatment due to possible treatment-related morbidity and / or poor cosmetic outcome. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC 1260/17 | Accepted | 20/04/2018 |
| Lopinavir + ritonavir (Kaletra®) | In Northern Ireland, lopinavir + ritonavir (Kaletra®) oral solution is accepted for use in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected children, adolescents and adults aged from 14 days and older. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 20/04/2018 |
| Obinutuzumab (Gazyvaro®) | In Northern Ireland, obinutuzumab (Gazvaro®) is accepted for use as an option for untreated advanced follicular lymphoma in adults (that is, first as induction treatment with chemotherapy, then alone as maintenance therapy), only if: - the person has a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2 or more - the company provides obinutuzumab with the discount agreed in the patient access scheme. For further information see NICE TA513 | NICE TA513 | Accepted | 20/04/2018 |
| Tivozanib (Tivopath®) | In Northern Ireland, tivozanib (Tivopath®) is accepted for use as an option for treating advanced renal cell carcinoma in adults, only if: - they have had no previous treatment and - the company provides tivozanib with the discount agreed in the patient access scheme. For further information see NICE TA512 | NICE TA512 | Accepted | 20/04/2018 |
| Brodalumab (Kyntheum®) | In Northern Ireland, brodalumab (Kyntheum®) is accepted for use as an option for treating plaque psoriasis in adults, only if: - the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and - the disease has not responded to other systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet A radiation), or these options are contraindicated or not tolerated and - the company provides the drug with the discount agreed in the patient access scheme. Stop brodalumab at 12 weeks if the psoriasis has not responded adequately, defined as: - a 75% reduction in the PASI score (PASI 75) from when treatment started or - a 50% reduction in the PASI score (PASI 50) and a 5-point reduction in DLQI from when treatment started. For further information see NICE TA511 | NICE TA511 | Accepted | 20/04/2018 |
| Cabozantinib (Cometriq®) | In Northern Ireland, cabozantinib (Cometriq®) is accepted for use, within its marketing authorisation, as an option for treating progressive medullary thyroid cancer in adults with unresectable, locally advanced or metastatic disease only if the company provides cabozantinib with the discount agreed in the patient access scheme. For further information see NICE TA516 | NICE TA516 | Accepted | 20/04/2018 |
| Sofosbuvir + voxilaprevir + velpatasvir (Vosevi®) | In Northern Ireland, sofosbuvir + voxilaprevir + velpatasvir (Vosevi®) is accepted for use as an option for treating chronic hepatitis C in adults only if it is used as specified in NICE TA507 and the company provides the drug at the same price or lower than that agreed with the Commercial Medicines Unit. For further information see NICE TA507 | NICE TA507 | Accepted | 20/04/2018 |
| Daptomycin (Cubicin®) | In Northern Ireland, daptomycin (Cubicin®) is not accepted for use for the treatment of paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia associated with complicated skin and soft-tissue infections. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 27/03/2018 |
| Adalimumab (Humira®) | In Northern Ireland, adalimumab (Humira®) is not accepted for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 27/03/2018 |
| Fulvestrant (Faslodex®) | In Northern Ireland, fulvestrant (Faslodex®) is not accepted for use for treating locally advanced or metastatic oestrogen-receptor positive breast cancer in postmenopausal women who have not had endocrine therapy before. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA503 | NICE TA503 | Not Accepted | 27/03/2018 |
| Pertuzumab (Perjeta®) + trastuzumab + docetaxel | In Northern Ireland, pertuzumab (Perjeta®) is accepted for use, in combination with trastuzumab and docetaxel, for treating HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti HER2 therapy or chemotherapy for their metastatic disease, only if the company provides pertuzumab within the agreed commercial access arrangement. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA509 | NICE TA509 | Accepted | 27/03/2018 |
| Fluticasone furoate + umeclidinium + vilanterol | In Northern Ireland, fluticasone furoate + umeclidinium + vilanterol (delivered via the Ellipta inhaler) (Trelegy®) is accepted for use as maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist. Use is restricted to patients with severe COPD (forced expiratory volume in one second [FEV1]. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium. | SMC | Accepted | 27/03/2018 |
| Lacosamide (Vimpat®) | In Northern Ireland, lacosamide (Vimpat®) is accepted for use as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adolescents and children from 4 years of age with epilepsy. Use is restricted to patients with refractory epilepsy. Treatment should be initiated by physicians who have appropriate experience in the treatment of epilepsy. For further information see Scottish Medicines Consortium | SMC | Accepted | 27/03/2018 |
| Levonorgestrel (Kyleena®) | In Northern Ireland, Levonorgestrel (Kyleena®) (intrauterine contraceptive system) is accepted for use as contraception for up to 5 years. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 27/03/2018 |
| Sevelamer carbonate (Renvela®) | In Northern Ireland, sevelamer carbonate (Renvela®) is accepted for use in the control of hyperphosphataemia in paediatric patients (> 6 years of age and a Body Surface Area of > 0.75m2) with chronic kidney disease. Use is restricted to the second-line management of hyperphosphataemia in patients receiving haemodialysis. For further information see Scottish Medicines Consortium | SMC | Accepted | 27/03/2018 |
| Darunavir + cobicistat + emtricitabine + tenofovir alafenamide (Symtuza®) | In Northern Ireland, Symtuza® is accepted for use in the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40kg). Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. Symtuza® provides a single-tablet alternative to Rezolsta® plus Descovy® at no additional cost. For further information see Scottish Medicines Consortium | SMC | Accepted | 27/03/2018 |
| Autologous chondrocyte implantation (Spherox®) | In Northern Ireland, autologous chondrocyte implantation (ACI) using chondrosphere is accepted for use in the treatment of symptomatic articular cartilage defects of the knee in adults, only if: - the person has not had previous surgery to repair articular cartilage defects - there is minimal osteoarthritic damage to the knee (as assessed by clinicians experienced in investigating knee cartilage damage using a validated measure for knee osteoarthritis) and - the defect is over 2 cm2 Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA508 | NICE TA508 | Accepted | 27/03/2018 |
| Evolocumab (Repatha®) | In Northern Ireland, evolocumab (Repatha®) is accepted as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if: - The dosage is 140 mg every 2 weeks. - Low-density lipoprotein concentrations are persistently above the thresholds specified in the TA despite maximal tolerated lipid-lowering therapy. That is, either the maximum dose has been reached, or further titration is limited by intolerance (as defined in NICE’s guideline on familial hypercholesterolaemia: identification and management). - The company provides evolocumab with the discount agreed in the patient access scheme (PAS). A price parity scheme (primary care patient access scheme) for evolocumab is currently in place in Northern Ireland. This allows evolocumab to be prescribed in primary care. Refer to Interface Pharmacy website for further information. For further information see NICE TA394 | NICE TA394 | Accepted | 20/02/2018 |
| Carbetocin (Pabal®) | In Northern Ireland, carbetocin (Pabal®) is not accepted for use for the prevention of uterine atony following delivery of the infant by Caesarean section under epidural or spinal anaesthesia. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 13/02/2018 |
| Ceftaroline (Zinforo®) | In Northern Ireland, ceftaroline (Zinforo®) is not accepted for use in the treatment of: · complicated skin and soft tissue infections in children from the age of 2 months · community-acquired pneumonia in children from the age of 2 months. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 13/02/2018 |
| Ceftazidime + avibactam (Zavicefta®) | In Northern Ireland, ceftazidime avibactam (Zavicefta®) is not accepted for use in the treatment of the following infections in adults: · complicated intra-abdominal Infection (cIAI) · complicated urinary tract infection (cUTI), including pyelonephritis · hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) · infections due to aerobic Gram-negative organisms in adult patients with limited treatment options. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 13/02/2018 |
| Lesinurad (Zurampic®) | In Northern Ireland, lesinurad (Zurampic®) is not accepted for use within its marketing authorisation, that is, with a xanthine oxidase inhibitor for treating hyperuricaemia in adults with gout whose serum uric acid is above the target level despite an adequate dose of a xanthine oxidase inhibitor alone. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA506 | NICE TA506 | Not Accepted | 13/02/2018 |
| Bezlotoxumab (Zinplava®) | In Northern Ireland, bezlotoxumab (Zinplava®) is not accepted for use for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 13/02/2018 |
| Ibrutinib (Imbruvica®) | In Northern Ireland, ibrutinib (Imbruvica®) is accepted for use as an option for treating relapsed or refractory mantle cell lymphoma in adults, only if: - they have had only 1 previous line of therapy and- the company provides ibrutinib with the discount agreed in the commercial access agreement. For further information see NICE TA502 | NICE TA502 | Accepted | 13/02/2018 |
| Glecaprevir + pibrentasvir (Maviret®) | In Northern Ireland, glecaprevir + pibrentasvir (Maviret®) is accepted for use, within its marketing authorisation, as an option for treating chronic hepatitis C in adults, only if the company provides the drug at the same price or lower than that agreed with the Commercial Medicines Unit. For further information see NICE TA499 | NICE TA499 | Accepted | 13/02/2018 |
| Ceritinib (Zykadia®) | In Northern Ireland, ceritinib (Zykadia®) is accepted for use within its marketing authorisation, as an option for untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer in adults, only if the company provides it with the discount agreed in the patient access scheme. For further information see NICE TA500 | NICE TA500 | Accepted | 13/02/2018 |
| Lenvatinib (Kisplyx®) | In Northern Ireland, lenvatinib (Kisplyx®) plus everolimus is accepted for use as an option for treating advanced renal cell carcinoma in adults who have had 1 previous vascular endothelial growth factor (VEGF)-targeted therapy, only if: - their Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1 and - the company provides lenvatinib with the discount agreed in the patient access scheme. For further information see NICE TA498 | NICE TA498 | Accepted | 13/02/2018 |
| Abatacept (Orencia®) | In Northern Ireland, abatacept (Orencia®) is not accepted for use, alone or in combination with methotrexate for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy including methotrexate has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 22/01/2018 |
| Ibrutinib (Imbruvica®) | In Northern Ireland, ibrutinib (Imbruvica®) is not accepted for use, as a single agent for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (who do not have 17p deletion or TP53 mutation). People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 22/01/2018 |
| Golimumab (Simponi®) | In Northern Ireland, golimumab (Simponi®) is accepted for use, within its marketing authorisation, as an option for treating severe non-radiographic axial spondyloarthritis in adults whose disease has responded inadequately to, or who cannot tolerate, nonsteroidal anti-inflammatory drugs. If patients and their clinicians consider golimumab to be one of a range of suitable treatments, including adalimumab, etanercept and certolizumab pegol, the least expensive (taking into account administration costs and patient access schemes) should be chosen. For further information see NICE TA497 | NICE TA497 | Accepted | 22/01/2018 |
| Aviptadil + phentolamine (Invicorp®) | In Northern Ireland, aviptadil + phentolamine (Invicorp®) is accepted for use for the symptomatic treatment of erectile dysfunction in adult males due to neurogenic, vasculogenic, psychogenic, or mixed aetiology. Use is restricted to those who have failed on oral therapies (oral phosphodiesterase type-5 inhibitors) and other non-injectable formulations of erectile dysfunction medications. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 22/01/2018 |
| Tiotropium (Spiriva Respimat®) | In Northern Ireland, tiotropium (Spiriva Respimat®) is accepted for use as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). For further information see Scottish Medicines Consortium | SMC | Accepted | 22/01/2018 |
| Pegvisomant (Somavert®) | In Northern Ireland, pegvisomant (Somavert®) is accepted for use for the treatment of adult patients with acromegaly who have had an inadequate response to surgery and / or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalise IGF-1 [insulin-like growth factor 1] concentrations or was not tolerated. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of pegvisomant and is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 22/01/2018 |
| Palbociclib (Ibrance®) | In Northern Ireland, palbociclib (Ibrance®) is accepted for use with an aromatase inhibitor, within its marketing authorisation, as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer as initial endocrine based therapy in adults. Palbociclib is recommended only if the company provides it with the discount agreed in the patient access scheme. For further information see NICE TA495 | NICE TA495 | Accepted | 22/01/2018 |
| Ribociclib (Kisqali®) | In Northern Ireland, ribociclib (Kisqali®) is accepted for use with an aromatase inhibitor, within its marketing authorisation, as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer as initial endocrine based therapy in adults. Ribociclib is recommended only if the company provides it with the discount agreed in the patient access scheme. For further information see NICE TA496. | NICE TA496 | Accepted | 22/01/2018 |
| Raltegravir 600mg film-coated tablets (Isentress®) | In Northern Ireland, Raltegravir (Isentress®) 600mg film-coated tablets are accepted for use, in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and paediatric patients weighing at least 40kg. Usage is restricted to patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium. | SMC | Accepted | 22/01/2018 |
| Vismodegib (Erivedge®) | In Northern Ireland, vismodegib (Erivedge®) is not accepted for use within its marketing authorisation for treating symptomatic metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that is inappropriate for surgery or radiotherapy, in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA489 | NICE TA489 | Not Accepted | 18/12/2017 |
| Midazolam(Epistatus®) | In Northern Ireland, midazolam (Epistatus®) is accepted for use in the treatment of prolonged, acute, convulsive seizures in children and adolescents aged 10 to less than 18 years. The availability of midazolam (Epistatus®) provides a licensed alternative to a previously available unlicensed preparation (10mg/mL). For further information see Scottish Medicines Consortium | SMC | Accepted | 18/12/2017 |
| Tofacitinib(Xeljanz®) | In Northern Ireland, tofacitinib (Xeljanz®) is accepted for use as indicated in NICE TA480. For further information see NICE TA480 | NICE TA480 | Accepted | 18/12/2017 |
| Regorafenib(Stivarga®) | In Northern Ireland, regorafenib (Stivarga®) is accepted as an option for treating unresectable or metastatic gastrointestinal stromal tumours in adults whose disease has progressed on, or who are intolerant to, prior treatment with imatinib and sunitinib, only if: -their Eastern Cooperative Oncology Group (ECOG) status is 0 to 1, and -the company provides regorafenib with the discount agreed in the patient access schemethe company provides regorafenib with the discount agreed in the patient access scheme. For further information see NICE TA488 | NICE TA488 | Accepted | 18/12/2017 |
| Aflibercept(Eylea®) | In Northern Ireland, aflibercept (Eylea®) is accepted for use, within its marketing authorisation, as an option for treating visual impairment due to myopic choroidal neovascularisation in adults, only if the company provides aflibercept with the discount agreed in the patient access scheme. If patients and their clinicians consider both aflibercept and ranibizumab to be suitable treatments, the least costly should be used, taking into account anticipated administration costs, dosage and price per dose. For further information see NICE TA486 | NICE TA486 | Accepted | 18/12/2017 |
| Cladribine(Mavenclad®) | In Northern Ireland, cladribine is accepted for use as an option for treating highly active multiple sclerosis in adults, only if the person has: - rapidly evolving severe relapsing–remitting multiple sclerosis, that is, at least 2 relapses in the previous year and at least 1 T1 gadolinium-enhancing lesion at baseline MRI or- relapsing–remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as 1 relapse in the previous year and MRI evidence of disease activity. For further information seeNICE TA493 | NICE TA493 | Accepted | 18/12/2017 |
| Maraviroc (Celsentri®) | In Northern Ireland, maraviroc (Celsentri®) is not accepted for use in combination with other antiretroviral medicinal products for treatment-experienced adolescents and children of 2 years and older and weighing at least 10kg infected with only CCR5-tropic HIV-1 detectable. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 15/12/2017 |
| Reslizumab (Cinqaero®) | In Northern Ireland, reslizumab (Cinqaero®) is accepted for use as add-on therapy as an option for the treatment of severe eosinophilic asthma that is inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids plus another drug, only if: - the blood eosinophil count has been recorded as 400 cells per microlitre or more - the person has had 3 or more asthma exacerbations in the past 12 months and - the company provides reslizumab with the discount agreed in the patient access scheme. At 12 months: - stop reslizumab if the asthma has not responded adequately or - continue reslizumab if the asthma has responded adequately and assess response each year. An adequate response is defined as: - a clinically meaningful reduction in the number of severe exacerbations needing systemic corticosteroids or - a clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma control. For further information see NICE TA479 | NICE TA479 | Accepted | 30/11/2017 |
| Bevacizumab (Avastin®) | In Northern Ireland, bevacizumab (Avastin®) is not accepted for use, in combination with carboplatin and paclitaxel for the treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 20/11/2017 |
| Beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium bromide (Trimbow®) | In Northern Ireland, beclometasone + formoterol + glycopyrrolate (Trimbow®) is accepted for use for the maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. Use is restricted to patients with severe COPD (forced expiratory volume in one second less than 50% predicted normal). *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 20/11/2017 |
| Stiripentol (Diacomit®) | In Northern Ireland, stiripentol ((Diacomit®) is accepted for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI; Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and valproate. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 20/11/2017 |
| Sarilumab (Kevzara®) | In Northern Ireland, sarilumab (Kevzara®), with methotrexate, is accepted for use as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs), only if: - disease is severe (a disease activity score [DAS28] of more than 5.1) and - the company provides sarilumab with the discount agreed in the patient access scheme. Sarilumab, with methotrexate, is accepted for use as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to or who cannot have other DMARDs, including at least 1 biological DMARD, only if: - disease is severe (a DAS28 of more than 5.1) and - they cannot have rituximab and - the company provides sarilumab with the discount agreed in the patient access scheme. Sarilumab, with methotrexate, is accepted for use as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to rituximab and at least 1 biological DMARD, only if: - disease is severe (a DAS28 of more than 5.1) and - the company provides sarilumab with the discount agreed in the patient access scheme. Sarilumab can be used as monotherapy for people who cannot take methotrexate because it is contraindicated or because of intolerance. For Further information see NICE TA485 | NICE TA485 | Accepted | 20/11/2017 |
| Autologous cultured chondrocytes (MACI®) | In Northern Ireland, Autologous cultured chondrocytes (MACI®) is accepted as an option for treating symptomatic articular cartilage defects of the knee, only if: - the person has not had previous knee repair surgery - there is minimal osteoarthritic damage to the knee (as assessed by clinicians experienced in investigating knee cartilage damage using a validated measure for knee osteoarthritis) - the defect is over 2 square cm - the procedure is done at a tertiary referral centre. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For Further information see NICE TA477 | NICE TA477 | Accepted | 20/11/2017 |
| Canakinumab (Ilaris®) | In Northern Ireland, canakinumab (Ilaris®) is not accepted for use in the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: - tumour necrosis factor receptor associated periodic syndrome, - hyperimmunoglobulin D syndrome / mevalonate kinase deficiency - Familial Mediterranean Fever. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 23/10/2017 |
| Magnesium glycerophosphate (Neomag®) | In Northern Ireland, magnesium glycerophosphate (Neomag®) is accepted for use as an oral magnesium supplement for the treatment of patients with chronic magnesium loss or hypomagnesaemia as diagnosed by a doctor. Magnesium glycerophosphate is also indicated for adult patients with hypomagnesaemia due to the concomitant administration of loop and thiazide diuretics or other drugs which cause hypomagnesaemia. Unlicensed tablet formulations of magnesium glycerophosphate have been used. This product provides a licensed preparation at a similar cost. For further information see Scottish Medicines Consortium | SMC | Accepted | 23/10/2017 |
| Rolapitant (Varuby®) | Marketing Authorisation Withdrawn On 13 December 2019, Tesaro ceased the commercialization of rolapitant (as hydrochloride monohydrate) 90mg film-coated tablets (Varuby). In Northern Ireland, rolapitant (Varuby®) is accepted for use in the prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults. Rolapitant is given as part of combination therapy. Use of rolapitant is restricted to use as a first-line option in adults undergoing highly emetogenic chemotherapy. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of rolapitant. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. For further information see Scottish Medicines Consortium | SMC | Accepted | 23/10/2017 |
| Adalimumab (Humira®) and dexamethasone intravitreal implant (Ozurdex®) | In Northern Ireland, adalimumab is accepted for use as an option for treating non-infectious uveitis in the posterior segment of the eye in adults with inadequate response to corticosteroids, only if there is: · active disease (that is, current inflammation in the eye) and · inadequate response or intolerance to immunosuppressants and · systemic disease or both eyes are affected (or 1 eye is affected if the second eye has poor visual acuity) and · worsening vision with a high risk of blindness (for example, risk of blindness that is similar to that seen in people with macular oedema). Dexamethasone intravitreal implant is accepted for use as an option for treating non-infectious uveitis in the posterior segment of the eye in adults, only if there is: · active disease (that is, current inflammation in the eye) and · worsening vision with a risk of blindness. For further information see NICE TA460 | NICE TA460 | Accepted | 23/10/2017 |
| Cetuximab (Erbitux®) | In Northern Ireland, cetuximab (Erbitux®) is accepted for use, in combination with platinum-based chemotherapy, as an option for treating recurrent or metastatic squamous cell cancer of the head and neck in adults only: - if the cancer started in the oral cavity and - when the company provides the drug in line with the commercial access agreement. For further information see NICE TA473 | NICE TA473 | Accepted | 23/10/2017 |
| Paclitaxel, albumin-bound (Abraxane®) | In Northern Ireland, paclitaxel, albumin-bound (Abraxane®) is accepted for use in combination with gemcitabine as an option for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas, only if: - other combination chemotherapies are unsuitable and they would otherwise have gemcitabine monotherapy and - the company provides nab-paclitaxel with the discount agreed in the patient access scheme. For further information see NICE TA476 | NICE TA476 | Accepted | 23/10/2017 |
| Dimethyl fumarate (Skilarence®) | In Northern Ireland, dimethyl fumarate (Skilarence®) is accepted for use as an option for treating plaque psoriasis in adults, only if the disease: - is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and - has not responded to other systemic therapies, including, ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet A radiation), or these options are contraindicated or not tolerated. Stop dimethyl fumarate treatment at 16 weeks if the psoriasis has not responded adequately. An adequate response is defined as: - a 75% reduction in the PASI score (PASI 75) from when treatment started or - a 50% reduction in the PASI score (PASI 50) and a 5-point reduction in DLQI from when treatment started. For further information see NICE TA475 | NICE TA475 | Accepted | 23/10/2017 |
| Sorafenib (Nexavar®) | In Northern Ireland, sorafenib (Nexavar®) is accepted for use as an option for treating advanced hepatocellular carcinoma only for people with Child-Pugh grade A liver impairment, only if the company provides sorafenib within the agreed commercial access arrangement. For further information see NICE TA474 | NICE TA474 | Accepted | 23/10/2017 |
| Brentuximab (Adcetris®) | In Northern Ireland, brentuximab is accepted as an option for treating relapsed or refractory systemic anaplastic large cell lymphoma in adults, only if: - they have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and - the company provides brentuximab vedotin according to the commercial access agreement. For further information see NICE TA478 | NICE TA478 | Accepted | 23/10/2017 |
| Immumosuppresive Therapy in Adults (Various Recommendations). | Please refer to NICE TA481. | NICE TA481 | Accepted | 23/10/2017 |
| Immunosuppresive Therapy in Children and Young People (Various Recommendations) | Please refere to NICE TA482 | NICE TA482 | Accepted | 23/10/2017 |
| Naltrexone + bupropion (Mysimba®) | In NorthernIreland, naltrexone + bupropion (Mysimba®) is not accepted for use in the management of overweight and obesity. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA494 | NICE TA494 | Not Accepted | 12/09/2017 |
| Follitropin delta (Rekovelle®) | In Northern Ireland, follitropin delta (Rekovelle®) is not accepted for use as controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies such as an in vitro fertilisation or intracytoplasmic sperm injection cycle. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 12/09/2017 |
| Sufentanil citrate sublingual tablets (Zalviso®) | In Northern Ireland, sufentanil sublingual tablets (Zalviso®) are not accepted for use in the management of acute moderate to severe post-operative pain in adult patients. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 12/09/2017 |
| Ibrutinib (Imbruvica®) | In Northern Ireland, ibrutinib (Imbruvica®) is not accepted for use in combination with bendamustine and rituximab for the treatment of adult patients with chronic lymphocytic leukaemia who have received at least one prior therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 12/09/2017 |
| Emtricitabine/tenofovir disoproxil (Truvada®) | In Northern Ireland, emtricitabine/tenofovir disoproxil (Truvada®) is not accepted for use in the treatment of HIV-1 infected adolescents aged 12 to <18 years with nucleoside reverse transcriptase inhibitor resistance or toxicities precluding the use of first line agents. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 12/09/2017 |
| Dabrafenib (Tafinlar®) | In Northern Ireland, trametinib (Mekinist®) is not accepted for use, in combination with dabrafenib, for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 12/09/2017 |
| Eluxadoline (Truberzi®) | Eluxadoline is accepted for use as an option for treating irritable bowel syndrome with diarrhoea in adults, only if: · the condition has not responded to other pharmacological treatments (for example, antimotility agents, antispasmodics, tricyclic antidepressants) or · pharmacological treatments are contraindicated or not tolerated, and · it is started in secondary care. Stop eluxadoline at 4 weeks if there is inadequate relief of the symptoms of irritable bowel syndrome with diarrhoea. For further information see NICE TA471 | NICE TA471 | Accepted | 12/09/2017 |
| Desmopressin (Noqdirna®) | In Northern Ireland, desmopressin (Noqdirna®) is accepted for use in the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults. Use is restricted to patients aged 65 years and over. For further information see Scottish Medicines Consortium | SMC | Accepted | 12/09/2017 |
| Bisphosphonates for treating osteoporosis | In Northern Ireland, oral bisphosphonates (alendronic acid, ibandronic acid and risedronate sodium) are recommended as options for treating osteoporosis in adults only if: · the person is eligible for risk assessment as defined in NICE's guideline on osteoporosis, and · the 10‑year probability of osteoporotic fragility fracture is at least 1%. Intravenous bisphosphonates (ibandronic acid and zoledronic acid) are recommended as options for treating osteoporosis in adults only if: · the person is eligible for risk assessment as defined in NICE's guideline on osteoporosis, and · the 10‑year probability of osteoporotic fragility fracture is at least 10% or · the 10‑year probability of osteoporotic fragility fracture is at least 1% and the person has difficulty taking oral bisphosphonates (alendronic acid, ibandronic acid or risedronate sodium) or these drugs are contraindicated or not tolerated. Estimate the 10‑year probability of osteoporotic fragility fracture using the FRAX or QFracture risk tools, in line with NICE's guideline on osteoporosis. The choice of treatment should be made on an individual basis after discussion between the responsible clinician and the patient, or their carers, about the advantages and disadvantages of the treatments available. If generic products are available, start treatment with the least expensive formulation, taking into account administration costs, the dose needed and the cost per dose. For further information seeNICE TA464 | NICE TA464 | Accepted | 12/09/2017 |
| Adalimumab (Humira®) | In Northern Ireland, adalimumab (Humira®) is accepted for use in the treatment of active moderate to severe hidradenitis suppurativa (HS) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. The use of adalimumab for the treatment of active moderate to severe HS in adult patients with an inadequate response to conventional systemic HS therapy has previously been accepted. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC 1243/17/a> | Accepted | 12/09/2017 |
| Aprepitant (Emend®) | In Northern Ireland, aprepitant (Emend®) is accepted for use as part of combination therapy, for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in infants, toddlers and children from the age of six months to less than 12 years (powder for oral suspension) and adolescents from the age of 12 years to 17 years (hard capsules). Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 12/09/2017 |
| Cabozantinib (Cabometyx®) | In Northern Ireland, cabozantinib (Cabometyx®) is accepted for use, within its marketing authorisation, as an option for treating advanced renal cell carcinoma in adults after vascular endothelial growth factor (VEGF) targeted therapy, only if the company provides cabozantinib with the discount agreed in the patient access scheme. For further information see NICE TA463 | NICE TA463 | Accepted | 12/09/2017 |
| Trastuzumab emtansine (Kadcyla®) | In Northern Ireland, trastuzumab emtansine (Kadcyla®) is accepted for use, within its marketing authorisation, as an option for treating human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced or metastatic breast cancer in adults who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for locally advanced or metastatic disease or developed disease recurrence during or within 6 months of completing adjuvant therapy. Trastuzumab emtansine is recommended only if the company provides it in line with the commercial access agreement with NHS England. For further information see NICE TA458 | NICE TA458 | Accepted | 12/09/2017 |
| Baricitinib (Olumiant®) | In Northern Ireland, baricitinib (Olumiant®) is accepted for use as per the NICE TA. For further information see NICE TA466 | NICE TA466 | Accepted | 12/09/2017 |
| Adalimumab, etanercept, ustekinumab | Adalimumab is accepted for use as an option for treating plaque psoriasis in children and young people aged 4 years or older, only if the disease: - is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and - has not responded to standard systemic therapy, such as ciclosporin, methotrexate or phototherapy, or these options are contraindicated or not tolerated. Etanercept is recommended as an option for treating plaque psoriasis in children and young people aged 6 years or older, only if the disease: - is severe, as defined by a total PASI of 10 or more and - has not responded to standard systemic therapy, such as ciclosporin, methotrexate or phototherapy, or these options arecontraindicated or not tolerated. Ustekinumab is recommended as an option for treating plaque psoriasis in children and young people aged 12 years or older, only if the disease: - is severe, as defined by a total PASI of 10 or more - has not responded to standard systemic therapy, such as ciclosporin, methotrexate or phototherapy, or these options are contraindicated or not tolerated. For further information see NICE TA455 | NICE TA455 | Accepted | 12/09/2017 |
| Autologous human corneal epithelial cells (Holoclar®) | In Northern Ireland, Holoclar® (ex vivo expanded autologous human corneal epithelial cells containing stem cells), is accepted for use as indicated in NICE TA467. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE TA467 | NICE TA467 | Accepted | 12/09/2017 |
| Dolutegravir (Tivicay®) | In Northern Ireland, dolutegravir (Tivicay®) is accepted for use, in combination with other anti-retroviral medicinal products, for the treatment of Human Immunodeficiency Virus (HIV) infected children aged >6 to 12 years of age. This advice takes account of the benefits of a patient access scheme (PAS) that improves the cost-effectiveness of dolutegravir. This advice is contingent upon the continuing availability of the patient access scheme in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 12/09/2017 |
| Ponatinib (Iclusig®) | In Northern Ireland, ponatinib (Iclusig®) is accepted for use within its marketing authorisation, as an option for treating chronic-, accelerated- or blast-phase chronic myeloid leukaemia in adults when: · the disease is resistant to dasatinib or nilotinib or · they cannot tolerate dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate or · when the T315I gene mutation is present. Ponatinib is also accepted for use, within its marketing authorisation, as an option for treating Philadelphia-chromosome-positive acute lymphoblastic leukaemia in adults when: · the disease is resistant to dasatinib or · they cannot tolerate dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate or · the T315I gene mutation is present. In both cases, ponatinib is accepted for use only if the company provides the drug with the discount agreed in the patient access scheme. For further information see NICE TA451 | NICE TA451 | Accepted | 11/08/2017 |
| Blinatumomab (Blincyto®) | In Northern Ireland, blinatumomab (Blincyto®) is accepted for use in line with its marketing authorisation as an option for treating Philadelphia-chromosome-negative relapsed or refractory precursor B-cell acute lymphoblastic leukaemia in adults, only if the company provides it with the discount agreed in the patient access scheme. For further information see NICE TA450 | NICE TA450 | Accepted | 11/08/2017 |
| Alectinib (Alecensa®) | In Northern Ireland, alecitinib (Alecensa®) is not accepted for use as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer previously treated with crizotinib. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 10/08/2017 |
| Deferasirox (Exjade®) | In Northern Ireland, deferasirox (Exjade®) film-coated tablets are accepted for restricted use for: • Treatment of chronic iron overload due to frequent blood transfusions (≥7mL/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older. • Treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: - in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7mL/kg/month of packed red blood cells) aged 2 to 5 years, - in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7mL/kg/month of packed red blood cells) aged 2 years and older, - in adult and paediatric patients with other anaemias aged 2 years and older. Use is restricted to treatment of chronic iron overload associated with the treatment of rare acquired or inherited anaemias requiring recurrent blood transfusions. For further information see Scottish Medcines Compendium. | SMC | Accepted | 10/08/2017 |
| Roflumilast (Daxas®) | In Northern Ireland, roflumilast (Daxas®) is accepted for use as an add-on to bronchodilator therapy, as an option for treating severe chronic obstructive pulmonary disease in adults with chronic bronchitis, only if: ·the disease is severe, defined as a forced expiratory volume in 1 second (FEV1) after a bronchodilator of less than 50% of predicted normal, and ·the person has had 2 or more exacerbations in the previous 12 months despite triple inhaled therapy with a long-acting muscarinic antagonist, a long-acting beta-2 agonist and an inhaled corticosteroid. *This drug is not on the NI Formulary and is not a first-line option.Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see NICE TA461 | NICE TA461 | Accepted | 10/08/2017 |
| Ciprofloxacin + dexamethasone eardrops (Cilodex®) | In Northern Ireland, ciprofloxacin + dexamethasone eardrops (Cilodex®) is accepted for use for treatment of the following infections in adults and children: Acute otitis media in patients with tympanostomy tubes (AOMT). Cilodex® provides a licensed alternative to “off-label” use of ciprofloxacin and dexamethasone eye drops in the treatment of AOMT and is available at an equivalent cost. For further information see Scottish Medicines consortium | SMC | Accepted | 10/08/2017 |
| Glycopyrronium (Sialanar®) | In Northern Ireland, glycopyrronium bromide (Sialanar®) is accepted for use for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders. The availability of glycopyrronium (Sialanar®) provides a licensed alternative to an existing generic preparation used outwith the terms of its marketing authorisation, at a small additional cost. For further information see Scottish Medicines Consortium | SMC | Accepted | 10/08/2017 |
| Idebenone (Raxone®) | In Northern Ireland, idebenone (Raxone®) is accepted for use in the treatment of visual impairment in adolescent and adult patients with Leber’s Hereditary Optic Neuropathy (LHON). Use is restricted to patients with LHON who are not yet blind i.e. they do not meet the UK criteria to be registered as severely sight impaired. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of idebenone. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information seeScottish Medicines Consortium | SMC 122617 | Accepted | 10/08/2017 |
| Everolimus and sunitinib | In Northern Ireland, everolimus and sunitinib are accepted for use, within their marketing authorisations, as options for treating well- or moderately-differentiated unresectable or metastatic neuroendocrine tumours (NETs) of pancreatic origin in adults with progressive disease. Everolimus is accepted for use, within its marketing authorisation, as an option for treating well-differentiated (grade 1 or grade 2) non-functional unresectable or metastatic NETs of gastrointestinal or lung origin in adults with progressive disease. Everolimus is recommended only when the company provides it with the discount agreed in the patient access scheme. For further information seeNICE TA449 | NICE TA449 | Accepted | 10/08/2017 |
| Etelcalcetide | In Northern Ireland, etelcalcetide is accepted for use as an option for treating secondary hyperparathyroidism in adults with chronic kidney disease on haemodialysis, only if: - treatment with a calcimimetic is indicated but cinacalcet is not suitable and - the company provides etelcalcetide with the discount agreed in the patient access scheme. For further information see NICE TA448 | NICE TA448 | Accepted | 10/08/2017 |
| Nivolumab (Opdivo®) | In Northern Ireland, Nivolumab (Opdivo®) is accepted for use, within its marketing authorisation, as an option for treating relapsed or refractory classical Hodgkin lymphoma in adults after autologous stem cell transplant and treatment with brentuximab vedotin, when the company provides nivolumab with the discount agreed in the patient access scheme. For further information seeNICE TA462 | NICE TA462 | Accepted | 10/08/2017 |
| Ofatumumab (Arzerra®) | In Northern Ireland, ofatumumab (Arzerra®) is not accepted for use in the treatment of adult patients with relapsed CLL in combination with fludarabine and cyclophosphamide. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 07/07/2017 |
| Tenofovir alafenamide (Vemlidy®) | In Northern Ireland, tenofovir alafenamide (Vemlidy®) is not accepted for use for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35 kg). People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 07/07/2017 |
| Irinotecan sucrosofate nanoliposomal (Onivyde®) | In Northern Ireland, pegylated liposomal irinotecan (Onivyde®), in combination with 5-fluorouracil and leucovorin, is not accepted for use, within its marketing authorisation, for treating metastatic adenocarcinoma of the pancreas in adults whose disease has progressed after gemcitabine-based therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA440 | NICE TA440 | Not Accepted | 07/07/2017 |
| Brentuximab (Adcetris®) | Brentuximab vedotin is recommended as an option for treating CD30-positive Hodgkin lymphoma in adults, only if: · they have relapsed or refractory disease after autologous stem cell transplant and · the company provides brentuximab vedotin at the price agreed with NHS England in the commercial access agreement. For further information see NICE TA446 | NICE TA446 | Accepted | 07/07/2017 |
| Certolizumab pegol (Cimzia®) and secukinumab (Cosentyx®) | In Northern Ireland, certolizumab pegol (Cimzia®) alone, or in combination with methotrexate, is accepted for use as an option for treating active psoriatic arthritis in adults only if: ·it is used as described in the NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis (recommendations 1.1 and 1.2) or ·the person has had a tumour necrosis factor (TNF)-alpha inhibitor but their disease has stopped responding after the first 12 weeks. Certolizumab pegol is only recommended if the company provides it as agreed in the patient access scheme. Secukinumab (Cosentyx®) alone, or in combination with methotrexate, is accepted for use as an option for treating active psoriatic arthritis in adults only if: ·it is used as described in the NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis (recommendations 1.1 and 1.2) or ·the person has had a TNF-alpha inhibitor but their disease has not responded within the first 12 weeks or has stopped responding after 12 weeks or ·TNF-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis). Secukinumab is only recommended if the company provides it as agreed in the patient access scheme. For further information see NICE TA445 | NICE TA445 | Accepted | 07/07/2017 |
| Micronised progesterone (Utrogestan Vaginal) | In Northern Ireland, micronised progesterone (Utrogestan Vaginal) is accepted for use in women for supplementation of the luteal phase during Assisted Reproductive Technology (ART) cycles. For further information see Scottish Medicines Consortium | SMC | Accepted | 07/07/2017 |
| Nepafenac (Nevanac®) | In Northern Ireland, nepafenac (Nevanac®) is accepted for use to reduce the risk of postoperative macular oedema associated with cataract surgery in DIABETIC patients. For further information see Scottish Medicines Consortium | SMC | Accepted | 07/07/2017 |
| Ustekinumab (Stelara®) | In Northern Ireland, ustekinumab (Stelara®) is accepted for use, within its marketing authorisation, as an option for treating moderately to severely active Crohn’s disease, that is, for adults who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-alpha inhibitor or have medical contraindications to such therapies. The choice of treatment between ustekinumab or another biological therapy should be made on an individual basis after discussion between the patient and their clinician about the advantages and disadvantages of the treatments available. If more than 1 treatment is suitable, the least expensive should be chosen (taking into account administration costs, dosage and price per dose). For further information see NICE TA456 | NICE TA456 | Accepted | 07/07/2017 |
| Ixekizumab (Taltz®) | In Northern Ireland, ixekizumab (Taltz®) is accepted for use as an option for treating plaque psoriasis in adults, only if: ·the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 ·the disease has not responded to standard systemic therapies, for example, ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet radiation), or these treatments are contraindicated or the person cannot tolerate them, and ·the company provides the drug with the discount agreed in the patient access scheme. Stop ixekizumab treatment at 12 weeks if the psoriasis has not responded adequately. An adequate response is defined as: ·a 75% reduction in the PASI score (PASI 75) from when treatment started or ·a 50% reduction in the PASI score (PASI 50) and a 5-point reduction in DLQI from when treatment started. For further information see NICE TA442 | NICE TA442 | Accepted | 09/05/2017 |
| Co-careldopa (Duodopa ®) | In Northern Ireland, co-careldopa-levodopa (Duodopa®) intestinal gel is accepted for use in the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. Use is restricted to patients not eligible for deep brain stimulation. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of co-careldopa intestinal gel. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 09/05/2017 |
| Abatacept (Orencia®) | In Northern Ireland, abatacept (Orencia®) is not accepted for use in the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 08/05/2017 |
| Insulin aspart (Fiasp®) | In Northern Ireland, insulin aspart (Fiasp®) is accepted for use for the treatment of diabetes mellitus in adults. This drug is not on the NI Formulary and is not a first-line option. Please refer tohttp://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 08/05/2017 |
| Cetuximab (Erbitux®) and panitumumab (Vectibix®) | In Northern Ireland, cetuximab (Erbitux®) is accepted, within its marketing authorisation, as an option for previously untreated epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer in adults in combination with: ·5-fluorouracil, folinic acid and oxaliplatin (FOLFOX) or ·5-fluorouracil, folinic acid and irinotecan (FOLFIRI). Panitumumab is recommended, within its marketing authorisation, as an option for previously untreated RAS wild-type metastatic colorectal cancer in adults in combination with: ·FOLFOX or ·FOLFIRI Cetuximab and panitumumab areaccepted for use when the companies provide them with the discounts agreed in their patient access schemes. For further informacion see NICE TA439 | NICE TA439 | Accepted | 08/05/2017 |
| Obeticholic acid (Ocaliva®) | In Northern Ireland, obeticholic acid (Ocaliva®) is accepted for use, within its marketing authorisation, as an option for treating primary biliary cholangitis in combination with ursodeoxycholic acid for people whose disease has responded inadequately to ursodeoxycholic acid or as monotherapy for people who cannot tolerate ursodeoxycholic acid. Obeticholic acid is recommended only if the company provides it with the discount agreed in the patient access scheme. Assess the response to obeticholic acid after 12 months. Only continue if there is evidence of clinical benefit. Because the agreed Patient Access Scheme is only available to Trusts, the prescribing and dispensing of obeticholic acid (Ocaliva®) should remain in Secondary Care in NI. For further information see NICE TA443 | NICE TA443 | Accepted | 13/04/2017 |
| Apremilast (Otezla®) | In Northern Ireland, apremilast (Otezla®) is accepted alone or in combination with disease-modifying antirheumatic drugs (DMARDs), as an option for treating active psoriatic arthritis in adults only if: ·they have peripheral arthritis with 3 or more tender joints and 3 or more swollen joints and ·their disease has not responded to adequate trials of at least 2 standard DMARDs, given either alone or in combination and ·the company provides apremilast with the discount agreed in the patient access scheme. A price parity scheme (primary care patient access scheme) for apremilast is currently in place in Northern Ireland. This allows apremilast to be prescribed in primary care Stop apremilast at 16 weeks if the psoriatic arthritis has not shown an adequate response using the Psoriatic Arthritis Response Criteria (PsARC), defined as an improvement in at least 2 of the 4 PsARC criteria (including joint tenderness or swelling score) with no worsening in any criteria. If the disease has a Psoriasis Area and Severity Index (PASI) 75 response, a dermatologist should decide whether to continue treatment with apremilast after 16 weeks based on skin response. For further information see NICE TA433 | NICE TA443 | Accepted | 01/04/2017 |
| Pitolisant (Wakix®) | In Northern Ireland, pitolisant (Wakix®) is not accepted for use in the treatment of narcolepsy with or without cataplexy in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 06/03/2017 |
| Vernakalant (Brinavess®) | In Northern Ireland, vernakalant (Brinavess®), is not accepted for use for rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults • For non-surgery patients: atrial fibrillation ≤ 7 days duration • For post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 06/03/2017 |
| Iron (III) isomaltoside (Diafer®) | In Northern Ireland, iron (III) isomaltoside (Diafer®) is accepted for use for the treatment of iron deficiency in adults with chronic kidney disease (CKD) on dialysis, when oral iron preparations are ineffective or cannot be used. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of iron III isomaltoside. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. For further information see Scottish Medicines Consortium | SMC | Accepted | 06/03/2017 |
| Dasatinib, nilotinib, imatinib | In Northern Ireland, dasatinib and nilotinib are accepted as options for treating only chronic- or accelerated-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults, if: - they cannot have imatinib, or their disease is imatinib resistant and - the companies provide the drugs with the discounts agreed in the relevant patient access schemes. High-dose imatinib (that is, 600 mg in the chronic phase or 800 mg in the accelerated and blast-crisis phases) is not accepted for treating Philadelphia-chromosome-positive chronic myeloid leukaemia in adults whose disease is imatinib-resistant. For Further Information see NICE TA425 | NICE TA425 | Accepted | 06/03/2017 |
| Dasatinib, nilotinib and standard-dose imatinib | In Northern Ireland, imatinib is accepted as an option for untreated, chronic-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults. Dasatinib and nilotinib are accepted, within their marketing authorisations, as options for untreated chronic-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults. The drugs are accepted only if the companies provide them with the discounts agreed in the relevant patient access schemes. For Further Information see NICE TA426 | NICE TA 426 | Accepted | 06/03/2017 |
| Pomalidomide (Imnovid®) | In Northern Ireland, pomalidomide (Imnovid®), in combination with low-dose dexamethasone, is accepted for use as an option for treating multiple myeloma in adults at third or subsequent relapse; that is, after 3 previous treatments including both lenalidomide and bortezomib, only when the company provides pomalidomide with the discount agreed in the patient access scheme. For Further Information see NICE TA427 | NICE TA427 | Accepted | 06/03/2017 |
| Ibrutinib (Imbruvica®) | In Northern Ireland, ibrutinib (Imbruvica®) alone is accepted for use within its marketing authorisation as an option for treating chronic lymphocytic leukaemia in adults: ·who have had at least 1 prior therapy or ·who have a 17p deletion or TP53 mutation, and in whom chemo-immunotherapy is unsuitable and ·only when the company provides ibrutinib with the discount agreed in the patient access scheme. For Further Information see NICE TA429 | NICE TA429 | Accepted | 06/03/2017 |
| Everolimus (Afinitor®) | In Northern Ireland, everolimus (Afinitor®) is accepted for use within its marketing authorisation as an option for treating advanced renal cell carcinoma that has progressed during or after treatment with vascular endothelial growth factor targeted therapy, only if the company provides it with the discount agreed in the patient access scheme. For further information see NICE TA432 | NICE TA432 | Accepted | 06/03/2017 |
| Eltrombopag (Revolade®) | In Northern Ireland, eltrombopag (Revolade®) is accepted for use in the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients aged 1 year to 17 years who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Use is restricted to patients with severe symptomatic ITP or a high risk of bleeding. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of eltrombopag. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 06/03/2017 |
| Conjugated oestrogens and bazedoxifene acetate (Duavive®) | In Northern Ireland, conjugated oestrogens and bazedoxifene acetate (Duavive®) is not accepted for use in the treatment of oestrogen deficiency symptoms in postmenopausal women. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 06/02/2017 |
| Idelalisib (Zydelig®) | In Northern Ireland, idelalisib (Zydelig®) is not accepted for use in combination with ofatumumab for the treatment of adult patients with chronic lymphocytic leukaemia: ·who have received at least one prior therapy, or ·first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 06/02/2017 |
| Ivacaftor (Kalydeco®) | In Northern Ireland, ivacaftor (Kalydeco®) is not accepted for use for the treatment of patients with cystic fibrosis aged 18 years and older who have an R117H mutation in the CF transmembrane conductance regulator (CFTR) gene. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 06/02/2017 |
| Dalbavancin (Xydalba®) | In Northern Ireland, dalbavancin (Xydalba®) is accepted for use for the treatmentof acute bacterial skin and skin structure infections (ABSSSI) in adults. Use is restricted to: ·second-line use or when meticillin-resistant Staphylococcus aureus (MRSA) infection is suspected, or on the advice of local microbiologists or specialists in infectious disease, and ·the patient is initially hospitalised due to ABSSSI, requires intravenous antibiotics, but is eligible for early discharge as soon as their medical condition does not require further inpatient treatment. For further information see Scottish Medicines Consortium | SMC | Accepted | 06/02/2017 |
| Deferasirox (Exjade®) | In Northern Ireland, Deferasirox (Exjade®) is accepted for use in the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate, in adult and paediatric patients aged 2 years and older with myelodysplastic syndrome (MDS) with an International Prognostic Scoring System (IPSS) score of low or intermediate -1 risk. For further information see Scottish Medicines Consortium | SMC | Accepted | 06/02/2017 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab (Keytruda®)is accepted as an option for treating locally advanced or metastatic PD-L1-positive non-small-cell lung cancer in adults who have had at least one chemotherapy (and targeted treatment if they have an epidermal growth factor receptor [EGFR]- or anaplastic lymphoma kinase [ALK]-positive tumour), only if: ·pembrolizumab is stopped at 2 years of uninterrupted treatment and no documented disease progression, and ·the company provides pembrolizumab with the discount agreed in the patient access scheme revised in the context of this NICE appraisal For further information see NICE TA428 | NICE TA428 | Accepted | 06/02/2017 |
| Sofosbuvir + velpatasvir (Epclusa®) | In Northern Ireland, sofosbuvir + velpatasvir (Epclusa®) is accepted as an option for treating chronic hepatitis C in line with the criteria laid out by NICE and only if the company provides the drug with the discount agreed in the simple discount agreement For further information see NICE TA430 | NICE TA430 | Accepted | 06/02/2017 |
| Fentanyl hydrochloride (Ionsys®) | In Northern Ireland, fentanyl hydrochloride (Ionsys®) is NOT accepted for use in the management of acute moderate to severe post-operative pain in adult patients. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 20/01/2017 |
| Ferric maltol (Feraccru®) | In Northern Ireland, ferric maltol (Feraccru®) is Not accepted for use in adults for the treatment of iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD). For further information see Scottish Medicines Consortium | SMC | Not Accepted | 20/01/2017 |
| Hydrocortisone (Plenadren®) | In Northern Ireland, hydrocortisone (Plenadren®) is NOT accepted for the management of adrenal insufficiency. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 20/01/2017 |
| Adalimumab (Humira®) | In Northern Ireland, adalimumab (Humira®) is NOT accepted for use in the treatment of moderately active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 20/01/2017 |
| Lenalidomide (Revlimid®) | In Northern Ireland, lenalidomide (Revlimid®) is NOT accepted for use in the treatment of adult patients with relapsed or refractory mantle cell lymphoma. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 20/01/2017 |
| Canakinumab (Ilaris®) | In Northern Ireland, canakinumab (Ilaris®) is NOT accepted for the treatment of active Still's disease including Adult-Onset Still's Disease who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 20/01/2017 |
| Pertuzumab (Perjeta®) | In Northern Ireland, pertuzumab (Perjeta®) is accepted for use in combination with trastuzumab and chemotherapy, as an option for the neoadjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer; that is, in patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence, only if the company provides pertuzumab with the discount agreed in the patient access scheme. For further information see NICE TA424 | NICE TA424 | Accepted | 20/01/2017 |
| Cefuroxime sodium (Aprokam®) | In Northern Ireland, cefuroxime sodium (Aprokam®) is accepted as antibiotic prophylaxis of postoperative endophthalmitis after cataract surgery. For further information see Scottish Medicines Consortium | SMC | Accepted | 20/01/2017 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) is accepted for use, within its marketing authorisation, as an option for previously treated advanced renal cell carcinoma in adults, when the company provides nivolumab with the discount agreed in the patient access scheme. For Further Information see NICE TA417 | NICE TA417 | Accepted | 20/01/2017 |
| Eribulin (Halaven®) | In Northern Ireland, eribulin (Halaven®) is accepted for use as an option for treating locally advanced or metastatic breast cancer in adults, only when:it has progressed after at least 2 chemotherapy regimens (which may include an anthracycline or a taxane, and capecitabine)the company provides eribulin with the discount agreed in the patient access scheme. For Further Information seeNICE TA423 | NICE TA423 | Accepted | 20/01/2017 |
| Everolimus (Afinitor®) | In Northern Ireland, everolimus (Afinitor®), in combination with exemestane, is accepted for use within its marketing authorisation as an option for treating advanced human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor-positive breast cancer in postmenopausal women without symptomatic visceral disease that has recurred or progressed after a non-steroidal aromatase inhibitor. Everolimus is recommended only if the company provides it with the discount agreed in the patient access scheme. For Further Information see NICE TA421 | NICE TA421 | Accepted | 20/01/2017 |
| Crizotinib (Xalkori®) | In Northern Ireland, crizotinib (Xalkori®) is accepted for use within its marketing authorisation, as an option for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer in adults. The drug is recommended only if the company provides it with the discount agreed in the patient access scheme. For Further Information see NICE TA422 | NICE TA422 | Accepted | 20/01/2017 |
| Golimumab (Simponi®) | In Northern Ireland, golimumab (Simponi®) is NOT accepted for use in combination with methotrexate for the treatment of polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40kg, who have responded inadequately to previous therapy with methotrexate. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see Scottish Medicines Consortium | SMC | Not Accepted | 12/12/2016 |
| Tocilizumab (RoActemra®) | In Northern Ireland, Tocilizumab (RoActemra®) - subcut formulation is NOT accepted for use in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see Scottish Medicines Consortium | SMC | Not Accepted | 12/12/2016 |
| Ticagrelor (Brilique®) | In Northern Ireland, ticagrelor (Brilique®) 60mg tablet is accepted for use, in combination with aspirin, within its marketing authorisation as an option for preventing atherothrombotic events in adults who have had a myocardial infarction and who are at high risk of a further event. Treatment should be stopped when clinically indicated or at a maximum of 3 years. For more information see NICE TA420 | NICE TA420 | Accepted | 12/12/2016 |
| Dequalinium (Fluomizin®) | In Northern Ireland, dequalinium (Fluomizin®) is accepted for use in the treatment of bacterial vaginosis. Use is restricted to patients for whom the initial treatment is not effective or well tolerated. For more information see Scottish Medicines Consortium | SMC | Accepted | 12/12/2016 |
| Rilpivirine + emtricitabine + tenofovir alafenamide (Odefsey®) | In Northern Ireland, (Odefsey®) is accepted for use in the treatment of adults and adolescents (aged 12 years and older with body weight at least 35kg), infected with human immunodeficiency virus type 1 (HIV 1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with viral load HIV 1 RNA ≤100,000 copies/mL. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For more information see Scottish Medicines Consortium | SMC | Accepted | 12/12/2016 |
| Apremilast (Otezla®) | In Northern Ireland, apremilast (Otezla®) is accepted as an option for treating chronic plaque psoriasis in adults whose disease has not responded to other systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and ultraviolet-A light), or when these treatments are contraindicated or not tolerated, only if: - the disease is severe, as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 - treatment is stopped if the psoriasis has not responded adequately at 16 weeks; an adequate response is defined as: ·a 75% reduction in the PASI score (PASI 75) from when treatment started or ·a 50% reduction in the PASI score (PASI 50) and a 5-point reduction in DLQI from start of treatment - the company provides apremilast with the discount agreed in the patient access scheme. A price parity scheme (primary care patient access scheme) for apremilast is currently in place in Northern Ireland. This allows apremilast to be prescribed in primary care. For more information see NICE TA419 | NICE TA419 | Accepted | 12/12/2016 |
| Budesonide (Cortiment®) | In Northern Ireland, Budesonide (Cortiment®) is accepted for use in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where aminosalicylate (5-ASA) treatment is not sufficient. Use is restricted to patients with UC who present with active left-sided disease and/or proctosigmoiditis who are not suitable for oral prednisolone, as an alternative to budesonide rectal formulations or off-label oral budesonide. This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices For further Information see Scottish Medicines Consortium | SMC | Accepted | 09/11/2016 |
| Progesterone vaginal tablets (Lutigest®) | In Northern Ireland, progesterone vaginal tablets (Lutigest®) is accepted for use as luteal support as part of an assisted reproductive technology (ART) treatment program for infertile women. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of progesterone 100mg vaginal tablets. This advice is contingent on the continuing availability of the patient access scheme in Northern Ireland or a list price that is equivalent or lower. For more information see Scottish Medicines Consortium | SMC | Accepted | 08/11/2016 |
| Dapagliflozin (Forxiga®) | In Northern Ireland, dapagliflozin (Forxiga®) in a triple therapy regimen is accepted as an option for treating type 2 diabetes in adults, only in combination with metformin and a sulfonylurea. For more information see NICE TA418 | NICE TA418 | Accepted | 08/11/2016 |
| Radium-223 chloride (Xofigo®) | In Northern Ireland, radium-223 chloride (Xofigo®) is accepted as an option for treating hormone-relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases in adults, only if: · they have already had docetaxel or · docetaxel is contraindicated or is not suitable for them The drug is only recommended if the company provides radium-223 dichloride with the discount agreed in the patient access scheme. For more information see NICE TA412 | NICE TA412 | Accepted | 08/11/2016 |
| Grazoprevir + elbasvir (Zepatier®) | In Northern Ireland, elbasvir-grazoprevir (Zepatier®) is accepted for use within its marketing authorisation, as an option for treating genotype 1 or 4 chronic hepatitis C in adults, as specified in the NICE guidance, only if the company provides the drug at the same price or lower than that agreed with the Commercial Medicines Unit. For more information see NICE TA413 | NICE TA413 | Accepted | 08/11/2016 |
| Pirfenidone (Esbriet®) | In Northern Ireland, pirfenidone is accepted as an option for treating idiopathic pulmonary fibrosis in adults only if: · the person has a forced vital capacity (FVC) between 50% and 80% predicted · the company provides pirfenidone with the discount agreed in the patient access scheme and · treatment is stopped if there is evidence of disease progression (an absolute decline of 10% or more in predicted FVC within any 12-month period). For more information see NICE | NICE TA504 | Accepted | 08/11/2016 |
| Crizotinib (Xalkori®) | In Northern Ireland, crizotinib (Xalkori®) is accepted within its marketing authorisation, as an option for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer in adults. The drug is recommended only if the company provides it with the discount agreed in the patient access scheme. For more information see NICE TA406 | NICE TA406 | Accepted | 08/11/2016 |
| Certolizumab (Cimzia®) | In Northern Ireland, certolizumab (Cimzia®) is accepted to use, in combination with methotrexate, as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to, or who cannot tolerate, other disease-modifying antirheumatic drugs (DMARDs) including at least 1 tumour necrosis factor-alpha (TNF-alpha) inhibitor, only if: · disease activity is severe and · rituximab is contraindicated or not tolerated and · the company provides certolizumab pegol with the agreed patient access scheme. Certolizumab, as monotherapy, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to, or who cannot tolerate, other DMARDs including at least 1 TNF-alpha inhibitor, only if: · disease activity is severe and· rituximab therapy cannot be given because methotrexate is contraindicated or not tolerated and · the company provides certolizumab pegol with the agreed patient access scheme. Continue treatment only if there is at least a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months. After an initial response within 6 months, withdraw treatment if at least a moderate EULAR response is not maintained. For more information see NICE TA415 | NICE TA415 | Accepted | 08/11/2016 |
| Perampanel tablets (Fycompa®) | In Northern Ireland, perampanel (Fycompa®) is NOT accepted for use as adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see Scottish Medicines Consortium | SMC | Not Accepted | 07/11/2016 |
| Cobimetinib (Cotellic®) | In Northern Ireland, cobimetinib (Cotellic®) is not accepted within its marketing authorisation for treating unresectable or metastatic melanoma in adults with a BRAF V600 mutation. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see NICE TA414 | NICE TA414 | Not Accepted | 07/11/2016 |
| Bevacizumab (Avastin®) | In Northern Ireland, bevacizumab (Avastin®) is not accepted, in combination with erlotinib for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see Scottish Medicines Consortium | SMC | Not Accepted | 07/11/2016 |
| Necitumumab (Portrazza®) | In Northern Ireland, necitumumab (Portrazza®) in combination with gemcitabine and cisplatin is not accepted within its marketing authorisation for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-expressing squamous non-small-cell lung cancer that has not been treated with chemotherapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see NICE TA411 | NICE TA411 | Not Accepted | 07/11/2016 |
| Liraglutide (Victoza®) | In Northern Ireland, liraglutide (Victoza®) is not accepted for use as monotherapy for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance or contraindications. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see Scottish Medicines Consortium | SMC | Not Accepted | 02/11/2016 |
| Azacitidine (Vidaza®) | In Northern Ireland, azacitidine (Vidaza®) is not accepted for the treatment of acute myeloid leukaemia with more than 30% bone marrow blasts in people of 65 years or older who are not eligible for haematopoietic stem cell transplant. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see NICE TA399 | NICE TA399 | Not Accepted | 02/11/2016 |
| Afatinib (Giotrif®) | In Northern Ireland, afatinib (Giotrif®) is not accepted for use as monotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer of squamous histology progressing on or after platinum-based chemotherapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see Scottish Medicines Consortium | SMC | Not Accepted | 02/11/2016 |
| Elotuzumab (Empliciti®) | In Northern Ireland, elotuzumab (Empliciti®) is not accepted for use for the treatment of multiple myeloma in combination with lenalidomide and dexamethasone in adult patients who have received at least one prior therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see Scottish Medicines Consortium | SMC | Not Accepted | 02/11/2016 |
| Necitumumab (Portrazza®) | In Northern Ireland, necitumumab (Portrazza®) in combination with gemcitabine and cisplatin is not accepted within its marketing authorisation for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-expressing squamous non-small-cell lung cancer that has not been treated with chemotherapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see NICE TA411 | NICE TA411 | Not Accepted | 02/11/2016 |
| Dinutuximab (Unituxin®) | In Northern Ireland, dinutuximab (Unituxin®) is not accepted for treating high-risk neuroblastoma in children and young people aged 1–17 years whose disease has at least partially responded to induction chemotherapy, myeloablative therapy and autologous stem cell transplant. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see NICE | NICE | Not Accepted | 02/11/2016 |
| Ramucirumab (Cyramza®) | In Northern Ireland, ramucirumab (Cyramza®) is not accepted for treating locally advanced or metastatic non-small-cell lung cancer in adults whose disease has progressed after platinum-based chemotherapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see NICE TA403 | NICE TA403 | Not Accepted | 02/11/2016 |
| Betamethasone dipropionate + calcipotriol (Enstilar®) | In Northern Ireland, betamethasone dipropionate + calcipotriol (Enstilar®) is accepted for use in the topical treatment of psoriasis vulgaris in adults. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For more information see Scottish Medicines Consortium | SMC | Accepted | 02/11/2016 |
| Idarucizumab (Praxbind®) | In Northern Ireland, idarucizumab (Praxbind®) is accepted for use in adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. For more information see Scottish Medicines Consortium | SMC | Accepted | 02/11/2016 |
| Paliperidone palmitate (Trevicta®) | In Northern Ireland, paliperidone palmitate (Trevicta®) is accepted for the maintenance treatment of schizophrenia in adult patients who are clinically stable on one-monthly paliperidone palmitate injectable product. For more information see Scottish Medicines Consortium | SMC | Accepted | 02/11/2016 |
| Fosfomycin trometamol granules (Monuril®) | In Northern Ireland, fosfomycin trometamol granules for oral solution (equivalent to 3g fosfomycin) (Monuril®) is accepted for use in: · Treatment of acute lower uncomplicated urinary tract infections, caused by pathogens sensitive to fosfomycin in adult and adolescent females. · Prophylaxis in diagnostic and surgical transurethral procedures. For more information see Scottish Medicines Consortium | SMC | Accepted | 02/11/2016 |
| Secukinumab (Cosentyx®) | In Northern Ireland, secukinumab (Cosentyx®) is accepted, within its marketing authorisation, as an option for treating active ankylosing spondylitis in adults whose disease has responded inadequately to conventional therapy (non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors). The drug is recommended only if the company provides it with the discount agreed in the patient access scheme. For more information see NICE TA407 | NICE TA407 | Accepted | 02/11/2016 |
| Emtricitabine + tenofovir alafenamide (Descovy®) | In Northern Ireland, emtricitabine + tenofovir alafenamide (Descovy®) is accepted for use in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35kg) infected with human immunodeficiency virus type 1. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For more information see Scottish Medicines Consortium | SMC | Accepted | 02/11/2016 |
| Levofloxacin (Quinsair®) | In Northern Ireland, levofloxacin (Quinsair®) is accepted for use in the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis. Use is restricted to a third line treatment option after colistimethate sodium (first line) and tobramycin (second line). This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of levofloxacin. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For more information see Scottish Medicines Consortium | SMC | Accepted | 02/11/2016 |
| Rilpivirine hydrochloride (Edurant®) | In Northern Ireland, rilpivirine hydrochloride (Edurant®) is accepted for use in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients aged 12 to 18 years of age and older with a viral load (VL) ≤ 100,000 HIV-1 RNA copies/mL. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For more information see Scottish Medicines Consortium | SMC | Accepted | 02/11/2016 |
| Trametinib (Mekinist®) and Dabrafenib (Tafinlar®) | In Northern Ireland, trametinib in combination with dabrafenib is accepted within its marketing authorisation, as an option for treating unresectable or metastatic melanoma in adults with a BRAF V600 mutation only when the company provides trametinib and dabrafenib with the discounts agreed in the patient access schemes. For more information see NICE TA396 | NICE TA396 | Accepted | 02/11/2016 |
| Bosutinib (Bosulif®) | In Northern Ireland, bosutinib is accepted as an option, within its marketing authorisation, for chronic, accelerated and blast phase Philadelphia chromosome positive chronic myeloid leukaemia in adults, when: · they have previously had 1 or more tyrosine kinase inhibitor and · imatinib, nilotinib and dasatinib are not appropriate and · the company provides bosutinib with the discount agreed in the patient access scheme (as revised in 2016). For more information see NICE TA401 | NICE TA401 | Accepted | 02/11/2016 |
| Pemetrexed (Alimta®) | In Northern Ireland, pemetrexed (Alimta®) is accepted as an option for the maintenance treatment of locally advanced or metastatic non-squamous non-small-cell lung cancer in adults when: - their disease has not progressed immediately after 4 cycles of pemetrexed and cisplatin induction therapy - their Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1 at the start of maintenance treatment and - the company provides the drug according to the terms of the commercial access agreement For more information see NICE TA402 | NICE TA402 | Accepted | 02/11/2016 |
| Trifluridine +Tipiracil (Lonsurf®) | In Northern Ireland, trifluridine-tipiracil is accepted as an option for treating metastatic colorectal cancer, that is: - in adults who have had previous treatment with available therapies including fluoropyrimidine-, oxaliplatin- or irinotecan-based chemotherapies, anti-vascular endothelial growth factor (VEGF) agents and anti-epidermal growth factor receptor (EGFR) agents, or when these therapies are not suitable, and - only when the company provides trifluridine–tipiracil hydrochloride with the discount agreed in the patient access scheme For more information see NICE TA405 | NICE TA405 | Accepted | 02/11/2016 |
| Talimogene laherparepvec (Imlygic®) | In Northern Ireland, talimogene laherparepvec (Imlygic®) is accepted, in adults, as an option for treating unresectable, regionally or distantly metastatic (Stage IIIB, IIIC or IVM1a) melanoma that has not spread to bone, brain, lung or other internal organs, only if: - treatment with systemically administered immunotherapies is not suitable and - the company provides talimogene laherparepvec with the discount agreed in the patient access schemeWhere infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For more information see NICE TA410 | NICE TA410 | Accepted | 02/11/2016 |
| Pegaspargase (Oncaspar®) | In Northern Ireland, pegaspargase (Oncaspar®) is accepted as part of antineoplastic combination therapy, as an option for treating acute lymphoblastic leukaemia in children, young people and adults only when they have untreated newly diagnosed disease. For more information see NICE TA408 | NICE TA408 | Accepted | 02/11/2016 |
| Aflibercept (Eylea®) | In Northern Ireland, aflibercept (Eylea®) is accepted for use as an option within its marketing authorisation for treating visual impairment in adults caused by macular oedema after branch retinal vein occlusion, only if the company provides aflibercept with the discount agreed in the patient access scheme. For more information see NICE TA409 | NICE TA409 | Accepted | 02/11/2016 |
| Ramucirumab (Cyramza®) | In Northern Ireland, ramucirumab (Cyramza®) is NOT accepted for use in combination with FOLFIRI (irinotecan, folinic acid and 5-fluorouracil) for the treatment of adult patients with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 13/09/2016 |
| Eltrombopag (Revolade®) | In Northern Ireland, eltrombopag (Revolade®) is NOT accepted for use for the treatment of adult patients with acquired severe aplastic anaemia who were either refractory to prior immunosuppressive therapy or heavily pre-treated and are unsuitable for haematopoietic stem cell transplantation. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 13/09/2016 |
| Lumacaftor – ivacaftor (Orkambi®) | In Northern Ireland, lumacaftor-ivacaftor is NOT accepted for use, within its marketing authorisation, for treating cystic fibrosis in people 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA398 | NICE TA398 | Not Accepted | 13/09/2016 |
| Insulin degludec (Tresiba®) | Insulin degludec (Tresiba®) is accepted for use in Northern Ireland for the treatment of diabetes mellitus in adults. For further information see Scottish Medicines Consortium | SMC | Accepted | 13/09/2016 |
| Diamorphine hydrochloride nasal spray (Ayendi®) | In Northern Ireland, diamorphine hydrochloride nasal spray (Ayendi®) is accepted for use for the treatment of acute severe nociceptive pain in children and adolescents in a hospital setting. Diamorphine hydrochloride nasal spray (Ayendi®) should be administered in the emergency setting by practitioners experienced in the administration of opioids in children and with appropriate monitoring. For further information see Scottish Medicines Consortium | SMC | Accepted | 13/09/2016 |
| Bevacizumab (Avastin®) | In Northern Ireland, bevacizumab (Avastin®) is accepted as an option, for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix. Use is restricted to combination with cisplatin and paclitaxel. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of bevacizumab. This advice is contingent upon the continuing availability of the patient access scheme in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 13/09/2016 |
| Tenofovir alafenamide + elvitegravir + cobicistat + emtricitabine (Genvoya®) | In Northern Ireland, Genvoya® is accepted for use in the treatment of adults and adolescents (aged 12 years and older with body weight at least 35kg) infected with human immunodeficiency virus-1 (HIV-1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of Genvoya®. This advice is contingent upon the continuing availability of the patient access scheme in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 13/09/2016 |
| Abiraterone (Zytiga®) | Abiraterone in combination with prednisone or prednisolone is recommended, within its marketing authority, as an option for treating metastatic hormone-relapsed prostate cancer. ·In people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated. ·This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of abiraterone. This advice is contingent upon the continuing availability of the patient access scheme in Northern Ireland or a list price that is equivalent or lower. For further information see NICE TA387 | NICE TA387 | Accepted | 13/09/2016 |
| Ceritinib (Zykadia®) | In Northern Ireland, ceritinib (Zykadia®) is accepted, within its marketing authorisation, as an option for treating advanced anaplastic lymphoma kinase positive non-small-cell lung cancer in adults who have previously had crizotinib. The drug is recommended only if the company provides it with the discount agreed in the patient access scheme. For further information see NICE TA395 | NICE TA395 | Accepted | 13/09/2016 |
| Adalimumab (Humira®) | In Northern Ireland, adalimumab (Humira®) is accepted within its marketing authorisation, as an option for treating active moderate to severe hidradenitis suppurativa in adults whose disease has not responded to conventional systemic therapy. The drug is recommended only if the company provides it at the price agreed in the patient access scheme. Assess the response to adalimumab after 12 weeks of treatment, and only continue if there is clear evidence of response, defined as: - a reduction of 25% or more in the total abscess and inflammatory nodule count and - no increase in abscesses and draining fistulas. For further information see NICE TA392 | NICE TA392 | Accepted | 13/09/2016 |
| Eculizumab (Soliris®) | In Northern Ireland, eculizumab (Soliris®) is accepted within its marketing authorisation for treating atypical haemolytic uraemic syndrome, only if all the following arrangements are in place: -coordination of eculizumab use through an expert centre -monitoring systems to record the number of people with a diagnosis of atypical haemolytic uraemic syndrome and the number who have eculizumab, and the dose and duration of treatment -a national protocol for starting and stopping eculizumab for clinical reasons -a research programme with robust methods to evaluate when stopping treatment or dose adjustment might occur. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see NICE HST1 | NICE HST1 | Accepted | 13/09/2016 |
| Febuxostat (Adenuric®) | In Northern Ireland, febuxostat (Adenuric®) is accepted for use for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumour Lysis Syndrome (TLS). Use is restricted to prevention of hyperuricaemia in adult patients at intermediate risk of TLS in whom allopurinol is either unsuitable or contraindicated, such as: • Those intolerant of allopurinol • Those in whom allopurinol is contraindicated, e.g. patients with renal impairment. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 13/09/2016 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab in combination with ipilimumab is accepted for use, within its marketing authorisation, as an option for treating advanced (unresectable or metastatic) melanoma in adults, only when the company provides ipilimumab with the discount agreed in the patient access scheme. For further information see NICE TA400 | NICE TA400 | Accepted | 13/09/2016 |
| Certolizumab (Cimzia®) | In Northern Ireland, certolizumab (Cimzia®) is NOT accepted for use in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate or other DMARDs. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 12/09/2016 |
| Ivacaftor (Kalydeco®) | In Northern Ireland, ivacaftor (Kalydeco®) is NOT accepted for use for the treatment of children with cystic fibrosis (CF) aged 2 years and older and weighing less than 25kg who have one of the following gating (class III) mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 12/09/2016 |
| Naproxen 250mg eff tablets (Stirlescent®) | In Northern Ireland, naproxen 250mg eff tablets (Stirlescent®) are accepted for use in the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal disorders, dysmenorrhoea and acute gout in adults. Use is restricted to patients unable to swallow naproxen tablets. For further information see Scottish Medicines Consortium | SMC | Accepted | 20/07/2016 |
| Alirocumab (Praluent®) | In Northern Ireland, alirocumab (Praluent®) is accepted for use as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia, only if: - Low-density lipoprotein concentrations are persistently above the thresholds specified in the TA despite maximal tolerated lipid-lowering therapy. That is, either the maximum dose has been reached or further titration is limited by intolerance (as defined in NICE’s guideline on familial hypercholesterolaemia: identification and management). - The company provides alirocumab with the discount agreed in the patient access scheme (PAS). A price parity scheme (primary care patient access scheme) for alirocumab is currently in place in Northern Ireland. This allows alirocumab to be prescribed in primary care. Refer to Interface Pharmacy website for further information. For further information see NICE TA393 | NICE TA393 | Accepted | 20/07/2016 |
| Isavuconazole (Cresemba®) | In Northern Ireland, isavuconazole (Cresemba®) is accepted for use in adults for the treatment of: • invasive aspergillosis • mucormycosis in patients for whom amphotericin B is inappropriate Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium | SMC | Accepted | 20/07/2016 |
| Cabazitaxel (Jevtana®) | In Northern Ireland, cabazitaxel (Jevtana®) is accepted, in combination with prednisone or prednisolone, as an option for treating metastatic hormone-relapsed prostate cancer in people whose disease has progressed during or after docetaxel chemotherapy, only if: - the person has an eastern cooperative oncology group (ECOG) performance status of 0 or 1 - the person has had 225 mg/m2 or more of docetaxel - treatment with cabazitaxel is stopped when the disease progresses or after a maximum of 10 cycles (whichever happens first) In addition, cabazitaxel is recommended only if: - the company provides cabazitaxel with the discount agreed in the patient access scheme agreed with the Department of Health, and - NHS trusts purchase cabazitaxel in accordance with the commercial access agreement, either: - in pre‑prepared intravenous infusion bags, or - in vials, at a reduced price that includes a further discount reflecting the average cost of waste per patient This advice takes account of the benefits of a commercial access agreement that improves the cost-effectiveness of cabazitaxel. This advice is contingent upon the continuing availability of the commercial access agreement in Northern Ireland or a list price that is equivalent or lower. For further information see NICE TA391 | NICE TA391 | Accepted | 20/07/2016 |
| Ceftolozane + tazobactam (Zerbaxa®) | In Northern Ireland, ceftolozane + tazobactam (Zerbaxa®) is NOT accepted for use for the treatment of the following infections in adults: - Complicated intra-abdominal infections - Acute pyelonephritis - Complicated urinary tract infections People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish MedicinesConsortium | SMC | Not Accepted | 14/06/2016 |
| Regorafenib (Stivarga®) | In Northern Ireland, regorafenib (Stivarga®) is not accepted for use in adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 14/06/2016 |
| Bevacizumab (Avastin®) | In Northern Ireland, bevacizumab (Avastin®) is accepted for use in combination with paclitaxel, for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of bevacizumab. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see SMC1063/15 | SMC | Accepted | 14/06/2016 |
| Simeprevir (Olysio®) | In Northern Ireland, simeprevir (Olysio®) is accepted for use in combination with other medicinal products for the treatment of chronic hepatitis C in adult patients. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 14/06/2016 |
| Alendronic acid (Binosto®) | In Northern Ireland, alendronic acid effervescent tablets (Binosto®) are accepted for use for the treatment of postmenopausal osteoporosis. Use is restricted to patients who are unable to swallow tablets where alendronic acid is the appropriate treatment choice. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices For further information see Scottish Medicines Consortium | SMC | Accepted | 09/05/2016 |
| Camellia sinensis (green tea) leaf extract (Catephen®) | In Northern Ireland, camellia sinensis (green tea) leaf extract (Catephen®) is accepted for use for the cutaneous treatment of external genital and perianal warts (condylomata acuminata) in immunocompetent patients from the age of 18 years. Use is restricted to patients not suitable for podophyllotoxin or who have not responded to treatment with podophyllotoxin. For further information see Scottish Medicines Consortium | SMC | Accepted | 09/05/2016 |
| Canagliflozin, dapagliflozin and empagliflozin | In Northern Ireland, canagliflozin, dapagliflozin and empagliflozin as monotherapies are accepted for use as options for treating type 2 diabetes in adults for whom metformin is contraindicated or not tolerated and when diet and exercise alone do not provide adequate glycaemic control, only if: - a dipeptidyl peptidase-4 (DPP-4) inhibitor would otherwise be prescribed and - a sulfonylurea or pioglitazone is not appropriate. *These drugs are not on the NI Formulary and are not first-line options. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices For more information see NICE TA390 | NICE TA390 | Accepted | 09/05/2016 |
| TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis | In Northern Ireland, adalimumab, certolizumab pegol, etanercept, golimumab and infliximab, are accepted for use as indicated by the NICE Technology Appraisal guidance TA383. For further information see NICE TA383 | NICE TA383 | Accepted | 09/05/2016 |
| Ruxolitinib (Jakavi®) | In Northern Ireland, ruxolitinib (Jakavi®) is accepted as an option for treating disease-related splenomegaly or symptoms in adults with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis, only: - in people with intermediate-2 or high-risk disease, and - if the company provides ruxolitinib with the discount agreed in the patient access scheme. For further information see NICE TA386 | NICE TA386 | Accepted | 09/05/2016 |
| Capsaicin cutaneous patches (Qutenza®) | In Northern Ireland, capsaicin cutaneous patches are not accepted for the treatment of peripheral neuropathic pain in diabetic adults either alone or in combination with other medicinal products for pain. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 12/04/2016 |
| Daptomycin for injection or infusion (Cubicin®) | In Northern Ireland, daptomycin for injection or infusion (Cubicin®) is not accepted for treatment of paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 12/04/2016 |
| Ramucirumab (Cyramza®) | In Northern Ireland, ramucirumab (Cyramza®) is not accepted for treating advanced gastric cancer or gastro–oesophageal junction adenocarcinoma previously treated with chemotherapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For more information see NICE TA378 | NICE TA378 | Not Accepted | 12/04/2016 |
| Oseltamivir (Tamiflu®) | In Northern Ireland, oseltamivir (Tamiflu®) is accepted for use for treatment of influenza in children aged <1 year including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms. For further information see Scottish Medicines Consortium | SMC | Accepted | 12/04/2016 |
| Sacubitril/valsartan (Entresto®) | In Northern Ireland, sacubitril + valsartan (Entresto®) is accepted for use as an option for treating symptomatic chronic heart failure with reduced ejection fraction, only in people: - with New York Heart Association (NYHA) class II to IV symptoms and - with a left ventricular ejection fraction of 35% or less and - who are already taking a stable dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor-blockers (ARBs). Treatment with sacubitril valsartan should be started by a heart failure specialist with access to a multidisciplinary heart failure team. Dose titration and monitoring should be performed by the most appropriate team member as defined in NICE’s guideline on chronic heart failure in adults: management. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices For further information see NICE TA388 | NICE TA388 | Accepted | 12/04/2016 |
| Ustekinumab (Stelara®) | In Northern Ireland, ustekinumab (Stelara®) is accepted for use in the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Continued treatment should be restricted to patients who achieve at least 75% improvement in their Psoriasis Area and Severity Index (PASI 75) within 16 weeks. For the small number of adolescent patients weighing >100kg that require a dose of 90mg, a 90mg prefilled syringe is available at the same price as the 45mg prefilled syringe. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 12/04/2016 |
| Nivolumab (Opdivo®) | In Northern Ireland, nivolumab (Opdivo®) is accepted for use within its marketing authorisation, as an option for treating advanced (unresectable or metastatic) melanoma in adults. For further information see NICE TA384 | NICE TA384 | Accepted | 12/04/2016 |
| Biosimilar Medicines | Biosimilar medicines are new biological medicinal products that have demonstrated ‘similar’ efficacy and safety to an existing biological reference (‘originator’) product. The NI Managed Entry mechanism is based upon appraisal by recognised Health Technology Appraisal bodies e.g. NICE; SMC. The position of NICE in respect of biosimilars is set out at https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/biosimilars-statement.pdf Given this position, where the originator product has been accepted for use in Northern Ireland, any biosimilar medicine will generally be deemed ‘accepted for use’ in Northern Ireland also. However, each individual biosimilar medicine may not have its own entry on the Managed Entry web page For example:Lantus® (insulin glargine) is accepted for use in Northern Ireland. Abasaglar® is a biosimilar of insulin glargine and, although it is not specifically mentioned on the Managed Entry website, it is also accepted for use in Northern Ireland. Please note: Biosimilar medicines should always be prescribed by brand name. | Website Link | Accepted | 05/04/2016 |
| Anakinra (Kineret®) | In Northern Ireland, anakinra (Kineret®) is not accepted for use in the management of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above, including: • Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) • Muckle-Wells Syndrome (MWS) • Familial Cold Auto inflammatory Syndrome (FCAS) People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 11/03/2016 |
| Denosumab (Xgeva®) | In Northern Ireland, denosumab (Xgeva®) is not accepted for the management of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 11/03/2016 |
| Ezetimibe (Ezetrol®) | In Northern Ireland, Ezetimibe (Ezetrol®) is accepted for use for treating primary heterozygous-familial and non-familial hypercholesterolaemia. This guidance updates and replaces NICE technology appraisal guidance on ezetimibe for the treatment of primary (heterozygous-familial and non-familial) hypercholesterolaemia. This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see NICE TA385 | NICE TA385 | Accepted | 11/03/2016 |
| Ulipristal acetate (Esmya®) | In Northern Ireland, ulipristal acetate (Esmya®) is accepted for use for the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. For further information see Scottish Medicines Consortium | SMC | Accepted | 11/03/2016 |
| Guanfacine hydrochloride (Intuniv®) | In Northern Ireland, guanfacine hydrochloride (Intuniv®) is accepted for use for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Treatment must be used as part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures. For further information see Scottish Medicines Consortium | SMC | Accepted | 11/03/2016 |
| Efavirenz (Sustiva®) | In Northern Ireland, efavirenz (Sustiva®) is accepted for use in an antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected children aged 3 months to 3 years and weighing at least 3.5kg. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 11/03/2016 |
| Glatiramer acetate 40mg/mL (Copaxone®) | In Northern Ireland, glatiramer acetate 40mg/ml injection (Copaxone®) is accepted for use in the treatment of relapsing remitting forms of MS. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 11/03/2016 |
| Bortezomib (Velcade®) | In Northern Ireland, bortezomib (Velcade®) is accepted for use within its marketing authorisation, as an option for previously untreated mantle cell lymphoma in adults for whom haematopoietic stem cell transplantation is unsuitable. For further information see NICE TA370 | NICE TA370 | Accepted | 11/03/2016 |
| Panobinostat (Farydak®) | In Northern Ireland, panobinostat (Farydak®) is accepted for use within its marketing authorisation, as an option for treating multiple myeloma, that is, for ‘adult patients with relapsed and/or refractory multiple myeloma who have received at least 2 prior regimens including bortezomib and an immunomodulatory agent’ when the company provides panobinostat with the discount agreed in the patient access scheme. For further information see NICE TA380 | NICE TA380 | Accepted | 11/03/2016 |
| Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis (JIA) | In Northern Ireland, abatacept, adalimumab, etanercept and tocilizumab are accepted for use, within their marketing authorisations, as options for treating polyarticular juvenile idiopathic arthritis - see NICE website for full details. For further information see NICE TA373 | NICE TA373 | Accepted | 11/03/2016 |
| Nintedanib (Ofev®) | In Northern Ireland, nintedanib (Ofev®) is accepted as an option for treating idiopathic pulmonary fibrosis, only if: - the person has a forced vital capacity (FVC) between 50% and 80% of predicted - the company provides nintedanib with the discount agreed in the patient access scheme and - treatment is stopped if disease progresses (a confirmed decline in percent predicted FVC of 10% or more) in any 12-month period. For further information see NICE TA379 | NICE TA379 | Accepted | 11/03/2016 |
| Enzalutamide (Xtandi®) | In Northern Ireland, enzalutamide (Xtandi®) is accepted as an option for treating metastatic hormone-relapsed prostate cancer: -in people who have no or mild symptoms after androgen deprivation therapy has failed, and -before chemotherapy is indicated, and -only when the company provides it with the discount agreed in the patient access scheme. For further information see NICE TA377 | NICE TA377 | Accepted | 11/03/2016 |
| Netupitant + palonosetron (Akynzeo®) | In Northern Ireland, netupitant + palonosetron (Akynzeo®) is accepted for use in adults for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy. This advice takes account of the benefits of Patient Access Scheme (PAS) that improves the cost-effectiveness of netupitant/palonosetron. This advice is contingent upon the continuing availability of the patient access scheme in Northern Ireland or a list price that is equivalent or lower. For further information see Scottish Medicines Consortium | SMC | Accepted | 15/02/2016 |
| Atazanavir/cobicistat 300mg/150mg film-coated tablets (Evotaz®) | In Northern Ireland, atazanavir/cobicistat 300mg/150mg film-coated tablets (Evotaz®) are accepted for use in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 15/02/2016 |
| Raltegravir chewable tablets 25mg, 100mg (Isentress®) | In Northern Ireland, Raltegravir (Isentress®) chewable tablets are accepted for use in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in children from the age of 4 weeks to <2 years. Use is restricted to patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions; raltegravir chewable tablets should be prescribed under the supervision of specialists in paediatric HIV. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 15/02/2016 |
| Raltegravir granules for oral suspension 100mg (Isentress®) | In Northern Ireland, Raltegravir (Isentress®) oral suspension is accepted for use in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection. Use is restricted to patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions; raltegravir oral suspension should be prescribed under the supervision of specialists in paediatric HIV. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 15/02/2016 |
| Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed following prior chemotherapy | In Northern Ireland, Erlotinib (Tarceva) is accepted as a possible treatment for people with locally advanced or metastatic non‑small‑cell lung cancer that has already been treated with non-targeted chemotherapy because of delayed confirmation of epidermal growth factor receptor tyrosine kinase (EGFR‑TK) mutation status, if: ·their cancer tests positive for the EGFR‑TK mutation or ·it is not known if the cancer is EGFR‑TK mutation‑positive because of problems with the test, and -the cancer is very likely to be EGFR‑TK mutation‑positive -it responds to the first 2 cycles of treatment with erlotinib Erlotinib is not recommended for treating locally advanced or metastatic non‑small‑cell lung cancer that doesn’t test positive for the EGFR‑TK mutation. Gefitinib (Iressa) is not recommended for treating non‑small‑cell lung cancer that has progressed after chemotherapy. For further information see NICE TA374 | NICE TA374 | Accepted | 15/02/2016 |
| Insulin degludec/liraglutide (Xultophy®) | In Northern Ireland, insulin degludec/liraglutide (Xultophy®) is accepted for restricted use in treatment of adults with type 2 diabetes mellitus. Restriction: for use in patients who are uncontrolled on basal insulin analogues (glycosylated haemoglobin [HbA1c] >7.5% [59mmol/mol]) and for whom a GLP-1 receptor agonist is appropriate as an add-on intensification therapy to basal insulin to obtain glucose control. This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 15/02/2016 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, Pembrolizumab is accepted as an option for treating advanced (unresectable or metastatic) melanoma in adults who have not been previously treated with ipilimumab. This advice is contingent upon the availability of the Patient Access Scheme in Northern Ireland or a list price that is equivalent or lower. For further information see NICE TA366 | NICE TA366 | Accepted | 14/01/2016 |
| Daclatasvir (Daklinza®) | In Northern Ireland, Daclatasvir is accepted as an option for treating adults with some types of chronic hepatitis C, depending on their level of fibrosis. It is taken with sofosbuvir or peginteron alfa, and sometimes with ribavirin. Please see appropriate tables in the guidance. The company must provide daclatasvir at the same price or lower than that agreed with the Commercial Medicines Unit. People not eligible for treatment as described should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information seee NICE TA364 | NICE TA364 | Accepted | 14/01/2016 |
| Ledipasvir & Sofosbuvir (Harvoni®) | In Northern Ireland, Ledipasvir & Sofosbuvir is accepted as an option for treating adults with some types of chronic hepatitis C. Please see appropriate tables in the guidance. People not eligible for treatment as described should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see NICE TA363 | NICE TA363 | Accepted | 14/01/2016 |
| Ombitasvir-paritaprevir-ritonavir (Viekirax®) | In Northern Ireland, Ombitasvir-paritaprevir-ritonavir with or without dasabuvir is accepted as an option for treatment of genotype 1 or 4 chronic hepatitis C in adults as specified in the table in the guidance, only if the company provides ombitasvir-partitaprevir- ritonavir and dasabuvir at the same price or lower than that agreed with the Commercial Medicines Unit. For further information see NICE TA365 | NICE TA365 | Accepted | 14/01/2016 |
| Atomoxetine oral solution (Strattera®) | In Northern Ireland, atomoxetine (Strattera®) oral solution is accepted for restricted use in the treatment of attention-deficit/hyperactivity disorder (ADHD) in children of 6 years and older, in adolescents and in adults as part of a comprehensive treatment programme. Treatment must be initiated by a specialist in the treatment of ADHD, such as a paediatrician, child/adolescent psychiatrist, or psychiatrist. Diagnosis should be made according to current DSM criteria or the guidelines in ICD. For further information see Scottish Medicines Consortium | SMC | Accepted | 14/01/2016 |
| Ivermectin (Soolantra®) | In Northern Ireland, ivermectin (Soolantra®) is accepted for use for the treatment of moderate to severe inflammatory lesions of rosacea where a topical treatment is considered appropriate. For further information see Scottish Medicines Consortium | SMC | Accepted | 14/01/2016 |
| Tiotropium/olodaterol inhalation solution (Spiolto® Respimat®) | In Northern Ireland, tiotropium/olodaterol inhalation solution (Spiolto® Respimat®) is accepted for use as maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Spiolto® Respimat® should be used in patients for whom tiotropium and olodaterol are appropriate choices of antimuscarinic and long-acting beta2-agonist respectively. For further information see Scottish Medicines Consortium | SMC | Accepted | 14/12/2015 |
| Triamcinolone hexacetonide 20mg/ml suspension | In Northern Ireland, triamcinolone hexacetonide 20mg/mL suspension for injection is accepted for use for the treatment of juvenile idiopathic arthritis (JIA). For further information see Scottish Medicines Consortium | SMC | Accepted | 14/12/2015 |
| Ciclosporin (Ikervis®) | In Northern Ireland, ciclosporin (Ikervis®) is accepted as an option treating severe keratitis in adult patients with dry eye disease that has not improved despite treatment with tear substitutes. For further information see NICE TA369 | NICE TA369 | Accepted | 14/12/2015 |
| Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept | In Northern Ireland, adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept, all in combination with methotrexate, are accepted as options for treating rheumatoid arthritis, only if: ·disease is severe, that is, a disease activity score (DAS28) greater than 5.1 and ·disease has not responded to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs) and ·the companies provide certolizumab pegol, golimumab, abatacept and tocilizumab with the discount agreed in their patient access schemes Adalimumab, etanercept, certolizumab pegol or tocilizumab can be used as monotherapy for people who cannot take methotrexate because it is contraindicated or because of intolerance where the criteria above are met. Continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. After initial response within 6 months, withdraw treatment if a moderate EULAR response is not maintained. Start treatment with the least expensive drug (taking into account administration costs, dose needed and product price per dose). This may need to be varied for some people because of differences in the mode of administration and treatment schedules. Some of the treatments recommended in this appraisal for severe rheumatoid arthritis are also recommended for moderate rheumatoid arthritis. See NICE technology appraisal guidance 715 for details For further information see NICE TA375 | NICE TA375 | Accepted | 14/12/2015 |
| Pembrolizumab (Keytruda®) | In Northern Ireland, pembrolizumab is accepted as an option for treating advanced (unresectable or metastatic) melanoma in adults only: ·after the disease has progressed with ipilimumab and, for BRAF V600 mutation-positive disease, a BRAF or MEK inhibitor and ·when the company provides pembrolizumab with the discount agreed in the patient access scheme For further information see NICE TA357 | NICE TA357 | Accepted | 14/12/2015 |
| Adalimumab, etanercept infliximab and golimumab | In Northern Ireland, adalimumab, certolizumab pegol, etanercept, golimumab and infliximab are accepted for use, within their marketing authorisations, as options for treating severe active ankylosing spondylitis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs. Infliximab is recommended only if treatment is started with the least expensive infliximab product. People currently receiving infliximab should be able to continue treatment with the same infliximab product until they and their clinician consider it appropriate to stop. Adalimumab, certolizumab pegol and etanercept are accepted for use, within their marketing authorisations, as options for treating severe non-radiographic axial spondyloarthritis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs. The choice of treatment should be made after discussion between the clinician and the patient about the advantages and disadvantages of the treatments available. This may include considering associated conditions such as extra-articular manifestations. If more than 1 treatment is suitable, the least expensive (taking into account administration costs and patient access schemes) should be chosen. The response to adalimumab, certolizumab pegol, etanercept, golimumab or infliximab treatment should be assessed 12 weeks after the start of treatment. Treatment should only be continued if there is clear evidence of response, defined as: ·a reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to 50% of the pre-treatment value or by 2 or more units and ·a reduction in the spinal pain visual analogue scale (VAS) by 2 cm or more Treatment with another tumour necrosis factor (TNF)-alpha inhibitor is recommended for people who cannot tolerate, or whose disease has not responded to, treatment with the first TNF-alpha inhibitor, or whose disease has stopped responding after an initial response. For further information see NICE Final appraisal Determination | NICE Final appraisal Determination | Accepted | 14/12/2015 |
| Idelalisib (Zydelig®) | In Northern Ireland, idelalisib (Zydelig®) is accepted for restricted use in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): - who have received at least one prior therapy, or -as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. Use is restricted to patients with relapsed CLL who are unsuitable for chemotherapy and treatment naïve patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of idelalisib. It is contingent upon the continuing availability of the patient access scheme in Northern Ireland or a list price that is equivalent or lower. For further information see NICE TA359 | NICE TA359 | Accepted | 30/11/2015 |
| Midodrine hydrochloride (Bramox®) | In Northern Ireland, midodrine hydrochloride tablets (Bramox®) are accepted for use in adults for the treatment of severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 13/11/2015 |
| Travoprost (Travatan®) | In Northern Ireland, travoprost (Travatan®) is accepted for use to decrease elevated intraocular pressure in paediatric patients aged 2 months to <18 years with ocular hypertension or paediatric glaucoma. Another topical ocular prostaglandin analogue preparation is licensed for use in children for this indication and is considerably cheaper. In reducing intra-ocular pressure, travoprost is comparable in effect to other drugs in its class. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 13/11/2015 |
| Darunavir + cobicistat (Rezolsta®) | In Northern Ireland, darunavir + cobicistat (Rezolsta®) is accepted for use in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older. Genotypic testing should guide its use. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 13/11/2015 |
| Vortioxetine (Brintellix®) | In Northern Ireland, vortioxetine (Brintellix®) is accepted as an option for treating major depressive episodes in adults whose condition has responded inadequately to 2 antidepressants within the current episode. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For Further Information see NICE TA367 | NICE TA367 | Accepted | 13/11/2015 |
| Ketoconazole (Ketoconazole HRA) | In Northern Ireland, ketoconazole HRA is not accepted for Treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For Further Information see Scottish Medicines Consortium | SMC | Not Accepted | 22/10/2015 |
| Tigecycline (Tygacil®) | In Northern Ireland, tigecycline (Tygacil®) for infusion is not accepted for use for the treatment of children from the age of eight years for the following infections: • complicated skin and soft tissue infections, excluding diabetic foot infections • complicated intra-abdominal infections People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For Further Information see Scottish Medicines Consortium | SMC | Not Accepted | 22/10/2015 |
| Insulin glargine (Toujeo®) | In Northern Ireland, insulin glargine (Toujeo®) is accepted for restricted use for the treatment of type 1 or type 2 diabetes mellitus in adults aged 18 years and above. Its use should be targeted on patients with type 1 diabetes who are at risk of or experience unacceptable frequency and/or severity of nocturnal hypoglycaemia on attempting to achieve better hypoglycaemic control during treatment with established insulins. It is also acceptable as a once daily insulin therapy for patients who require carer administration of their insulin. In patients with type 2 diabetes it should be restricted to those who suffer from recurrent episodes of hypoglycaemia or require assistance with their insulin injections. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NIFormulary choices. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 22/10/2015 |
| Lisdexamfetamine dimesylate (Elvanse Adult®) | In Northern Ireland, lisdexamfetamine (Elvanse Adult) is accepted for use as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adults. Based on clinical judgement, patients should have ADHD of at least moderate severity. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 22/10/2015 |
| Pasireotide (as pamoate) (Signifor®) | In Northern Ireland, pasireotide pamoate (Signifor®) is accepted for use for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 22/10/2015 |
| Sitagliptin (Januvia®) | In Northern Ireland, sitagliptin (Januvia®) is accepted for use for the treatment of type 2 diabetes mellitus to improve glycaemic control in adults in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control. Sitagliptin is also accepted for use as monotherapy, in combination with metformin, and in combination with a sulfonylurea and metformin. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 22/10/2015 |
| Tafluprost + timolol (Taptiqom®) | In Northern Ireland, tafluprost + timolol (Taptiqom®) preservative-free eye drops are accepted for use for the reduction of intraocular pressure in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta-blockers or prostaglandin analogues and require a combination therapy, and who would benefit from preservative-free eye drops. Use is restricted to patients who have proven sensitivity to preservatives. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 22/10/2015 |
| Tolvaptan (Jinarc®) | In Northern Ireland, tolvaptan (Jinarc®) is accepted as an option for treating autosomal dominant polycystic kidney disease in adults to slow the progression of cyst development and renal insufficiency only if: ·they have chronic kidney disease stage 2 or 3 at the start of treatment ·there is evidence of rapidly progressing disease and ·the company provides it with the discount agreed in the patient access scheme. For further information see NICE TA358 | NICE TA358 | Accepted | 22/10/2015 |
| Adalimumab (Humira®) | In Northern Ireland, adalimumab (Humira®) is accepted for use in the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Use is restricted to treatment of patients with severe disease as defined by a total Psoriasis Area Severity Index (PASI) score of ≥10 and a Dermatology Life Quality Index (DLQI) of >10. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 22/10/2015 |
| Darunavir (Prezista®) | In Northern Ireland, darunavir (Prezista®) is accepted for use co-administered with low dose ritonavir in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in paediatric patients aged 3 to 12 years and ≥15kg who are ·treatment-naïve, or ·treatment-experienced with no darunavir resistance-associated mutations, plasma-HIV-1 RNA 100x106 cells/L. Darunavir is to be prescribed under the supervision of specialists in paediatric HIV. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 22/10/2015 |
| Posaconazole (Noxafil®) | In Northern Ireland, Posaconazole (Noxafil®) (intravenous formulation) is accepted for use for the treatment of the following fungal infections in adults: ·Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; ·Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; ·Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; ·Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. It is also accepted for use for prophylaxis of invasive fungal infections (IFI) in the following patients: ·Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing IFI; ·Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing IFI. Posaconazole 300mg solution for infusion will generally result in higher plasma concentrations than posaconazole oral suspension and is expected to result in similar plasma concentrations as the tablet formulation. Posaconazole solution for infusion is more expensive than oral preparations. It is intended for patients who are not able to receive an oral formulation, and should be used for the minimum time required. Patients should be switched to an oral formulation of posaconazole as soon as clinically practical. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 22/10/2015 |
| Riociguat (Adempas®) | In Northern Ireland, riociguat (Ademaps®) is accepted for use in the treatment of pulmonary arterial hypertension (PAH) in adult patients with PAH with World Health Organisation Functional Class (WHO FC) II to III to improve exercise capacity. Use is restricted to PAH-specific monotherapy as an alternative treatment option to endothelin receptor antagonist (ERA) monotherapy in adult patients with PAH of WHO FC II to III. It is restricted to initiation and prescribing by specialists in the management of PAH. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of riociguat. This advice is contingent upon the continuing availability of the patient access scheme in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 22/10/2015 |
| Vedolizumab (Entyvio®) | In Northern Ireland, vedolizumab (Entyvio®) is accepted as an option for treating moderately to severely active Crohn’s disease only if: ·a tumour necrosis factor-alpha inhibitor has failed (that is the disease has responded inadequately or has lost response to treatment), or ·a tumour necrosis factor-alpha inhibitor cannot be tolerated or is contra-indicated. Vedolizumab is recommended only if the company provides it with the discount agreed in the patient access scheme. Vedolizumab should be given as a planned course of treatment until it stops working or surgery is needed, or until 12 months after the start of treatment, whichever is shorter. At 12 months, people should be reassessed to determine whether treatment should continue. Treatment should only continue if there is clear evidence of ongoing clinical benefit. For people in complete remission at 12 months, consider stopping vedolizumab, resuming treatment if there is a relapse. People who continue vedolizumab should be reassessed at least every 12 months to decide whether continued treatment is justified. For further information see NICE TA352 | NICE TA352 | Accepted | 22/10/2015 |
| Ceftobiprole medocaril (Zevtera®) | In Northern Ireland, ceftobiprole (Zevtera®) is accepted for restricted use in the treatment of hospital-acquired pneumonia (HAP) (excluding ventilator-associated pneumonia) when activity is required against suspected methicillin-resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens (including Pseudomonas aeruginosa, Escherichia coli and Klebsiella pneumoniae) and when combination treatment that includes vancomycin or teicoplanin is inappropriate or has not been tolerated, or when treatment modification is required, i.e. as an alternative to linezolid-based regimens. Consideration should be given to official guidance on the appropriate use of antibacterial agents. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 22/10/2015 |
| Paclitaxel Albumin (Abraxane®) | In Northern Ireland, paclitaxel albumin (Abraxane®) is not accepted for use in combination with carboplatin for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 30/09/2015 |
| Everolimus (Certican®) | In Northern Ireland, everolimus is not accepted within its marketing authorisation for preventing organ rejection in people having a liver transplant. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For Further Information see NICE TA348 | NICE TA348 | Not Accepted | 24/09/2015 |
| Edoxaban (Lixiana®) | In Northern Ireland, edoxaban (Lixiana®) is accepted for use, within its marketing authorisation, as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation with one or more risk factors, including: ·congestive heart failure ·hypertension ·diabetes ·prior stroke or transient ischaemic attack ·age 75 years or older The decision about whether to start treatment with edoxaban should be made after an informed discussion between the clinician and the person about the risks and benefits of edoxaban compared with warfarin, apixaban, dabigatran etexilate and rivaroxaban. For people considering switching from warfarin, edoxaban’s potential benefits should be considered against its potential risks, taking into account the person’s level of international normalised ratio (INR) control. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For Further Information see NICE Final Appraisal Determination | NICE TA355 | Accepted | 24/09/2015 |
| Palonosetron (Aloxi®) | In Northern Ireland, palonosetron (Aloxi®) is accepted for use for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, in paediatric patients 1 month of age and older. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 24/09/2015 |
| Tedizolid phosphate (Sivextro®) | In Northern Ireland, tedizolid phosphate (Sivextro®) is accepted for use for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Use is restricted to: ·patients with ABSSSI caused by Gram-positive Staphylococcus aureus (specifically methicillin-resistant Staphylococcus aureus [MRSA] isolates. ·use as an alternative oxazolidinone antibacterial on the specific advice of local microbiologists or specialists in infectious disease. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 24/09/2015 |
| Tiotropium solution for inhalation (Spiriva® Respimat®) | In Northern Ireland, tiotropium, 2.5 microgram, solution for inhalation (Spiriva® Respimat®) is accepted as add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800 micrograms budesonide/day or equivalent) and long-acting beta2 agonists and who experienced one or more severe exacerbations in the previous year. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NIFormulary choices. For Further Information see Scottish Medicines Consortium | SMC | Accepted | 24/09/2015 |
| Secukinumab (Cosentyx®) | In Northern Ireland, secukinumab (Cosentyx®) is accepted for use as an option for treating adults with plaque psoriasis only when: ·the disease is severe, as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 ·the disease has failed to respond to standard systemic therapies, for example, ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet radiation), or these treatments are contraindicated or the person cannot tolerate them ·the company provides secukinumab with the discount agreed in the patient access scheme. Secukinumab treatment should be stopped in people whose psoriasis has not responded adequately at 12 weeks. Further treatment cycles are not recommended in these people. An adequate response is defined as either: ·a 75% reduction in the PASI score from when the treatment started (PASI 75) or ·a 50% reduction in the PASI score (PASI 50) and a 5-point reduction in DLQL from when treatment started. For Further Information see NICE TA350 | NICE TA350 | Accepted | 24/09/2015 |
| Aflibercept (Eylea®) | In Northern Ireland, aflibercept (Eylea®) is recommended as an option for treating visual impairment caused by diabetic macular oedema only if: ·the eye has a central retinal thickness of 400 micrometres or more at the start of treatment and ·the company provides aflibercept with the discount agreed in the patient access scheme. People whose treatment with aflibercept is not recommended in this NICE guidance, but was started within the HSC before this guidance was published, should be able to continue aflibercept until they and their NHS clinician consider it appropriate to stop. For Further Information see NICE TA346 | NICE TA346 | Accepted | 24/09/2015 |
| Nintedanib (Vargatef®) | In Northern Ireland, nintedanib in combination with docetaxel is accepted, within its marketing authorisation, as an option for treating locally advanced, metastatic or locally recurrent non-small-cell lung cancer of adenocarcinoma histology that has progressed after first-line chemotherapy, only if the company provides nintedanib with the discount agreed in the patient access scheme. For Further Information see NICE TA347 | NICE TA347 | Accepted | 24/09/2015 |
| Tinzaparin (Innohep®) | In Northern Ireland, tinzaparin sodium (Innohep®) is accepted for use for the extended treatment of symptomatic venous thromboembolism (VTE) and prevention of its recurrence in patients with solid tumours. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of tinzaparin. This advice is contingent upon the continuing availability of the patient access scheme in Northern Ireland or a list price that is equivalent or lower. For further information see Scottish Medicines Consortium | SMC | Accepted | 11/08/2015 |
| Edoxaban (Lixiana®) | In Northern Ireland, edoxaban (Lixiana®) is accepted for use as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary embolism in adults. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see NICE Final Appraisal Determination | NICE TA354 | Accepted | 11/08/2015 |
| Cangrelor (Kengrexal®) | In Northern Ireland, cangrelor (Kengrexal®) is not accepted in combination with acetylsalicylic acid for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further advice see Scottish Medicines Consortium | SMC | Not Accepted | 09/07/2015 |
| Naloxegol (Moventig®) | In Northern Ireland, naloxegol (Moventig®) is accepted for use as an option for treating opioid induced constipation in adults whose constipation has not adequately responded to laxatives. An inadequate response is defined as opioid-induced constipation symptoms of at least moderate severity in at least 1 of the 4 stool symptom domains (that is, incomplete bowel movement, hard stools, straining or false alarms) while taking at least 1 laxative class for at least 4 days during the prior 2 weeks. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NIFormulary choices. For Further information see NICE TA345 | NICE TA345 | Accepted | 09/07/2015 |
| Levonorgestrel (Levosert®) | In Northern Ireland, levonorgestrel (Levosert®) is accepted for use as an option for treating heavy menstrual bleeding. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 09/07/2015 |
| Linagliptin + metformin combination tablets (Jentadueto®) | In Northern Ireland, linagliptin + metformin combination tablets (Jentadueto®) is accepted for use for the treatment of adult patients with type 2 diabetes mellitus in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control when insulin and metformin alone do not provide adequate glycaemic control. Restricted to use in patients for whom a combination of linagliptin and metformin is an appropriate choice of therapy and the fixed doses are considered appropriate. For patients in whom combination therapy with linagliptin and metformin is appropriate, it has the potential to reduce the pill burden at no additional cost. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NIFormulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 09/07/2015 |
| Magnesium aspartate dihydrate (Magnaspartate®) | In Northern Ireland, magnesium aspartate dihydrate (Magnaspartate®) is accepted for use for the treatment and prevention of magnesium deficiency, as diagnosed by a doctor. This is the first licensed oral magnesium product to be available in the UK for the treatment and prevention of magnesium deficiency. Magnesium supplementation has previously been available as a food supplement. For further information see Scottish Medicines Consortium | SMC | Accepted | 09/07/2015 |
| Sucroferric oxyhydroxide (Velphoro®) | In Northern Irelandsucroferric oxyhydroxide (Velphoro®) is accepted for use for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). It should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease. For further information see Scottish Medicines Consortium | SMC | Accepted | 09/07/2015 |
| Adalimumab (Humira®) | In Northern Irelandadalimumab (Humira®) is accepted for restricted use for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. Use is restricted to within specialist rheumatology services (including those working within the network for paediatric rheumatology). For further information see Scottish Medicines Consortium | SMC | Accepted | 09/07/2015 |
| Apixaban (Eliquis®) | In Northern Ireland, apixaban (Eliquis®) is accepted for use as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary embolism in adults. For further information see NICE TA341 | NICE TA341 | Accepted | 07/07/2015 |
| Collagenase clostridium histolyticum (Xiapex®) | In Northern Ireland, collagenase clostridium histolyticum (Xiapex®) is NOT accepted for use for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 10/06/2015 |
| Aclidinium/formoterol (Duaklir Genuair®) | In Northern Ireland, aclidinium/formoterol (Duaklir Genuair®) is accepted as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) for patients in whom the combination of aclidinium/formoterol is an appropriate choice of therapy. For further information see Scottish Medicines Consortium | SMC | Accepted | 10/06/2015 |
| Levonorgestrel (Jaydess®) | In Northern Ireland, levonorgestrel (Jaydess®) is accepted for use for contraception. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 10/06/2015 |
| Tacrolimus (Envarsus®) | In Northern Ireland, tacrolimus prolonged-release tablets (Envarsus®) are accepted for use as prophylaxis of transplant rejection in adult kidney or liver allograft recipients and treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. Tacrolimus (Envarsus®) is suitable for use by patients for whom tacrolimus is an appropriate choice of immunosuppressive therapy. It has increased bioavailability compared with other tacrolimus preparations. Tacrolimus (Envarsus®) has demonstrated non-inferiority to a tacrolimus immediate-release capsule and has a similar cost per equivalent dose. For further information see Scottish Medicines Consortium | SMC | Accepted | 10/06/2015 |
| Entecavir (Baraclude®) | In Northern Ireland, entecavir (Baraclude®) is accepted for use for the treatment of chronic hepatitis B virus infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum alanine aminotransferase levels, or histological evidence of moderate to severe inflammation and/or fibrosis. Entecavir (Baraclude®) is to be prescribed under the supervision of specialists in paediatric infectious diseases. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 10/06/2015 |
| Linagliptin (Trajenta®) | In Northern Ireland, linagliptin (Trajenta®) is accepted for use for the treatment of type 2 diabetes mellitus to improve glycaemic control in adults in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control. Linagliptin is also accepted for use as monotherapy in combination with metformin, and in combination with a sulphonylurea and metformin. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 10/06/2015 |
| Liraglutide (Victoza®) | In Northern Ireland, liraglutide (Victoza®) is accepted for use for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with basal insulin when this, together with diet and exercise, does not provide adequate glycaemic control. Liraglutide has previously been accepted for restricted use as a third line antidiabetic agent for use in combination with oral antidiabetic agents. This now extends the advice to include its use in combination with insulin. For further information see Scottish Medicines Consortium | SMC | Accepted | 10/06/2015 |
| Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine | In Northern Ireland topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine are accepted for use in the management of ovarian cancer in line with the guidance issued by NICE. Please see below link for full guidance. For further information see NICE TA389 | NICE TA389 | Accepted | 01/05/2015 |
| Sipuleucel-T (Provenge®) | In Northern Ireland, Sipuleucel-T is not accepted as a treatment for people with metastatic non-visceral hormone-relapsed prostate cancer, who have few or no symptoms and when chemotherapy is not yet suitable People currently receiving this drug should be able to continue therapy until they and their clinical consider it clinically appropriate to stop. For further information see NICE TA332 | NICE TA332 | Not Accepted | 27/04/2015 |
| Fosfomycin (Fomicyt®) | In Northern Ireland, fosfomycin (Fomicyt®) is accepted for restricted use for the treatment of the following infections in adults and children including neonates: - Acute osteomyelitis -Complicated urinary tract infections -Nosocomial lower respiratory tract infections -Bacterial meningitis -Bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Fosfomycin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of the infections listed above, or when these alternative antibacterial agents have failed to demonstrate efficacy. Consideration should be given to national guidance on the appropriate use of antibacterial agents. Fosfomycin should be initiated by microbiologists or infectious disease specialists. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 27/04/2015 |
| Omalizumab (Xolair®) | In Northern Ireland, omalizumab (Xolair®) is accepted as an option as add-on therapy for treating severe chronic spontaneous urticaria in adults and young people aged 12 years and over only if: -the severity of the condition is assessed objectively, for example, using a weekly urticaria activity score of 28 or more -the person’s condition has not responded to standard treatment with H1-antihistamines and leukotriene receptor antagonists -omalizumab is stopped at or before the fourth dose if the condition has not responded -omalizumab is stopped at the end of a course of treatment (6 doses) if the condition has responded, to establish whether the condition has gone into spontaneous remission, and is restarted only if the condition relapses -omalizumab is administered under the management of a secondary care specialist in dermatology, immunology or allergy - the company provides omalizumab with the discount agreed in the patient access scheme. For further information see NICE TA339 | NICE TA339 | Accepted | 27/04/2015 |
| Vedolizumab (Entyvio®) | In Northern Ireland, vedolizumab (Entyvio®) is accepted as an option for treating moderately to severely active ulcerative colitis in adults only if the company provides vedolizumab with the discount agreed in the patient access scheme. Vedolizumab should be given until it stops working or surgery is needed. At 12 months after the start of treatment, people should be reassessed to see whether treatment should continue. Treatment should only continue if there is clear evidence of ongoing clinical benefit. For people in complete remission at 12 months, consider stopping vedolizumab, resuming treatment if there is a relapse. People who continue vedolizumab should be reassessed at least every 12 months to see whether continued treatment is justified. For further information see NICE TA342 | NICE TA342 | Accepted | 27/04/2015 |
| Ustekinumab (Stelara®) | In Northern Ireland, Ustekinumab (Stelara®), is accepted as an option, alone or in combination with methotrexate, for treating active psoriatic arthritis in adults only when: -treatment with tumour necrosis factor (TNF) alpha inhibitors is contraindicated but would otherwise be considered (as described in other relevant NICE technology appraisal guidance), or -the person has had treatment with 1 or more TNF-alpha inhibitors Ustekinumab is accepted only if the company provides the 90 mg dose of ustekinumab for people who weigh more than 100 kg at the same cost as the 45 mg dose, as agreed in the patient access scheme. For further information see NICE TA340 | NICE TA340 | Accepted | 27/04/2015 |
| Rifaximin (Targaxan®) | In Northern Ireland, rifaximin (Targaxan®) is accepted for use as an option for reducing the recurrence of episodes of overt hepatic encephalopathy in people aged 18 years or older. For further information see NICE TA337 | NICE TA337 | Accepted | 27/04/2015 |
| Aztreonam lysine (Cayston®) | In Northern Ireland, aztreonam lysine (Cayston®) is accepted for restricted use for suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis aged six years and older. This use is restricted to inhaled colistimethate sodium and inhaled tobramycin are not tolerated or not providing satisfactory therapeutic benefit (measured as ≥2% decline in forced expiratory volume in 1 second [FEV1]). This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of aztreonam lysine. It is contingent upon the continuing availability of the Patient Access Scheme in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 27/04/2015 |
| Obinutuzumab (Gazyvaro®) | In Northern Ireland obinutuzumab, in combination with chlorambucil, is accepted for use in adults with untreated chronic lymphocytic leukaemia who have comorbidities that make full-dose fludarabine based therapy unsuitable for them, only if: •the person is ineligible for fludarabine-based therapy and •bendamustine is not suitable and •the company provides obinutuzumab with the discount agreed in the patient access scheme People whose treatment with obinutuzumab is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue treatment until they and their NHS clinician consider it appropriate to stop. For further information see NICE TA343 | NICE TA343 | Accepted | 27/04/2015 |
| Ofatumumab(Arzerra®) | In Northern Ireland, ofatumumab (Arzerra®) in combination with chlorambucil is accepted as an option for untreated chronic lymphocytic leukaemia only if: •the person is ineligible for fludarabine-based therapy and •bendamustine is not suitable and •the company provides ofatumumab with the discount agreed in the patient access scheme For further information see NICE TA344 | NICE TA344 | Accepted | 27/04/2015 |
| Colestilan (BindRen®) | In Northern Ireland, colestilan (BindRen®) is NOT ACCEPTED for the treatment of hyperphosphataemia in adult patients with chronic kidney disease (CKD) stage 5 receiving haemodialysis or peritoneal dialysis. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 28/02/2015 |
| Umeclidinium + vilanterol (Anoro®) | In Northern Ireland, umeclidinium/vilanterol (Anoro®) is accepted as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) for patients in whom the combination of umeclidinium/vilanterol is an appropriate choice of therapy. For further information see Scottish Medicines Consortium | SMC | Accepted | 28/02/2015 |
| Sofosbuvir (Sovaldi®) | In Northern Ireland, sofosbuvir (Sovaldi®) is accepted for use as an option for treating chronic hepatitis C in adults, as specified in the Technology Appraisal. For further information see NICE TA330 | NICE TA330 | Accepted | 28/02/2015 |
| Rivaroxaban▼(Xarelto®) | In Northern Ireland, rivaroxaban▼ (Xarelto®) is accepted as an option in combination with aspirin plus clopidogrel or aspirin alone, for preventing atherothrombotic events in people who have had an acute coronary syndrome with elevated cardiac biomarkers. For further information see NICE TA335 | NICE TA335 | Accepted | 28/02/2015 |
| Simeprevir (Olysio®) | In Northern Ireland, simeprevir (Olysio®), in combination with peginterferon alfa and ribavirin, is accepted for use within its marketing authorisation as an option for treating genotype 1 and 4 chronic hepatitis C in adults. For further information see NICE TA331 | NICE TA331 | Accepted | 28/02/2015 |
| Follitropin alfa (Bemfola®) | In Northern Ireland, follitropin alfa (Bemfola®) is accepted: In adult women for: ● anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate. ● stimulation of multi-follicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer. ● in association with a luteinising hormone (LH) preparation for the stimulation of follicular development in women with severe LH and follicle-stimulating hormone (FSH) deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 units/L. In adult men for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy. Follitropin alfa (Bemfola®) is a biosimilar that has demonstrated clinical equivalence to another follitropin alfa product for stimulation of multi-follicular development for superovulation in ART. The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name. For further information see Scottish Medicines Consortium | SMC | Accepted | 28/02/2015 |
| Axtinib (Inlyta®) | In Northern Ireland, axitinib (Inlyta®) is accepted for use as an option for treating adults with advanced renal cell carcinoma after failure of treatment with a first-line tyrosine kinase inhibitor or a cytokine, only if the company provides axitinib with the discount agreed in the patient access scheme. At the time of publication, axitinib has a UK marketing authorisation only for use after failure with first-line sunitinib or a cytokine. If it is considered for use after any other first-line treatments, the prescriber should obtain and document informed consent and follow the relevant guidance published by the General Medical Council. For more information see NICE TA333 | NICE TA333 | Accepted | 30/01/2015 |
| Brimonidine gel (Mirvaso®) | In Northern Ireland, brimonidine gel (Mirvaso®) is accepted for restricted use for the symptomatic treatment of facial erythema of rosacea in adult patients. Use is restricted to patients with moderate to severe persistent facial erythema associated with rosacea. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 30/01/2015 |
| Dolutegravir, abacavir, lamivudine (Triumeq®) | In Northern Ireland, dolutegravir, abacavir, lamivudine (Triumeq®) is accepted for use for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age weighing at least 40 kg. In patients for whom this combination is appropriate, it offers a single tablet at a lower cost per dose compared with the individual components. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of (Triumeq®). This advice is contingent upon the availability of the Patient Access Scheme in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 30/01/2015 |
| Empagliflozin (Jardiance®) | In Northern Ireland, empagliflozin (Jardiance®) is accepted for use for treatment of type 2 diabetes as follows: In a dual therapy regimen in combination with metformin only if: · a sulfonylurea is contraindicated or not tolerated, or · the person is at significant risk of hypoglycaemia or its consequences. In a triple therapy regimen in combination with: · metformin and a sulfonylurea or · metformin and a thiazolidinedione. In combination with insulin with or without other antidiabetic drugs. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NIFormulary choices. For more information see NICE TA336 | NICE TA336 | Accepted | 30/01/2015 |
| Infliximab, adalimumab and golimumab | In Northern Ireland, infliximab, adalimumab and golimumab are accepted for use within their marketing authorisations, as options for treating moderately to severely active ulcerative colitis in adults whose disease has responded inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate, or have medical contraindications for, such therapies. For more information see NICE TA329 | NICE TA329 | Accepted | 30/01/2015 |
| Olodaterol Respimat (Striverdi Respimat®) | In Northern Ireland, olodaterol (Striverdi Respimat®) is accepted for use as maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 30/01/2015 |
| Riociguat (Adempas®) | In Northern Ireland, riociguat (Adempas®) is accepted for restricted use in the management of chronic thromboembolic pulmonary hypertension (CTEPH) in adult patients with World Health Organisation (WHO) functional class II to III with • inoperable CTEPH, • persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity Use is restricted to patients in whom a PDE5 inhibitor is inappropriate, not tolerated, or ineffective.This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of riociguat. This advice is contingent upon the availability of the Patient Access Scheme in Northern Ireland or a list price that is equivalent or lower. A PAS is not yet in place in Northern Ireland so this product should not be routinely prescribed until further notification. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 30/01/2015 |
| Cholecalciferol 25,000 international units oral solution (InVita D3®) | In Northern Ireland, cholecalciferol 25,000 international units oral solution (InVita D3®) is accepted for use for the prevention and treatment of vitamin D deficiency, as an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency. For further information see Scottish Medicines Consortium | SMC | Accepted | 19/12/2014 |
| Daclatasvir (Daklinza®) | In Northern Ireland, daclatasvir (Daklinza®) is accepted for restricted use in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults. Use is restricted to patients with significant fibrosis (Metavir scores F3-F4) or compensated cirrhosis. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 19/12/2014 |
| Fingolimod (Gilenya®) | In Northern Ireland, fingolimod (Gilenya®) is accepted for restricted use in patients with rapidly evolving severe relapsing remitting multiple sclerosis. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of fingolimod. This advice is contingent upon the continuing availability of the patient access scheme in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. For further information see Scottish Medicines Consortium | SMC | Accepted | 19/12/2014 |
| Indacaterol maleate, glycopyrronium bromide (Ultibro Breezhaler®) | In Northern Ireland, indacaterol maleate, glycopyrronium bromide (Ultibro Breezhaler®) is accepted for use as maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). For patients in whom the combination of indacaterol maleate and glycopyrronium bromide is an appropriate choice of therapy, Ultibro® Breezhaler® provides the two ingredients in a single hard capsule at a lower cost than the individual components. For further information see Scottish Medicines Consortium | SMC | Accepted | 19/12/2014 |
| Umeclidinium (Incruse®) | In Northern Ireland, umeclidinium (Incruse®) is accepted for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Umeclidinium is an alternative to other long-acting muscarinic antagonists (LAMAs). For further information see Scottish Medicines Consortium | SMC | Accepted | 19/12/2014 |
| Denosumab (Prolia®) | In Northern Ireland, denosumab (Prolia®) is not accepted for the management of osteoporosis in men at increased risk of fractures. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 28/11/2014 |
| Telavancin hydrochloride (Vibativ®) | In Northern Ireland, telavancin (Vibativ®) is not accepted for the treatment of adults with nosocomial pneumonia including ventilator associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA). People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 28/11/2014 |
| Voriconazole (Vfend®). | In Northern Ireland, voriconazole (Vfend®) is not accepted for the prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant recipients. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 28/11/2014 |
| Lidocaine + tetracaine (Pliaglis®) | In Northern Ireland, lidocaine + tetracaine (Pliaglis®) is not accepted for use as local dermal anaesthesia on intact skin prior to dermatological procedures in adults. People currently on this treatment should be able to continue therapy until they andtheir clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 28/11/2014 |
| Brinzolamide + brimonidine (Simbrinza®) | In Northern Ireland, brinzolamide + brimonidine (Simbrinza®) is accepted for use to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. For further information see Scottish Medicines Consortium | SMC | Accepted | 28/11/2014 |
| Erythropoiesis‑stimulating agents (Epoetin & Darbepoetin) | In Northern Ireland, erythropoiesis-stimulating agents (epoetin alfa, beta, theta and zeta, and darbepoetin alfa) are accepted as options for treating anaemia in people with cancer who are having chemotherapy. If different erythropoiesis-stimulating agents are equally suitable, the product with the lowest acquisition cost for the course of treatment should be used. For further information see NICE TA323 | NICE TA323 | Accepted | 28/11/2014 |
| Alogliptin (Vipidia®) | In Northern Ireland, alogliptin (Vipidia®) is accepted for restricted use for the treatments of adults aged 18 years and older with type 2 diabetes mellitus. Use is restricted to dual therapy: ·In combination with metformin, when metformin alone, together with diet and exercise does not provide adequate glycaemic control in patients for whom the addition of a sulfonylurea is inappropriate ·In combination with a sulfonylurea, when sulfonylurea alone, together with diet and exercise does not provide adequate glycaemic control in patients for whom the addition of metformin is inappropriate due to contra-indications or intolerance. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 31/10/2014 |
| Azelastine + fluticasone (Dymista®) | In Northern Ireland, azelastine + fluticasone (Dymista®) is accepted for use for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 31/10/2014 |
| Dabigatran (Pradaxa®) | In Northern Ireland, dabigatran (Pradaxa®) is accepted for use for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. For further information see NICE TA327 | NICE TA327 | Accepted | 31/10/2014 |
| Imatinib (Glivec®) | In Northern Ireland, imatinib (Glivec®) is accepted for use as an option as adjuvant treatment for up to 3 years for adults who are at high risk of relapse after surgery for KIT (CD117)-positive gastrointestinal stromal tumours, as defined by the Miettinen 2006 criteria For further information see NICE TA 326 | NICE TA326 | Accepted | 31/10/2014 |
| Lurasidone (Latuda®) | In Northern Ireland, lurasidone (Latuda®) is accepted for restricted use for the treatment of schizophrenia in adults aged 18 years and over. Use is restricted to use as an alternative treatment option in patients in whom it is important to avoid weight gain and metabolic adverse effects. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices For further information see Scottish Medicines Consortium | SMC | Accepted | 31/10/2014 |
| Misoprostol vaginal insert (Mysodelle®) | In Northern Ireland, misoprostol vaginal insert (Mysodelle®) is accepted for use for induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated. For further information see Scottish Medicines Consortium | SMC | Accepted | 31/10/2014 |
| Nalmefene (Selincro®) | In Northern Ireland, nalmefene (Selincro®) is accepted for use within its marketing authorisation, as an option for reducing alcohol consumption, for people with alcohol dependence: who have a high drinking risk level (defined as alcohol consumption of more than 60g per day for men and more than 40g per day for women, according to the World Health Organization’s drinking risk levels) without physical withdrawal symptoms, and who do not require immediate detoxification The marketing authorisation states that nalmefene should: ·only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption, and ·be initiated only in patients who continue to have a high drinking risk level 2 weeks after initial assessment. For further information see NICE TA325 | NICE TA325 | Accepted | 31/10/2014 |
| Posaconazole tablet formulation (Noxafil®) | In Northern Ireland, posaconazole gastro-resistant tablets (Noxafil ®) are accepted for restricted use for treatment of specific fungal infections. Use is restricted to patients in whom there is a specific risk of Aspergillus infection or where fluconazole or itraconazole are not tolerated on the advice of local microbiologists or specialists in infectious diseases. For further information see Scottish Medicines Consortium | SMC | Accepted | 31/10/2014 |
| Alogliptin + metformin (Vipdomet®) | In Northern Ireland, alogliptin + metformin (Vipdomet®) is accepted for restricted use for the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus. Use is restricted to the treatment of patients for whom this fixed dose combination of alogliptin and metformin is an appropriate choice of therapy and only when the addition of a sulphonylurea to metformin monotherapy is not appropriate. *This drug is not on the NI Formulary and is not a first-line option. Please refer to http://niformulary.hscni.net for preferred NI Formulary choices For further information see Scottish Medicines Consortium | SMC | Accepted | 30/10/2014 |
| Dabrafenib (Tafinlar®) | In Northern Ireland, Dabrafenib (Tafinlar®) is accepted for use as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma only if the company provides dabrafenib with the discount agreed in the patient access scheme. For further information see NICE TA321 | NICE TA321 | Accepted | 26/09/2014 |
| Colestilan (BindRen®) | In Northern Ireland, colestilan (BindRen®) is not accepted for the treatment of hyperphosphataemia in adult patients with chronic kidney disease (CKD) stage 5 receivinghaemodialysis or peritoneal dialysis. People currently receiving this drug should be able to continue therapy until they andtheir clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 29/08/2014 |
| Racecadotril (Hidrasec®, Hidrasec® Infants, Hidrasec® Children) | In Northern Ireland, racecadotril (Hidrasec Infants®, Hidrasec Children®) is not accepted for the complementary symptomatic treatment of acute diarrhoea in infants older thanthree months and in children, together with oral rehydration and the usual supportmeasures, when these measures alone are insufficient to control the clinical conditionand when causal treatment is not possible. If causal treatment is possible racecadotril canbe administered as a complementary treatment. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 29/08/2014 |
| Dapagliflozin + Metformin (Xigduo®) | In Northern Ireland dapagliflozin + metformin is accepted for restricted use for use in patients for whom a combination of dapagliflozin and metformin is an appropriate choice of therapy i.e. ·when metformin alone does not provide adequate glycaemic control and a sulphonylurea is inappropriate. ·in combination with insulin, when insulin and metformin does not provide adequate control. ·in combination with a sulphonylurea, when a sulphonylurea and metformin does not provide adequate control Dapagliflozin in combination with metformin has been shown to be bioequivalent to dapagliflozin and metformin administered separately and dapagliflozin administered twice daily has been shown to provide similar exposure to the equivalent dose administered once daily. *This drug is not on the NI Formulary and is not a first-line option. Please refer to NI Formulary for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 29/08/2014 |
| Lenalidomide (Revlimid®) | In Northern Ireland, lenalidomide is accepted for use for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate with the following condition: The drug cost of lenalidomide (excluding any related costs) for people who remain on treatment for more than 26 cycles (each of 28 days; normally a period of 2 years) will be met by the company. Trusts are required to make quarterly monitoring returns on the use of this drug for the next 12 months to the Medicine Management Commissioning Team and to the Specialist Services Commissioning Team. For further information see NICE TA322 | NICE TA322/a> | Accepted | 29/08/2014 |
| Dimethyl fumarate(also known as BG-12) (Tecfidera®) | In Northern Ireland, dimethyl fumarate (Tecfidera®) is accepted for use as an option for treating adults with active relapsing–remitting multiple sclerosis (normally defined as 2 clinically significant relapses in the previous 2 years), only if: ·they do not have highly active or rapidly evolving severe relapsing–remitting multiple sclerosis and ·the manufacturer provides dimethyl fumarate with the discount agreed in the patient access scheme. Trusts are required to make quarterly monitoring returns on the use of this drug for the next 12 months to the Medicines Management Commissioning Team and to the Specialist Services Commissioning Team. For more information see NICE TA 320 | NICE TA320 | Accepted | 31/07/2014 |
| Botulinum toxin type A (Botox®) | In Northern Ireland, botulinum toxin type A (Botox®) is not recommended for the management of focal lower limb spasticity, including the treatment of ankle disability due to lower limb spasticity associated with stroke in adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 25/07/2014 |
| Dapoxetine (Priligy®) | In Northern Ireland, dapoxetine (Priligy®) is not recommended for the management of premature ejaculation (PE) in adult men aged 18 to 64 years. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further advice see Scottish Medicines consortium | SMC | Not Accepted | 25/07/2014 |
| Beclometasone dipropionate and formoterol fumarate dihydrate metered dose inhaler100microgram / 6microgram (Fostair®) | In Northern Ireland, beclometasone dipropionate and formoterol fumarate dehydrate metered dose inhaler 100microgram / 6microgram (Fostair®) is accepted for use for symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. Fostair® should be used in patients for whom beclometasone and formoterol are appropriate choices of corticosteroid and long-acting beta2-agonist respectively, and for whom a metered dose inhaler is an appropriate delivery device. The introduction of Fostair® is likely to be cost neutral. The 100mcg dose of beclometasone in Fostair® is not bioequivalent to a 100mcg dose of beclometasone in several other inhaler formulations. For further information see Scottish Medicines Consortium | SMC | Accepted | 25/07/2014 |
| Rituximab (MabThera®) | In Northern Ireland, rituximab (MabThera®) subcutaneous formulation, is accepted for restricted use for non-Hodgkin’s lymphoma (NHL) in adults: ·previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy; ·maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy; ·treatment of patients with CD20 positive diffuse large B cell - non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Restriction: Subcutaneous rituximab is accepted for use in line with previous SMC advice for intravenous rituximab i.e. accepted within licensed indication as above except in the maintenance setting, where use is restricted to patients who have responded to induction therapy with rituximab plus chemotherapy. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of rituximab subcutaneous injection. This advice is contingent upon the availability of the patient access scheme in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis until the Service Notification is issued. Trusts are required to make quarterly monitoring returns on the use of this drug for the next 12 months to the Medicines Management Commissioning Team and to the Specialist Services Commissioning Team. For further information see Scottish Medicines Consortium | SMC | Accepted | 25/07/2014 |
| Avanafil (Spedra®) | In Northern Ireland, avanafil (Spedra®) is Not Accepted for the management of erectile dysfunction. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC 980/14 | Not Accepted | 27/06/2014 |
| Natalizumab (Tysabri®) | In Northern Ireland, natalizumab (Tysabri®) is Not Accepted for use as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) for adult patients aged 18 years and over with high disease activity despite treatment with glatiramer acetate. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. Natalizumab (Tysabri®) is already routinely commissioned under NICE TA127 as an option for the treatment of rapidly evolving severe relapsing–remitting multiple sclerosis (RES). RES is defined by two or more disabling relapses in 1 year, and one or more gadolinium-enhancing lesions on brain magnetic resonance imaging (MRI) or a significant increase in T2 lesion load compared with a previous MRI. This advice remains in place. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 27/06/2014 |
| Budesonide gastro-resistant granules (Budenofalk®) | In Northern Ireland budesonide gastro-resistant granules (Budenofalk®) are accepted for use for induction of remission in patients with mild to moderate active Crohn’s disease affecting the ileum and/or ascending colon. For further information see Scottish Medicines Consortium | SMC | Accepted | 27/06/2014 |
| Defibrotide (Defitelio®) | In Northern Ireland, defibrotide (Defitelio®) is accepted for use for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of defibrotide. This advice is contingent upon the continuing availability of the patient access scheme or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis. For further information see Scottish Medicines Consortium 967/14 | SMC 967/14 | Accepted | 27/06/2014 |
| Fluticasone furoate/vilanterol (Relvar Ellipta®) | In Northern Ireland, fluticasone furoate/vilanterol (Relvar Ellipta®) is accepted for use for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate in patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta2-agonists. *This drug is not on the NI Formulary and is not a first-line option. Please refer to Northern Ireland Formulary for preferred NI Formulary choices. For further information see Scottish Medicines Consortium | SMC | Accepted | 27/06/2014 |
| Ipilimumab (Yervoy®) | In Northern Ireland, Ipilimumab (Yervoy®) is accepted as an option for treating adults with previously untreated advanced (unresectable or metastatic) melanoma, only if the manufacturer provides ipilimumab with the discount agreed in the patient access scheme. For further information see NICE TA319 | NICE TA319 | Accepted | 27/06/2014 |
| Lubiprostone (Amitiza®) | In Northern Ireland, Lubiprostone is accepted as an option for treating chronic idiopathic constipation, that is, for adults in whom treatment with at least 2 laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and for whom invasive treatment for constipation is being considered. If treatment with lubiprostone is not effective after 2 weeks, the person should be re-examined and the benefit of continuing treatment reconsidered. Lubiprostone should only be prescribed by a clinician with experience of treating chronic idiopathic constipation, who has carefully reviewed the person’s previous courses of laxative treatments. *This drug is not on the NI Formulary and is not a first-line option. Please refer to NI Formulary for preferred NI Formulary choices. For further information see NICE TA318 | NICE TA318 | Accepted | 27/06/2014 |
| Prasugrel (Efient®) | In Northern Ireland, Prasugrel 10 mg in combination with aspirin is recommended as an option within its marketing authorisation, that is, for preventing atherothrombotic events in adults with acute coronary syndrome (unstable angina, non-ST segment elevation [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) having primary or delayed percutaneous coronary intervention. *This drug is not on the NI Formulary and is not a first-line option. Please refer to Northern Ireland Formulary for NI Formulary choices. For further information see NICE TA317 | NICE TA317 | Accepted | 27/06/2014 |
| Cobicistat (Tybost®) | In Northern Ireland, cobicistat (Tybost®) is Not Accepted for use as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults. People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop. For further information see Scottish Medicines Consortium | SMC | Not Accepted | 30/05/2014 |
| Canagliflozin (Invokana®) | In Northern Ireland, canagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if: ·a sulfonylurea is contraindicated or not tolerated or ·the person is at significant risk of hypoglycaemia or its consequences. Canagliflozin in a triple therapy regimen is recommended as an option for treating type 2 diabetes in combination with: ·metformin and a sulfonylurea or ·metformin and a thiazolidinedione. Canagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes. *This drug is not on the NI Formulary and is not a first-line option. Please refer to NI Formulary for preferred choices. For Further information see NICE TA 315 | NICE TA315 | Accepted | 30/05/2014 |
| Dolutegravir (Trivicay®) | In Northern Ireland dolutegravir (Tivicay®) is accepted for use in combination with other antiretroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age. This advice takes account of the benefits of a patient access scheme (PAS) that improves the cost-effectiveness of dolutegravir. This advice is contingent upon the availability of the patient access scheme in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis from existing baseline funds until routine commissioning is agreed and recurrent funding is allocated. For further information see Scottish Medicines Consortium | SMC 961/14 | Accepted | 30/05/2014 |
| Enzalutamide (Xtandi®) | In Northern Ireland, enzalutamide is accepted for use for treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after docetaxel therapy, only if the manufacturer provides enzalutamide with the discount agreed in the patient access scheme. For further information see NICE TA316 | NICE TA316 | Accepted | 30/05/2014 |
| Certolizumab (Cimzia®) | In Northern Ireland, certolizumab pegol (Cimzia®) is accepted for use for the treatment of adult patients with severe active axial spondyloarthritis, comprising: · Ankylosing spondylitis (AS) Adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). · Axial spondyloarthritis without radiographic evidence of AS (nr-axSpA) Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and /or MRI, who have had an inadequate response to, or are intolerant to NSAIDs. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of certolizumab. This advice is contingent upon the availability of the Patient Access Scheme in Northern Ireland or a list price that is equivalent or lower. Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis from existing baseline funds until routine commissioning is agreed and recurrent funding is allocated. For further information see Scottish Medicines Consortium | SMC | Accepted | 27/05/2014 |