Managed Entry Decisions

DrugDecisionLink To guidanceStatusDate Added to website
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.

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 TA642
NICE TA642Accepted16/9/2020
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.

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 TA641

NICE TA641Accepted16/9/2020
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.

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 TA639

NICE TA639Accepted16/9/2020
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

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 TA638
NICE TA638Accepted16/9/2020
Abiraterone (Zytiga®)In Northern Ireland, abiraterone (Zytiga®) is not accepted for use with prednisone or prednisolone plus androgen deprivation therapy, 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 Gid-ta1022

NICE gid-ta10122Not 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 TA644Accepted16/9/2020
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.

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 TA633

NICE TA633Accepted16/9/2020
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.

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 TA632

NICE TA632Accepted 16/9/2020
Fremanezumab (Ajovy®)In Northern Ireland, fremanezumab (Ajovy®) is accepted for use as an option for preventing migraine in adults, only if:
- the migraine is chronic, that is, 15 or more headache days a month for more than 3 months with at least 8 of those having features of migraine
- at least 3 preventive drug treatments have failed 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 TA631
NICE TA631Accepted16/9/2020
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.

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 TA629

NICE TA629Accepted16/9/2020
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 TA630Accepted16/9/2020
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.

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 TA628
NICE TA628Accepted16/9/2020
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 (CDF). 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 ID1536
NICE ID1536Not Accepted16/9/2020
Mexiletine (Namuscla®)In Northern Ireland, mexiletine (Namuscla®) is not accepted for use for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.

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

SMCNot Accepted16/9/2020
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
SMCNot 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.

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 TA626.
NICE TA626Accepted14/07/2020
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.
SMCNot Accepted14/07/2020
Apalutamide (Erleada®)In Northern Ireland, apalutamide (Erleada®) is not accepted for use in adult men for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC) who are at high risk of developing 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 see Scottish Medicines Consortium.
SMCNot Accepted14/07/2020
Daratumumab (Darzalex®)In Northern Ireland, daratumumab (Darzalex®) is not accepted for use, in combination with lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for 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.
SMCNot Accepted14/07/2020
Teduglutide (Revestive®)In Northern Ireland, teduglutide (Revestive®) is accepted for the treatment of patients age 1 year and above with short bowel syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery. This submission relates to use in adult patients.

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.
SMCAccepted14/07/2020
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.
SMCAccepted14/07/2020
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.

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 TA627.
NICE TA627Accepted14/07/2020
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.
SMCNot Accepted14/07/2020
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.
SMCAccepted14/07/2020
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.
SMCAccepted10/03/2020
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 TA624Accepted10/03/2020
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
SMCNot Accepted24/02/2020
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.SMCNot Accepted24/02/2020
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.
SMCAccepted24/02/2020
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.
SMCAccepted24/02/2020
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 TA622Accepted24/02/2020
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.SMCNot Accepted24/02/2020
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.SMCNot Accepted24/02/2020
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.SMCAccepted24/02/2020
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.SMCAccepted24/02/2020
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.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.
NICE TA615Accepted24/02/2020
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.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.
NICE TA614Accepted24/02/2020
Fluocinolone acetonide (Iluvien®)In Northern Ireland, fluocinolone acetonide intravitreal implant (Iluvien®) is not accepted for use as an option for treating chronic diabetic macular oedema that is insufficiently responsive to available therapies in an eye with a natural lens (phakic eye).People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.NICE TA613Not Accepted24/02/2020
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 TA612Accepted24/02/2020
Ruxolitinib (Jakavi®)In Northern Ireland, ruxolitinib (Jakavi®) is accepted for use in the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea (hydroxycarbamide).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 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.SMCAccepted24/02/2020
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.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.NICE TA617Accepted24/02/2020
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.SMCNot Accepted24/02/2020
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 HST12Accepted24/02/2020
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 people 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 conditions in the managed access agreement for palbociclib with fulvestrant are followed.
This advice takes account of the benefits of Patient Access Schemes (PAS) that improve the cost-effectiveness of palbociclib and fulvestrant. This advice is contingent upon the continuing availability of these PAS in Northern Ireland or list prices that are 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.
NICE TA619Accepted24/02/2020
Olaparib (Lynparza®)In Northern Ireland, olaparib 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 disease has responded to platinum-based chemotherapy only if:
- they have a BRCA1 or BRCA2 mutation
- they have had 3 or more courses of platinum-based chemotherapy and
- the company provides olaparib according to the commercial arrangement

Olaparib is recommended for use within the Cancer Drugs Fund as an option for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose disease has responded to platinum-based chemotherapy only if:
- they have a BRCA1 or BRCA2 mutation - they have had 2 courses of platinum-based chemotherapy and
- the conditions in the managed access agreement for olaparib 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 TA620Accepted24/02/2020
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 seeSMC2236SMCNot Accepted17/12/2019
​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 TA610Accepted17/12/2019
​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 HST11NICE HST11Accepted17/12/2019
​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 TA611NICE TA611Accepted17/12/2019
​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 seeSMC2211SMCAccepted17/12/2019
​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 seeSMC2237SMCNot Accepted20/11/2019
​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 seeSMC2231SMCNot Accepted20/11/2019
​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 TA604NICE TA604Not Accepted20/11/2019
​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 TA607NICE TA607Accepted20/11/2019
​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 seeSMC2205SMCAccepted20/11/2019
​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 TA606Accepted20/11/2019
​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 TA605NICE TA605Accepted20/11/2019
​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 SMC2182SMCNot Accepted10/10/2019
​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
SMCNot Accepted10/10/2019
​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 seeSMC2219SMCNot Accepted10/10/2019
​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 seeSMC2217SMCNot Accepted10/10/2019
​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 seeSMC2221SMCNot Accepted10/10/2019
​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 TA404NICE TA404Accepted10/10/2019
​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
SMCAccepted10/10/2019
​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
SMCAccepted10/10/2019
​Olaparib (Lynparza®)​In Northern Ireland, olaparib (Lynparza®) is accepted for use as an option for the 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 recommended only if the conditions in the managed access agreement for olaparib 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 TA598NICE TA598Accepted10/10/2019
​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 HST10NICE HST10Accepted10/10/2019
​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:
• pembrolizumab is stopped at 2 years of uninterrupted treatment, or earlier if disease progresses, and
• the company provides pembrolizumab 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 TA600
NICE TA600Accepted10/10/2019
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 ConsortiumSMCNot Accepted19/09/2019
​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 ConsortiumSMCNot Accepted19/09/2019
​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 ConsortiumSMCNot Accepted19/09/2019
​Osimertinib (Tagrisso®)​In Northern Ireland, osimertinib (Tagrisso®) is not 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.People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.NICE TA621Not Accepted10/03/2020
​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
SMCAccepted19/09/2019
​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 
• in outpatient care 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,
− are not taking an optimised dosage of renin-angiotensin-aldosterone system (RAAS) inhibitor because of hyperkalaemia, and
− are not on dialysis.
Sodium zirconium cyclosilicate is accepted only if the company provides it according to the commercial arrangement
For further information see NICE TA599
NICE TA599Accepted19/09/2019
​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 TA607NICE TA607Accepted19/09/2019
​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
SMCAccepted19/09/2019
​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
SMCAccepted19/09/2019
​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 seeNICE TA590SMCAccepted19/09/2019
​Cemiplimab (Libtayo®)​In Northern Ireland, cemiplimab (Libtayo®) is accepted for use as an option for treating locally advanced or metastatic cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not appropriate. 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 TA592NICE TA592Accepted19/09/2019
​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 TA595NICE TA595Accepted19/09/2019
​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 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 TA596
NICE TA596Accepted19/09/2019
​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 people 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 conditions in the managed access agreement for ribociclib with fulvestrant 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 TA593
NICE TA593Accepted19/09/2019
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
SMCNot Accepted23/08/2019
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 SMC2193SMCNot Accepted23/08/2019
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 SMC2191SMCNot Accepted23/08/2019
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 SMC2192SMCNot Accepted23/08/2019
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 SMC2190SMCNot Accepted23/08/2019
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 TA580NICE TA580Not Accepted23/08/2019
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 TA583Accepted23/08/2019
​Hydrocortisone -extended release (Alkindi®)​In Northern Ireland, Hydrocortisone -extended release (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
SMCAccepted23/08/2019
Dapagliflozin (Forxiga®)In Northern Ireland, dapagliflozin (Forxiga®) 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:
• they are on insulin doses of more than 0.5 units/kg of body weight/day and
• they have completed a structured education programme that includes information about:
− the risk of diabetic ketoacidosis
− how to recognise risk factors for diabetic ketoacidosis, and its signs and symptoms
−  how and when to monitor blood ketone levels
−  what actions to take for elevated blood ketones, and treatment is started and supervised in a hospital diabetes clinic.
*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
For further information see NICE TA597
NICE TA597kAccepted23/08/2019
​GLP-1 mimetics (for example albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, and semaglutide)​In Northern Ireland, glucagon‑like peptide‑1 (GLP‑1) mimetics (including albiglutide, 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.
Please refer to http://niformulary.hscni.net  for preferred NI Formulary choices
NICE NG28Accepted23/08/2019
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.

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 TA584
NICE TA584Accepted23/08/2019
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. 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 TA585​NICE TA585Accepted23/08/2019
​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 TA586Accepted23/08/2019
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 HST9NICE HST9Accepted23/08/2019
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 TA588Accepted23/08/2019
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 TA587Accepted23/08/2019
​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.
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 TA591
NICE TA591Accepted23/08/2019
​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 ConsortiumSMCNot Accepted25/06/2019
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 ConsortiumSMCAccepted25/06/2019
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
SMCAccepted25/06/2019
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 ConsortiumSMCAccepted25/06/2019
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 ConsortiumSMCAccepted25/06/2019
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 ConsortiumSMCAccepted25/06/2019
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 TA577Accepted25/06/2019
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 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 TA578
NICE TA578Accepted25/06/2019
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 people who have had endocrine therapy only if: 
- exemestane plus everolimus would be the most appropriate alternative and 
- the conditions in the managed access agreement for abemaciclib with fulvestrant 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 TA579
NICE TA579Accepted25/06/2019
Nivolumab (Opdivo®)​In Northern Ireland, nivolumab with ipilimumab is accepted for use as an option 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 conditions in the managed access agreement for nivolumab with ipilimumab 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 TA581NICE TA581Accepted25/06/2019
Cabozantinib (Cabometyx®)In Northern Ireland, cabozantinib (Cabometyx®) is not accepted for use as monotherapy for the treatment of hepatocellular carcinoma in adults who have previously been 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. For further information see Scottish Medicines ConsortiumSMCNot Accepted09/05/2019
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 seeScottish Medicines ConsortiumSMCNot Accepted09/05/2019
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 ConsortiumSMCNot Accepted09/05/2019
​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 ConsortiumSMCAccepted09/05/2019
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 ConsortiumSMCAccepted09/05/2019
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 ConsortiumSMCAccepted09/05/2019
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 TA569Accepted09/05/2019
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 TA571NICE TA571Accepted09/05/2019
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

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 TA575
NICE TA575Accepted09/05/2019
Daratumumab (Darzalex®)​In Northern Ireland, daratumumab (Darzalex®) is accepted for use, in combination with bortezomib and dexamethasone, as an option for treating relapsed multiple myeloma in people who have had 1 previous treatment. It is recommended only if the conditions in the managed access agreement for daratumumab plus bortezomib plus 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 seeNICE TA573NICE TA573Accepted09/05/2019
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

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 TA574
NICE TA574Accepted09/05/2019
​Eculizumab (Soliris®)​In Northern Ireland, Eculizumab is accepted for use,within its marketing authorisation, is recommended for funding 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 HST1Accepted09/05/2019
Elosulfase alfa (Vimizim®)​In Northern Ireland, elosulfase alfa is accepted for use, within its marketing authorisation, as an option for treating mucopolysaccharidosis type IVa (MPS IVa) according to the conditions in the managed access agreementfor elosulfase alfa. 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 HST2NICE HST2Accepted09/05/2019
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 HST4NICE HST4Accepted09/05/2019
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 HST5NICE HST5Accepted09/05/2019
Asfotase alfa (Strensiq®)​In Northern Ireland, asfotase alfa is accepted for use as an option for treating paediatric-onset hypophosphatasia only:

-         for people who meet the criteria for treatment within the managed access arrangement, and
-         for the duration of this arrangement and in line with the other conditions it specifies, and
-         when the company provides asfotase alfa with the confidential commercial terms agreed

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 HST6
NICE HST6Accepted09/05/2019
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 HST7NICE HST7Accepted09/05/2019
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 HST8NICE HST8Accepted09/05/2019
Doravirine/lamivudine/tenofovir disoproxil (Delstrigo®)In Northern Ireland, doravirine + lamivudine + tenofovir disoproxil (Delstrigo®) is not accepted for use in the treatment of adults infected with human immunodeficiency virus 1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor class, lamivudine, or tenofovir. 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 ConsortiumSMCNot Accepted08/05/2019
Doravirine (Pifeltro®)In Northern Ireland, doravirine (Pifeltro®) is not accepted for use, in combination with other antiretroviral medicinal products, for the treatment of adults infected with human immunodeficiency virus 1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor class. 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 ConsortiumSMCNot Accepted07/05/2019
​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 TA556NICE TA556Not Accepted26/03/2019
​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 ConsortiumSMCNot Accepted26/03/2019
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 TA572Accepted26/03/2019
​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 ConsortiumSMCAccepted26/03/2019
​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 TA565Accepted26/03/2019
​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 TA563NICE TA563Accepted26/03/2019
​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 TA561NICE TA561Accepted26/03/2019
​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 TA562NICE TA562Accepted26/03/2019
​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 TA567NICE TA567Accepted26/03/2019
​Olaratumab (Lartruvo®)In Northern Ireland, Olaratumab (Lartruvo®) is accepted for use, in combination with doxorubicin, as an option for treating advanced soft tissue sarcoma in adults, only if:
• they have not had any previous systemic chemotherapy for advanced soft tissue sarcoma
• they cannot have curative treatment with surgery or their disease does not respond to radiotherapy
• the conditions in the managed access agreement for olaratumab 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 TA465 

January 2019: The European Medicines Agency (EMA) has issued a press release following preliminary results from the ANNOUNCE study. ANNOUNCE is a phase 3 study of olaratumab with doxorubicin in people with advanced or metastatic soft tissue sarcoma. Early results show that olaratumab is not more effective at prolonging the lives of people compared with doxorubicin alone (a standard care treatment). The EMA have advised that no new people should start treatment with olaratumab, while full results from the study are awaited. People taking olaratumab and appearing to benefit from it, should talk to their doctor about their continued treatment or other treatment options.
NICE TA465Accepted04/03/2019
​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 ConsortiumSMCNot Accepted14/02/2019
​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 ConsortiumSMCNot Accepted14/02/2019
​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 ConsortiumSMCAccepted14/02/2019
​Axicabtagene ciloleucel (Yescarta®)​In Northern Ireland axicabtagene ciloleucel (Yescarta®) is accepted for use for use 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, 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 TA559NICE TA559Accepted14/02/2019
​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
SMCNot Accepted25/01/2019
​Brivaracetam (Briviact®)​In Northern Ireland, brivaracetam (Briviact®) is accepted for use as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in children from 4 years to ≤15 years of age with epilepsy. Use is restricted to patients with refractory epilepsy and treatment should be initiated by physicians who have appropriate experience in the treatment of epilepsy. Note: HSCB has previously accepted brivaracetam for restricted use as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy For further information seeScottish Medicines ConsortiumSMCAccepted25/01/2019
​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 ConsortiumSMCAccepted25/01/2019
​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 ConsortiumSMCAccepted25/01/2019
​Pembrolizumab (Keytruda®)​In Northern Ireland, pembrolizumab (Keytruda®) is accepted for use as an option for the adjuvant treatment of stage III melanoma with lymph node involvement in adults who have had complete resection. It is recommended only if 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 seeNICE TA553NICE TA553Accepted25/01/2019
​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 TA554NICE TA554Accepted25/01/2019
​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)- or anaplastic lymphoma kinase (ALK)-positive mutations. It is only recommended if:pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier if disease progresses andthe company provides pembrolizumab 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 seeNICE TA557NICE TA557Accepted25/01/2019
​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 TA547NICE TA547Accepted25/01/2019
​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 TA555NICE TA555Accepted25/01/2019
​Nivolumab (Opdivo®)​In Northern Ireland nivolumab (Opdivo®) is accepted for use 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 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 TA558NICE TA558Accepted25/01/2019
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 ConsortiumSMCNot Accepted18/12/2018
​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 ConsortiumSMCNot Accepted18/12/2018
​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 TA550NICE TA550Not Accepted18/12/2018
​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 TA546NICE TA546Not Accepted18/12/2018
​Anakinra (Kineret®)​In Northern Ireland, anakinra (Kineret®) is accepted for use in adults, adolescents, children and infants aged 8 months and older with a body weight of 10kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs). 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 ConsortiumSMCAccepted18/12/2018
​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 ConsortiumSMCAccepted18/12/2018
​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 TA551NICE TA551Accepted18/12/2018
​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 TA552NICE TA552Accepted18/12/2018
​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 TA540Accepted11/12/2018
​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 TA540Not Accepted10/12/2018
​Ibrutinib (Imbruvica®)​In Northern Ireland, ibrutinib (Inbruvica®) is accepted for use as an option for treating Waldenström’s macroglobulinaemia in adults who have had at least 1 prior therapy, only if the conditions in the managed access agreement for ibrutinib 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 TA491NICE TA491Accepted10/12/2018
​Venetoclax (Venclyxto®)In Northern Ireland, Venetoclax (Venclyxto®) is accepted for use, within its marketing authorisation, as an option for treating chronic lymphocytic leukaemia, that is, 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 and·        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 TA487NICE TA487Accepted10/12/2018
​Nivolumab (Opdivo®)​In Northern Ireland, nivolumab (Opdivo®) is accepted for use as an option for treating 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·        nivolumab is stopped at 2 years of uninterrupted treatment, or earlier in the event of disease progression 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 basisFor further information seeNICE TA490NICE TA490Accepted10/12/2018
​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 in adults after chemotherapy, only if:·        their tumours are PD‑L1 positive and·        nivolumab is stopped at 2 years of uninterrupted treatment, or earlier in the event of disease progression, 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 seeNICE TA484NICE TA484Accepted10/12/2018
​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 in adults after chemotherapy, only if: ·        nivolumab is stopped at 2 years of uninterrupted treatment, or earlier in the event of disease progression, 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 seeNICE TA483NICE TA483Accepted10/12/2018
​Atezolizumab (Tecentriq®)In Northern Ireland, atezolizumab (Tecentriq®) is accepted for use as an option for untreated locally advanced or metastatic urothelial carcinoma in adults when cisplatin-containing chemotherapy is unsuitable, only if:·        their tumours express PD-L1 at a level of 5% or more and·        the conditions of the managed access agreement for atezolizumab are followed.Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basisFor further information seeNICE TA492Please note: In July 2018 the European Medicines Agency restricted the use of atezolizumab for untreated urothelial carcinoma. It should now only be used in adults with high levels of PD-L1. For more information, see the summary of product characteristics for atezolizumab.NICE TA492Accepted10/12/2018
​Osimertinib (Tagrisso®)​In Northern Ireland, osimertinib (Tagrisso®) is accepted for use as an option for treating locally advanced or metastaticepidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer in adults whose disease has progressed only:·        after first-line treatment with an EGFR tyrosine kinase inhibitor and·        if the conditions in the managed access agreement for osimertinib are followedWhere 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 TA416NICE TA416Accepted10/12/2018
​Ixazomib (Ninlaro®)​ In Northern Ireland, ixazomib (Ninlaro®) is accepted for use, with lenalidomide and dexamethasone, as an option for treating multiple myeloma in adults only if:·        they have already had 2 or 3 lines of therapy and·        the conditions in the managed access agreement for ixazomib are followedWhere infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basisFor further information seeNICE TA505NICE TA505Accepted10/12/2018
​Daratumumab (Daralex®)​In Northern Ireland, daratumumab (Daralex®) monotherapy is accepted as an option for treating relapsed and refractory multiple myeloma in adults whose previous therapy included a proteasome inhibitor and an immunomodulator, and whose disease progressed on the last therapy, only if:
·        they have daratumumab after 3 previous therapies 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 TA510
NICE TA510Accepted10/12/2018
Avelumab (Bavencio®)​In Northern Ireland, avelumab (Bavencio®) is accepted for use as an option for treating metastatic Merkel cell carcinoma in adults, if they have had 1 or more lines of chemotherapy for metastatic disease.

In adults with metastatic Merkel cell carcinoma who have not had chemotherapy for metastatic disease, avelumab is accepted for use only if the conditions in the managed access agreement for avelumab are followed.

For further information see NICE TA517
NICE TA517Accepted10/12/2018
​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, only if:
·        they have a germline BRCA mutation and have had 2 courses of platinum-based chemotherapy or
·        they do not have a germline BRCA mutation and have had 2 or more courses of platinum-based chemotherapy and
·        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 TA528
NICE TA528Accepted10/12/2018
​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 TA529Accepted10/12/2018
​Pembrolizumab (Keytruda®)​In Northern Ireland pembrolizumab (Keytruda®) is accepted for use as an option for untreated locally advanced or metastatic urothelial carcinoma in adults when cisplatin-containing chemotherapy is unsuitable, only if:
·        their tumours express PD-L1 with a combined positive score of 10 or more
·        pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier if the disease progresses and
·        the conditions of 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 TA522.

Please note: In July 2018 the European Medicines Agency restricted the use of pembrolizumab for untreated urothelial carcinoma. It should now only be used in adults with high levels of PD-L1. For more information, see the summary of product characteristics for pembrolizumab.
NICE TA522Accepted10/12/2018
​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
SMCNot Accepted12/11/2018
​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
SMCAccepted12/11/2018
​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
SMCAccepted12/11/2018
​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 TA544Accepted12/11/2018
​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 TA543Accepted12/11/2018
​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 TA545Accepted12/11/2018
​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
SMCNot Accepted02/11/2018
​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
SMCNot Accepted02/11/2018
​Sapropterin (Kuvan®)​In Northern Ireland, sapropterin (Kuvan®) is not accepted for use for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such 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
SMCNot Accepted02/11/2018
​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. 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
SMCAccepted02/11/2018
​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 TA537Accepted02/11/2018
​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.

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 TA541
NICE TA541Accepted02/11/2018
​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 TA542Accepted02/11/2018
​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
SMCAccepted02/11/2018
​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 TA530Not Accepted21/09/2018
​Midostaurin (Rydapt®)​In Northern Ireland, midostaurin (Rydapt®) is not accepted for use as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm, or mast cell 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
SMCNot Accepted21/09/2018
​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
SMCNot Accepted21/09/2018
​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 TA532Not Accepted21/09/2018
​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
SMCAccepted21/09/2018
​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
SMCAccepted21/09/2018
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
SMCAccepted21/09/2018
​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 TA539Accepted21/09/2018
​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 TA533Accepted21/09/2018
​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 TA534Accepted21/09/2018
​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 TA536Accepted21/09/2018
​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 TA538Accepted21/09/2018
​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 TA531Accepted21/09/2018
​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 TA535Accepted21/09/2018
​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
SMCNot Accepted10/08/2018
​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
SMCNot Accepted10/08/2018
​ 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 TA527Not Accepted10/08/2018
​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
SMCAccepted10/08/2018
​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
SMCAccepted10/08/2018
​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
SMCAccepted10/08/2018
​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
SMCAccepted10/08/2018
​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 TA524Accepted10/08/2018
​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 TA523Accepted10/08/2018
​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 TA526Accepted10/08/2018
​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 TA527Accepted10/08/2018
​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 TA521Accepted10/08/2018
​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 TA525Accepted10/08/2018
Teduglutide (Revestive®)In Northern Ireland, teduglutide (Revestive®) is accepted for use for the treatment of adult patients with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery. Use is restricted to initiation in paediatric patients.

This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of teduglutide. 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
SMCAccepted14/06/2018
​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
SMCAccepted14/06/2018
​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 TA520Accepted14/06/2018
​Bedaquiline (Sirturo®)​In Northern Ireland, bedaquiline (Sirturo®) is accepted as an option for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis in adult patients 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 AWMSG 1334
AWMSGAccepted14/06/2018
​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
SMCNot Accepted04/05/2018
​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
SMCNot Accepted04/05/2018
​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
SMCNot Accepted04/05/2018
​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
SMCNot Accepted04/05/2018
​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
SMCNot Accepted04/05/2018
​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
SMCAccepted04/05/2018
​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 TA518Accepted04/05/2018
​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
SMCNot Accepted03/05/2018
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
SMCNot Accepted20/04/2018
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
SMCNot Accepted20/04/2018
​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
SMCNot Accepted20/04/2018
​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 TA515Not Accepted20/04/2018
​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 cosmeticoutcome.

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
SMCAccepted20/04/2018
​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
SMCAccepted20/04/2018
​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 TA513Accepted20/04/2018
​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 TA512Accepted20/04/2018
​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 TA511Accepted20/04/2018
​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 TA516Accepted20/04/2018
​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 TA507Accepted20/04/2018
​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
SMCNot Accepted27/03/2018
​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
SMCNot Accepted27/03/2018
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 TA503Not Accepted27/03/2018
​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 AWMSG 3316
AWMSGNot Accepted27/03/2018
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 TA509Accepted27/03/2018
​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.
SMCAccepted27/03/2018
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
SMCAccepted27/03/2018
​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
SMCAccepted27/03/2018
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
SMCAccepted27/03/2018
​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
SMCAccepted27/03/2018
​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 TA508Accepted27/03/2018
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 TA394Accepted20/02/2018
​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
SMCNot Accepted13/02/2018
​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
SMCNot Accepted13/02/2018
​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
SMCNot Accepted13/02/2018
​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 TA506Not Accepted13/02/2018
​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
SMCNot Accepted13/02/2018
​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 TA502Accepted13/02/2018
​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 TA499Accepted13/02/2018
​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 TA500Accepted13/02/2018
​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 TA498Accepted13/02/2018
​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
SMCNot Accepted22/01/2018
​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
SMCNot Accepted22/01/2018
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 TA497Accepted22/01/2018
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
SMCAccepted22/01/2018
​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
SMCAccepted22/01/2018
​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
SMCAccepted22/01/2018
​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 TA495Accepted22/01/2018
​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 TA496Accepted22/01/2018
​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.
SMCAccepted22/01/2018
​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 TA489Not Accepted18/12/2017
​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
SMCAccepted18/12/2017
​Tofacitinib(Xeljanz®)​In Northern Ireland, tofacitinib (Xeljanz®) is accepted for use as indicated in NICE TA480.

For further information see NICE TA480
NICE TA480Accepted18/12/2017
​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 TA488Accepted18/12/2017
​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 TA486Accepted18/12/2017
​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 TA493NICE TA493Accepted18/12/2017
​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
SMCNot Accepted15/12/2017
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 TA479Accepted30/11/2017
​Opicapone (Ongentys®)In Northern Ireland, opicapone (Ongentys®) is not accepted for use as adjunctive therapy to preparations of levodopa / DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.

*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
SMCNot Accepted20/11/2017
​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
SMCNot Accepted20/11/2017
​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
SMCAccepted20/11/2017
​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
SMCAccepted20/11/2017
​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 TA485Accepted20/11/2017
​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 TA477Accepted20/11/2017
​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
SMCNot Accepted23/10/2017
​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
SMCAccepted23/10/2017
​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
SMCAccepted23/10/2017
​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 TA460Accepted23/10/2017
​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 TA473Accepted23/10/2017
​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 TA476Accepted23/10/2017
​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 TA475Accepted23/10/2017
​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 TA474Accepted23/10/2017
​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 TA478Accepted23/10/2017
​Immumosuppresive Therapy in Adults (Various Recommendations).​Please refer to NICE TA481.NICE TA481Accepted23/10/2017
​Immunosuppresive Therapy in Children and Young People (Various Recommendations)​Please refere to NICE TA482NICE TA482Accepted23/10/2017
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 TA494Not Accepted12/09/2017
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
SMCNot Accepted12/09/2017
​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
SMCNot Accepted12/09/2017
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
SMCNot Accepted12/09/2017
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
SMCNot Accepted12/09/2017
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
SMCNot Accepted12/09/2017
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 TA471Accepted12/09/2017
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
SMCAccepted12/09/2017
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 TA464Accepted12/09/2017
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
SMCAccepted12/09/2017
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
SMCAccepted12/09/2017
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 TA463Accepted12/09/2017
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 TA458Accepted12/09/2017
Carfilzomib (Kyprolis®)​In Northern Ireland, carfilzomib (Kyprolis®) is accepted for use in combination with dexamethasone is recommended as an option for treating multiple myeloma in adults, only if:

· they have had 1 previous therapy that did not include bortezomib and
· the company provides carfilzomib with the discount agreed in the patient access scheme.

For further information see NICE TA457
NICE TA457Accepted12/09/2017
Baricitinib (Olumiant®)​In Northern Ireland, baricitinib (Olumiant®) is accepted for use as per the NICE TA.

For further information see NICE TA466
NICE TA466Accepted12/09/2017
Collagenase clostridium histolyticum (Xiapex®)​People who meet the inclusion criteria for the ongoing clinical trial (hta-15/102/04), comparing collagenase clostridium histolyticum (CCH) to limited fasciectomy, are encouraged to participate in the study.

For people not taking part in the ongoing clinical trial, CCH is accepted for use as an option for treating Dupuytren’s contracture with a palpable cord in adults only if all of the following apply:

-  There is evidence of moderate disease (functional problems and metacarpophalangeal joint contracture of 30° to 60°and proximal interphalangeal joint contracture of less than 30° or first web contracture) plus up to 2 affected joints.
-  Percutaneous needle fasciotomy (PNF) is not considered appropriate, but limited fasciectomy is considered appropriate by the treating hand surgeon.
-  The choice of treatment (CCH or limited fasciectomy) is made on an individual basis after discussion between the responsible hand surgeon and the patient about the risks and benefits of the treatments available.
-  1 injection is given per treatment session by a hand surgeon in an outpatient setting.

For further information see NICE TA459
NICE TA459Accepted12/09/2017
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 TA455Accepted12/09/2017
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 TA467Accepted12/09/2017
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
SMCAccepted12/09/2017
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 TA451Accepted11/08/2017
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 TA450Accepted11/08/2017
Safinamide (Xadago®)​In Northern Ireland, safinamide (Xadago®) is not accepted for use in the treatment of adult patients with idiopathic Parkinson's disease (PD) as add-on therapy to a stable dose of Levodopa alone or in combination with other PD medicinal products in mid-to late-stage fluctuating 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
SMCNot Accepted10/08/2017
​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
SMCNot Accepted10/08/2017
​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.
SMCAccepted10/08/2017
​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 TA461Accepted10/08/2017
​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
SMCAccepted10/08/2017
​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
SMCAccepted10/08/2017
​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
SMCAccepted10/08/2017
​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 TA449Accepted10/08/2017
​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 TA448Accepted10/08/2017
​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 TA462Accepted10/08/2017
Liraglutide (Saxenda®)​In Northern Ireland, liraglutide (Saxenda®) is not accepted for use as an adjunct to a reduced-calorie diet and increased physical activity for weight management 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
SMCNot Accepted07/07/2017
​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
SMCNot Accepted07/07/2017
​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
SMCNot Accepted07/07/2017
​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 TA440Not Accepted07/07/2017
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 TA446Accepted07/07/2017
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 TA445Accepted07/07/2017
​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
SMCAccepted07/07/2017
​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
SMCAccepted07/07/2017
​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 TA456Accepted07/07/2017
​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 TA442Accepted09/05/2017
​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
SMCAccepted09/05/2017
​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
SMCNot Accepted08/05/2017
​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
SMCAccepted08/05/2017
​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 TA439Accepted08/05/2017
​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.

For further information see NICE TA443
NICE TA443Accepted13/04/2017
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 TA443Accepted01/04/2017
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
SMCNot Accepted06/03/2017
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
SMCNot Accepted06/03/2017
​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
SMCAccepted06/03/2017
Dasatinib, nilotinib, imatinibIn 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 TA425Accepted06/03/2017
Dasatinib, nilotinib and standard-dose imatinibIn 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 426Accepted06/03/2017
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 TA427Accepted06/03/2017
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 TA429Accepted06/03/2017
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 TA432Accepted06/03/2017
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
SMCAccepted06/03/2017
​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
SMCNot Accepted06/02/2017
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
SMCNot Accepted06/02/2017
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
SMCNot Accepted06/02/2017
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
SMCAccepted06/02/2017
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
SMCAccepted06/02/2017
Mepolizumab (Nucala®)In Northern Ireland, mepolizumab (Nucala®) is accepted as an add-on to optimised standard therapy, as an option for treating severe refractory eosinophilic asthma in adults, only if:

·the blood eosinophil count is 300 cells/microlitre or more in the previous 12 months and
·the person has agreed to and followed the optimised standard treatment plan and:
·the person has had 4 or more asthma exacerbations needing systemic corticosteroids in the previous 12 months or
·the person has had continuous oral corticosteroids of at least the equivalent of prednisolone 5 mg per day over the previous 6 months and
·the company provides the drug with the discount agreed in the patient access scheme.   

For further information see NICE TA431
NICE TA431Accepted06/02/2017
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 TA428Accepted06/02/2017
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 TA430Accepted06/02/2017
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
SMCNot Accepted20/01/2017
​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
SMCNot Accepted20/01/2017
Hydrocortisone (Plenadren®)In Northern Ireland, hydrocortisone (Plenadren®) is NOT accepted for the management of adrenal insufficiency.  

For further information see Scottish Medicines Consortium
SMCNot Accepted20/01/2017
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
SMCNot Accepted20/01/2017
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
SMCNot Accepted20/01/2017
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
SMCNot Accepted20/01/2017
​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 TA424Accepted20/01/2017
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
SMCAccepted20/01/2017
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 TA417Accepted20/01/2017
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 TA423NICE TA423Accepted20/01/2017
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.

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 TA421
NICE TA421Accepted20/01/2017
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 TA422Accepted20/01/2017
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
SMCNot Accepted12/12/2016
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
SMCNot Accepted12/12/2016
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 TA420Accepted12/12/2016
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
SMCAccepted12/12/2016
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
SMCAccepted12/12/2016
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 TA419Accepted12/12/2016
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 ​
SMCAccepted09/11/2016
​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
SMCAccepted08/11/2016
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 TA418Accepted08/11/2016
​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 TA412Accepted08/11/2016
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 TA413Accepted08/11/2016
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 TA504Accepted08/11/2016
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 TA406Accepted08/11/2016
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 TA415Accepted08/11/2016
​Perampanel (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
SMCNot Accepted07/11/2016
​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 TA414Not Accepted07/11/2016
​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
SMCNot Accepted07/11/2016
​Carfilzomib (Kyprolis®)In Northern Ireland, carfilzomib (Kyprolis®) is not accepted for use, in combination with lenalidomide 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 more information see Scottish Medicines Consortium
SMCNot Accepted07/11/2016
​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 TA411Not Accepted07/11/2016
​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
SMCNot Accepted02/11/2016
​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 TA399Not Accepted02/11/2016
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
SMCNot Accepted02/11/2016
​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
SMCNot Accepted02/11/2016
​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 TA411Not Accepted02/11/2016
​ 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
NICENot Accepted02/11/2016
​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 TA403Not Accepted02/11/2016
​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
SMCAccepted02/11/2016
​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
SMCAccepted02/11/2016
​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
SMCAccepted02/11/2016
​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
SMCAccepted02/11/2016
​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 TA407Accepted02/11/2016
​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
SMCAccepted02/11/2016
​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
SMCAccepted02/11/2016
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
SMCAccepted02/11/2016
​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 TA396Accepted02/11/2016
​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 TA401Accepted02/11/2016
​Ataluren (Translarna®)In Northern Ireland, ataluren (Translarna®) is accepted, within its marketing authorisation, for treating Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene in people aged 5 years and older who can walk, only when:

•the company provides ataluren with the discount agreed in the patient access scheme
•the conditions under which ataluren is made available are set out in the managed access agreement, which should include the conditions set out in HST3.

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 NICE HST3
NICE HST3Accepted02/11/2016
​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 TA402Accepted02/11/2016
​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 TA405Accepted02/11/2016
​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 TA410Accepted02/11/2016
​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 TA408Accepted02/11/2016
​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 TA409Accepted02/11/2016
​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
SMCNot Accepted13/09/2016
​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
SMCNot Accepted13/09/2016
​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 TA398Not Accepted13/09/2016
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
SMCAccepted13/09/2016
​Brivaracetam (Briviact®)​In Northern Ireland, brivaracetam (Briviact®) is accepted for restricted use as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy.

Use is restricted to patients with refractory epilepsy and treatment should be initiated 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

For further information see Scottish Medicines Consortium
SMCAccepted13/09/2016
​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
SMCAccepted13/09/2016
​Elosulfase alfa (Vimizim®)​In Northern Ireland, elosulfase alfa (Vimizim®) is accepted for use within its marketing authorisation for treating mucopolysaccharidosis type IVa (MPS IVa), in line with the Managed Access Arrangement including a PAS.

For further information see NICE Guidance
NICE HST2Accepted13/09/2016
​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
SMCAccepted13/09/2016
​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
SMCAccepted13/09/2016
​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 TA387Accepted13/09/2016
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 TA395Accepted13/09/2016
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 TA392Accepted13/09/2016
Belimumab (Benlysta®)​In Northern Ireland, belimumab (Benlysta®) is accepted as an option as add-on treatment for active autoantibody-positive systemic lupus erythematosus in adults only if all of the following apply:

·There is evidence for serological disease activity (defined as positive anti-double-stranded DNA and low complement) and a Safety of Estrogen in Lupus National Assessment – Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score of greater than or equal to 10 despite standard treatment;

·Treatment with belimumab is continued beyond 24 weeks only if the SELENA-SLEDAI score has improved by 4 points or more;

·The company provides belimumab with the discount agreed in the patient access scheme;

·Under the conditions for data collection, monitoring, patient consent, cost to the NHS, and review by NICE as laid out in sections 5 and 6 of TA397.

For further information see NICE TA397
NICE TA397Accepted13/09/2016
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 until the Service Notification is issued.

For further information see NICE Guidance
NICE GUIDANCEHST1Accepted13/09/2016
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
SMCAccepted13/09/2016
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 TA400Accepted13/09/2016
​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
SMCNot Accepted12/09/2016
​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
SMCNot Accepted12/09/2016
​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
SMCAccepted20/07/2016
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 TA393Accepted20/07/2016
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 until the Service Notification is issued.

For further information see Scottish Medicines Consortium
SMCAccepted20/07/2016
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 TA391Accepted20/07/2016
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
SMCNot Accepted14/06/2016
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
SMCNot Accepted14/06/2016
​Idelalisib(Zydelig®)​In Northern Ireland, idelalisib (Zydelig®) is accepted for use as monotherapy for the treatment of adult patients with follicular lymphoma that is refractory to two prior lines of treatment.

This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of idelalisib 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 until the Service Notification is issued.

For further information see Scottish Medicines Consortium
NICE TA604Accepted14/06/2016
​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 Scottish Medicines Consortium
SMCAccepted14/06/2016
​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
SMCAccepted14/06/2016
​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
SMCAccepted09/05/2016
​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
SMCAccepted09/05/2016
​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 TA390Accepted09/05/2016
TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritisIn 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 TA383Accepted09/05/2016
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 TA386Accepted09/05/2016
​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
SMCNot Accepted12/04/2016
​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
SMCNot Accepted12/04/2016
​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 TA378Not Accepted12/04/2016
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
SMCAccepted12/04/2016
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 TA388Accepted12/04/2016
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
SMCAccepted12/04/2016
​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 TA384Accepted12/04/2016
​Biosimilar MedicinesBiosimilar 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 LinkAccepted05/04/2016
​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
SMCNot Accepted11/03/2016
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
SMCNot Accepted11/03/2016
​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 TA385Accepted11/03/2016
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
SMCAccepted11/03/2016
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
SMCAccepted11/03/2016
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
SMCAccepted11/03/2016
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
SMCAccepted11/03/2016
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 TA370Accepted11/03/2016
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 TA380Accepted11/03/2016
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 TA373Accepted11/03/2016
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 TA379Accepted11/03/2016
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 TA377Accepted11/03/2016
​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
SMCAccepted15/02/2016
​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
SMCAccepted15/02/2016
​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
SMCAccepted15/02/2016
​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
SMCAccepted15/02/2016
​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 TA374Accepted15/02/2016
​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
SMCAccepted15/02/2016
​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 TA366Accepted14/01/2016
​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 TA364Accepted14/01/2016
​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 TA363Accepted14/01/2016
​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 TA365Accepted14/01/2016
​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
SMCAccepted14/01/2016
​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
SMCAccepted14/01/2016
​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
SMCAccepted14/12/2015
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
SMCAccepted14/12/2015
​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 TA369Accepted14/12/2015
​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. 

For further information see NICE TA375
NICE TA375Accepted14/12/2015
​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 TA357Accepted14/12/2015
​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 DeterminationAccepted14/12/2015
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 TA359Accepted30/11/2015
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 ​
SMCAccepted13/11/2015
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 ​
SMCAccepted13/11/2015
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 ​
SMCAccepted13/11/2015
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 TA367Accepted13/11/2015
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 ​
SMCNot Accepted22/10/2015
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
SMCNot Accepted22/10/2015
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​
SMCAccepted22/10/2015
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​
SMCAccepted22/10/2015
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 ​
SMCAccepted22/10/2015
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​
SMCAccepted22/10/2015
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 ​
SMCAccepted22/10/2015
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 TA358Accepted22/10/2015
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 ​
SMCAccepted22/10/2015
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
SMCAccepted22/10/2015
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​
SMCAccepted22/10/2015
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​
SMCAccepted22/10/2015
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 TA352Accepted22/10/2015
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
SMCAccepted22/10/2015
​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
SMCNot Accepted30/09/2015
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 TA348Not Accepted24/09/2015
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 TA355Accepted24/09/2015
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 ​
SMCAccepted24/09/2015
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​
SMCAccepted24/09/2015
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​
SMCAccepted24/09/2015
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 TA​350
NICE TA350Accepted24/09/2015
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 TA​346
NICE TA346Accepted24/09/2015
Dexamethasone (Ozurdex®)In Northern Ireland, dexamethasone intravitreal implant (Ozurdex®) is accepted for use as an option for treating diabetic macular oedema only if:

·the implant is to be used in an eye with an intraocular (pseudophakic) lens and
·the diabetic macular oedema does not respond to non-corticosteroid treatment, or such treatment is unsuitable.

People whose treatment with dexamethasone intravitreal implant was started within the HSC before this guidance was published, but is not recommended for them by NICE in this guidance, should be able to continue treatment until they and their NHS clinician consider it appropriate to stop. 

For Further Information see NICE TA​349
NICE TA349Accepted24/09/2015
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 TA347Accepted24/09/2015
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​
SMCAccepted11/08/2015
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 TA354Accepted11/08/2015
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​
SMCNot Accepted09/07/2015
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 TA345Accepted09/07/2015
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​
SMCAccepted09/07/2015
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​
SMCAccepted09/07/2015
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​
SMCAccepted09/07/2015
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​
SMCAccepted09/07/2015
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​
SMCAccepted09/07/2015
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 TA341Accepted07/07/2015
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
SMCNot Accepted10/06/2015
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
SMCAccepted10/06/2015
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
SMCAccepted10/06/2015
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 ​
SMCAccepted10/06/2015
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 ​
SMCAccepted10/06/2015
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​
SMCAccepted10/06/2015
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​
SMCAccepted10/06/2015
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 TA389Accepted01/05/2015
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 TA332Not Accepted27/04/2015
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​
SMCAccepted27/04/2015
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 TA339Accepted27/04/2015
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 TA342Accepted27/04/2015
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 TA340Accepted27/04/2015
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 TA337Accepted27/04/2015
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​
SMCAccepted27/04/2015
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 TA343Accepted27/04/2015
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 TA344Accepted27/04/2015
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​
SMCNot Accepted28/02/2015
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 ​
SMCAccepted28/02/2015
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 TA330Accepted28/02/2015
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 TA335Accepted28/02/2015
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 TA331Accepted28/02/2015
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​
SMCAccepted28/02/2015
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 TA333Accepted30/01/2015
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 ​
SMCAccepted30/01/2015
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​ ​
SMCAccepted30/01/2015
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 TA336Accepted30/01/2015
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 TA329Accepted30/01/2015
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 ​
SMCAccepted30/01/2015
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​
SMCAccepted30/01/2015
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​ ​
SMCAccepted19/12/2014
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​ ​
SMCAccepted19/12/2014
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 ​
SMCAccepted19/12/2014
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 ​
SMCAccepted19/12/2014
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 ​
SMCAccepted19/12/2014
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
SMCNot Accepted28/11/2014
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​
SMCNot Accepted28/11/2014
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 ​
SMCNot Accepted28/11/2014
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​​ ​
SMCAccepted28/11/2014
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 TA323Accepted28/11/2014
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​ ​
SMCAccepted31/10/2014
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​​
SMCAccepted31/10/2014
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 TA327Accepted31/10/2014
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 TA326Accepted31/10/2014
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​
SMCAccepted31/10/2014
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 ​ ​
SMCAccepted31/10/2014
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 TA325Accepted31/10/2014
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 ​
SMCAccepted31/10/2014
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​
SMCAccepted30/10/2014
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 TA321Accepted26/09/2014
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 ​
SMCNot Accepted29/08/2014
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 ​
SMCNot Accepted29/08/2014
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​ ​
SMCAccepted29/08/2014
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>Accepted29/08/2014
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 TA320Accepted31/07/2014
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 ​
SMCNot Accepted25/07/2014
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 ​
SMCNot Accepted25/07/2014
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

SMCAccepted25/07/2014
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​​
SMCAccepted25/07/2014
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 ​
SMCNot Accepted27/06/2014
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​
SMCNot Accepted27/06/2014
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 ​
SMCAccepted27/06/2014
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 until Service Notification is issued.  

For further information see Scottish Medicines Consortium ​
SMCAccepted27/06/2014
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 ​
SMCAccepted27/06/2014
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 TA319Accepted27/06/2014
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 TA318Accepted27/06/2014
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 TA317Accepted27/06/2014