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Managed Entry

Managed Entry Decisions

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Please use search filter below to find drugs by selected criteria. i.e. Drug Name, Date, Decision 

 

 Not Accepted

    Feb 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.
    For Further Information see NICE TA613

    Feb 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.
    For further information see Scottish Medicines Consortium

    Feb 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

    Feb 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.
    For further information see Scottish Medicines Consortium

    Feb 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.
    For further information see Scottish Medicines Consortium

    Feb 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.
    For further information see Scottish Medicines Consortium

    Dec 2019

    Eculizumab (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 see SMC2236

    Nov 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 see SMC2237
     
     
     

    Nov 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 see SMC2231

    Nov 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 see NICE TA604

    Oct 2019

    Ivacaftor + lumacaftor (Orkambi®)

    In Northern Ireland, ivacaftor + lumacaftor (Orkambi®) is not accepted for use in the treatment of cystic fibrosis in patients aged 6 years and older (tablets) and aged 2 to 5 years (granules) who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

    People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
    For further information see SMC2182

    Oct 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+3AG, S945L, S977F, R1070W, D1152H, 2789+5GA, 3272-26AG, and 3849+10kbCT.

    People currently 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

    Oct 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.

    People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
    For further information see SMC2219

    Oct 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 see SMC2217

    Oct 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 see SMC2221

    Sep 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 see Scottish Medicines Consortium

    Sep 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 see Scottish Medicines Consortium
     

    Sep 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 see Scottish Medicines Consortium

    Sep 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.
    For further information see NICE FAD ID1302

    Aug 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. However, at present, alirocumab should not be prescribed in Primary Care in Northern Ireland because the price parity scheme is not yet in place.
    For further information see SMC2201

    Aug 2019

    Rituximab (MabThera®)

    In Northern Ireland, rituximab (MabThera®) is not accepted for use for the treatment of patients with moderate to severe pemphigus vulgaris.

    People currently receiving this drug for this indication should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
    For further information see SMC2193

    Aug 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 SMC2191

    Aug 2019

    Dasatinib (Sprycel®)

    In Northern Ireland, dasatinib (Sprycel®) is not accepted for use in the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia in combination with chemotherapy.

    People currently receiving this drug for this indication should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
    For further information see SMC2192

    Aug 2019

    Chenodeoxycholic acid Leadiant®

    In Northern Ireland, chenodeoxycholic acid Leadiant® is not accepted for use for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis) in infants, children and adolescents aged 1 month to 18 years and adults.

    People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
    For further information see SMC2190

    Aug 2019

    Enzalutamide (Xtandi®)

    In Northern Ireland, enzalutamide (Xtandi®) is not accepted for use for treating high-risk hormone-relapsed non-metastatic prostate cancer in adults.

    People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
    For further information see NICE TA580

    Jun 2019

    Doxylamine + pyridoxine (Xonvea®)

    In Northern Ireland, doxylamine succinate and pyridoxine hydrochloride (Xonvea®) is not accepted for use in the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

    People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
    For further information see Scottish Medicines Consortium

    May 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 Consortium

    May 2019

    Rituximab (MabThera®)

    In Northern Ireland, rituximab (MabThera®) is not accepted for use in combination with glucocorticoids, for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).

    People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
    For further information see Scottish Medicines Consortium

    May 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 see Scottish Medicines Consortium

    May 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 Consortium

    May 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 Consortium

    Mar 2019

    Darvadstrocel (Alofisel®)

    In Northern Ireland, darvadstrocel (Alofisel®) is not accepted for use, within its marketing authorisation, for previously treated complex perianal fistulas in adults with non-active or mildly active luminal Crohn’s disease.

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

    For further information see  NICE TA556

    Mar 2019

    Dexmedetomidine (Dexdor®)

    In Northern Ireland, dexmedetomidine (Dexdor®) is not accepted for use in the sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.

    For further information see Scottish Medicines Consortium

    Feb 2019

    Pembrolizumab (Keytruda®)

    In Northern Ireland, pembrolizumab (Keytruda®) is not accepted as monotherapy for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a ≥50% TPS and progressing on or after platinum-containing chemotherapy.

    People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
    For further information see Scottish Medicines Consortium

    Feb 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 Consortium

    Jan 2019

    Evolocumab (Repatha SureClick)

    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

    Dec 2018

    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 see Scottish Medicines Consortium

    Dec 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 see Scottish Medicines Consortium

    Dec 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 see NICE TA550

    Dec 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 see NICE TA546

    Dec 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.
    ·         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 TA 540

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Sep 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 TA 530

    Sep 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

    Sep 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

    Sep 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 TA 532

    Aug 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

    Aug 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

    Aug 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
     

    May 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

    May 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

    May 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

    May 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

    May 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

    May 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

    Apr 2018

    lvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (Stribild®)

    In Northern Ireland, Stribild® is not accepted for use in the treatment of HIV1 infection in adolescents aged 12 to <18 years weighing 35kg who are infected with HIV1 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

    Apr 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

    Apr 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

    Apr 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

    Mar 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

    Mar 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

    Mar 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

    Mar 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

    Feb 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 

    Feb 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

    Feb 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

    Feb 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

    Feb 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

    Jan 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

    Jan 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

    Jan 2018

    Mercaptamine bitartrate (Procysbi®)

    In Northern Ireland, mercaptamine (Procysbi®) is not accepted for use for the treatment of proven nephropathic cystinosis.

    People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
    For further information see Scottish Medicines Consortium

    Dec 2017

    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

    Dec 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

    Nov 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

    Nov 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

    Oct 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

    Sep 2017

    Naltrexone + bupropion (Mysimba®)

    ​In Northern Ireland, 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Aug 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

    Aug 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

    Jul 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

    Jul 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

    Jul 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

    Jul 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

    May 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

     

    Mar 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

    Mar 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

    Feb 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

    Feb 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

    Feb 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

    Jan 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

    Jan 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

    Jan 2017

    Hydrocortisone (Plenadren®)
    In Northern Ireland, hydrocortisone (Plenadren®) is NOT accepted for the management of adrenal insufficiency.
     
    For further information see Scottish Medicines Consortium

    Jan 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

    Jan 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

    Jan 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

    Dec 2016

    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

    Dec 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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
     
     

    Sep 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

    Jun 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 Medicines Consortium

    Jun 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 

    Apr 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

    Apr 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

    Apr 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 

    Mar 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
     

    Mar 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

    Oct 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

    Oct 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

    Sep 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

    Sep 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

    Jul 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

    Jun 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

    Apr 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

    Feb 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

    Nov 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 

    Nov 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

    Nov 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

    Nov 2014

    Lidocaine + tetracaine (Pliaglis®)

    In Northern Ireland, lidocaine + tetracaine (Pliaglis®) is not accepted for use as local dermal anaesthesia on intact skin prior to dermatological procedures in adults.
     
    People currently on this treatment should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
    For further information see Scottish Medicines Consortium

    Aug 2014

    Abiraterone (Zytiga®)

    In Northern Ireland, abiraterone (Zytiga®) is NOT ACCEPTED for treating metastatic hormone relapsed prostate cancer in people who have no or mild symptoms after androgen deprivation therapy has failed and in whom chemotherapy is not yet clinically indicated.
    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 Final appraisal determination

    Aug 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 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

    Aug 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 than three months and in children, together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition and when causal treatment is not possible. If causal treatment is possible racecadotril can be 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

    Jul 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

    Jul 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.
     

    Jun 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

    Jun 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

    May 2014

    Cobicistat (Tybost®)

    In Northern Ireland, cobicistat (Tybost®) is Not Accepted for use as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults.
     
    People currently receiving this drug should be able to continue therapy until they and their clinician consider it clinically appropriate to stop.
     
    For further information see Scottish Medicines Consortium

    Apr 2014

    Aflibercept (Zaltrap®)

    In Northern Ireland aflibercept is Not Accepted in combination with irinotecan and fluorouracil-based therapy for the treatment of metastatic colorectal cancer which has progressed following prior oxaplatin-based chemotherapy.
     
    People currently receiving aflibercept in combination with irinotecan and fluorouracil-based therapy for treating metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen should be able to continue treatment until they and their clinician consider it appropriate to stop
     
    For further information see NICE TA307

    Apr 2014

    Pemetrexed (Alimta®)

    In Northern Ireland pemetrexed is Not Accepted for the maintenance treatment of locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) in people whose disease has not progressed immediately following induction therapy with pemetrexed and cisplatin.
     
    People currently receiving treatment with pemetrexed that 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 TA309 

     

     

    Accepted

    Feb 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.
    For further information see Scottish Medicines Consortium

    Feb 2020

    Cannabidiol (Epidyolex®)

    In Northern Ireland, Cannabidiol (Epidyolex®) with clobazam 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.
    For further information see NICE TA615

    Feb 2020

    Cannabidiol (Epidyolex®)

    In Northern Ireland, Cannabidiol (Epidyolex®) with clobazam is accepted for use 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.
    For further information see NICE TA614

    Feb 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.

    For Further Information see NICE TA612

    Feb 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.
    For further information see Scottish Medicines Consortium

    Feb 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.
    For further information see NICE TA617

    Feb 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.
    For further information see NICE HST12

    Feb 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.
    For further information see NICE TA619

    Feb 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.
    For further information see NICE TA620

    Feb 2020

    Cladribine (Mavenclad®)

    In Northern Ireland, cladribine (Mavenclad®) is accepted 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 with at least:

    - 2 relapses in the previous year and

    - 1 T1 gadolinium-enhancing lesion at baseline MRI or a significant increase in T2lesion load compared with a previous 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.

    Where infrastructure 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 TA616

    Feb 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.
    For further information see Scottish Medicines Consortium

    Feb 2020

    Patiromer (Veltassa®)

    In Northern Ireland, patiromer (Veltassa®) is accepted for use as an option for treating hyperkalaemia in adults only if used:

    • in emergency care for acute life-threatening hyperkalaemia alongside standard care or
    • for people with persistent hyperkalaemia and stages 3b to 5 chronic kidney disease or heart failure, if they:
     - have a confirmed serum potassium level of at least 6.0mmol/litre and
    - are not taking, or are taking a reduced dosage of, a renin-angiotensin-aldosterone system (RAAS) inhibitor because of hyperkalaemia and
     - are not on dialysis.
    For further information see NICE TA623

    Feb 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.
    For further information see NICE TA622

    Feb 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.
    For further information see Scottish Medicines Consortium

    Dec 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

    Dec 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 see NICE HST11

    Dec 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 see NICE TA611

    Dec 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 see SMC2211

    Nov 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 see NICE TA607
     
     

    Nov 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 see SMC2205

    Nov 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

     

    Nov 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 see NICE TA605

    Oct 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 see NICE TA404

    Oct 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

     

     
     

    Oct 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
     
     
     

    Oct 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 see NICE TA598

    Oct 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 see NICE HST10

    Oct 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

    Sep 2019

    Perampanel oral suspension (Fycompa®)

     

    In Northern Ireland, perampanel oral suspension (Fycompa®) is accepted for use for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy. Use is restricted to second-line adjunctive treatment in patients with refractory partial onset epilepsy who are unable to swallow perampanel tablets. Treatment should be initiated only by physicians who have appropriate experience in the treatment of epilepsy.

     
    *This drug is not on the NI Formulary and is not a first-line option.  Please refer to http://niformulary.hscni.net  for preferred NI Formulary choices

    Sep 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

    Sep 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

    Sep 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

    Sep 2019

    Fluocinolone acetonide (Iluvien®)

    In Northern Ireland, fluocinolone acetonide intravitreal implant (Iluvien®) is accepted for use, within its marketing authorisation, as an option for preventing relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. It is recommended only if the company provides it according to the commercial arrangement

    Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.
    For further information see NICE TA590

    Sep 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 TA592

    Sep 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 see NICE TA595

    Sep 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

    Sep 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

    Aug 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 see NICE TA583

    Aug 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

    Aug 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

    Aug 2019

    GLP-1 mimetics (for example albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide, and semaglutide)

    In Northern Ireland,  glucagonlike peptide1 (GLP1) 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

     

    Aug 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

    Aug 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

    Aug 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

    Aug 2019

    Inotersen (Tegsedi®)

    In Northern Ireland, inotersen (Tegsedi®) is accepted for use, within its marketing authorisation, as an option for treating stage 1 and stage 2 polyneuropathy in adults with hereditary transthyretin amyloidosis. It is accepted for use only if the company provides inotersen according to the commercial arrangement.

    Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis
    For further information see NICE HST9

    Aug 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

    Aug 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

    Aug 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

    Jun 2019

    Cariprazine (Reagila®)

    In Northern Ireland, cariprazine (Reagila®) is accepted for use in the treatment of schizophrenia in adult patients. Use is restricted to second-line therapy in patients where predominantly negative symptoms have been identified as an important feature.

    For further information see Scottish Medicines Consortium

    Jun 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

    Jun 2019

     Ertugliflozin (Steglatro®)

    In Northern Ireland, ertugliflozin (Steglatro®) is accepted for use with metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor 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 see NICE TA572

    Jun 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 see Scottish Medicines Consortium

    Jun 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 see Scottish Medicines Consortium

    Jun 2019

    Mepolizumab (Nucala®)

    In Northern Ireland, mepolizumab (Nucala®) is accepted for use as an add-on treatment for severe refractory eosinophilic asthma in adolescents and children aged 6 years and older.

    This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of mepolizumab. This advice is contingent upon the continuing availability of the PAS in Northern Ireland or a list price that is equivalent or lower.
    Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.
    For further information see Scottish Medicines Consortium

    Jun 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

    Jun 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

    Jun 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

    Jun 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 see NICE TA581

    May 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 see Scottish Medicines Consortium

    May 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 see Scottish Medicines Consortium

    May 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 see Scottish Medicines Consortium

    May 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.

    May 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 arrangement.

    For further information see NICE TA571

    May 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

    May 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 see NICE TA573

    May 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

    May 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

    May 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 agreement for 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 HST2

    May 2019

    Migalastat (Galafold®)

    In Northern Ireland, migalastat is accepted for use, within its marketing authorisation, as an option for treating Fabry disease in people over 16 years of age with an amenable mutation, only if migalastat is provided with the discount agreed in the patient access scheme, and only if enzyme replacement therapy (ERT) would otherwise be offered. Criteria for starting and stopping ERT for Fabry disease are described in the UK adult Fabry disease standard operating procedures (Hughes et al. 2013). With the discount provided in the patient access scheme, migalastat has a lower total cost than ERT, and potentially provides greater health benefits than ERT.

    Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.
    For further information see NICE HST4

    May 2019

    Eliglustat (Cerdelga®)

    In Northern Ireland, eliglustat is accepted for use within its marketing authorisation for treating type 1 Gaucher disease, that is, for long-term treatment in adults who are cytochrome P450 2D6 poor, intermediate or extensive metabolisers. Eliglustat is only recommended when the company provides it with the discount agreed in the patient access scheme.

    Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.
    For further information see NICE HST5

    May 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

    May 2019

    Strimvelis

    In Northern Ireland, strimvelis is accepted for use, within its marketing authorisation, as an option for treating adenosine deaminase deficiency–severe combined immunodeficiency (ADA–SCID) when no suitable human leukocyte antigen-matched related stem cell donor is available.

    Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.
    For further information see NICE HST7

    May 2019

    Burosumab (Crysvita®)

    In Northern Ireland, Burosumab is accepted for use within its marketing authorisation, for treating Xlinked hypophosphataemia (XLH) with radiographic evidence of bone disease in children aged 1 year and over, and in young people with growing bones. It is recommended only if the company provides burosumab according to the commercial arrangement.

    Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.
    For further information see NICE HST8

    Mar 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 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
    Ertugliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if:
    ·    a sulfonylurea is contraindicated or not tolerated or
    ·    the person is at significant risk of hypoglycaemia or its consequences

    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

    Mar 2019

    Eslicarbazepine (Zebinix®)

    In Northern Ireland, eslicarbazepine (Zebinix®) is accepted for use as adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation.

    Use is restricted to patients with highly refractory epilepsy who have been heavily pre-treated and remain uncontrolled with existing anti-epileptic drugs.

    For further information see Scottish Medicines Consortium

    Mar 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

    Mar 2019

    Abemaciclib (Verzenios®)

    In Northern Ireland, abemaciclib (Verzenios®) with an aromatase inhibitor is accepted for use, within its marketing authorisation, as an option for treating locally advanced or metastatic, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer as first endocrine-based therapy in adults. Abemaciclib is recommended only if the company provides it according to the commercial arrangement.

    For further information see NICE TA563

    Mar 2019

    Venetoclax (Venclyxto®)

    In Northern Ireland, venetoclax (Venclyxto®) with rituximab is accepted for use, within its marketing authorisation, as an option for treating chronic lymphocytic leukaemia in adults who have had at least 1 previous therapy. It is recommended only if the company provides it according to the commercial arrangement.

    For further information see NICE TA561

    Mar 2019

    Encorafenib (Braftovi®)

    In Northern Ireland, encorafenib with binimetinib is accepted for use, within its marketing authorisation, as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma in adults. It is recommended only if the company provides encorafenib and binimetinib according to the commercial arrangements.

    For further information see NICE TA562

    Mar 2019

    Tisagenlecleucel (Kymriah®)

    In Northern Ireland, tisagenlecleucel (Kymriah®) is accepted for use as an option for treating relapsed or refractory diffuse large B-cell lymphoma in adults after 2 or more systemic therapies, only if the conditions in the managed access agreement are followed.

    Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.

    For further information see NICE TA567

    Mar 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.

     

    Feb 2019

    Tiotropium bromide (Spiriva® Respimat)

    In Northern Ireland, tiotropium bromide (Spiriva® Respimat) is accepted for use as add-on maintenance bronchodilator treatment in patients aged 6 years and older with severe asthma who experienced one or more severe asthma exacerbations in the preceding year.

    For further information see Scottish Medicines Consortium

    Feb 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 TA559

    Jan 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 see Scottish Medicines Consortium

    Jan 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 see Scottish Medicines Consortium

    Jan 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 see Scottish Medicines Consortium

    Jan 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 see NICE TA553

    Jan 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 see NICE TA554

    Jan 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 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 TA557

    Jan 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 see NICE TA547

    Jan 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 and
    • the company provides it according to the commercial arrangement.

    For further information see NICE TA555

    Jan 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 TA558

    Dec 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 see Scottish Medicines Consortium

    Dec 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 see Scottish Medicines Consortium

    Dec 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 and
    • the company provides it according to the commercial arrangement.

    For further information see NICE TA551

    Dec 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 see NICE TA552

    Dec 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.
     
    ·         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

    Dec 2018

    Obinutuzumab (Gazyvaro®)

    In Northern Ireland, obinutuzumab (Gazyvaro®) is accepted for use, in combination with bendamustine, followed by obinutuzumab maintenance, as an option for treating adults with follicular lymphoma that did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen, only if the conditions in the managed access agreement for obinutuzumab are followed.

    Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis
    For further information see NICE TA472 

    Dec 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 see NICE TA491

    Dec 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 Bcell receptor pathway inhibitor is unsuitable, or whose disease has progressed after a Bcell receptor pathway inhibitor or
    ·         without a 17p deletion or TP53 mutation, and whose disease has progressed after both chemoimmunotherapy and a Bcell 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 see NICE TA487

    Dec 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 basis
    For further information see NICE TA490

    Dec 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 PDL1 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 see NICE TA484

    Dec 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 see NICE TA483

    Dec 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 basis
    For further information see NICE TA492
    Please 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.

    Dec 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 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 TA416

    Dec 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 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 TA505

    Dec 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

    Dec 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

    Dec 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.

    Dec 2018

    Crizotinib (Xalkori®)

    In Northern Ireland, crizotinib (Xalkori®) is accepted for use as an option for treating ROS1positive 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.

    Dec 2018

    Pembrolizumab (Keytruda®)

    In Northern Ireland, pembrolizumab (Keytruda®) 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:

    ·         pembrolizumab is stopped at 2 years of uninterrupted treatment or earlier in the event of disease progression 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 TA519

    Dec 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.

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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
     
     

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis.
    For further information see NICE TA 539

    Sep 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 TA 533

    Sep 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 TA 534

    Sep 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 TA 536

    Sep 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
    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 see NICE TA 538

    Sep 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 TA 531

    Sep 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 TA 535

    Aug 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

    Aug 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

    Aug 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

    Aug 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

    Aug 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

    Aug 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

    Aug 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

    Aug 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 with
    continuing 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

    Aug 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

    Aug 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

    Jun 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

    Jun 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

    Jun 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

    Jun 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

    May 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

    May 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

    Apr 2018

    5-aminolaevulinic acid gel (Ameluz®)

    In Northern Ireland, 5-aminolaevulinic acid (Ameluz®) gel is accepted for use in the treatment of adults with superficial and / or nodular basal cell carcinoma (BCC) unsuitable for surgical treatment due to possible treatment-related morbidity and / or poor cosmetic outcome.

    Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis
    For further information see Scottish Medicines Consortium

    Apr 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

    Apr 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

    Apr 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

    Apr 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

    Apr 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

    Apr 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

    Mar 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

    Mar 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] <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

    Mar 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

    Mar 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

    Mar 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

    Mar 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

    Mar 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

    Feb 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

    Feb 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

    Feb 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

    Feb 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

    Feb 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

    Jan 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

    Jan 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

    Jan 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

    Jan 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

    Jan 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

    Jan 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

    Jan 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

    Dec 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

    Dec 2017

    Tofacitinib (Xeljanz®)

    In Northern Ireland, tofacitinib (Xeljanz®) is accepted for use as indicated in NICE TA480.

    For further information see NICE TA480

    Dec 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

    Dec 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

    Nov 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 TA 479

    Nov 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
     

    Nov 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

    Nov 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

    Nov 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

    Oct 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

    Oct 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

    Oct 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

    Oct 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

    Oct 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

    Oct 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

    Oct 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

    Oct 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

    Oct 2017

    Immumosuppresive Therapy in Adults (Various Recommendations). 

    Please refer to NICE TA481

    Oct 2017

    Immunosuppresive Therapy in Children and Young People (Various Recommendations)

    ​Please refere to NICE TA482

    Sep 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

    Sep 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

    Sep 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 10year 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 10year probability of osteoporotic fragility fracture is at least 10% or
    ·    the 10year 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 10year 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 see NICE TA464

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Sep 2017

    Baricitinib (Olumiant®)

    In Northern Ireland, baricitinib (Olumiant®) is accepted for use as per the NICE TA.

    For further information see NICE TA466

    Sep 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

    Sep 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 are contraindicated 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

    Sep 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

    Sep 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

    Aug 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

    Aug 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

    Aug 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 Medicines Consortium

    Aug 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

    Aug 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

    Aug 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

    Aug 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 see Scottish Medicines Consortium

    Aug 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 see NICE TA449

    Aug 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

    Aug 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 see NICE TA462

    Jul 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

    Jul 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

    Jul 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

    Jul 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

    Jul 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

    May 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
     

    May 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

    May 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 to http://niformulary.hscni.net for preferred NI Formulary choices.

    For further information see Scottish Medicines Consortium

    May 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 are accepted for use when the companies provide them with the discounts agreed in their patient access schemes.

    For further informacion see NICE TA439

     


     

    Apr 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 

    Apr 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 TA 433

    Mar 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

    Mar 2017

    Dasatinib, nilotinib, imatinib
    In Northern Ireland, dasatinib and nilotinib are accepted as options for treating only chronic- or accelerated-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults, if:
    - they cannot have imatinib, or their disease is imatinib-resistant and
    - the companies provide the drugs with the discounts agreed in the relevant patient access schemes.
     
    High-dose imatinib (that is, 600 mg in the chronic phase or 800 mg in the accelerated and blast-crisis phases) is not accepted for treating Philadelphia-chromosome-positive chronic myeloid leukaemia in adults whose disease is imatinib-resistant.
     
    For Further Information see NICE TA425

    Mar 2017

    Dasatinib, nilotinib and standard-dose imatinib
    In Northern Ireland, imatinib is accepted as an option for untreated, chronic-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults.
    Dasatinib and nilotinib are accepted, within their marketing authorisations, as options for untreated chronic-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults. The drugs are accepted only if the companies provide them with the discounts agreed in the relevant patient access schemes.
     
    For Further Information see NICE TA426

    Mar 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

    Mar 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 TA 429

    Mar 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

    Mar 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

    Feb 2017

    Dalbavancin (Xydalba®)
    In Northern Ireland, dalbavancin (Xydalba®) is accepted for use for the treatment of 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

    Feb 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

    Feb 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:
    o   the person has had 4 or more asthma exacerbations needing systemic corticosteroids in the previous 12 months or
    o   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 

    Feb 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

    Feb 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

    Jan 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

    Jan 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

    Jan 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

    Jan 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 see NICE TA423

    Jan 2017

    Everolimus (Afinitor®)
    In Northern Ireland, everolimus (Afinitor®), in combination with exemestane, is accepted for use within its marketing authorisation as an option for treating advanced human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor-positive breast cancer in postmenopausal women without symptomatic visceral disease that has recurred or progressed after a non-steroidal aromatase inhibitor. Everolimus is recommended only if the company provides it with the discount agreed in the patient access scheme.
     
    For Further Information see NICE TA421

    Jan 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

    Dec 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

    Dec 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

    Dec 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 

    Dec 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

     

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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

    Nov 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 scheme
    For more information see NICE TA410

    Nov 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

    Nov 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Sep 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

    Jul 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

    Jul 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). However, as a PAS is not yet in place in Northern Ireland so this product should not be prescribed in primary care until further notification
    For further information see NICE TA393 

    Jul 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

    Jul 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
     

    Jun 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

    Jun 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

    May 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
     

    May 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

    May 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

    May 2016

    TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
    In Northern Ireland, adalimumab, certolizumab pegol, etanercept, golimumab and infliximab, are accepted for use as indicated by the NICE Technology Appraisal guidance TA383.
    For further information see NICE TA383

    May 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

    Apr 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
     

    Apr 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

    Apr 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
     

    Apr 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

    Apr 2016

    Biosimilar Medicines

    Biosimilar medicines are new biological medicinal products that have demonstrated ‘similar’ efficacy and safety to an existing biological reference (‘originator’) product.

     
    The NI Managed Entry mechanism is based upon appraisal by recognised Health Technology Appraisal bodies e.g. NICE; SMC. The position of NICE in respect of biosimilars is set out at https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/biosimilars-statement.pdf
    Given this position, where the originator product has been accepted for use in Northern Ireland, any biosimilar medicine will generally be deemed ‘accepted for use’ in Northern Ireland also. However, each individual biosimilar medicine may not have its own entry on the Managed Entry web page
     
    For example:
    Lantus® (insulin glargine) is accepted for use in Northern Ireland. Abasaglar® is a biosimilar of insulin glargine and, although it is not specifically mentioned on the Managed Entry website, it is also accepted for use in Northern Ireland.
     
    Please note: Biosimilar medicines should always be prescribed by brand name.
     

    Mar 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

    Mar 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

    Mar 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

    Mar 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

    Mar 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.