Specialist drugs and high cost drugs excluded from the
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Specialist drugs and high cost drugs excluded from the 2015/16 National Tariff – should GPs prescribe these? Some drugs are so expensive that payments made to Trusts using the National Tariff payment system would not cover the drug costs. There is a nationally agreed list of these and they are referred to as high cost drugs excluded from the National Tariff. There are also specialist drugs which are usually only used in specialist centres. Both of these types of drugs are normally used and prescribed within Trusts and GPs are not expected to prescribe them. Responsibility for commissioning these drugs is either the CCG or NHS England (NHSE), although there can be some overlap and most drugs fall under NHSE, especially for paediatric use. Appendix 1 lists the new additions, removals and changes to the lists for 2015/16 financial year. Appendix 2 lists the drugs which are the commissioning responsibility of NHSE. Appendix 3 the drugs for which BCCG is the commissioner. Each appendix includes tables which provide the drug name, indication, commissioning policy and BNF section. Although the majority of the drugs in these appendices are not suitable for prescribing under GP shared care arrangements, some are. We have stated that there are GP shared care arrangements in place under the individual drugs to assist you if you are asked to prescribe one of them by a Trust. If no such advice is in the table then the default position is no GP prescribing. However, if you find that you are prescribing one of these drugs for one of your patients, please check with the Medicine Management Team (Tel: 01525 864430 ext. 5903 as the drug may be included in a shared care arrangement or there may be plans in place to repatriate prescribing to the NHSE over the next year. We have produced the tables over the last 2 years and have updated these for 2015/16 with the new high cost drugs which have been added for 2015/16 and where new NHSE or local policies have been introduced. We hope you find them useful. Any comments or questions, please contact e-mail: karen.homan@bedfordshireccg.nhs.uk . 1 Appendix 1: High Cost Drugs Excluded from National Tariff – new additions / changes for 2015/16 Drugs added to NHSE commissioning responsibility Drug name Indication BNF category TA/Policy HIV in combination with other antiretroviral drugs 5.3.1 Adalimumab Hidradenitis Suppurativa 10.1.3 Afatinib Albumin bound paclitaxel Alpha Mannosidase recombinant human Cancer Cancer Alpha Mannosidase deficiency Asfotase alpha Hypophosphatasia 9.8.1 Bedaquiline fumarate Multi drug resistant TB 5.1.9 Botulinum toxin Focal spasticity in children 4.9.3 Botulinum toxin Intravesical use in spinal cord injury 4.9.3 Cabozantinib Cancer 8.1 Daclatasivir Hepatitis C n/a Darunavir + cobicistat (Rezolsta®) HIV in combination with other antiretroviral drugs 5.3.1 Not routinely commissioned Delamanid Multi drug resistant TB 5.1.9 Not routine commissioned Dibotermin Complex spinal surgery n/a Not routinely commissioned Drisapersen Duchenne Muscular Dystrophy n/a Efraloctocog alpha Haemophilia A n/a Eftrenonacog alpha Haemophilia B n/a Epratuzumab SLE Eprodisate Amyloidosis n/a Eptotermin Complex spinal surgery n/a Everolimus (Votubia®) Tubular sclerosis 8.1.5 Filgrastim Barth Syndrome 9.1.6 Forigerimod acetate SLE 10.1.3 Ganetespib Cancer Abacavir + dolutegravir + lamivudine (Triumeq®) 8.1 8.1 9.8.1 10.1.3 n/a NHS England Policy: B06/P/b Not routinely commissioned policy in progress TA 310 CDF policy Not routinely commissioned Not routinely commissioned Not routinely commissioned policy in progress Agreed Trust Guidelines Not routinely commissioned for new patients CDF policy Not routinely commissioned NICE TA in progress Not routinely commissioned Not routinely commissioned Not routinely commissioned Not routinely commissioned Not routinely commissioned Not routinely commissioned Not routinely commissioned Highly specialised criteria only Not routinely commissioned Not routinely commissioned Comment New exclusion NHS England policy in development TA310 added CDF addition New exclusion New exclusion NHS England - new drug Existing indication added for clarification Existing indication added for clarification CDF addition New exclusion New exclusion NHS England - new drug Spinal surgery is NHS England commissioned New exclusion New exclusion New exclusion New exclusion New exclusion Spinal surgery is NHS England commissioned NHS England - new indication Highly specialised indication New exclusion New exclusion 2 Drug name Indication BNF category Gevokizumab Uveitis Glucarpidase Methotrexate induced renal dysfunction n/a Human Heterologous Liver Cells Urea cycle disorders n/a Hyvqia As per National DMP 14.5.1 Idebenone Idelalisib Imatinib Infliximab Duchenne Muscular Dystrophy Cancer Graft versus host disease Graft versus host disease 10.1.3 n/a 8.1.5 10.1.3 10.1.3 Infliximab Hidradenitis Suppurativa 10.1.3 Ipilimumab Cancer 8.1.5 Ixazamib Amyloidosis Lanreotide Congenital hyperinsulinism 8.3.4.3 Lanreotide**** Acromegaly 8.3.4.3 Lenograstim Barth Syndrome 9.1.6 Lixivaptan Hyponatraemia and other endocrine uses 6.5.2 Lumacaftor + Ivacaftor Cystic fibrosis 3.7 Macrimorelin Growth failure 6.7.4 Mifepristone Cushing's Disease Nitisinone Tyrosinaemia 9.8.1 Obinutuzumab Cancer 8.2.3 Ocrelizumab Multiple Sclerosis 8.2.3 Octocog alpha Haemophilia A n/a Octreotide Congenital hyperinsulinism 8.3.4.3 Octreotide**** Acromegaly 8.3.4.3 Ofatumumab Pemphigus vulgaris 10.1.3 Olesoxime Spinal muscular atrophy Omalizumab Chronic spontaneous urticaria n/a 6.7 n/a 3.4.2 TA/Policy Not routinely commissioned NHS England Policy: B15/P/a Not routinely commissioned Not routinely commissioned****** Not routinely commissioned CDF policy Not routinely commissioned Not routinely commissioned Not routinely commissioned policy in progress TA268 & TA319 Not routinely commissioned Highly specialised criteria only Agreed Trust Guidelines Highly specialised criteria only Not routinely commissioned Not routinely commissioned Not routinely commissioned Not routinely commissioned NHS England Service Specification Not routinely commissioned: TA in progress Not routinely commissioned Not routinely commissioned Highly specialised criteria only Agreed Trust Guidelines Not routinely commissioned Not routinely commissioned Not routinely commissioned NICE TA in progress Comment New exclusion Updated for policy New exclusion New product - only available in six centres New exclusion New CDF inclusion NHS England - new indication NHS England - new indication NHS England policy in development TA268 & TA319 added New exclusion New indication Existing indication added for clarification Highly specialised indication NHS England - new drug New exclusion New exclusion New exclusion Highly specialised indication As per NICE TAs in consultation New exclusion New exclusion Highly specialised indication Existing indication added for clarification New exclusion New exclusion NHS England - new indication 3 Drug name BNF category Indication Ombitasvir/paritaprevir/ritonavir + dasabuvir +/- ribavirin Hepatitis C n/a Pomolidomide Myelofibrosis n/a Rituximab Pemphigus vulgaris 10.1.3 Rituximab Juvenile arthritis 10.1.3 Rituximab Graft versus host disease 10.1.3 Rituximab Myositis 10.1.3 Rituximab ABO-incompatible kidney transplants 10.1.3 Rituximab subcutaneous formulation Cancer TA/Policy Not routinely commissioned NICE TA in progress Not routinely commissioned Not routinely commissioned NHS England Interim Policy: B03/Ps/a Not routinely commissioned Not routinely commissioned Castleman's Disease 10.1.3 Sodium oxybate Narcolepsy - paediatric services only 4.1.1 Tabalumab SLE 10.1.3 Teriparatide Male osteoporosis 6.6.1 Tocilizumab Large vessel vasculitis 10.1.3 Trabectadin Cancer 8.1.5 Trenonacog alpha Haemophilia B Vedolizumab Crohn's disease in children 10.1.3 Voriconazole Chronic pulmonary aspergillosis 5.2.1 New exclusion New exclusion New indication from IFR requests Update for policy As per specification As per circular i.e. only commissioned for Follicular Lymphoma maintenance treatment Not routinely commissioned Not routinely commissioned Not routinely commissioned Not routinely commissioned Not routinely commissioned 8.2 Siltuximab Comment TA185 Not routinely commissioned Not routinely commissioned - TA in progress Highly specialised criteria only n/a NHS England - new indication NHS England - new indication NHS England existing indication New formulation New exclusion NHS England - new indication New exclusion Updated in line with The Manual NHS England - new indication TA 185 for soft tissue sarcoma New exclusion NHS England - new drug Highly specialised indication Drug removed from NHSE commissioning responsibility Drug name Indication Anakinra Paediatric indications Cysteamine bitartrate Cystinosis BNF category 10.1.3 n/a Epoetin (all variants) Cancer and chemotherapyinduced anaemia Cancer and chemotherapyinduced anaemia Faldaprevir Hepatitis C n/a Vicriviroc HIV in combination with other anti-retroviral drugs n/a Darbepoetin TA/Policy Not routinely commissioned Not routinely commissioned 9.1.3 TA323 9.1.3 TA323 Not routinely commissioned Comment Replaced by juvenile arthritis policy Same as mercaptamine Not excluded when used in cancer Not excluded when used in cancer Discontinued Never licensed 4 Changes made to descriptions in NHSE commissioning responsibility drug list Drug name Abatacept Indication Juvenile arthritis BNF category TA/Policy 10.1.3 NHS England Interim Policy: B03/Ps/a Updated for policy TA259 (see also SSC1438) CDF policy - both: only in enzalutamide naïve patients Amended to reflect where enzalutamide naive came from. NB NHSE policy refers to SSC. Still on CDF for patients with no previous chemo. Comment Abiraterone Cancer 8.3.4.2 Abiraterone Cancer 8.3.4.2 Adalimumab Juvenile arthritis 10.1.3 Aflibercept Cancer Anakinra Juvenile arthritis 10.1.3 Bedaquiline fumarate Multi drug resistant TB 5.1.9 Bosentan Digital ulcers 2.5.1 Cabazitaxel Cancer 8.1 Dabrafenib Cancer 8.1.5 Defibrotide Hepatic veno-occlusive disease n/a Delamanid Multi drug resistant TB 5.1.9 Dimethyl fumarate Multiple sclerosis 8.2.4 TA320 Updated for NICE TA Dolutegravir HIV in combination with other anti-retroviral drugs 5.3.1 NHS England Policy: B06/P/b Updated for policy and outcome measures Eliglustat Gaucher's disease Not routinely commissioned Emtricitabine HIV in combination with other anti-retroviral drugs Changed to 'not routinely commissioned' as original entry incorrect Not routinely commissioned removed Amended to reflect where enzalutamide naive came from. NB NHSE policy refers to SSC. Still on CDF for patients with no previous chemo for metastatic disease. 8.1 n/a TA259 or CDF - only in enzalutamide naïve patients NHS England Interim Policy: B03/Ps/a Not routinely commissioned NHS England Interim Policy: B03/Ps/a Not routinely commissioned - policy in progress NHS England Policy: A13/P/e Not routinely commissioned TA321 NHS England Policy: D04/P/c Not routinely commissioned - policy in progress 5.3.1 Enzalutamide Cancer 8.3.4.2 Enzalutamide Cancer 8.3.4.2 Epoprostenol5 Pulmonary Arterial Hypertension 2.8.1 Iloprost5 Pulmonary Arterial Hypertension 2.5.1 TA316 (see also SSC1439) CDFpolicy - both: only in abiraterone naïve patients TA316 - only in abiraterone naïve patients NHS England Policy: A11/PS/b NHS England Policy: A11/PS/b Clarify position in relation to new enzalutamide TA Updated for policy Removed from CDF list Updated for policy Moved into official excluded list Updated for policy Removed from CDF list Updated for NICE TA Updated for policy Moved into official excluded list TA316 added Footnote added regarding use in vascular disease Footnote added regarding use in vascular disease 5 Drug name Indication BNF category Imatinib Cancer 8.1.5 Ipilimumab Cancer 8.1.5 Lapatinib Cancer 8.1.5 Lenalidomide Cancer 8.2.4 Simeprevir Hepatitis C 5.3.3 Sofosbuvir with Ledipasvir Hepatitis C 5.3.3 TA/Policy TA70, TA86, TA251, TA326 CDF policy TA268 & TA319 Not routinely commissioned TA171, 322 & CDF policy NHS England Policy: A02/PS/c NHS England Policy: A02/PS/b Comment Updated for NICE TA Updated for NICE TA Removed from CDF list Updated for NICE TA Updated for policy and outcome measures Removed daclatasvir; updated outcome measures Male and juvenile Not routinely 6.6.1 Juvenile indication added osteoporosis commissioned * Drug is being repatriated from primary to secondary care therefore supply route may vary at present ** From April 2016 - until then CCG commissioned Teriparatide *** Routinely commissioned in combination when dual therapy required **** Only when prescribed in a specialist centre ***** only where it is a recognised MS centre with specialist nurse support Drug changes to CCG commissioning responsibility Drug name Abaloparatide Abatacept subcutaneous Alirocumab Amikacin liposomal inhalation Anakinra Apremilast Avatrombopag Aztreonam lysine nebuliser solution Baricitinib Botulinum toxin Brodalumab Certolizumab pegol Deferasirox Deferiprone Desferrioxamine Dexamethasone intravitreal implant Dibotermin alfa Digoxin immune fab Dimethyl fumarate Category Analogue of human parathyroid hormone-related protein Cytokine modulators Lipid-regulating drugs Aminoglycosides Cytokine modulators Cytokine modulators Platelet disorder drugs Antibacterial drugs BNF 6.6.2 Cytokine modulators Torsion, dystonias and other involuntary movements. Drugs affecting the immune response Cytokine modulators Iron overload Iron overload Iron overload Macular oedema 10.1.3 4.9.3 Bone morphogenetic protein Poisoning Preparations for psoriasis 10.1.3 2.12 5.1.4 10.1.3 10.1.3 9.1.4 5.1.2.3 13.5.3 10.1.3 9.1.3 9.1.3 9.1.3 11.4.1 / 11.4.2 Not in BNF 2.1.1 13.5.2 6 Drug name Fumaderm® Eltrombopag Etanercept Evolocumab Fluocinolone acetonide intravitreal implant Human Parathyroid hormonerelated protein analogue Ixekizumab Octreotide Odanacatib Pasireotide Serelaxin - removed Category Preparations for psoriasis Platelet disorder drugs Cytokine modulators PCSK9 monoclonal antibody inhibitor Macular oedema BNF 13.5.2 9.1.4 10.1.3 2.12 11.4.1 Drugs affecting bone metabolism 6.6.1 Drugs affecting the immune response Somatostatin analogues Drugs affecting bone metabolism Somatostatin analogues Hypertension and heart failure Teplizumab Teriparatide Tesamorelin - removed Drugs used in diabetes Drugs affecting bone metabolism Filing withdrawn Vapreotide Growth Hormone & growth hormone Receptor Antagonist 13.4.2 8.3.4.3 6.6.2 8.3.4.3 Not in BNF 6.1 6.6.1 Not in BNF 6.5.2 7 Appendix 2: Specialist drugs and high cost drugs which are excluded from the National Tariff which are the commissioning responsibility of NHS England 2015/16 (Version 9.0) Please also refer to latest version available at: http://www.england.nhs.uk/commissioning/spec-services/key-docs/ Indication BNF category Abacavir HIV in combination with other anti-retroviral drugs 5.3.1 Abacavir with lamivudine HIV in combination with other anti-retroviral drugs 5.3.1 Abacavir + dolutegravir + lamivudine (Triumeq®) HIV in combination with other anti-retroviral drugs 5.3.1 NHS England Policy: B06/P/b Abatacept Paediatric indications (where adult TA available) 10.1.3 As per adult TA's (TA195, TA280) Abatacept Juvenile arthritis 10.1.3 NHS England Interim Policy: B03/Ps/a Abiraterone Cancer 8.3.4.2 TA259 (see also SSC1438) CDF policy - both: only in enzalutamide naïve patients Adalimumab Paediatric indications (where adult TA available) 10.1.3 As per adult TA's (TA130, TA143, TA146, TA187, TA199) Adalimumab Uveitis 10.1.3 Not routinely commissioned - policy in progress Adalimumab Juvenile arthritis 10.1.3 NHS England Interim Policy: B03/Ps/a Adalimumab Hidradenitis Suppurativa 10.1.3 Not routinely commissioned - policy in progress Adefovir Hepatitis B 5.3.3 Not routinely commissioned (CG165) Agalsidase alfa Fabry's disease 9.8.1 NHS England Service Specification Agalsidase beta Fabry's disease 9.8.1 NHS England Service Specification Aldesleukin Cancer 8.2.4 Not routinely commissioned Alemtuzumab Multiple sclerosis 8.2.3 TA312 Alemtuzumab Pre-transplant immunosuppression 8.2.3 Alemtuzumab CLL 8.2.3 Alpha Mannosidase recombinant human Alpha Mannosidase deficiency 9.8.1 Not routinely commissioned Alglucosidase alfa Pompe disease 9.8.1 NHS England Service Specification Alipogene Tiparvovec Lipoprotein lipase deficiency n/a Not routinely commissioned Alisporivir Hepatitis C n/a Not routinely commissioned Drug name TA/Policy Trust guidelines: Islet transplantation (only if provided at zero drug cost) Trust guidelines: (only if provided at zero drug cost) 8 Drug name Indication BNF category TA/Policy Ambrisentan Pulmonary Arterial Hypertension 2.5.1 NHS England Policies: A11/P/b & A11/PS/a Amifampridine phosphate LEMS 10.2.1 NHS England Policy: D04/PS/a Amikacin liposomal Cystic fibrosis Amphotericin liposomal Fungal infection 5.2.3 Agreed Trust Guidelines Anakinra Specialist Autoinflammatory disease 10.1.3 Not routinely commissioned Anakinra Juvenile arthritis 10.1.3 NHS England Interim Policy: B03/Ps/a Anakinra Paediatric indications 10.1.3 Not routinely commissioned Anakinra Cryopyrin Associated Periodic Syndrome 10.1.3 Cryopyrin Associated Periodic Syndrome Service Specification Anidulafungin Fungal infection 5.2.4 Agreed Trust Guidelines Antihaemophilic Factor/von Willebrand Factor Complex As per BCSH Guidelines 2.11 BCSH guidelines Antilymphocyte globulin Aplastic anaemia, organ transplant 9.1.3 BCSH guidelines Antithrombin III As per BCSH Guidelines 2.11 BCSH Guidelines Antithymocyte Immunoglobulin Aplastic anaemia, organ transplant 8.2.2 BCSH Guidelines Apremilast Paediatric indications n/a Aragam As per National DMP 14.5.1 Clinical guidelines for immunoglobulin use, second edition update (July 2011) Asfotase alpha Hypophosphatasia 9.8.1 Not routinely commissioned Asunaprevir with Daclatasvir Hepatitis C n/a Not routinely commissioned Ataluren Duchenne muscular dystrophy n/a Not routinely commissioned Atazanavir HIV in combination with other anti-retroviral drugs 5.3.1 Axitinib Cancer 8.1.5 CDF policy Azacitidine Cancer 8.1.3 TA218 Aztreonam Lysine Cystic fibrosis Basiliximab Renal transplant Not routinely commissioned 5.1.2.3 8.2.2 Not routinely commissioned NHS England Policy: A01/PS/a TA85 & TA99 9 Drug name Indication BNF category TA/Policy Bedaquiline fumarate Multi drug resistant TB 5.1.9 Not routinely commissioned - policy in progress Belatacept Renal transplant 8.2.2 NICE TA in progress- not routinely commissioned Belimumab SLE 10.1.3 NICE TA in progress- not routinely commissioned Beractant Respiratory distress syndrome 3.5.2 Betaine Homocystinuria 9.8.1 NHS England Service Specification Bevacizumab Cancer 8.1.5 CDF policy Bevacizumab Neurofibromatosis 8.1.5 As per National protocol (see NF2 service spec) Boceprevir Hepatitis C 5.3.3 TA253 Bortezomib Cancer 8.1.5 TA129, TA228, TA311 CDF policy Bosentan Pulmonary Arterial Hypertension 2.5.1 NHS England Policy: A11/PS/b Bosentan Digital ulcers 2.5.1 NHS England Policy: A13/P/e Botulinum toxin Focal spasticity in children 4.9.3 Agreed Trust Guidelines Botulinum toxin Intravesical use in spinal cord injury 4.9.3 Not routinely commissioned for new patients C1 Esterase inhibitors Hereditary angioedema acute treatment only 3.4.3 NHS England Policy: B09/P/b Canakinumab Cryopyrin Associated Periodic Syndrome 8.2.4 Cryopyrin Associated Periodic Syndrome Service Specification Canakinumab Juvenile arthritis 8.2.4 Not routinely commissioned (TA 302) Carglumic acid Urea cycle disorders 9.8.1 NHS England Service Specification Carnitine Carnitine deficiency 9.8.1 NHS England Service Specification Caspofungin Fungal infection 5.2.4 Agreed Trust Guidelines Catridecacog Congenital factor XIII Asubunit deficiency Certolizumab Pegol n/a Not routinely commissioned Paediatric indications 10.1.3 Not routinely commissioned Cetuximab Cancer 8.1.5 TA145, TA176 CDF policy Cidofovir Cytomegalovirus 5.3.2.2 Cladribine Multiple sclerosis 8.1.3 Not routinely commissioned Cladribine Pulmonary Langerhans histiocytosis 8.1.3 Not routinely commissioned Agreed Trust Guidelines 10 Indication BNF category TA/Policy Cobicistat HIV in combination with other anti-retroviral drugs n/a Not routinely commissioned - policy in progress Co-careldopa intestinal gel Parkinson's disease 4.9.1 Not routinely commissioned Colistimethate sodium Cystic fibrosis 5.1.7 TA276 & NHS England Policy: A01/PS/a Conestat alfa Hereditary angioedema acute treatment only 3..4.3 NHS England Policy: B09/P/b Crizotinib Cancer 8.1.5 CDF policy Daclizumab Organ transplant n/a Drug has been discontinued Daclizumab Multiple sclerosis n/a Drug has been discontinued Darunavir HIV in combination with other anti-retroviral drugs 5.3.1 Darunavir + cobicistat (Rezolsta®) HIV in combination with other anti-retroviral drugs 5.3.1 Not routinely commissioned Dasatinib Cancer 8.1.5 CDF policy Decitabine Cancer n/a Not routinely commissioned (TA270) Daclatasivir Hepatitis C n/a Not routinely commissioned - NICE TA in progress Deferasirox Iron chelation in thalassaemia and sickle cell 9.1.3 Policy in progress Deferiprone*** Iron chelation in thalassaemia and sickle cell 9.1.3 Policy in progress Defibrotide Hepatic veno-occlusive disease n/a Delamanid Multi drug resistant TB 5.1.9 Not routinely commissioned - policy in progress Desferrioxamine*** Iron chelation in thalassaemia and sickle cell 9.1.3 Policy in progress Dexrazoxane Anthracycline extravasation 8.1 Agreed Trust Guidelines Dexrazoxane Anthracycline cardiotoxicity 8.1 Not routinely commissioned Dibotermin Complex spinal surgery n/a Not routinely commissioned Didanosine HIV in combination with other anti-retroviral drugs 5.3.1 Dimethyl fumarate Multiple sclerosis 8.2.4 TA320 Dolutegravir HIV in combination with other anti-retroviral drugs 5.3.1 NHS England Policy: B06/P/b Dornase alfa Cystic fibrosis 3.7 TA276 & NHS England Policy: A01/PS/a Drug name NHS England Policy: B04/P/c 11 Drug name Indication BNF category TA/Policy Drisapersen Duchenne Muscular Dystrophy n/a Not routinely commissioned Ecallantide Hereditary angioedema acute treatment only n/a Not routinely commissioned Eculizumab aHUS 9.1.3 NHS England Policy: E03/PS(HSS)/a Eculizumab Paroxysmal nocturnal haemoglobinuria 9.1.3 NHS National Specialised Commissioning Team Service Specification Efavirenz HIV in combination with other anti-retroviral drugs 5.3.1 Efraloctocog alpha Haemophilia A n/a Not routinely commissioned Eftrenonacog alpha Haemophilia B n/a Not routinely commissioned Eliglustat Gaucher's disease n/a Not routinely commissioned Elosulfase alfa Mucopolysaccharidosis IVA n/a Not routinely commissioned - policy in progress Elvitegravir HIV in combination with other anti-retroviral drugs n/a Not routinely commissioned - policy in progress Elvitegravir with Cobicistat, Emtricitabine and Tenofovir (Stribild®) HIV in combination with other anti-retroviral drugs 5.3.1 NHS England Policy: B06/PS/a Elvucitabine HIV in combination with other anti-retroviral drugs 5.3.1 Not routinely commissioned Emtricitabine HIV in combination with other anti-retroviral drugs 5.3.1 Emtricitabine with rilpivirine and tenofovir HIV in combination with other anti-retroviral drugs 5.3.1 Enfuvirtide HIV in combination with other anti-retroviral drugs 5.3.1 Entecavir Hepatitis B 5.3.3 Enzalutamide Cancer Epoprostenol5 Pulmonary Arterial Hypertension 2.8.1 NHS England Policy: A11/PS/b Epratuzumab SLE 10.1.3 Not routinely commissioned Eprodisate Amyloidosis n/a Not routinely commissioned Eptotermin Complex spinal surgery n/a Not routinely commissioned Erlotinib Cancer 8.1.5 TA162, TA227 & In Progress NHSE letter Etanercept Paediatric indications (where adult TA available) 10.1.3 As per Adult TA's (TA103, TA130, TA143, TA199) Etanercept Juvenile arthritis 10.1.3 TA35 8.3.4.2 TA153 & In Progress TA316 (see also SSC1439) CDFpolicy - both: only in abiraterone naïve patients 12 Indication BNF category Etravirine HIV in combination with other anti-retroviral drugs 5.3.1 Everolimus (Afinitor®) Cancer 8.1.5 CDF policy Everolimus (Votubia®) Renal angiomyolipoma 8.1.5 Not routinely commissioned Everolimus (Votubia®) Tubular sclerosis 8.1.5 Not routinely commissioned Factor IX As per BCSH Guidelines 2.11 BCSH Guidelines Factor VII As per BCSH Guidelines 2.11 BCSH Guidelines Factor VIIa As per BCSH Guidelines 2.11 BCSH Guidelines Factor VIII As per BCSH Guidelines 2.11 BCSH Guidelines Factor VIII Fc Fusion Protein As per BCSH Guidelines n/a BCSH Guidelines Factor VIII inhibitor bypassing factor As per BCSH Guidelines 2.11 BCSH Guidelines Factor XIII As per BCSH Guidelines 2.11 BCSH Guidelines Fampridine Multiple sclerosis Fibrinogen As per BCSH Guidelines 2.11 BCSH Guidelines Fibroblast growth factor 1 gene therapy Somatostatin analogue n/a Not routinely commissioned Filgrastim Barth Syndrome 9.1.6 Highly specialised criteria only Filgrastim Neutropenia 9.1.6 SPC Filibuvir Hepatitis C n/a Fingolimod Multiple sclerosis 8.2.4 Flebogamma As per National DMP 14.5.1 Flebogammadif As per National DMP 14.5.1 Forigerimod acetate SLE 10.1.3 Fosamprenavir HIV in combination with other anti-retroviral drugs 5.3.1 Foscarnet Cytomegalovirus Galsulfase Mucopolysaccharidosis Drug name 10.2.1 5.3.2.2 9.8.1 TA/Policy Not routinely commissioned: NHS England Policy: D04/PS/d Not routinely commissioned TA254 NHS England Policy: D04/P/b Clinical guidelines for immunoglobulin use, second edition update (July 2011) Clinical guidelines for immunoglobulin use, second edition update (July 2011) Not routinely commissioned Agreed Trust Guidelines NHS England Service Specification 13 Drug name Indication BNF category TA/Policy Clinical guidelines for immunoglobulin use, second edition update (July 2011) Clinical guidelines for immunoglobulin use, second edition update (July 2011) Clinical guidelines for immunoglobulin use, second edition update (July 2011) Clinical guidelines for immunoglobulin use, second edition update (July 2011) Gammagard As per National DMP 14.5.1 Gammanorm As per National DMP 14.5.1 Gammaplex As per National DMP 14.5.1 Gamunex As per National DMP 14.5.1 Ganciclovir Cytomegalovirus 5.3.2.2 Ganetespib Cancer n/a Gefitinib Cancer 8.1.5 TA192 Gevokizumab Uveitis 10.1.3 Not routinely commissioned Glatiramer Multiple sclerosis 8.2.4 TA32 & NHS England Policy: D04/P/b GlycoPEGylated Factor IX Haemophilia A Golimumab Paediatric indications 10.1.3 As per adults TA's (TA220, TA233) Granulocyte-macrophage colony-stimulating factor (Leukine® - Import) Antibody-positive pulmonary alveolar proteinosis 9.1.6 Not routinely commissioned Hizentra As per National DMP 14.5.1 Clinical guidelines for immunoglobulin use, second edition update (July 2011) Human Arginate Hepatic porphyria 9.8.2 NHS England Service Specification Human Heterologous Liver Cells Urea cycle disorders n/a Hyvqia As per National DMP 14.5.1 Not routinely commissioned****** Icatibant Hereditary angioedema acute treatment only 3.4.3 NHS England Policy: B09/P/b Idebenone Duchenne Muscular Dystrophy Idursulfase Mucopolysaccharidosis 9.8.1 NHS England Service Specification Iloprost5 Pulmonary Arterial Hypertension 2.5.1 NHS England Policy: A11/PS/b Imatinib Cancer 8.1.5 TA70, TA86, TA251, TA326 CDF policy Imatinib Graft versus host disease 10.1.3 Not routinely commissioned Imiglucerase Gaucher's disease 9.8.1 NHS England Service Specification n/a n/a Agreed Trust Guidelines Not routinely commissioned Not routinely commissioned Not routinely commissioned Not routinely commissioned 14 Indication BNF category Indinavir HIV in combination with other anti-retroviral drugs 5.3.1 Infliximab Paediatric indications (where adult TA available) 10.1.3 As per Adult TA's (TA130, TA134, TA140, TA143, TA163, TA199) Infliximab Connective tissue disease interstitial lung disease 10.1.3 Not routinely commissioned - policy in progress Infliximab Crohn's disease in children 10.1.3 TA187 Infliximab Graft versus host disease 10.1.3 Not routinely commissioned Infliximab Renal 10.1.3 Not routinely commissioned Infliximab Sarcoidosis 10.1.3 Not routinely commissioned Infliximab Uveitis 10.1.3 Not routinely commissioned - policy in progress Infliximab Hidradenitis Suppurativa 10.1.3 Not routinely commissioned - policy in progress Interferon Alfa Hepatitis B and C 8.2.4 TA75 Interferon Beta Multiple sclerosis 8.2.4 Intratect As per National DMP 14.5.1 Isavuconazole Fungal infection Ivacaftor Cystic fibrosis 3.7 NHS England Policy: A01/P/b Ixazamib Amyloidosis n/a Not routinely commissioned Kiovig As per National DMP 14.5.1 Clinical guidelines for immunoglobulin use, second edition update (July 2011) Lamivudine Hepatitis B 5.3.3 CG165 Lamivudine HIV in combination with other anti-retroviral drugs 5.3.1 Lamivudine with Abacavir HIV in combination with other anti-retroviral drugs 5.3.1 Lanreotide Cancer 8.3.4.3 Agreed Trust Guidelines Lanreotide**** Acromegaly 8.3.4.3 Agreed Trust Guidelines Lanreotide Congenital hyperinsulinism 8.3.4.3 Highly specialised criteria only Lapatinib Cancer Laquinimod Multiple sclerosis Laronidase Mucopolysaccharidosis Drug name TA/Policy TA32 NHS England Policy: D04/P/b Clinical guidelines for immunoglobulin use, second edition update (July 2011) Not routinely commisisoned 8.1.5 Not routinely commissioned n/a Not routinely commissioned 9.8.1 NHS England Service Specification 15 Drug name Indication BNF category TA/Policy Lenalidomide Cancer 8.2.4 TA171, TA322 CDF policy Lenograstim Neutropenia 9.1.6 SPC Lenograstim Barth Syndrome 9.1.6 Highly specialised criteria only Levofloxacin (inhaled) Cystic fibrosis Lipegfilgrastim Neutropenia 9.1.6 Not routinely commissioned - policy in progress Lixivaptan Hyponatraemia and other endocrine uses 6.5.2 Not routinely commissioned Lomitapide Homozygous familial hypercholesterolemia 2.12 Not routinely commissioned Lopinavir with Ritonavir HIV in combination with other anti-retroviral drugs 5.3.1 Lumacaftor + Ivacaftor Cystic fibrosis Macitentan Pulmonary Arterial Hypertension 2.5.1 NHS England Policy: A11/PS/b Macrimorelin Growth failure 6.7.4 Not routinely commissioned Mannitol Cystic fibrosis 3.7 TA266 Masitinib Pancreatic cancer/GIST n/a Not routinely commissioned Maraviroc HIV in combination with other anti-retroviral drugs 5.3.1 Mecasermin Growth failure 6.7.4 NHS England Policy: EO3/P/a Mepolizumab Asthma 3.4.2 Not routinely commissioned Mercaptamine (cysteamine) Nephropathic cystinosis 9.8.1 NHS England Service Specification Micafungin Fungal infection 5.2.4 SPC Mifepristone Cushing's Disease Migalastat Fabry's Disease 9.8.1 NHS England Service Specification Miglustat Gaucher's disease/ NiemannPick 9.8.1 NHS England Service Specification Motavizumab RSV prophylaxis n/a Natalizumab Multiple sclerosis 8.2.4 Nelfinavir HIV in combination with other anti-retroviral drugs 5.3.1 Not routinely commissioned 3.7 6.7 Not routinely commissioned Not routinely commissioned Not routinely commissioned TA127 NHS England Policy: D04/P/b 16 Indication BNF category Nevirapine HIV in combination with other anti-retroviral drugs 5.3.1 Nilotinib Cancer 8.1.5 Nintedanib NSCLC/pulmonary fibrosis/ovarian cancer n/a Not routinely commissioned Nitazoxanide Hepatitis C n/a Not routinely commissioned Nitisinone Alkaptonuria 9.8.1 NHS England Service Specification Nitisinone Tyrosinaemia 9.8.1 NHS England Service Specification Nitric Oxide Pulmonary Arterial Hypertension Normal Immunoglobulin As per National DMP 14.5.1 Clinical guidelines for immunoglobulin use, second edition update (July 2011) Ocrelizumab Multiple sclerosis 8.2.3 Not routinely commissioned Octagam As per National DMP 14.5.1 Clinical guidelines for immunoglobulin use, second edition update (July 2011) Octocog alpha Haemophilia A n/a Not routinely commissioned Octreolin Acromegaly n/a Not routinely commissioned Octreotide Cancer 8.3.4.3 Agreed Trust Guidelines Octreotide**** Acromegaly 8.3.4.3 Agreed Trust Guidelines Octreotide Congenital hyperinsulinism 8.3.4.3 Highly specialised criteria only Ofatumumab Pemphigus vulgaris 10.1.3 Not routinely commissioned Olesoxime Spinal muscular atrophy n/a Not routinely commissioned Omalizumab Asthma 3.4.2 TA278 Omalizumab Chronic spontaneous urticaria 3.4.2 Not routinely commissioned - NICE TA in progress Ombitasvir/paritaprevir/rito navir + dasabuvir +/ribavirin Hepatitis C n/a Not routinely commissioned - NICE TA in progress Pacritinib Myelofibrosis n/a Not routinely commissioned Palivizumab RSV prophylaxis 5.3.5 JCVI Guidelines PHE specification Parathyroid hormone Specialist endocrinology conditions 6.6.1 Agreed Trust Guidelines Drug name n/a TA/Policy TA241, TA251 Agreed Trust Guidelines 17 Drug name Indication BNF category TA/Policy Only when duration of PN is > 14 days or initiated prior to admission. Adults; see also CG32. See also 'Manual for prescribed specialised services' Parenteral Nutrition Intestinal failure; inadequate/ unsafe enteral feeding Pasireotide Cushing's Disease Pazopanib Cancer 8.1.5 TA215 CDF policy Peg interferon alfa Hepatitis B and C 8.2.4 TA75, TA96, TA106, TA200, TA 300 CG165 Peginterferon Beta-1a Multiple sclerosis n/a Not routinely commissioned Peginterferon Lambda-1a Hepatitis C n/a Not routinely commissioned Pegfilgrastim Neutropenia 9.1.6 Not routinely commissioned - policy in progress Pegvisomant Acromegaly 6.5.1 Not routinely commissioned - policy in progress Pirfenidone Idiopathic pulmonary fibrosis 3.11 TA282 (specialist centre only) Plerixafor Stem cell mobilisation 9.1.7 NHS England policy: B04/P/2 Pomolidomide Myelofibrosis Poractant alfa Respiratory distress syndrome Porcine Factor As per BCSH Guidelines Posaconazole Fungal infection 5.2.1 Agreed Trust Guidelines Privigen As per National DMP 14.5.1 Clinical guidelines for immunoglobulin use, second edition update (July 2011) Protein C As per BCSH Guidelines 2.11 BCSH Guidelines Prothrombin Complex As per BCSH Guidelines 2.11 BCSH Guidelines Raltegravir HIV in combination with other anti-retroviral drugs 5.3.1 Rasburicase Hyperuricaemia 10.1.4 Agreed Trust Guidelines Reslizumab Asthma 3.4.2 Not routinely commissioned Ribavirin Hepatitis C 5.3.5 TA75, TA106, TA200 Rigosertib MDS/pancreatic cancer 9.3 8.3.4.3 n/a Not routinely commissioned Not routinely commissioned 3.5.2 n/a n/a BCSH Guidelines Not routinely commissioned 18 BNF category Drug name Indication Rilonacept Cryopyrin-associated periodic syndromes n/a Rilpivirine HIV in combination with other anti-retroviral drugs 5.3.1 Riociguat Pulmonary Arterial Hypertension Ritonavir HIV in combination with other anti-retroviral drugs 5.3.1 Rituximab ANCA-positive vasculitis 10.1.3 TA308 NHS England Policy: A13/P/a Rituximab iv Cancer 8.2 TA65, TA137, TA174, TA193, TA226, TA243 NHS England CDF letter Rituximab subcutaneous formulation Cancer 8.2 As per circular ie only commissioned for Follicular Lymphoma maintenance treatment Rituximab Haemophilia 10.1.3 Not routinely commissioned Rituximab Paediatric indications (where adult TA available) 10.1.3 NHS England Policy TA195 Rituximab Connective tissue disease interstitial lung disease 10.1.3 Not routinely commissioned - policy in progress Rituximab Graft versus host disease 10.1.3 Not routinely commissioned Rituximab SLE 10.1.3 NHS England Policy: A13/PS/a Rituximab Myositis 10.1.3 Not routinely commissioned Rituximab Nephritis 10.1.3 Not routinely commissioned Rituximab Neuromyelitis optica 10.1.3 As per specification Rituximab ABO-incompatible kidney transplants 10.1.3 As per specification Rituximab Pemphigus vulgaris 10.1.3 Not routinely commissioned Rituximab Juvenile arthritis 10.1.3 NHS England Interim Policy: B03/Ps/a Ruxolitinib Cancer 8.1.5 CDF policy Sandoglobulin As per National DMP 14.5.1 Clinical guidelines for immunoglobulin use, second edition update (July 2011) Sapropterin Phenylalanine restriction 9.4.1 NHS England Policy: E12/P/a Saquinavir HIV in combination with other anti-retroviral drugs 5.3.1 Sebelipase alfa Lysosomal acid lipase deficiency n/a Not routinely commissioned Secukinumab Paediatric indications n/a Not routinely commissioned n/a TA/Policy Not routinely commissioned Not routinely commissioned 19 BNF category Drug name Indication Selexipag Pulmonary Arterial Hypertension n/a Sildenafil Pulmonary Arterial Hypertension 2.5.1 NHS England Policies: A11/P/b & A11/PS/a Siltuximab Castleman's Disease 10.1.3 Not routinely commissioned Simeprevir Hepatitis C 5.3.3 NHS England Interim Policy: A02/PS/c Sodium oxybate Narcolepsy - paediatric services only 4.1.1 Not routinely commissioned Sodium phenylbutyrate Urea cycle disorders 9.8.1 NHS England Service Specification Sofosbuvir Hepatitis C 5.3.3 Not routinely commissioned Sofosbuvir with Ledipasvir Hepatitis C 5.3.3 NHS England Policy: A02/PS/b Sorafenib Cancer HIV in combination with other anti-retroviral drugs 8.1.5 CDF policy Subcuvia As per National DMP 14.5.1 Subgam As per National DMP 14.5.1 Sunitinib Cancer 8.1.5 Tabalumab SLE 10.1.3 Not routinely commissioned Tadalafil Pulmonary Arterial Hypertension 7.4.5 NHS England Policies: A11/P/b & A11/PS/a Taliglucerase alfa Gaucher's Disease n/a NHS England Service Specification Taribavirin Hepatitis C n/a Not routinely commissioned Teduglutide Short bowel syndrome n/a Not routinely commissioned Telaprevir Hepatitis C 5.3.3 Telbivudine Hepatitis B 5.3.3 Temsirolimus Cancer 8.1.5 Not routinely commissioned (TA154) CDF policy Tenofovir HIV in combination with other anti-retroviral drugs Hepatitis B +/- other antiretroviral drugs 5.3.1 TA173 & In Progress Tenofovir with Emtricitabine HIV in combination with other anti-retroviral drugs 5.3.1 Stavudine TA/Policy Not routinely commissioned 5.3.1 Clinical guidelines for immunoglobulin use, second edition update (July 2011) Clinical guidelines for immunoglobulin use, second edition update (July 2011) TA169, TA179 CDF policy TA252 20 BNF category Drug name Indication Tenofovir with Emtricitabine and Efavirenz HIV in combination with other anti-retroviral drugs 5.3.1 Teriflunomide Multiple sclerosis 8.2.4 TA303 NHS England Policy: D04/P/b Teriparatide Male and juvenile osteoporosis 6.6.1 Not routinely commissioned Tetrahydrobiopterin Phenylketonuria 9.4.1 NHS England Service Specification Thalidomide Cancer 8.2.4 TA228 Thrombin Pseudoaneurysm n/a IPG060 Tipranavir HIV in combination with other anti-retroviral drugs 5.3.1 Tobramycin Cystic fibrosis 5.1.4 TA276 NHS England Policy: A01/PS/a Tocilizumab Paediatric indications (where adult TA available) 10.1.3 As per Adult TA's (TA247) Tocilizumab Juvenile arthritis 10.1.3 TA238 Tocilizumab Large vessel vasculitis 10.1.3 Not routinely commissioned Tolvaptan Hyponatraemia and other endocrine uses 6.5.2 Not routinely commissioned - policy in progress Trenonacog alpha Haemophilia B n/a Not routinely commissioned Treprostinil sodium Pulmonary Arterial Hypertension n/a NHS England Policy: A11/PS/a Turoctocog alfa As per BCSH Guidelines n/a BCSH Guidelines Valganciclovir Cytomegalovirus Vandetanib Thyroid cancer 8.1.5 CDF policy Vedolizumab Crohn's disease in children 10.1.3 Not routinely commissioned - TA in progress Velaglucerase alfa Gaucher's Disease 9.8.1 NHS England Service Specification Vemurafenib Melanoma 8.1.5 TA269 Vigam As per National DMP 14.5.1 Vivaglobin As per National DMP 14.5.1 Von Willebrand factor, recombinant von Willebrand deficiency 5.3.2.2 n/a TA/Policy Agreed Trust Guidelines Clinical guidelines for immunoglobulin use, second edition update (July 2011) Clinical guidelines for immunoglobulin use, second edition update (July 2011) Not routinely commissioned 21 BNF category Drug name Indication TA/Policy Voriconazole Fungal infection 5.2.1 Agreed Trust Guidelines Voriconazole Chronic pulmonary aspergillosis 5.2.1 Highly specialised criteria only Ziconotide Intrathecal analgesia 4.7.1 Not routinely commissioned - policy in progress Zidovudine HIV in combination with other anti-retroviral drugs 5.3.1 Zidovudine with Lamivudine HIV in combination with other anti-retroviral drugs 5.3.1 Zidovudine with Lamivudine and Abacavir HIV in combination with other anti-retroviral drugs 5.3.1 Other drugs not listed under PbR exclusions 3,4 Diaminopyridine Lambert Eaton Myasthenic Syndrome Afatinib Cancer 8.1 TA310 Aflibercept Cancer 8.1 Not routinely commissioned Albumin bound paclitaxel Cancer 8.1 CDF policy Azathioprine Transplant immunosuppression only 8.2.2 New patients only until formal repatriation agreed Bendamustine Cancer 8.1.1 TA216 CDF policy Brentuximab Cancer 8.1 CDF policy Bosutinib Cabazitaxel Cabozantinib Clofarabine Cancer Cancer Cancer Cancer - (not specifically listed) Transplant immunosuppression only Hyperparathyroidism dialysis patients only Cancer Colestilan Adult renal dialysis only Dabrafenib Cancer 8.1.5 Darbepoetin Dialysis-induced anaemia 9.1.3 Epoetin (all variants) Dialysis-induced anaemia 9.1.3 Eribulin Cancer 8.1.5 Glucarpidase Methotrexate induced renal dysfunction Chemotherapy Ciclosporin Cinacalcet Agreed Trust Guidelines 8.1 8.1 8.1 8.1 & 8.2 8.2.2 9.5.1.2 8.1 CDF policy Not routinely commissioned CDF policy Trust guidelines/ NICE/ CDF policy New patients only until formal repatriation agreed TA117 CDF policy 9.5.2.2 n/a TA321 Renal dialysis only, including via outpatients, and only as per NICE CG114 Renal dialysis only, including via outpatients, and only as per NICE CG114 CDF policy NHS England Policy: B15/P/a 22 BNF category Drug name Indication TA/Policy Idelalisib Cancer 8.1.5 CDF policy Ipilimumab Cancer 8.1.5 TA268, TA319 Lanthanum Adult renal dialysis only 9.5.2.2 Mesenchymal stem cells (e.g. Prochymal®) Acute GvHD and other indications (BCSH) n/a Mycophenolate mofetil Transplant immunosuppression only 8.2.2 New patients only until formal repatriation agreed Mycophenolic acid Transplant immunosuppression only 8.2.2 New patients only until formal repatriation agreed Nelarabine Cancer 8.1 Obinutuzumab Cancer 8.2.3 Ofatumumab Cancer 8.1 CDF policy Panitumumab Cancer 8.1 CDF policy Pegylated liposomal doxorubicin Cancer 8.1.2 TA91 CDF policy Pemetrexed Cancer 8.1.3 TA135, TA181, TA190 CDF policy Peptide receptor radionucleotide therapy Cancer Pertuzumab Cancer 8.1.5 CDF policy Pixantrone Cancer 8.1.5 TA306 Pomalidomide Cancer 8.1.5 CDF policy Ponatinib Cancer 8.1.5 CDF policy Radium-223 Dichloride Cancer 8.1.5 CDF policy Regorafenib Cancer 8.1.5 CDF policy Sevelamer Adult renal dialysis only Sirolimus (Rapamune) Lymphangioleiomyomatosis (LAM) 8.2.2 Not routinely commissioned Sirolimus (Rapamune) Transplant immunosuppression only 8.2.2 New patients only until formal repatriation agreed Tacrolimus Transplant immunosuppression only 8.2.2 New patients only until formal repatriation agreed Not routinely commissioned CDF policy Not routinely commissioned: TA in progress CDF policy 9.5.5.2 23 Drug name Indication Temozolomide Endocrinology; non-malignant conditions Trabectadin Cancer Trastuzumab Emtansine Cancer Protein kinase inhibitors Vismodegib Endocrinology; non-malignant conditions Cancer BNF category 8.1.5 8.1.5 TA/Policy Not routinely commissioned TA185 8.1.5 CDF policy 8.1.5 Not routinely commissioned n/a CDF policy * Drug is being repatriated from primary to secondary care therefore supply route may vary at present ** From April 2016 - until then CCG commissioned *** Routinely commissioned in combination when dual therapy required **** Only when prescribed in a specialist centre ***** only where it is a recognised MS centre with specialist nurse support Additional notes: 1. Where the funded indication is for paediatric use the CCG will become the responsible commissioner when the patient is transferred to the adult service. 2. CCGs are the responsible commissioner for rituximab in non-cancerous haematological conditions (e.g. ITP) and non-specialist auto-inflammatory conditions (eg RA) 3. Eltrombopag and romiplostim are the responsibility of CCGs regardless of the cause of the thrombocytopenia. 4. It is a mandated requirement that all use of chemotherapy is recorded in the SACT database including those treatments funded through the CDF. 5. Use in vascular disease is commissioned by NHS England within specialist centres - all other indications are CCG commissioned. 6. NHS England is the responsible commissioner when somatropin analogues (growth hormone) are prescribed in specialist centres for indications falling outside NICE Guidance 7. A derrogation list can be found under each Programme of Care - please refer to this link - https://www.england.nhs.uk/commissioning/spec-services/npc-crg/ 8. Trusts using the enhanced tariff option (ETO) should be aware of payment arrangements relating to excluded drugs. 24 Appendix 3 High cost drugs which are excluded from the National Tariff which are the commissioning responsibility of BCCG 2015/16 GPs should not normally prescribe the drugs listed in Appendix 3 as they are usually provided by Hospital Trusts. In addition, Bedfordshire CCG has not recommended prescribing policies for some of the drugs and so does not commission them. Appendix 3 provides advice on the circumstances in which GP prescribing under shared care is supported. Drug name Abaloparatide Abatacept Adalimumab Indication Osteoporosispost-menopausal with high risk fracture Rheumatoid arthritis, psoriatic arthritis Alteplase Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease, axial spondyloarthritis (non-radiographic), moderate to severe ulcerative colitis Erythropoietic protoporphyria wAMD, Macular oedema secondary to CRVO/BRVO, CNV due to myopia, diabetic macular oedema, diabetic retinopathy DMO Hypercholesterolaemia, familial and nonfamilial Severe chronic hand eczema Thrombolytic Amikacin liposomal inhalation Nontuberculous mycobacterial lung infection Afamelanotide Aflibercept Alirocumab Alitretinoin Bedfordshire CCG Commissioning Policy Predicted UK launch 2016. Not commissioned. No GP prescribing. BNF 6.6.2 Approved for use in RA in line with NICE TAs 195 and 280. Subcutaneous use in RA approved in line with JPC policy 196. Not commissioned for any other indication. No GP prescribing. NHSE for paediatric use. Approved for use in line with NICE TAs 130, 143, 146, 187, 195, 199, sequential use of second biologic in psoriasis NICE CG 153 and JPC policy April 2013. NOT commissioned as per NICE TA262 or other indications without positive NICE guidance. NHSE for paediatric use. No GP prescribing. 10.1.3 Not commissioned. Launch expected 2015. No GP prescribing. Approved for us in line with NICE TA 294, 305. Not commissioning for any other indication. No GP prescribing. 13.01 1.5.3 /10.1.3 11.8 Not commissioned. Launch expected 2015. No GP prescribing. 2.12 Severe chronic hand eczema in line with NICE TA177. No GP prescribing. Trust prescribe as part of the stroke pathway, so GP prescribing NOT expected. NICE TA 264. Not commissioned. NHSE responsible for use in CF. No GP prescribing. 13.5.1 2.10.2 5.1.4 25 Drug name Anakinra Indication Rheumatoid arthritis Apremilast Psoriatic arthritis Avatrombopag ITP, thrombocytopenia Cystic fibrosis, bronchiectasis Aztreonam lysine nebuliser solution Bedfordshire CCG Commissioning Policy Not commissioned. NHSE responsible for use in adult auto inflammatory disease and paediatric use. No GP prescribing. Not commissioned. Launch expected 2015. No GP prescribing. NHSE for paediatric use. Not commissioned. Launch expected 2015. No GP prescribing. JPC does not support use and prescribing should remain within secondary / tertiary care. No GP prescribing expected. NHSE responsible for use in CF. Not commissioned. Launch expected 2016. No GP prescribing. BNF 10.1.3 Approved in line with JPC policy. No GP prescribing. NHSE responsible for focal spasticity in children when given in a specialist centre. Approved for use in patients resistant to botulinum toxin A for cervical dystonia. No GP prescribing. 4.9.3 Not commissioned. Launch expected 2016. No GP prescribing. Approved in line with NICE TA186 and local JPC policies 194 and 195. Not commissioned for any other indication. No GP prescribing. 13.5.3 NHSE responsibility, but GPs may prescribe for new or existing patients. 5.1.7 Cystic fibrosis NICE TA 276, but no GP prescribing of Colobreathe® as Patient Access Scheme not available in primary care. 5.1.7 Dupuytren’s contracture, Peyronie’s disease Anaemia related to chronic iron overload for myelodysplastic syndrome only Anaemia related to chronic iron overload for myelodysplastic syndrome only Commissioned in line with JPC Policy 179, but no GP prescribing. Not commissioned for any other indication. Not commissioned for use in MDS. No GP prescribing. NHSE for use in thalassaemia and sickle cell. 10.1.3 Not commissioned for use in MDS. No GP prescribing. NHSE for use in thalassaemia and sickle cell. 9.1.3 Baricitinib Rheumatoid arthritis Botulinum toxin A Various, Migraine prophylaxis Botulinum toxin B Cervical dystonia Brodalumab Psoriasis Certolizumab pegol Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis Cystic fibrosis Colistimethate sodium powder (Promixin®) / injection for nebulisation Colistimethate sodium dry powder for inhalation (Colobreathe®) Collagenase Deferasirox Deferiprone 10.1.3 9.1.4 5.1.2.3 10.1.3 4.9.3 10.1.3 9.1.3 26 Drug name Desferrioxamine Dexamethasone intravitreal implant Dibotermin alfa (Bone Morphogenetic Protein) Digoxin immune fab Indication Anaemia related to chronic iron overload for myelodysplastic syndrome only Macular oedema secondary to retinal vein occlusion, diabetic macular oedema, uveitis Acute tibial fractures with Grade IIIB fractures Life threatening digoxin toxicity Dimethyl fumarate (Fumaderm®) Dimethyl fumarate Eltrombopag Plaque psoriasis, moderate to severe Etanercept or licensed biosimilar Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis Hyperlipidaemia, homozygous familial Evolocumab Psoriasis ITP, Thrombocytopenia in Hep C Bedfordshire CCG Commissioning Policy Not commissioned for use in MDS. No GP prescribing. NHSE for use in thalassaemia and sickle cell. BNF 9.1.3 Approved for use in line with NICE TA229. Not commissioned for uveitis JPC policy 157 or any other indication. No GP prescribing. 11.4.1 / 11.4.2 No GP prescribing. EoE PAC policy available. Not listed. Approved use in line with National Poisons Centre Guidelines and on a named patient basis only in hospitals. No GP prescribing. Only in line with JPC policy updated Sep 2012 2.1.1 Not commissioned. Launch expected 2016. No GP prescribing. Approved for use in line with NICE TA293 and PAC policy on thrombocytopenia in adults with chronic hepatitis C virus infection. No GP prescribing. Approved for use in line with NICE TAs 103,130, 143, 195, 199 and local JPC policy 167. Not commissioned for any other indication. NHSE for paediatric use. No GP prescribing. Not commissioned. Expected launch 2015. No GP prescribing. 13.5.2 13.5.2 9.1.4 10.1.3 2.12 hypercholesterolaemia Fibrin sealants Fluocinolone acetonide intravitreal implant Fomepizole Haemostatic Diabetic macular oedema No GP prescribing. Approved for use in line with NICE TA301. No GP prescribing. Not listed. 11.4.1 Poisoning For use in poisoning. No GP prescribing. Poisoning Golimumab Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis (non-radiographic), moderate to severe ulcerative colitis Approved for use in line with NICE TAs 220, 225, 233. Not recommended for RA in methotrexate naïve patients NICE TA 224. Not commissioned for any other indication. NHSE for paediatric use. No GP prescribing. 10.1.3 27 Drug name Human Parathyroid hormone-related protein analogue Infliximab or licensed biosimilar Ixekizumab Ketorolac with phenylephrine Lanreotide Indication Osteoporosis Bedfordshire CCG Commissioning Policy Not commissioned. Expected launch 2016. No GP prescribing. BNF 6.6.2 Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease, axial spondyloarthritis (non-radiographic), ulcerative colitis Psoriasis, ankylosing spondylitis, psoriatic arthritis Eye conditions Approved for use in line with NICE TAs 187, 130, 134, 163,195, 199 and JPC bulletin 167. Not recommended for ankylosing spondylitis NICE TA 143, sub-acute manifestations of ulcerative colitis NICE TA 140 or any other indications. NHSE for paediatric use. No GP prescribing. 1.5.3 /10.1.3 Not commissioned for any indication. Expected launch 2016. No GP prescribing. 13.4.2 Not yet licensed. No GP prescribing. Not listed. Non-cancerous thyroid tumours NHSE for cancer indications. CCGs non cancer use only. GPs may continue to prescribe after hospital initiation. NHSE for renal dialysis only. GPs may prescribe under shared care agreement. 8.3.4.3 NHSE responsibility- not commissioned. No GP prescribing. 5.1.12 Not commissioned. No GP prescribing. 2.12 For nebulisation / inhalation, but not recommended for prescribing by GPs. 3.7 NHSE for post-transplant use, but GPs may prescribe for new and existing transplant patients. NHSE will be transferring prescribing and supply from GPs to Trusts during 2015/16 on a Trust by Trust basis. Once transferred, GPs should no longer prescribe mycophenolate mofetil for these patients. 8.2.2 Approved for use in line with NICE TA 297. No GP prescribing. Not commissioned. Launch expected 2016. Use in acromegaly through a specialist centre is NHSE. No GP prescribing. 11.8.2 Lanthanum Hyperphosphataemia Levofloxacin via nebulisation / inhalation. Lomitapide associated with chronic renal failure on dialysis Pulmonary infections in Cystic fibrosis Hypercholesterolae mia, homozygous familial (HoFH) Cystic fibrosis Mannitol Mycophenolate mofetil Transplant Ocriplasmin Vitreomacular traction Acromegaly Octreolin immunosuppression 9.5.2.2 Not listed. 28 Drug name Octreotide Indication As per JPC policy. Odanacatib Postmenopausal osteoporosis Cushing’s disease Pasireotide Pegaptanib Ranibizumab Riluzole wAMD wAMD, diabetic macular oedema, macular oedema (RVO), CNV due to pathological myopia ALS form of MND Rituximab or licensed biosimilar Rheumatoid arthritis, ITP, refractory vasculitis Romiplostim ITP Secukinumab Psoriasis after failed anti-TNF Sevelamer Hyperphosphataemia Sildenafil Sirolimus associated with chronic renal failure on dialysis Pulmonary arterial hypertension Transplant immunosuppression Bedfordshire CCG Commissioning Policy NHSE for cancer indications, acromegaly and congenital hyperinsulinaemia and paediatric use. CCGs non cancer use only. GPs may continue to prescribe for non-cancer uses after hospital initiation in line with JPC policy. Not commissioned. Launch expected 2016. BNF 8.3.4.3 NHSE for acromegaly, cancer indications and Cushing’s disease. Not commissioned for other indications. No GP prescribing. NOT commissioned. No GP prescribing. Approved for use in line with NICE TAs 155, 274, 283, 298. No GP prescribing. 8.3.4.3 Approved for use in line with NICE guidance no. 20. GPs can prescribe under shared care after initial 3 month supply by hospital. 4.9.3 Approved for use in line with NICE TA195 and JPC local policy146 and refractory vasculitis. NHSE for ANCA-positive vasculitis, cancer, haemophilia, paediatric indications (where adult NICE TA available) ILD, graft vs host disease, SLE, myositis, neuromyelitis optica, ABO incompatible kidney transplants. No GP prescribing expected. Approved for use in line with NICE TA 221. NO GP prescribing. Not commissioned. Launch expected 2015. No GP prescribing. NHSE for renal dialysis only. GPs may prescribe under shared care agreement. 10.1.3 GPs not to prescribe for Pulmonary Arterial Hypertension indication as NHSE responsibility. GPs may prescribe for erectile dysfunction (ED). 2.5.1 NHSE for post-transplant use, but GPs may prescribe for new and existing transplant patients. NHSE will be transferring prescribing and supply from GPs to Trusts during 2015/16 on a Trust by Trust basis. Once transferred, GPs should no longer prescribe sirolimus for these patients. 8.2.2 6.6.2 11.8.2 11.8.2 9.1.4 9.5.2.2 29 Drug name Sodium oxybate Indication Narcolepsy with cataplexy Bedfordshire CCG Commissioning Policy Not commissioned. NHSE for paediatric use. No GP prescribing. BNF 4.1.1 Somatropin Growth hormone deficiency 6.5.1 Tacrolimus Transplant Approved for use in line with NICE TAs 42, 64, 188 in adults and children. GPs may prescribe under shared care arrangements. NHSE for post-transplant use, but GPs may prescribe for new and existing transplant patients. NHSE will be transferring prescribing and supply from GPs to Trusts during 2014/15 on a Trust by Trust basis. Once transferred, GPs should no longer prescribe tacrolimus for these patients. Not commissioned. No GP prescribing. Not commissioned. Launch expected 2016. No GP prescribing. Approved for use in line with NICE TA161. No GP prescribing. 6.6.1 NHSE responsibility, but GPs may prescribe for new or existing patients in line with NHSE policy NHSCB/A01/PS/Aa1A. 5.1.4 Cystic fibrosis No GP prescribing of Tobi® Podhaler as Patient Access Scheme not available in primary care. 5.1.4 Rheumatoid arthritis Approved for use in line with NICE TA 247 and JPC policy 183 and 203 (s/c use). NHSE for all paediatric uses. Not commissioned for any other indications. No GP prescribing. Not commissioned. Launch expected Q2 2016. NHSE for paediatric uses. No GP prescribing. Approved for use in psoriasis in line with NICE TA 180. Sequential use of second biologic in psoriasis NICE CG 153 and JPC policy April 2013. No GP prescribing. Not commissioned. Not yet licensed. No GP prescribing. Not commissioned. Paediatric use is NHSE. No GP prescribing. 10.1.3 Approved for use in line with NICE TA 68. No GP prescribing. 11.8.2 immunosuppression Tafamidis Teplizumab Teriparatide Tobramycin (Tobi® / Bramitob®) nebuliser solution Tobramycin (Tobi® Podhaler) dry powder for inhalation Tocilizumab TTR-FAP Type 1 diabetes mellitus prevention in very high risk patients Secondary prevention of osteoporotic fragility fractures Cystic fibrosis Tofacitinib Rheumatoid arthritis, psoriasis Ustekinumab Psoriasis, Crohn’s disease, psoriatic arthritis Vapreotide Oesophageal varices Crohn’s disease, moderate to severe ulcerative colitis Photodynamic therapy for wAMD Vedolizumab Verteporfin 8.2.2 4.9.3 6.1 Not listed. 13.5.3 6.5.2 Not listed. Karen Homan, on behalf of the BCCG Medicines Management Team, April 2015. N:\Medicines Management\Commissioning\PBR post April 13\2015_16 documents\2015_16 GPs Need To Be Aware Of High Cost Drugs Exlcuded from National Tariff Version 1.0.docx 30
