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2017/19 PbR Excluded Drugs: proposed GMMMG Advisory Position [Appendix 3]

Date of this document: Commissioner Further notes Note: many Group: A group Drugs in blue cells are Highlighted cells Highlighted cells April 2018. Updated in category: available at foot of BNF includes all drugs in new additions for 2017/19. are amendments in this colour are line with Annex A of C= CCG spreadsheet Categories that group Probable commissioner made to 2016/17 amendments National tariff payment N= NHS England N.B. for NHSE- inserted using regardless of indicated version made to 2017/19 system 2017/19 issued N*= expected to be commissioned drugs, NDO on NHSE specific drugs listed. version for 2018 22.12.16 (no changes to NHSE but not on consult NHSE s/sheet where Individual - This is drug content required V13 s/sheet information for Annex C of for the specific listed compared with V1.0 commissioning policy / NHSE s/sheet drug only which was approved by position. says "none" or "n/a" GMMMG on 17th For forthcoming new drugs, an November 2016 and expected time of availability is with reference to NHSE presented when stated by SPS V13 spreadsheet dated but this may change in the 23/03/18.) future.

No. Drug Name Commissioner PBR Category BNF category Group Indication Prior Approval Commissioning Commissioning Policy Comments (some brand names Category (legacy) Category Policy Type Link added for clarity in italics) AIDS/HIV HIV in combination with 1 Abacavir N antiretrovirals 5.3.1 Group other anti-retroviral drugs Abacavir with dolutegravir and lamivudine AIDS/HIV HIV in combination with 2 Triumeq N antiretrovirals 5.3.1 Group other anti-retroviral drugs included to match NHSE list AIDS/HIV HIV in combination with 3 Abacavir with lamivudine N antiretrovirals 5.3.1 Group other anti-retroviral drugs included to match NHSE list Drugs affecting bone Male and juvenile 4 Abaloparatide N metabolism 6.6.2 Individual osteoporosis Drugs affecting bone Postmenopausal Individual 5 Abaloparatide C metabolism 6.6.2 Individual osteoporosis Funding s/c injection; not in PO For children transitioning to adult services and becoming a CCG http://gmmmg.nhs.uk/docs/s commissioning responsibility, ubgroups/sbgrp-hcdsg/Child- category is monitored when in Juvenille Idiopathic to-adult-services-statement- line with the referenced GMMMG 6 Abatacept N modulators 10.1.3 Group Rheumatoid Arthritis amended-post-meeting.pdf guidance. Paediatric indications As per adult TA's 7 Abatacept N Cytokine modulators 10.1.3 Group (where adult TA available) (TA195, TA280) http://www.nice.org.uk/guida nce/ta375

http://gmmmg.nhs.uk/docs/g Rheumatoid Arthritis, after NICE TA375 / GM uidance/GMMMG%20RA%2 failure of conventional Harmonised 0Pathway%2022%20april_2 8 Abatacept C Cytokine modulators 10.1.3 Group DMARDs Monitored biologics pathway 015.pdf

Rheumatoid Arthritis, after failure of TNF inhibitor, if http://guidance.nice.org.uk/T 9 Abatacept C Cytokine modulators 10.1.3 Group rituximab contra-indicated Monitored NICE TA195 A195 New 31.10.16 but SPS says Clostridium difficile development discontinued infection -prevention of (actoxumab ineffectve, Actoxumab + recurrence after 2nd+ development restricted to 10 Bezlotoxumab C Cytokine modulators Group episode Individual funding bezlotoxumab) 11 Abiraterone N Hormone antagonists 8.3.4.2 Cancer included to match NHSE list

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 1 of 36 12 Adalimumab N Cytokine modulators 10.1.3 Group Hidradenitis Suppurativa For children transitioning to adult services and becoming a CCG http://gmmmg.nhs.uk/docs/s commissioning responsibility, ubgroups/sbgrp-hcdsg/Child- category is monitored when in to-adult-services-statement- line with the referenced GMMMG 13 Adalimumab N Cytokine modulators 10.1.3 Group Juvenille Arthritis amended-post-meeting.pdf guidance. 14 Adalimumab N Cytokine modulators 10.1.3 Group Uveitis [paediatric] 15 Adalimumab N Cytokine modulators 10.1.3 Group Uveitis [adult] http://guidance.nice.org.uk/T A383 NICE TA383 / GM Harmonised http://gmmmg.nhs.uk/docs/g Pathway for uidance/GMMMG%20AS%2 biologics in AS 0PsA%20pathway%20v4%2 16 Adalimumab C Cytokine modulators 10.1.3 Group Ankylosing spondylitis Monitored and PsA. 0FINAL.pdf http://guidance.nice.org.uk/T 17 Adalimumab C Cytokine modulators 13.5.3 Group Psoriasis (plaque) Monitored NICE TA146 A146 http://guidance.nice.org.uk/T A199 NICE TA199 / GM Harmonised http://gmmmg.nhs.uk/docs/g Pathway for uidance/GMMMG%20AS%2 biologics in AS 0PsA%20pathway%20v4%2 18 Adalimumab C Cytokine modulators 10.1.3 Group Psoriatic Arthritis Monitored and PsA. 0FINAL.pdf http://gmmmg.nhs.uk/docs/g Psoriasis (plaque) - uidance/GMMMG-Biologics- sequential use of biologic pathway-for-psoriasis-v2- reference to psoriasis pathway 19 Adalimumab C Cytokine modulators 13.5.3 Group agents Monitored GMMMG 0.pdf updated http://www.nice.org.uk/guida nce/ta375

Rheumatoid Arthritis, after NICE TA375 / GM http://gmmmg.nhs.uk/docs/g failure of conventional Harmonised uidance/GMMMG-RA- 20 Adalimumab C Cytokine modulators 10.1.3 Group DMARDs Monitored biologics pathway pathway-v4-1.pdf Rheumatoid Arthritis, after http://guidance.nice.org.uk/T failure of TNF inhibitor, if A195 rituximab contra-indicated, or as monotherapy if http://gmmmg.nhs.uk/docs/g rituximab and NICE TA195 / GM uidance/GMMMG%20RA%2 methotrexate contra- Harmonised 0Pathway%2022%20april_2 21 Adalimumab C Cytokine modulators 10.1.3 Group indicated Monitored biologics pathway 015.pdf Crohn's Disease, http://guidance.nice.org.uk/T 22 Adalimumab C Cytokine modulators 1.5.3 Group gastroenterology Monitored NICE TA187 A187 Ulcerative colitis, http://www.nice.org.uk/guida 23 Adalimumab C Cytokine modulators 1.5.3 Group gastroenterology Monitored NICE TA329 nce/ta329 24 Adalimumab C Cytokine modulators 10.1.3 Group All other adult indications Individual funding Funding for paediatric TA 455 or as per indications not being treated at adult TA's an NHSE-commissioned Paediatric indications (TA103, TA375, Specialist Centre may also fall to 25 Adalimumab N Cytokine modulators 10.1.3 Group (where adult TA available) TA143, TA199) CCGs 26 Adalimumab N Cytokine modulators 10.1.3 Group BehÇet's Syndrome Added to match NHSE s/sheet Viral Hepatitis (B&C) & respiratory Syncytial 27 Adefovir N Virus 5.3.3 Group Hepatits B Approved in the EU and UK for Erythropoietic proto- prophylactic treatment in adult 28 Afamelanotide C Skin Conditions 13.1 Individual porphyria (EPP) Individual funding patients with EPP.

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 2 of 36 Protein kinase 29 N inhibitors 8.1.5 Individual 30 N Cancer exclusion 8.1 Cancer Added to match NHSE s/sheet Neovascular (wet) age- Subfoveal choroidal related macular http://guidance.nice.org.uk/T 31 Aflibercept C neovascularisation 11.8.2 Individual degeneration (AMD) Monitored NICE TA294 A294

Visual impairment caused by macular oedema Subfoveal choroidal secondary to central http://www.nice.org.uk/guida 32 Aflibercept C neovascularisation 11.8.2 Individual retinal vein occlusion Monitored NICE TA305 nce/TA305

Visual impairment caused by macular oedema Subfoveal choroidal secondary to branch https://www.nice.org.uk/guid New entry for positive NICE TA 33 Aflibercept C neovascularisation 11.8.2 Individual retinal vein occlusion Monitored NICE TA 409 ance/ta409 for this indication. Subfoveal choroidal http://www.nice.org.uk/guida 34 Aflibercept C neovascularisation 11.8.2 Individual Diabetic macular oedema Monitored NICE TA346 nce/ta346 Subfoveal choroidal Myopic choroidal https://www.nice.org.uk/guid New entry for positive NICE TA 35 Aflibercept C neovascularisation 11.8.3 Individual neovascularisation Monitored NICE TA486 ance/ta486 for this indication. Lysosomal Storage 36 Agalsidase alfa N Disorder drugs 9.8.1 Group Fabry's disease Lysosomal Storage 37 Agalsidase beta N Disorder drugs 9.8.1 Group Fabry's disease Corneal neovascularisation 2018 Subfoveal choroidal associated with NHSE commissions keratoplasty 38 Aganirsen N* neovascularisation 11.8.2 Individual keratoplasty rejection [PSS No.12] Tenofovir alafenamide is a pro- drug of tenofovir with the aim of improving renal and bone safety - AIDS/HIV should really be with tenofovir 39 Alafenamide N antiretrovirals Group HIV which is where NHSE lists it.

Blood-related products 40 Albutrepenonacog alfa N except Fibrin Sealants 2.11 Group B An albumin/somatropin fusion protein that acts as a receptor agonist. Growth Hormone & Commissioner changed to growth hormone Growth hormone NHSE as per V11 s/sheet 41 Albutropin N Receptor Antagonist 6.5.1 Individual deficiency adult onset 2018. Immunomodulating 42 Aldesleukin N drugs 8.2.4 Individual cancer Drugs affecting the 43 Alemtuzumab N immune response 8.2.3 Individual Multiple Sclerosis Drugs affecting the Pre-transplant 44 Alemtuzumab N immune response 8.2.3 Individual immunosuppression Drugs affecting the 45 Alemtuzumab N immune response 8.2.3 Individual CLL Drugs affecting the 46 Alemtuzumab N immune response 8.2.3 Individual BehÇet's Syndrome Added to match NHSE s/sheet

Alglucosidase alfa Lysosomal Storage Pompe disease - late 47 (Lumizyme® Myozyme®) N Disorder drugs 9.8.1 Group onset (pts 8yrs & over) Drugs used in 48 Alipogene Tiparvovec N Metabolic disorders 9.8 Individual Hyperlipoproteinaemia https://www.nice.org.uk/guid 49 Alirocumab C Lipid regulating drugs 2.12 Individual Hypercholesterolaemia Monitored NICE TA393 ance/ta393

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 3 of 36 Viral Hepatitis (B&C) & respiratory Syncytial 50 Alisporivir N Virus none Group Hepatits C Severe chronic hand http://guidance.nice.org.uk/T 51 Alitretinoin C Skin Conditions 13.5.1 Individual eczema in adults Monitored NICE TA177 A177 Drugs used in Alpha-1 anti-trypsin 52 Alpha-1 Antitrypsin N Metabolic disorders 3 Individual deficiency: Emphysema Intravenous and inhaled Alpha-1 anti-trypsin deficiency: Type 1 Drugs used in diabetes mellitus in 53 Alpha-1 Antitrypsin N Metabolic disorders 6.1 Individual children. Intravenous Alpha-Mannosidase Lysosomal Storage 54 recombinant human N Disorder drugs none Group Removed from national list. However, a locally agreed tariff for hyper acute stroke units has http://guidance.nice.org.uk/T agreed that this can be re- 55 Alteplase C Acute ischaemic stroke Monitored NICE TA264 A264 charged to commissioners. Vasodilator antihypertensive drugs/Pulmanory 56 Ambrisentan N Arterial Hypertension 2.5.1 Individual Pulmonary hypertension Lambert-Eaton Myasthenic Syndrome or Amifampridine Neuromuscular Congenital Myasthenia 57 phosphate N Disorders 10.2.1 Individual Gravis Ventilator Assisted Individual 58 Amikacin Inhalation C Antibacterial Drugs 5.1.4 Individual Pneumonia Funding Individual 59 Amikacin Inhalation N Antibacterial Drugs 5.1.4 Individual Cystic fibrosis Funding Added to match NHSE s/sheet Management of cystic 60 Amikacin liposomal N Antibacterial Drugs Individual fibrosis

Licensed indications and/or Consultant 61 Amphotericin liposomal N Antifungals 5.2.3 Individual Microbilogist approval only

Not recommended by NICE for Rheumatoid Arthritis, http://www.nice.org.uk/guida RA; former TA72 now 62 Anakinra C Cytokine modulators 10.1.3 Group rheumatology [adults] Exceptional case NICE CG79 nce/CG79 incorporated into updated CG79 63 Anakinra N Cytokine modulators 10.1.3 Group Juvenile Arthritis 64 Anakinra N Cytokine modulators 10.1.3 Group Paediatric indications

Specialist 65 Anakinra N Cytokine modulators 10.1.3 Group Autoinflammatory disease Cryopyrin Associated 66 Anakinra N Cytokine modulators 10.1.3 Group Periodic Syndrome 67 Anidulafungin N Antifungals 5.2.4 Individual Invasive candiasis

Licensed indications (Not Antihaemophilic all products are Factor/von Willebrand Blood-related products listed in the BNF, but they 68 Factor Complex N except Fibrin Sealants 2.11 Group are all excluded from PbR) Drugs used in hypoplastic, haemolytic and renal 69 Antilymphocyte globulin N anaemias 9.1.3 Group Licensed indications

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 4 of 36 Pseudomonas aeruginosa in ventilated ICU patients - to Anti-pseudomonas Pseudomonas Aeruginosa Individual prevent infections in Cystic 70 aeruginosa IgY N Antibacterial Drugs 5.1.7 Individual Funding Fibrosis patients

Licensed indications (Not all blood products are listed in the BNF, but they 71 Antithrombin III N Blood related products 2.11 Group are all excluded from PbR) Drugs used in hypoplastic, Antithymocyte haemolytic and renal 72 Immunoglobulin N anaemias 8.2.2 Group Licensed indications https://www.nice.org.uk/guid 73 Apremilast C Cytokine modulators none Group Psoriasis Monitored NICE TA419 ance/ta419 NICE TA now positive

Exceptional case; will change to monitored if final NICE guidance Being re-evaluated by NICE; becomes Final Appraisal Determination positive. Due https://www.nice.org.uk/guid document positive (subject to 74 Apremilast C Cytokine modulators none Group Psoriatic arthritis February 17. NICE TA372 ance/ta372 criteria) 75 Apremilast N Cytokine modulators none Group Paediatric indications Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 76 Aragam N immunoglobulins 14.5.1 Group Neurology Lysosomal Storage 77 Asfotase alfa N Disorder drugs 9.8.1 Group Hypophosphatasia Viral Hepatitis (B&C) & respiratory Syncytial 78 Asunaprevir N Virus 5.3.3 Group Hepatits C Viral Hepatitis (B&C) & Asunaprevir + respiratory Syncytial NHSE s/sheet shows this 79 Daclatasvir N Virus 5.3.3 Group Hepatits C combination. Viral Hepatitis (B&C) & Asunaprevir + Beclabuvir respiratory Syncytial This combination not on official 80 + Daclatasvir N Virus 5.3.3 Group Hepatits C lists but is being trialled. Drugs affecting the Systemic lupus 81 Atacicept N immune response 8.2.2 Individual erythematosus (SLE) Neuromuscular 82 Ataluren N Disorders 3 Individual Cystic fibrosis Neuromuscular Duchenne Muscular 83 Ataluren N Disorders 10.2 Individual Dystrophy AIDS/HIV HIV in combination with 84 Atazanavir N antiretrovirals 5.3.1 Group other anti-retroviral drugs AIDS/HIV HIV in combination with 85 Atazanavir and Cobsistat N antiretrovirals 5.3.1 Group other anti-retroviral drugs Added to match NHSE s/sheet

Age-related macular degeneration (AMD); Subfoveal choroidal geographic atrophy 86 Avacincaptad pegol C neovascularisation Individual (advanced dry-type AMD). Individual funding 2019 Chronic Immune Thrombocytopenic Platelet Disorder purpura (ITP), 87 C Drugs 9.1.4 Individual thrombocytopenia Individual funding First line prevention of 88 Avoralstat N Allergic Emergencies 3.4.3 Individual hereditary angiodema

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 5 of 36 Protein kinase 89 N inhibitors 8.1.5 Individual Myelodysplastic 90 Azacitidine N Syndrome 8.1.3 Individual Aztreonam Lysine Management of cystic 91 [=nebulised] N Antibacterial Drugs 5.1.2.3 Individual fibrosis https://www.nice.org.uk/guid ance/ta466 Rheumatoid arthritis - http://gmmmg.nhs.uk/docs/g Immunomodulating selective JAK1 and JAK2 uidance/GMMMG-RA- 92 C drugs 10.1.3 Individual inhibitor Monitored NICE TA466 pathway-v4-1.pdf NICE TA referenced Corticosteroids and Prophylaxis of acute organ other rejection - Adolescents 93 Basiliximab N immunosuppressants 8.2.2 Individual and children Viral Hepatitis (B&C) & Annex C has inserted this as a Respiratory Syncytial separate entry but only 94 Beclabuvir N Virus 5.3.3 Group Hepatitis C combination products in NDO. Extensively drug resistant Two rows to match NHSE 95 Bedaquiline N Antituberculosis drugs 5.1.9 Individual TB s/sheet Two rows to match NHSE 96 Bedaquiline N Antituberculosis drugs 5.1.9 Individual Multi drug resistant s/sheet

Marketing application withdrawn pending receipt of further data. Malignant disease and Graft versus host disease Included only for completeness 97 Begelomab N immunosuppression 8 Individual (GvHD) and match to national list. Prevention of organ Drugs affecting the rejection following renal 98 Belatacept N immune response 8.2.2 Individual transplant Drugs affecting the Systemic lupus 99 N immune response Individual erythematosus (SLE) Asthma - uncontrolled on high-dose inhaled Monoclonal antibody binding to Allergen corticosteroid + LABA - in the -5 receptor that 100 Benralizumab N Group adults and adolescents depletes eosinophils. 2017 Monoclonal antibody binding to Allergen the interleukin-5 receptor that 101 Benralizumab C Immunotherapy Group COPD Individual funding depletes eosinophils. 2019 Respiratory Distress 102 Beractant N Pulmonary surfactants 3.5.2 Individual Syndrome Homocystinuria, tetrahydrofolate reductase Drugs used in deficiency, cobalamin 103 Betaine N Metabolic disorders 9.8.1 Individual cofactor metabolism. http://gmmmg.nhs.uk/docs/g uidance/GMMMG%20recom mendation%20Bevacizumab %20wAMD%20Nov%2015.p 104 C Antineoplastic drugs 11.8.2 Individual AMD Individual funding GMMMG df 105 Bevacizumab N Antineoplastic drugs 8.1.5 Individual Cancer 106 Bevacizumab N Antineoplastic drugs 8.1.5 Individual Neurofibromatosis Myopathy sporadic inclusion body myositis 107 Bimagrumab N Cytokine modulators Group (sIBM) - first-line 108 Biotin N ? 9.6 Individual Multiple Sclerosis Systemic lupus 109 N Cytokine modulators 10.1.3 Group erythematosus Viral Hepatitis (B&C) & respiratory Syncytial 110 Boceprevir N Virus 5.3.3 Group Hepatits C

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 6 of 36 111 Bortezomib N Antineoplastic drugs 8.1.5 Individual Cancer Organ rejection post 112 Bortezomib N Antineoplastic drugs 8.1.5 Individual kidney transplant Added to match NHSE s/sheet Vasodilator antihypertensive drugs/Pulmanory 113 Bosentan N Arterial Hypertension 2.5.1 Individual Pulmonary hypertension Vasodilator antihypertensive drugs/Pulmanory 114 Bosentan N Arterial Hypertension 2.5.1 Individual Digital ulcers Protein kinase Chronic myelogenous 115 Bosutinib N inhibitors 8.1.5 Individual leukaemia (CML) Torsion Dystonias and other involuntary Prevention of headaches Migraine only: http://guidance.nice.org.uk/T 116 Botulinum toxin C movements 4.9.3 Group in chronic migraine. Monitored NICE TA260 A260 When used in line with local GM policy: GM Torsion Dystonias and Hyperhidrosis Policy v1.0 other involuntary Final , available from CCG 117 Botulinum toxin C movements 4.9.3 Group Hyperhidrosis Monitored GM websites Torsion Dystonias and All other uses including Monitored / http://gmmmg.nhs.uk/docs/g other involuntary torsion dystonias, Individual uidance/Botulinum-toxin- 118 Botulinum toxin C movements 4.9.3 Group involuntary movements, Funding GM policy-1-0-080218.pdf Please check local GM policy. Torsion Dystonias and other involuntary 119 Botulinum toxin N movements 4.9.3 Group Focal spasticity in children Torsion Dystonias and other involuntary Intravesical use in spinal 120 Botulinum toxin N movements 4.9.3 Group cord injury In allogeneic Cytomegalovirus haematopoietic stem cell 121 Brincidofovir N infection 5.3.3.2 Individual transplant NICE TA expected 30/5/18. If positive, category changes to monitored when used in line with the TA. NHSE states on V11 that it will be responsible for paediatric indications should a positive Immunomodulating Psoriasis [IL-17 receptor Individual NICE TA become available for 122 Brodalumab C drugs 13.5.3 Individual blocker] Funding adult indications. Immunomodulating Psoriatic arthritis [IL-17 Individual policy will be required. SPS 123 Brodalumab C drugs 10.1.3 Individual receptor blocker] Funding suggests 2018 Neovascular (wet) age- Subfoveal choroidal related macular Individual 124 Brolucizumab C neovascularisation 11.8.2 Individual degeneration (AMD) Funding NOT in SPS Acute attack and prophylactic treatment of 125 C1 Esterase inhibitor N Allergic Emergencies 3.4.3 Individual hereditary angiodema Treating gouty arthritis attacks and reducing the Canakinumab Immunomodulating frequency of subsequent http://guidance.nice.org.uk/T NICE TAG terminated - unable 126 Ilaris C drugs 8.2.4 Individual attacks Exceptional case NICE TA281 A281 to recommend use Autoimmune disorders [e.g. CAPS, MWS, Canakinumab Immunomodulating NOMID, CINCA, FCAS, 127 Ilaris N drugs 8.2.4 Individual FCU] Canakinumab Immunomodulating 128 Ilaris N drugs 8.2.4 Individual Juvenile arthritis

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 7 of 36 Drugs used in Urea cycle disorders, 129 Carglumic acid N Metabolic disorders 9.8.1 Individual Hyperammonaemia Primary and secondary carnitine deficiency, haemotology / Drugs used in amminoacid supplement, 130 Carnitine N Metabolic disorders 9.8.1 Individual renal medicine 131 Caspofungin N Antifungals 5.2.4 Individual

Blood-related products Congenital factor XIII A- 132 N except Fibrin Sealants 2.11 Group subunit deficiency not in SPS list; drug development cancelled. Included here to match national 133 Ceralifimod N Group Multiple sclerosis (MS) list. Neuronal ceroid lipofuscinosis - late Central Nervous infantile type 2 (CLN2), a 134 Cerliponase alfa N System Individual form of Batten disease 135 Certolizumab Pegol N Cytokine modulators 10.1.3 Group Any paediatric use http://www.nice.org.uk/guida nce/ta375

http://gmmmg.nhs.uk/docs/g NICE TA375 / GM uidance/GMMMG%20RA%2 Rheumatoid Arthritis, Harmonised 0Pathway%2022%20april_2 136 Certolizumab Pegol C Cytokine modulators 10.1.3 Group rheumatology, Monitored biologics pathway 015.pdf Rheumatoid Arthritis: for treating rheumatoid arthritis after inadequate response to a TNF-alpha https://www.nice.org.uk/guid 137 Certolizumab Pegol C Cytokine modulators 10.1.3 Group inhibitor Monitored NICE TA415 ance/ta415 http://guidance.nice.org.uk/T NICE TA383 / GM A383 Harmonised Pathway for http://gmmmg.nhs.uk/docs/g biologics in AS uidance/GMMMG-AS-PsA- 138 Certolizumab Pegol C Cytokine modulators 10.1.3 Group Ankylosing spondylitis Monitored and PsA. pathway-Final-v4.pdf https://www.nice.org.uk/guid ance/ta445 GM Harmonised Pathway for http://gmmmg.nhs.uk/docs/g biologics in AS uidance/GMMMG-AS-PsA- 139 Certolizumab Pegol C Cytokine modulators 10.1.3 Group Psoriatic arthritis Monitored and PsA. pathway-Final-v4.pdf NICE TA referenced Crohn's Disease, 140 Certolizumab Pegol C Cytokine modulators 10.1.3 Group gastroenterology Individual funding 141 N Antineoplastic drugs 8.1.5 Individual Cancer Cerebrotendinous A lipid storage disorder. Drugs used in xanthomatosis Expected Q4 2016. 142 Chenodeoxycholic acid N Metabolic disorders Group Primary Biliary Cirrhosis Drugs used in Inborn errors in primary 143 Cholic acid N Metabolic disorders none Individual bile acid synthesis Cytomegalovirus 144 Cidofovir N Antiviral drugs 5.3.2.2 Individual infections Only when given by inhalation / 145 Ciprofloxacin inhalation N Antibacterial Drugs 5.1.12 Individual Bronchiectasis nebulisation. Only when given by inhalation / 146 Ciprofloxacin liposomal N Antibacterial Drugs 5.1.12 Individual Bronchiectasis nebulisation. Immunomodulating 147 Cladribine N drugs 8.1.3 Individual Multiple Sclerosis

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 8 of 36 Immunomodulating Pulmonary Langerhans 148 Cladribine N drugs 8.1.3 Individual histiocytosis AIDS/HIV HIV in combination with 149 Cobicistat N antiretrovirals Group other anti-retroviral drugs Drugs affecting the Ulcerative colitis (UC) 150 Cobitolimod C immune response Individual refractory, 3rd line Individual funding 2019 Co-careldopa internal Neurodegenerative Advanced parkinsons (via 151 tube intestinal gel N conditions 4.9.1 Individual PEG) Management of cystic 152 Colistimethate sodium N Antibacterial Drugs 5.1.7 Individual fibrosis Collagenase (outpatient https://www.nice.org.uk/guid Use in line with NICE / GM 153 use only) C Enzymes 10.1.3 Individual Dupytren's contracture Monitored NICE TA 459 ance/ta459 policy. Frozen Shoulder / Collagenase (outpatient Peyronie's Disease / any Any other use that's not 154 use only) C Enzymes 10.1.3 Individual other use Individual funding Dupytren's in line with GM policy Conestat alfa (Recombinant C1 Acute attack of hereditary 155 Esterase inhibitor) N Allergic Emergencies 3.4.3 Individual angiodema Protein kinase 156 N inhibitors 8.1.5 Individual Cancer Expected 2018. Policy will be Darvadstrocel (CX601, Drugs affecting the Perianal fistulas in Crohn's required. Allogeneic, expanded, 157 Alofisel) C immune response 1.5.3 Individual Disease Individual funding adipose-derived stem cells Cysteamine bitartrate (also known and shown Drugs used in 158 as mercaptamine) N Metabolic disorders 9.8.1 Individual Nephropathic cystinosis SPS says will be NHS England Cysteamine Drugs used in Cystinosis [Corneal funded. Dropcys eye drops 159 hydrochloride N* Metabolic disorders 11.1 Individual cystine crystals] (0.1% solution) Protein kinase 160 Dabrafenib N inhibitors 8.1.5 Individual Cancer Viral Hepatitis (B&C) & respiratory Syncytial 161 Daclatasvir N Virus 5.3.3 Individual Hepatitis C Corticosteroids and other No information regarding this 162 Daclizumab N immunosuppressants 8.2 Group Organ transplant use in SPS so removed. Corticosteroids and other Drug withdrawn. To be removed 163 Daclizumab N immunosuppressants 8.2 Group Multiple Sclerosis at next refresh. Not on NHSE V11 s/sheet yet was on V10 and no note. Haemophillia A Treatment of haemophilia is 164 N* Fibrinolytics 2.11 Individual prophylaxis and treatment commissioned by NHSE. AIDS/HIV HIV in combination with 165 Darunavir N antiretrovirals 5.3.1 Group other anti-retroviral drugs AIDS/HIV HIV in combination with 166 Darunavir + cobicistat N antiretrovirals 5.3.1 Group other anti-retroviral drugs included to match NHSE list Viral Hepatitis (B&C) & Respiratory Syncytial 167 Dasabuvir N Virus 5.3.3 Group Hepatitis C Protein kinase 168 N inhibitors 8.1.5 Individual Cancer Myelodysplastic 169 Decitabine N Syndrome 8.1.3 Individual Cancer Drugs used in hypoplastic, Iron chelation in haemolytic, and renal thlassaemia and sickle anaemias - Iron cell: myelodysplastic CCGs commission use in 170 Deferasirox C overload 9.1.3 Group syndrome Monitored myelodysplastic syndrome

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 9 of 36 Drugs used in hypoplastic, haemolytic, and renal Iron chelation in anaemias - Iron thlassaemia and sickle 171 Deferasirox N overload 9.1.3 Group cell Drugs used in hypoplastic, Iron chelation in haemolytic, and renal thlassaemia and sickle anaemias - Iron cell: myelodysplastic CCGs commission use in 172 Deferiprone C overload 9.1.3 Group syndrome Monitored myelodysplastic syndrome Drugs used in hypoplastic, haemolytic, and renal Iron chelation in anaemias - Iron thlassaemia and sickle 173 Deferiprone N overload 9.1.3 Group cell

Blood-related products Hepatic veno-occlusive 174 Defibrotide N except Fibrin Sealants none Group disease Extensively drug resistant Two rows to match NHSE 175 Delamanid N Antituberculosis drugs 5.1.9 Individual TB s/sheet Two rows to match NHSE 176 Delamanid N Antituberculosis drugs 5.1.9 Individual Multi drug resistant TB s/sheet Drugs used in hypoplastic, Iron chelation in haemolytic, and renal thlassaemia and sickle anaemias - Iron cell: myelodysplastic CCGs commission use in 177 Desferrioxamine C overload 9.1.3 Group syndrome Monitored myelodysplastic syndrome Drugs used in hypoplastic, haemolytic, and renal Iron chelation in anaemias - Iron thlassaemia and sickle 178 Desferrioxamine N overload 9.1.4 Group cell Macular oedema secondary to retinal vein http://guidance.nice.org.uk/T 179 intravitreal implant C Macular Oedema Individual occlusion Monitored NICE TA229 A229 Dexamethasone https://www.nice.org.uk/guid 180 intravitreal implant C Macular Oedema Individual Diabetic macular oedema Monitored NICE TA349 ance/ta349 Inflammation of the posterior segment of the Dexamethasone eye presenting as non- https://www.nice.org.uk/guid 181 intravitreal implant C Macular Oedema Individual infectious uveitis monitored NICE TA460 ance/ta460 Immunomodulating Anthracycline 182 Dexrazoxane N drugs 8.1 Group cardiotoxicity Immunomodulating Anthracycline 183 Dexrazoxane N drugs 8.1 Group extravasation Bone morphogenetic 184 Dibotermin alfa N protein none Individual Complex spinal injury Bone morphogenetic Orthopaedics / other than 185 Dibotermin alfa C protein none Individual complex spinal surgery Individual funding AIDS/HIV HIV in combination with 186 Didanosine N antiretrovirals 5.3.1 Group other anti-retroviral drugs 16.3.2 (BNF 187 Digoxin immune fab C Poisoning 70) Individual Digoxin toxicity Monitored Dermatology: plaque Immunomodulating psoriasis, moderate to https://www.nice.org.uk/guid 188 Dimethyl fumarate C drugs 13.5 Individual severe Monitored NICE TA475 ance/ta475 Immunomodulating Multiple Sclerosis, 189 Dimethyl fumarate N drugs 8.2.2 Individual neurology AIDS/HIV HIV in combination with 190 Dolutegravir N antiretrovirals 5.3.1 Group other anti-retroviral drugs

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 10 of 36 AIDS/HIV HIV in combination with 191 Doravirine N antiretrovirals 5.3.2 Group other anti-retroviral drugs Management of cystic 192 Dornase alfa N Mucolytics 3.7 Individual fibrosis

193 Dornase alfa N Mucolytics 3.7 Individual Primary ciliary dyskinesia Added to match NHSE s/sheet Neuromuscular Duchenne Muscular 194 Drisapersen N Disorders 10.2 Individual Dystrophy GMMMG recommendation in production; please consult when Drugs affecting the Atopic dermatitis; available pending NICE TA due 195 Dupilumab C immune response Group moderate-to-severe Individual funding 01/08/18 anti-interleukin-4 receptor (IL- 4R) and anti-interleukin-13 receptor (IL-13R) human Drugs affecting the Asthma; persistent, add- monoclonal antibody. 196 Dupilumab N immune response Group on therapy Individual funding 2019

Hereditary angiodema - Drug withdrawn but still appears 197 Ecallantide N Allergic emergencies none Individual acute treatment in NHSE list! IFR required Organ rejection post transplant Paroxysmal nocturnal C3 glomerulopathy (post 198 Eculizumab N haemoglobinuria 9.1.3 Individual transplant) Added to match NHSE s/sheet Paroxysmal nocturnal Atypical hemolytic uremic 199 Eculizumab N haemoglobinuria 9.1.3 Individual syndrome Paroxysmal nocturnal Paroxysmal nocturnal 200 Eculizumab N haemoglobinuria 9.1.3 Individual haemoglobinuria Drugs affecting the systemic lupus 201 Edratide N immune response 8.2 Group erythematosus (SLE) Not in SPS AIDS/HIV HIV in combination with 202 Efavirenz N antiretrovirals 5.3.1 Group other anti-retroviral drugs NHSE V11 also states Platelet Disorder / Factor VIII 203 Efraloctocog alfa N Drugs Individual Haemophilia A FC fusion protein with this drug Platelet Disorder 204 Eftrenonacog alfa N Drugs 2.11 Individual Haemophilia B Viral Hepatitis (B&C) & Respiratory Syncytial 205 Elbasvir N Virus 5.3.3 Group Hepatitis C Lysosomal Storage 206 Eliglustat N Disorder drugs 9.8.1 Group Gaucher's Disease Lysosomal Storage Mucopolysaccharidosis IV 207 Elosulfase alfa N Disorder drugs none Individual type A

While and are the responsibility of CCGs regardless of the cause Chronic Immune of the thromobcytopenia in Platelet Disorder Thrombocytopenic http://guidance.nice.org.uk/T adults, paediatrics are NHSE 208 Eltrombopag C Drugs 9.1.4 Individual purpura (ITP) Monitored NICE TA293 A293 responsibility. Severe aplastic anaemia refractory to Terminated NICE appraisal. New Platelet Disorder immunosuppressive http://www.nice.org.uk/guida row to account for additional 209 Eltrombopag C Drugs 9.1.4 Individual therapy Exceptional case NICE TA382 nce/ta382 licensed indication. AIDS/HIV HIV in combination with 210 Elvitegravir N antiretrovirals 5.3.1 Group other anti-retroviral drugs

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 11 of 36 Not in Annex C but kept in to Elvitegravir with accord with NHSE s/sheet. No cobicistat, emtricitabine AIDS/HIV HIV in combination with longer listed in NHSE V11 so will 211 and tenofovir N antiretrovirals 5.3.1 Group other anti-retroviral drugs be removed for next version. AIDS/HIV HIV in combination with 212 Elvucitabine N antiretrovirals 5.3.1 Group other anti-retroviral drugs Hepatitis C infection liver fibrosis after liver 213 Emricasan N Group transplant NHSE V11 adds the combination with tenofovir alafenamide to this entry; will be AIDS/HIV HIV in combination with added as a separate row on next 214 Emtricitabine N antiretrovirals 5.3.1 Group other anti-retroviral drugs version of this list. Emtricitabine with AIDS/HIV HIV in combination with 215 rilpivrine and tenofovir N antiretrovirals 5.3.1 Group other anti-retroviral drugs AIDS/HIV HIV in combination with 216 Enfuvirtide N antiretrovirals 5.3.1 Group other anti-retroviral drugs Viral Hepatitis (B&C) & respiratory Syncytial HIV indication removed [not 217 Entecavir N Virus 5.3.3 Group Hepatits B licensed nor on NHSE list] Hormone antagonists [not official PbR 218 Enzalutamide N category] 8.3.4.2 Cancer Added to match NHSE s/sheet Use in vascular disease is Vasodilator commissioned by NHSE within antihypertensive specialist centres. All other drugs/Pulmonary Pulmonary Arterial indications are CCG 219 Epoprostenol N Arterial Hypertension 2.8.1 Individual Hypertension commissioned [ref. NHSE] CD22 antigen inhibitor for Systemic lupus 220 Epratuzumab N Cytokine modulators 10.1.3 Group erythematosus (SLE) While NHSE commissions diagnostic service for patients with amyloidosis from Highly Specialist Amyloidosis centres, CCGs commission most treatments [PSS 46]. However NHSE states that it is responsible commissioner for Drugs used in this drug, although it is not hypoplastic, routinely commissioned and haemolytic and renal therefore requires IFRs 221 Eprodisate N anaemias 9.1 Group Amyloidosis submitting to NHSE Bone morphogenetic 222 Eptotermin alfa N protein none Group Complex spinal injury Bone morphogenetic Orthopaedics / other than Individual 223 Eptotermin alfa C protein none Group complex spinal surgery Funding Protein kinase 224 N inhibitors 8.1.5 Individual Cancer TA 455 or as per adult TA's Paediatric indications (TA103, TA375, 225 N Cytokine modulators 10.1.3 Group (where adult TA available) TA143, TA199)

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 12 of 36 For children transitioning to adult services and becoming a CCG http://gmmmg.nhs.uk/docs/s commissioning responsibility, ubgroups/sbgrp-hcdsg/Child- category is monitored when in to-adult-services-statement- line with the referenced GMMMG 226 Etanercept N Cytokine modulators 10.1.3 Group Juvenile arthritis amended-post-meeting.pdf guidance. http://guidance.nice.org.uk/T A383 NICE TA383 / GM Harmonised http://gmmmg.nhs.uk/docs/g Pathway for uidance/GMMMG%20AS%2 biologics in AS 0PsA%20pathway%20v4%2 227 Etanercept C Cytokine modulators 10.1.3 Group Ankylosing spondylitis Monitored and PsA. 0FINAL.pdf http://guidance.nice.org.uk/T 228 Etanercept C Cytokine modulators 10.1.3 Group Psoriasis (plaque) Monitored NICE TA103 A103 http://gmmmg.nhs.uk/docs/g Psoriasis (plaque) - uidance/GMMMG-Biologics- sequential use of biologic pathway-for-psoriasis-v2- reference to psoriasis pathway 229 Etanercept C Cytokine modulators 10.1.3 Group agents Monitored GMMMG 0.pdf updated http://guidance.nice.org.uk/T NICE TA199 / GM A199 Harmonised Pathway for http://gmmmg.nhs.uk/docs/g biologics in AS uidance/GMMMG-AS-PsA- reference to AS/ PsA pathway 230 Etanercept C Cytokine modulators 10.1.3 Group Psoriatic Arthritis Monitored and PsA. pathway-Final-v4.pdf updated http://www.nice.org.uk/guida nce/ta375

Rheumatoid Arthritis, after NICE TA375 / GM http://gmmmg.nhs.uk/docs/g failure of conventional Harmonised uidance/GMMMG-RA- reference to GMMMG RA 231 Etanercept C Cytokine modulators 10.1.3 Group DMARDs Monitored biologics pathway pathway-v4-1.pdf pathway updated Rheumatoid Arthritis, after failure of TNF inhibitor, if http://guidance.nice.org.uk/T rituximab contra-indicated, A195 or as monotherapy if rituximab and NICE TA195 / GM http://gmmmg.nhs.uk/docs/g methotrexate contra- Harmonised uidance/GMMMG-RA- reference to GMMMG RA 232 Etanercept C Cytokine modulators 10.1.3 Group indicated Monitored biologics pathway pathway-v4-1.pdf pathway updated 233 Etanercept C Cytokine modulators 10.1.3 Group All other adult indications Individual funding Duchenne muscular Neuromuscular dystrophy; amenable to 234 Eteplirsen N disorders Group exon 51 skipping AIDS/HIV HIV in combination with 235 Etravirine N antiretrovirals 5.3.1 Group other anti-retroviral drugs Ulcerative colitis (UC) naive to TNF inhibitors 2019 and refractory to or NHSE states on V11 that it will intolerant of prior be responsible for paediatric immunosuppressant indications should a positive Drugs affecting the and/or corticosteroid Individual NICE TA become available for 236 Etrolizumab C immune response 1.5.3 Individual treatment Funding adult indications. Drugs affecting the Crohn's disease moderate- Individual 237 Etrolizumab C immune response 1.5.3. Individual to-severe Funding 2020 Everolimus Protein kinase 238 Afinitor N inhibitors 8.1.5 Individual Cancer Preventing organ rejection Everolimus Protein kinase in heart and liver 239 Certican N inhibitors transplantation Added to match NHSE s/sheet

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 13 of 36 Renal angiomyolipoma Everolimus Protein kinase associated with tubular 240 Votubia N inhibitors 8.1.5 Individual sclerosis Subependymal giant cell astrocytoma (SEGA) and renal angiomyolipoma Everolimus Protein kinase associated with tubular two indications will be separated 241 Votubia N inhibitors 8.1.5 Individual sclerosis on next version https://www.nice.org.uk/guid 242 Evolocumab C Lipid regulating drugs 2.12 Individual Hypercholesterolaemia Monitored ance/ta394 Homozygous familial 243 Evolocumab N Lipid regulating drugs 2.12 Individual hypercholesterolaemia Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least Orphan market exclusivity two corneal quadrants, with Ex-vivo expanded for "Treatment of corneal central corneal involvement, and autologous human lesions, with associated severely impaired visual acuity), corneal epithelial cells corneal (limbal) stem cell unilateral or bilateral, due to containing stem cells 1 deficiency, due to ocular physical or chemical ocular 244 Holoclar N ? Individual burns" burns.

Licensed indications (Not all blood products are listed in the BNF, but they 245 Factor IX N Blood-related products 2.11 Group are all excluded from PbR)

Licensed indications (Not all blood products are listed in the BNF, but they 246 Factor VII N Blood-related products 2.11 Group are all excluded from PbR)

Licensed indications (Not all blood products are listed in the BNF, but they 247 Factor VIIa (Eptacog alfa) N Blood-related products 2.11 Group are all excluded from PbR)

Licensed indications (Not all blood products are listed in the BNF, but they 248 Factor VIII N Blood-related products 2.11 Group are all excluded from PbR)

Licensed indications (Not Not on NHSE V11 s/sheet yet all blood products are was on V10 and no note. Factor VIII Fc fusion listed in the BNF, but they Treatment of haemophilia is 249 protein N* Blood-related products 2.11 Group are all excluded from PbR) commissioned by NHSE.

Licensed indications (Not all blood products are Factor VIII inhibitor listed in the BNF, but they 250 bypassing factor N Blood-related products 2.11 Group are all excluded from PbR)

Licensed indications (Not all blood products are listed in the BNF, but they 251 Factor XIII N Blood-related products 2.11 Group are all excluded from PbR) Neuromuscular 252 Fampridine N Disorders 10.2.1 Individual Multiple Sclerosis

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 14 of 36 Individual 253 C Cytokine Modulators 4.7 Group Osteoarthritis Funding 2019

Licensed indications (Not all blood products are listed in the BNF, but they Removed from national and this 254 Fibrin sealants (Tisseel) C Blood related products are all excluded from PbR) Monitored list for 2017/19

Licensed indications (Not all blood products are listed in the BNF, but they 255 N Blood related products 2.11 Group are all excluded from PbR) 1 256 gene therapy N Analogues None Group 2019 NHSE states on V11 that it will be responsible for paediatric indications should a positive Drugs affecting the Individual NICE TA become available for 257 C immune response 1.5.3 Individual Crohn's disease Funding adult indications. Drugs affecting the Rheumatoid arthritis (RA); Individual 258 Filgotinib C immune response 10.1.3 Individual moderate-to-severe Funding 2019 New separate row for use in Drugs used in neutropenia as per NHSE 259 N neutropenia 9.1.6 Group Neutropenia s/sheet Drugs used in 260 Filgrastim N neutropenia 9.1.6 Group Barth Syndrome NHSE states that it is responsible commissioner for Viral Hepatitis (B&C) & this drug. Drug development Respiratory Syncytial discontinued in 2013! Not in 261 Filibuvir N Virus 5.3.3 Group Hepatits C SPS. Immunomodulating 262 Fingolimod N drugs 8.2.4 Individual Multiple Sclerosis

263 Fitusiran N Blood-related products 2.11 Individual Haemophilia not in SPS Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 264 Flebogamma N immunoglobulins 14.5.1 Group Neurology Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 265 Flebogammadif N immunoglobulins 14.5.1 Group Neurology Treatment of diabetic http://guidance.nice.org.uk/T 266 Fluocinolone acetonide C Macular Oedema 11.4.1 Individual macular oedema Monitored NICE TA301 A301 In line with Emergency treatment of recommendations from poisoning >Other poisons National Posions >Ethylene glycol and Information Service 267 Fomepizole C Poisoning none Individual methanol >Fomepizole Monitored http://www.npis.org/ Forigerimod acetate Drugs affecting the Systemic lupus 268 Lupuzor N immune response Individual erythematosus (SLE) AIDS/HIV HIV in combination with 269 Fosamprenavir N antiretrovirals 5.3.1 Group other anti-retroviral drugs Cytomegalovirus 270 Foscarnet N infection 5.3.2.2 Individual Cytomegalovirus infection Likely indication is CCG- commissioned (SPS says Idiopathic NHSE). Spleen tyrosine kinase Protein kinase thrombocytopenic purpura Individual (Syk) inhibitor. 271 disodium C inhibitors 9.1 Individual (ITP) Funding 2018

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 15 of 36 AIDS/HIV 272 Fostemsavir N antiretrovirals 5.3.1 Group HIV infection 2019

Cluster headache; chronic Individual 273 Galcanezumab C Cytokine modulators 4.7 Group and episodic; prevention Funding 2018 prevention of episodic Individual 274 Galcanezumab C Cytokine modulators 4.7.4 Group migraine Funding 2019 Mucopolysaccharidosis VI Lysosomal Storage [6 = Matoteaux-Lamy 275 Galsulfase N Disorder drugs 9.8.1 Group syndrome] Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 276 Gammagard S/D N immunoglobulins 14.5.1 Group Neurology Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 277 Gammanorm N immunoglobulins 14.5.1 Group Neurology Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 278 Gammaplex N immunoglobulins 14.5.1 Group Neurology Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 279 Gamunex N immunoglobulins 14.5.1 Group Neurology Cytomegalovirus 280 Ganciclovir N infection 5.3.2.2 Individual Cytomegalovirus infection

Non-small cell lung cancer Immunomodulating (NSCLC) and acute 281 Ganetespib N drugs 8.2.4 Individual myeloid leukaemia (AML) Individual 282 Gantenerumab C Drugs for dementia 4.11 Individual Alzheimer's disease Funding 2019 Protein kinase 283 N inhibitors 8.1.5 Individual Cancer Antibody that binds to the All development discontinued for uveitis. Also trialled in type 2 Immunomodulating interleukin-1 beta (IL-1 diabetes mellitus but unlikely to 284 Gevokizumab N drugs 11.4.2 / 6.1.2.3 Individual beta). Uveitis progress in this indication. Immunomodulating Multiple Sclerosis, 285 N drugs 8.2.4 Individual neurology Viral Hepatitis (B&C) & Respiratory Syncytial 286 Glecaprevir N Virus Group Hepatitis C For the urgent treatment of methotrexate-induced NHSE has commissioning policy 287 Glucarpidase N Poisoning None Individual renal dysfunction B15/P/a Urea cycle disorders - hyperammonaemia in Drugs used in adults and children ≥2 288 Glycerol phenylbutyrate N Metabolic disorders 9.8.1 Individual months of age

Licensed indications (Not all blood products are GlycoPEGylated Factor Blood-related products listed in the BNF, but they 289 IX N except Fibrin Sealants Group are all excluded from PbR) For children transitioning to adult services and becoming a CCG http://gmmmg.nhs.uk/docs/s commissioning responsibility, ubgroups/sbgrp-hcdsg/Child- category is monitored when in to-adult-services-statement- line with the referenced GMMMG 290 Golimumab N Cytokine modulators Group Any paediatric use As per adult TAs amended-post-meeting.pdf guidance.

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 16 of 36 http://guidance.nice.org.uk/T A497 http://gmmmg.nhs.uk/docs/g uidance/GMMMG-AS-PsA- reference to AS/ PsA pathway 291 Golimumab C Cytokine modulators Group Ankyosing spondylitis Monitored NICE TA497 pathway-Final-v4.pdf updated http://guidance.nice.org.uk/T NICE TA220 / GM A220 Harmonised Pathway for http://gmmmg.nhs.uk/docs/g biologics in AS uidance/GMMMG-AS-PsA- reference to AS/ PsA pathway 292 Golimumab C Cytokine modulators Group Psoriatic arthritis Monitored and PsA. pathway-Final-v4.pdf updated http://www.nice.org.uk/guida nce/ta375 http://gmmmg.nhs.uk/docs/g Rheumatoid arthritis uidance/GMMMG-RA- reference to RA pathway 293 Golimumab C Cytokine modulators Group (Methotrexate naïve) Monitored NICE TA375 pathway-v4-1.pdf updated http://www.nice.org.uk/guida nce/ta375 Rheumatoid arthritis (after http://gmmmg.nhs.uk/docs/g the failure of previous anti- uidance/GMMMG-RA- reference to RA pathway 294 Golimumab C Cytokine modulators Group rheumatic drugs) Monitored NICE TA375 pathway-v4-1.pdf updated

Granulocyte-macrophage Antibody-positive colony-stimulating factor Drugs used in pulmonary alveolar Not in Annex B1 but in NHSE 295 (Leukine - Import) N neutropenia proteinosis s/sheet Viral Hepatitis (B&C) & Respiratory Syncytial Will be a combination product 296 Grazoprevir N Virus 5.3.3 Group Hepatitis C with elbasvir.

Targets IL-23. Possibly available Drugs affecting the Individual in 2017. Not on NICE's agenda 297 Guselkumab C Immune response 13.5.3 Individual psoriasis Funding so may require local evaluation. Neuromuscular Duchenne muscular 298 Halofuginone N* Disorders Individual dystrophy 299 HIV vaccine N 14 Group HIV Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 300 Hizentra N immunoglobulins 14.5.1 Group Neurology Drugs used in 301 Human Arginate N Metabolic disorders 9.8.2 Individual Hepatic porphyria Human Heterologous Drugs used in Urea cycle disorders in 302 Liver Cells N Metabolic disorders 9.8.1 Individual children Human Parathyriod hormone-related protein Drugs affecting bone postmenopausal Individual 303 analogue C metabolism 6.6.1 Individual osteoporosis Funding This is abaloparatide (row 5) Human Parathyriod hormone-related protein Drugs affecting bone Male and juvenile 304 analogue N metabolism 6.6.1 Individual osteoporosis This is abaloparatide (row 5) Intravenous/subcutane ous human normal 305 Hyqvia N immunoglobulins 14.5.1 Group AIDS/HIV 306 Ibalizumab N antiretrovirals 5.3.1 Individual Not in SPS Hereditary angiodema - acute and prophylactic Prophylactic treatment added to 307 Icatibant N Allergic Emergencies 3.4.3 Individual treatment accord with V11 Neuromuscular Duchenne muscular 308 Idebenone N Disorders 10.2 Individual dystrophy

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 17 of 36 Separate row now: Not in NHSE V11 s/sheet but expected to commission as NHSE Neuromuscular commissions for other 309 Idebenone N* Disorders 4 Individual Friedreich's ataxia neurodegenerative disorders. Visual impairment in Not in NHSE V11 s/sheet but adolescent and adult expected to commission as patients with Leber’s NHSE commissions other rare Idebenone Neuromuscular Hereditary Optic mitochondrial diseases. 310 Raxone N* Disorders 11.8 Individual Neuropathy (LHON). Licensed. Lysosomal Storage Mucopolysaccharidosis II 311 Idursulfase N Disorder Drugs 9.8.1 Group [2] Use in vascular disease is Vasodilator commissioned by NHSE within antihypertensive specialist centres. All other drugs/Pulmonary indications are CCG 312 Iloprost (nebulised) N Arterial Hypertension 2.5.1 Individual Pulmonary hypertension commissioned [ref. NHSE] Protein kinase 313 N inhibitors 8.1.5 Individual Cancer Protein kinase 314 Imatinib N inhibitors 8.1.5 Group Graft versus host disease

Non-neurological Lysosomal Storage manifestations of type I or 315 Imiglucerase N Disorder Drugs 9.8.1 Group type III Gaucher’s disease. AIDS/HIV HIV in combination with 316 Indinavir N antiretrovirals 5.3.1 Group other anti-retroviral drugs Paediatric indications 317 Infliximab N Cytokine modulators 10.1.3 Group (where adult TA available) For children transitioning to adult services and becoming a CCG http://gmmmg.nhs.uk/docs/s commissioning responsibility, ubgroups/sbgrp-hcdsg/Child- category is monitored when in to-adult-services-statement- line with the referenced GMMMG 318 Infliximab N Cytokine modulators 10.1.3 Group Juvenile arthritis amended-post-meeting.pdf guidance.

Connective tissue disease 319 Infliximab N Cytokine modulators 10.1.3 Group - interstital lung disease Crohn's Disease in 320 Infliximab N Cytokine modulators 10.1.3 Group children NICE TA187 321 Infliximab N Cytokine modulators 10.1.3 Group Graft versus host disease 322 Infliximab N Cytokine modulators 10.1.3 Group Renal 323 Infliximab N Cytokine modulators 10.1.3 Group Sarcoidosis 324 Infliximab N Cytokine modulators 10.1.3 Group Uveitis [adult and child] 325 Infliximab N Cytokine modulators 10.1.3 Group Hidradenitis suppurativa 326 Infliximab N Cytokine modulators 10.1.3 Group BehÇet's Syndrome Added to match NHSE s/sheet http://guidance.nice.org.uk/T A383 NICE TA383 / GM Harmonised Pathway for http://gmmmg.nhs.uk/docs/g biologics in AS uidance/GMMMG-AS-PsA- reference to GMMMG AS/PsA 327 Infliximab C Cytokine modulators 10.1.3 Group Ankylosing spondylitis Monitored and PsA. pathway-Final-v4.pdf pathway updated http://guidance.nice.org.uk/T A134 http://gmmmg.nhs.uk/docs/g uidance/GMMMG-Biologics- pathway-for-psoriasis-v2- reference to GMMMG psoriasis 328 Infliximab C Cytokine modulators 10.1.3 Group Psoriasis (plaque) Monitored NICE TA134 0.pdf pathway updated

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 18 of 36 http://gmmmg.nhs.uk/docs/g Psoriasis (plaque) - uidance/GMMMG-Biologics- sequential use of biologic pathway-for-psoriasis-v2- reference to GMMMG psoriasis 329 Infliximab C Cytokine modulators 10.1.3 Group agents Monitored GMMMG 0.pdf pathway updated NICE TA199 / GM Harmonised Pathway for http://gmmmg.nhs.uk/docs/g biologics in AS uidance/GMMMG-AS-PsA- reference to GMMMG As/ PsA 330 Infliximab C Cytokine modulators 10.1.3 Group Psoriatic Arthritis Monitored and PsA. pathway-Final-v4.pdf pathway updated http://www.nice.org.uk/guida nce/ta375

http://gmmmg.nhs.uk/docs/g Rheumatoid Arthritis, after NICE TA375 / GM uidance/GMMMG%20AS%2 failure of conventional Harmonised 0PsA%20pathway%20v4%2 New row inserted for this 331 Infliximab C Cytokine modulators 10.1.3 Group DMARDs Monitored biologics pathway 0FINAL.pdf indication. http://guidance.nice.org.uk/T A195

http://gmmmg.nhs.uk/docs/g Rheumatoid Arthritis, after uidance/GMMMG%20RA%2 failure of TNF inhibitor, if 0Pathway%2022%20april_2 332 Infliximab C Cytokine modulators 10.1.3 Group rituximab contra-indicated Monitored NICE TA195 015.pdf Crohn's Disease, http://guidance.nice.org.uk/T 333 Infliximab C Cytokine modulators 10.1.3 Group gastroenterology Monitored NICE TA187 A187 Moderately to severely active ulcerative colitis after the failure of http://www.nice.org.uk/guida New row inserted for this 334 Infliximab C Cytokine modulators 10.1.3 Group conventional therapy Monitored NICE TA329 nce/ta329 indication for clarity. Acute exacerbations of http://guidance.nice.org.uk/T 335 Infliximab C Cytokine modulators 10.1.3 Group ulcerative colitis Monitored NICE TA163 A163 Sub-acute manifestations http://www.nice.org.uk/guida 336 Infliximab C Cytokine modulators 10.1.3 Group of ulcerative colitis Monitored NICE TA329 nce/ta329 C or N, seek guidance if 337 Infliximab necessary Cytokine modulators 10.1.3 Group All other indications Individual funding Immunomodulating 338 alfa N drugs 8.2.4 Individual Hepatitis B+C Immunomodulating 339 Interferon beta N drugs 8.2.4 Individual Multiple sclerosis Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 340 Intratect N immunoglobulins 14.5.1 Group Neurology 341 Isavuconazole N Antifungals 5.2 Individual Fungal infection Management of cystic 342 Ivacaftor N Mucolytics 3.7 Individual fibrosis Drugs used in hypoplastic, haemolytic and renal Multiple myeloma (MM) / 343 Ixazomib N anaemias 8.1.5 Group amyloidosis https://www.nice.org.uk/guid ance/ta442 http://gmmmg.nhs.uk/docs/g uidance/GMMMG-Biologics- references to NICE and pathway-for-psoriasis-v2- GMMMG psoriasis pathway 344 Ixekizumab C Cytokine modulators 13.5.3 Group Psoriasis Monitored NICE TA442 0.pdf updated

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 19 of 36 Spelling error in drug name continues on latest national lists. May be marketed for this indication in 2018. Policy 345 Ixekizumab C Cytokine modulators 13.5.3 Group Psoriatic arthritis Individual funding required. Spelling error in drug name continues on latest national lists. SPS suggests this indication not until 2019. Policy may be 346 Ixekizumab C Cytokine modulators 13.5.3 Group Ankylosing Spondylitis Individual funding required.

Retinal Do we need a policy on this? disorders/intraocular Licensed as Omidria 10 mg/mL Ketorolac with lens replacement Intraocular lens + 3 mg/mL concentrate for 347 Phenylephrine C surgery 11.8.2 Individual replacement surgery Individual funding solution for intraocular irrigation. Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 348 Kiovig N immunoglobulins 14.5.1 Group Neurology Viral Hepatitis (B&C) & respiratory Syncytial 349 Lamivudine N Virus 5.3.1 Group Hepatitis B AIDS/HIV HIV in combination with 350 Lamivudine N antiretrovirals Group other anti-retroviral drugs Geographic atrophy secondary to dry age- Subfoveal choroidal related macular 351 Lampalizumab C neovascularisation 11.8 Group degeneration Individual funding 2019 Somatostatin 352 N Analogues 8.3.4.3 Group Cancer

NHSE is the responsible commissioner when somatropin analogues are prescribed in Somatostatin Specialist Centres for indications 353 Lanreotide N Analogues 8.3.4.3 Group Acromegaly falling outside NICE guidance. Congenital Somatostatin hyperinsulinism - children 354 Lanreotide N Analogues 8.3.4.3 Group only

NHSE has indicated that the C or N, seek responsible commissioner for guidance if Somatostatin Congenital this use is the commissioner for 355 Lanreotide necessary Analogues 8.3.4.3 Group hyperinsulinism - adults Individual funding the service caring for the patient. Licensed indications: monitored. Unlicensed Somatostatin Other than NHSE indications: 356 Lanreotide C Analogues 8.3.4.3 Group commissioned indications Individual funding Protein kinase 357 N inhibitors 8.1.5 Individual Cancer Back in Annex B1 so replaced Immunomodulating back into this s/sheet. EMA: not 358 Laquinimod N drugs 8.2.4 Individual Multiple sclerosis recommended for approval. Non-neurological manifestations of Lysosomal Storage Mucopolysaccharidosis I 359 Laronidase N Disorder Drugs 9.8.1 Group (1)

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 20 of 36 IL-13 inhibitor. However, SPS says asthma programme discontinued after Allergen Asthma - various possible Individual primary outcome not met in a 360 Lebrikizumab N Immunotherapy Group indications Funding Phase III clinical trial. Ledipasvir* [and in Viral Hepatitis (B&C) & combination with Respiratory Syncytial 361 sofobusvir] N* Virus Group Hepatitis C POEMS is new to NHSE V13. Immunomodulating Cancer and POEMS These 2 indications will be 362 Lenalidomide N drugs 8.2.4 Individual syndrome separated on the next version. Drugs used in 363 N neutropenia 9.1.6 Group Neutropenia Drugs used in 364 Lenograstim N neutropenia 9.1.6 Group Barth Syndrome Cytomegalovirus 365 Letermovir N infection Group Cytomegalovirus infection 2018 Unique delivery mode (i.e. intestinal gel). Not a new drug. Arguably duplicates row 151 Neurodegenerative (both descriptions present in 366 Levodopa + Carbidopa N* Conditions 4.9.1 Group Parkinson's Disease National List). Management of cystic 367 Levofloxacin (inhaled) N Antibacterial Drugs 5.1.12 Individual fibrosis Drugs used in 368 Lipegfilgrastim N neutropenia 9.1.6 Group Neutropenia Vasopressin V2 Hyponatraemia and other 369 Lixivaptan N receptor antagonist 6.5.2 Individual endocrine uses Homozygous familial 370 Lomitapide N Lipid regulating Drugs 2.12 Individual hypercholesterolemia Hepatitis D infection (with Protein kinase ritonavir) 371 Lonafarnib N inhibitors Group and / or cancer 2018 AIDS/HIV HIV in combination with 372 Lopinavir with Ritonavir N antiretrovirals 5.3.1 Group other anti-retroviral drugs Not in BNF (Ivacaftor shown as BNF 3.7 on list) 373 Lumacaftor with Ivacaftor N Mucolytics Individual Cystic fibrosis In adults with chronic liver disease prior to undergoing elective invasive procedures to Platelet Disorder reduce the need for platelet 374 Mulpleta N*? Drugs Individual Thrombocytopenia transfusions Growth Hormone & growth hormone 375 N Receptor Antagonist 6.5 Individual Growth failure Vasodilator antihypertensive drugs/Pulmanory 376 Macitentan N Arterial Hypertension 2.5.1 Individual Management of cystic 377 Mannitol (inhaled) N Mucolytics 3.7 Individual fibrosis. AIDS/HIV HIV in combination with 378 Maraviroc N antiretrovirals 5.3.1 Group other anti-retroviral drugs Protein kinase 379 N inhibitors 8.1.5 Individual Pancreatic cancer / GIST

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 21 of 36 2020 NHSE states on V11 that it will be responsible for paediatric indications should a positive Drugs affecting the NICE TA become available for 380 C Immune response 10.1.3 Individual Rheumatoid arthritis Individual funding adult indications. Growth Hormone & growth hormone 381 N Receptor Antagonist 6.7.4 Individual Growth failure Allergen 382 Mepolizumab N Immunotherapy 3.4.2 Individual Asthma Allergen 383 Mepolizumab N* Immunotherapy 3.4.3 Individual Churg Strauss syndrome Allergen Individual SPS says COPD use is CCG 384 Mepolizumab C Immunotherapy 3.4.4 Individual COPD Funding commissioned duplicates row 158 but both Mercaptamine Drugs used in descriptions present in National 385 (cysteamine) N Metabolic disorders 9.8.1 Individual Nephropathic cystinosis list. SPS says use is NHSE 386 Metreleptin N* Other endocrine drugs 6.7 Individual Lipodystrophy commissioned 387 Metreleptin N Other endocrine drugs 6.7 Individual Dyslipidaemia as per entry on V11 Invasive candidiasis (risk 388 Micafungin N Antifungals 5.2.4 Individual of liver tumours) Lysosomal Storage 389 Migalastat N Disorder Drugs 9.8.1 Group Fabry's disease Mild to moderate type I Gaucher’s disease, Lysosomal Storage Niemann-Pick type C 390 Miglustat N Disorder Drugs 9.8.1 Group disease Protein kinase Pancreatic cancer / 391 N inhibitors Group myelofibrosis 2018 Viral Hepatitis (B&C) & respiratory Syncytial 392 Motavizumab N Virus none Group RSV prophylaxis Immunomodulating 393 Natalizumab N drugs 8.2.4 Individual Multiple sclerosis AIDS/HIV HIV in combination with 394 Nelfinavir N antiretrovirals 5.3.1 Group other anti-retroviral drugs AIDS/HIV HIV in combination with 395 Nevirapine N antiretrovirals 5.3.1 Group other anti-retroviral drugs Protein kinase 396 N inhibitors 8.1.5 Individual Cancer Immunomodulating 397 Vargatef N drugs 8.1.5 Individual Ovarian cancer Nintedanib Immunomodulating Idiopathic pulmonary 398 Ofev N drugs 8.1.5 Individual fibrosis Nintedanib Immunomodulating 399 Vargatef N drugs 8.1.5 Individual Non small cell lung cancer Viral Hepatitis (B&C) & respiratory Syncytial 400 Nitazoxanide N Virus none Group Hepatits C Drugs used in Hereditary tyrosinemia 401 Nitisinone N Metabolic disorders 9.8.1 Individual type 1 Drugs used in 402 Nitisinone N Metabolic disorders 9.8.1 Individual Alkaptonuria Vasodilator antihypertensive drugs/Pulmanory Pulmonary arterial 403 Nitric Oxide N Arterial Hypertension none Individual hypertension

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 22 of 36 Blood-related products 404 Nonacog alpha N except Fibrin Sealants none Group Haemophillia B

Blood-related products 405 Nonacog beta pegol N except Fibrin Sealants none Group Haemophillia B Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 406 Normal Immunoglobulin N immunoglobulins 14.5.1 Group Neurology Primary biliary cirrhosis / Q4 2016 Obeticholic acid Drugs used in Non-alcoholic 407 Ocaliva N Metabolic disorders Individual steatohepatitis (NASH) 2018 Immunomodulating 408 Ocrelizumab N drugs 8.2.4 Individual Multiple sclerosis Focal vitreomacular http://guidance.nice.org.uk/T 409 Ocriplasmin C Retinal disorders 11.8.2 Individual adhesion (VMA) Monitored NICE TA297 A297 Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 410 Octagam N immunoglobulins 14.5.1 Group Neurology Platelet Disorder 411 Octocog Alfa N Drugs 2.11 Group Haemophilia A Growth Hormone & growth hormone 412 Octreolin N Receptor Antagonist 6.5 Individual Acromegaly Somatostatin 413 N Analogues 8.3.4.3 Group Cancer

NHSE is the responsible commissioner when somatropin analogues are prescribed in Somatostatin Specialist Centres for indications 414 Octreotide N Analogues 8.3.4.3 Group Acromegaly falling outside NICE guidance. Somatostatin Congenital 415 Octreotide N Analogues 8.3.4.3 Group hyperinsulinism [children]

NHSE has indicated that the C or N, seek responsible commissioner for guidance if Somatostatin Congenital this use is the commissioner for 416 Octreotide necessary Analogues 8.3.4.3 Group hyperinsulinism [adults] Individual funding the service caring for the patient.

Licensed indications: monitored. Unlicensed indications: Individual funding http://gmmmg.nh except the s.uk/docs/subgro indications listed ups/sbgrp- Vomitting in palliative care adjacent for hcdsg/Octreotide- , Entereocutaneous fistula which the gastro- Somatostatin High output stoma category is recommendation. CCG commissioned for non- 417 Octreotide C Analogues 8.3.4.3 Group Refractory diarrhoea monitored pdf cancer use Drugs affecting bone Osteoporosis [post SPS says development 418 Odanacatib C metabolism 6.6.2 Individual menopausal] Individual funding discontinued Drugs affecting bone SPS says development 419 Odanacatib N* metabolism 6.6.3 Individual Osteoporosis [men] Individual funding discontinued; not in V11 Immunomodulating 420 Ofatumumab N drugs 8.2.3 Individual Cancer

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 23 of 36 Multiple sclerosis, pemphigus vulgaris, Immunomodulating chronic lymphocytic 421 Ofatumumab N drugs 8.2.3 Individual leukaemia (CLL) Individual funding Cholesterol oxime mitochondrial pore Neuromuscular modulator for spinal 422 Olesoxime N Disorders 10.2 Individual muscular atrophy. IgE mediated severe Allergen asthma all persons 423 Omalizumab N Immunotherapy 3.4.2 Individual 6years+ Allergen Chronic spontaneous http://www.nice.org.uk/guida 424 Omalizumab C Immunotherapy 3.4.2 Individual urticaria Monitored NICE TA339 nce/ta339 Ombitasvir with Paritaprevir with Viral Hepatitis (B&C) & Ritonavir with Dasabuvir Respiratory Syncytial 425 +/- ribavirin N Virus 5.3.3 Group Hepatitis C

inhibitor of aldosterone synthase 426 Osilodrostat N Other Endocrine drugs 6.7.3 Group Cushing's disease 2018

427 Ozanimod N Multiple sclerosis (MS) 8.2 Group relapsing-remitting 2019 Ulcerative colitis (UC); 428 Ozanimod C IBD 1.5.3 Group moderate-to-severe active Individual funding 2020 Protein kinase 429 N inhibitors 8.1.5 Individual Myelofibrosis Viral Hepatitis (B&C) & respiratory Syncytial 430 Palivizumab N Virus 5.3.5 Group RSV prophylaxis Para - Aminosalicylic 431 acid N Antituberculosis drugs 5.1.9 Individual Tuberculosis Additional row added for Drugs affecting bone Specialist endocrinology consistency with NHSE 432 Parathyroid hormone N metabolism 6.6.1 Individual conditions spreadsheet Drugs affecting bone 433 Parathyroid hormone C metabolism 6.6.1 Group Osteoporosis in women Individual funding NHSE commissions TPN for intestinal failure types II and III but CCGs will commission TPN for Type I i.e. where the primary Parenteral Nutrition (after medical issue isn't one of sub- 14 days or where the optimal bowel function. Further patient is receiving TPN Nutrition: Type I intestinal information is provided at the 434 prior to admission) C Parenteral Nutrition 9.3 Group failure Monitored foot of the spreadsheet. NHSE commissions TPN for intestinal failure types II and III but CCGs will commission TPN for Type I i.e. where the primary Parenteral Nutrition (after medical issue isn't one of sub- 14 days or where the optimal bowel function. Further patient is receiving TPN Nutrition: Types II and III information is provided at the 435 prior to admission) N Parenteral Nutrition 10.3 Group intestinal failure foot of the spreadsheet. Viral Hepatitis (B&C) & Respiratory Syncytial 436 Paritaprevir N Virus 5.3.3 Group Hepatitis C Somatostatin Two rows to match NHSE 437 N Analogues 6.3.4.3 Group Acromegaly s/sheet Somatostatin Two rows to match NHSE 438 Pasireotide N Analogues 6.3.4.3 Group Cushing's disease s/sheet

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 24 of 36 Protein kinase 439 N inhibitors 8.1.5 Individual Cancer Wet age related macular Subfoveal choroidal degeneration, http://guidance.nice.org.uk/T 440 C neovascularisation 11.8.2 Group opthalmology Exceptional case NICE TA155 A155 Neutropenia - where a Drugs used in single dose G-CSF is 441 N neutropenia 9.1.6 Individual necessary Viral Hepatitis (B&C) & respiratory Syncytial 442 Peginterferon alfa N Virus 8.2.4 Group Hepatitis B and C Immunomodulating 443 Peginterferon Beta-1a N drugs 8.2.4 Individual Multiple sclerosis Immunomodulating 444 Peginterferon Lambda-1a N drugs 8.2.4 Individual Hepatitis C

Treatment of acute Gout and cytotoxic- hyperuricaemia in patients induced with haematological http://guidance.nice.org.uk/T 445 Pegloticase C hyperuricaemia 10.1.4 Individual malignancy Exceptional case NICE TA291 A291 Retinal disorders/intraocular Pegpleranib lens replacement 446 Fovista C surgery 11.8.2 Individual Wet-AMD Individual funding 2018 Growth Hormone & growth hormone 447 N Receptor Antagonist 6.5.1 Individual Acromegaly N.B. This drug is not in Annex A Treatment naïve (nor was it on last year's list) but Immunomodulating melanoma (unresectable, is included here to match NHSE 448 Pembrolizumab N drugs 8.2.4 matastatic) s/sheets V11 through 13 Immunomodulating Melanoma (unresectable, 449 Pembrolizumab N drugs 8.2.4 matastatic) " Idiopathic pulmonary 450 Pirfenidone N Pulmonary Fibrosis 3.11 Individual fibrosis Drugs affecting the 451 N immune response 9.1.7 Individual Stem cell mobilisation Immunomodulating 452 Pomalidomide N drugs 8.2.4 Individual Cancer Immunomodulating Myelofibrosis and multiple 453 Pomalidomide N drugs 8.2.4 Individual myeloma Chronic myelogenous leukaemia (CML), Acute Protein kinase lymphoblastic leukaemia 454 Ponatinib N inhibitors 8.1.5 Individual (ALL) Multiple sclerosis 455 Ponesimod N (MS) 10.2 Group relapsing-remitting 2019 Respiratory Distress 456 Poractant alfa N Pulmonary surfactants 3.5.2 Individual Syndrome Licensed indications (Not all blood products are Blood-related products listed in the BNF, but they 457 Porcine Factor N* except Fibrin Sealants none Individual are all excluded from PbR) For all invasive fungal infections including those associated with Note that treatment of Allergic transplants and bronchopulmonary aspergillosis 458 Posaconazole N Antifungals 5.2.1 Individual aspergillosis (ABPA) is CCG-commisisoned. 459 Pretomanid N Antibacterial Drugs 5.1.9 Group Tuberculosis Not in SPS

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 25 of 36 Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 460 Privigen N immunoglobulins 14.5.1 Group Neurology

Licensed indications (Not all blood products are listed in the BNF, but they 461 Protein C N Blood related products 2.11 Group are all excluded from PbR)

Licensed indications (Not all blood products are listed in the BNF, but they 462 Prothrombin Complex N Blood related products 2.11 Group are all excluded from PbR) AIDS/HIV HIV in combination with 463 Raltegravir N antiretrovirals 5.3.1 Group other anti-retroviral drugs Wet age related macular degeneration, diabetic macular oedema, branch and central retinal vein occlusion, choroidal neovascularisation Subfoveal choroidal secondary to pathological NICE TA155 / http://guidance.nice.org.uk/T 464 C neovascularisation 11.8.2 Individual myopia Monitored 274 / 283 / 298 Axxx etc

Treatment of acute Gout and cytotoxic- hyperuricaemia in patients induced with haematological 465 Rasburicase N hyperuricaemia 10.1.4 Individual malignancy Protein kinase 466 N inhibitors 8.1.5 Individual Cancer Allergen Allergic, eosinophilic 467 Reslizumab N Immunotherapy 3.4.2 Individual asthma Lysosomal Storage 468 Reveglucosidase alfa N Disorder Drugs Group Pompe disease 2018 Viral Hepatitis (B&C) & respiratory Syncytial 469 Ribavirin N Virus 5.3.5 Individual Hepatitis C

Myelodysplastic Myelodysplastic Syndrome 470 Rigosertib N Syndrome 8 Individual and pancreatic cancer AIDS/HIV HIV in combination with 471 Rilpivirine N antiretrovirals 5.3.1 Group other anti-retroviral drugs

Torsion Dystonias and Amyotropic lateral other involuntary sclerosis in motor neurone http://guidance.nice.org.uk/T 472 Riluzole C movements 4.9.3 Group disease, neurology Monitored NICE TA20 A20 Vasodilator antihypertensive drugs/Pulmanory Pulmonary arterial 473 Riociguat N Arterial Hypertension 2.5.1 Individual hypertension AIDS/HIV HIV in combination with 474 Ritonavir N antiretrovirals 5.3.1 Group other anti-retroviral drugs 475 Rituximab N Cytokine modulators 10.1.3 Group ANCA-positive vasculitis 476 Rituximab N Cytokine modulators 10.1.3 Group Acquired haemophilia Steroid sensitive nephrotic 477 Rituximab N Cytokine modulators 10.1.3 Group syndrime Steroid resistant nephrotic 478 Rituximab N Cytokine modulators 10.1.3 Group syndrome Primary Sjorgen's 479 Rituximab N Cytokine modulators 10.1.3 Group Syndrome (PSS)

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 26 of 36 Chronic imflammarory demyelinating 480 Rituximab N Cytokine modulators 10.1.3 Group polyneuropathy

Connective tissue disease 481 Rituximab N Cytokine modulators 10.1.3 Group - interstital lung disease 482 Rituximab N Cytokine modulators 10.1.3 Group Graft versus host disease 483 Rituximab N Cytokine modulators 10.1.3 Group Myositis ABO-incompatible kidney 484 Rituximab N Cytokine modulators 10.1.3 Group transplants 485 Rituximab N Cytokine modulators 10.1.3 Group Nephritis 486 Rituximab N Cytokine modulators 10.1.3 Group Neuromyelitis Optica 487 Rituximab N Cytokine modulators 10.1.3 Group SLE Immunoglobulin G4 488 Rituximab N Cytokine modulators 10.1.3 Group related disease Added to match NHSE s/sheet 489 Rituximab N Cytokine modulators 10.1.3 Group Neuromyelitis optica Added to match NHSE s/sheet 490 Rituximab N Cytokine modulators 10.1.3 Group Pemphigus Vulgaris 491 Rituximab N Cytokine modulators 10.1.3 Group Juvenile arthritis

Unlicensed. Includes Refractory http://gmmmg.nhs.uk/docs/s Idiopathic Thrombocytopenia Refractory Primary ubgroups/sbgrp- Purpura (ITP), Autoimmune Idiopathic Immune hcdsg/GMMMG-Rituximab- Haemolytic Anaemia (AIHA) and 492 Rituximab C Cytokine modulators 10.1.3 Group Cytopenias Monitored recommendation-final.pdf Evans syndrome. http://guidance.nice.org.uk/T A195 Rheumatoid Arthritis, after http://gmmmg.nhs.uk/docs/g failure of TNF inhibitor, uidance/GMMMG-RA- 493 Rituximab C Cytokine modulators 10.1.3 Group Rheumatology Monitored NICE TA195 pathway-v4-1.pdf 494 Rituximab (IV) N Cytokine modulators 10.1.3 Group Cancer

Rituximab subcutaneous 495 formulation N Cytokine modulators 10.1.3 Group Cancer C or N, seek guidance if 496 Rituximab necessary Cytokine modulators 10.1.3 Group All other indications Individual funding

While eltrombopag and romiplostim are the responsibility of CCGs regardless of the cause Chronic immune of the thromobcytopenia in Platelet Disorder thrombocytopenic purpura http://www.nice.org.uk/guida adults, paediatrics are NHSE 497 Romiplostim C Drugs 9.1.4 Individual (ITP) Monitored NICE TA221 nce/TA221 responsibility. Viral Hepatitis (B&C) & Respiratory Syncytial Polycythemia vera; first- 498 Ropeginterferon alfa-2b N Virus Group line 2017 Drugs used in hypoplastic, Anaemia in chronic kidney haemolytic, and renal disease (non dialysis- SPS says CCG commissioned. 499 Roxadustat C anaemias 9.1 Group dependent) Individual funding 2019 SPS says CCG commissioned Drugs used in but use in dialysis-induced hypoplastic, patients is confirmed by V11 to haemolytic, and renal Anaemia in chronic kidney be NHSE. 500 Roxadustat N anaemias 9.1 Group disease (dialysis-induced ) 2019 Protein kinase 501 N inhibitors 8.1.5 Individual Cancer Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 502 Sandoglobulin N immunoglobulins 14.5.1 Group Neurology

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 27 of 36 Hyperphenylalaninaemia Drugs used in (HPA) [children with 503 Sapropterin N Metabolic disorders 9.4.1 Individual phenylketonuria] Hyperphenylalaninaemia Drugs used in (HPA) [Maternal 504 Sapropterin N Metabolic disorders 9.4.1 Individual phenylketonuria] AIDS/HIV HIV in combination with 505 Saquinavir N antiretrovirals 5.3.1 Group other anti-retroviral drugs https://www.nice.org.uk/guid ance/ta485 http://gmmmg.nhs.uk/docs/g uidance/GMMMG-RA- references to NICE and 506 Sarilumab C Cytokine modulators 10.1.3 Group Monitored NICE TA485 pathway-v4-1.pdf GMMMG RA pathway updated Lysosomal Storage Lysosomal acid lipase 507 Sebelipase alfa N Disorder Drugs 9.8.1 Group deficiency 508 Secukinumab N Cytokine modulators 13.5.3 Group Paediatric indications https://www.nice.org.uk/guid ance/ta350

http://gmmmg.nhs.uk/docs/g uidance/GMMMG-Biologics- pathway-for-psoriasis-v2- reference to GMMMG psoriasis 509 Secukinumab C Cytokine modulators 13.5.3 Group Psoriasis Monitored NICE TA350 0.pdf pathway updated https://www.nice.org.uk/guid ance/ta445 http://gmmmg.nhs.uk/docs/g references to NICE and uidance/GMMMG-AS-PsA- GMMMG AS/ PsA pathway 510 Secukinumab C Cytokine modulators 10.1.3 Group Psoriatic arthritis Individual funding NICE TA445 pathway-Final-v4.pdf updated https://www.nice.org.uk/guid ance/ta407

http://gmmmg.nhs.uk/docs/g Active Ankylosing uidance/GMMMG-AS-PsA- references to GMMMG AS/ PsA 511 Secukinumab C Cytokine modulators 10.1.3 Group spondylitis Monitored NICE TA407 pathway-Final-v4.pdf pathway updated Vasodilator antihypertensive drugs/Pulmonary Pulmonary arterial 512 Selexipag N Arterial Hypertension 2.5.1 Individual hypertension

Drug still in development. Technology Appraisal currently Hypertension and Acute decompensated suspended indefinitely by NICE. 513 Serelaxin C heart failure Individual heart failure Individual funding 2018 Viral Hepatitis (B&C) & Respiratory Syncytial 514 Setrobuvir N Virus 5.3.3 Group Hepatitis C Only PbR ecluded when used for Drugs used in a metabolic disorder. Not in 515 Sialic acid N Metabolic disorders 9.8.1 Individual Myopathy SPS. Vasodilator antihypertensive Sildenafil (only when drugs/Pulmonary Pulmonary arterial 516 used for PAH) N Arterial Hypertension 2.5.1 Individual hypertension 517 Siltuximab N* Cytokine modulators 8.2.4 Group Castleman's Disease Viral Hepatitis (B&C) & respiratory Syncytial 518 Simeprevir N Virus 5.3.3 Group Hepatitis C Viral Hepatitis (B&C) & Simeprevir / respiratory Syncytial 519 peginterferon + ribavirin N Virus 5.3.3 Group Hepatitis C Added to match NHSE s/sheet

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 28 of 36 Drugs affecting the Giant cell (temporal) 520 Sirukumab N* immune response 10.1.3 Individual arteritis IL-6 inhibitor. 2019 IL-6 inhibitor. Possibly Q3 2017. Not on NICE's agenda. NHSE states on V11 that it will be responsible for paediatric indications should a positive Drugs affecting the Individual NICE TA become available for 521 Sirukumab C immune response 10.1.3 Individual Rheumatoid arthritis Funding adult indications. New addition to Annex A 2016 /17. Only PbRe when used in metabolic disorders. Not in proposed list for 2017/19 so removed N.B. This drug is not in Annex A Drugs used in but is included here to match 522 Sodium benzoate N* Metabolic disorders Individual NHSE s/sheet V11 Hypnotics and Narcolepsy - paediatric 523 Sodium oxybate N anxiolytics 4.1.1 Individual services only http://gmmmg.nhs.uk/docs/n ts/NTS%20Sodium%20Oxyb All requests to go to CCGs for Hypnotics and ate%20for%20narcolepsy.p detailed consideration at IFR 524 Sodium oxybate C anxiolytics 4.1.1 Individual Narcolepsy with cataplexy Individual funding GMMMG NTS df Panels Drugs used in 525 Sodium phenylbutyrate N Metabolic disorders 9.8.1 Individual Urea cycle disorders Viral Hepatitis (B&C) & Sofosbuvir / daclatasvir + respiratory Syncytial Entries now match NHSE s/ 526 ribavirin N Virus 5.3.3.2 Group Hepatitis C sheet Viral Hepatitis (B&C) & Sofosbuvir / ledipasvir +/- respiratory Syncytial Entries now match NHSE s/ 527 ribavirin N Virus 5.3.3.2 Group Hepatitis C sheet Viral Hepatitis (B&C) & Sofosbuvir / respiratory Syncytial Entries now match NHSE s/ 528 peginterferon + ribavirin N Virus 5.3.3.2 Group Hepatitis C sheet Viral Hepatitis (B&C) & respiratory Syncytial Entries now match NHSE s/ 529 Sofosbuvir / velpatasvir N Virus 5.3.3.3 Group Hepatitis C sheet Drugs affecting the Individual 530 Solanezumab C immune system 4.11 Individual Alzheimer's disease Funding 2020 Growth Hormone & growth hormone Growth hormone http://www.nice.org.uk/guida 531 Somatropin C Receptor Antagonist 6.5.1 Individual deficiency children Monitored NICE TA188 nce/TA188 Growth Hormone & growth hormone Severe growth hormone http://www.nice.org.uk/guida 532 Somatropin C Receptor Antagonist 6.5.1 Individual deficiency in adults Monitored NICE TA64 nce/TA64 Protein kinase 533 N inhibitors 8.1.5 Individual Cancer AIDS/HIV HIV in combination with 534 Stavudine N antiretrovirals 5.3.1 Group other anti-retroviral drugs Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 535 Subcuvia N immunoglobulins 14.5.1 Group Neurology Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 536 Subgam N immunoglobulins 14.5.1 Group Neurology

End stage renal disease. V11 through 13 place this at the Phosphate biniding end within non -PbRe but it is on 537 Sucroferric oxyhdroxide N agents 9.5.2.2 Individual Phosphate binding agent the National List as PbRe.

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 29 of 36 Protein kinase 538 N inhibitors 8.1.5 Individual Cancer

Blood-related products 539 N except Fibrin Sealants 9.1.3 Group Haemophilia A Vasodilator antihypertensive Tadalafil (only when used drugs/Pulmonary Pulmonary arterial 540 for PAH) N Arterial Hypertension 7.4.5 Individual hypertension Despite PSS 46 saying CCGs commission the majority of treatment services for patients with amyloidosis, NHSE V13 now lists this and so the commissioner has been changed to NHSE. The two indications rows 541 and 542 will be merged on the Tafamidis Neurodegenerative Amyloidosis; senile, next version. 541 Vyndaqel N Conditions 4.9.3 Individual systemic Individual funding 2022

Cardiovascular disorders; Tafamidis Neurodegenerative transthyretin 542 Vyndaqel N Conditions Individual cardiomyopathy (TTR-CM) NHSE commissioned on V13 Lysosomal Storage 543 Taliglucerase alfa N Disorder Drugs Group Gaucher's disease 544 C Cytokine modulators 4.7 Group Osteoarthritis Individual funding 2018 Viral Hepatitis (B&C) & respiratory Syncytial 545 Taribavirin N Virus 5.3.5 Group Hepatitis C Cytokine modulators 546 Teduglutide N [GLP-2 analogue] 1 Group Short bowel syndrome Viral Hepatitis (B&C) & respiratory Syncytial 547 Telaprevir N Virus 5.3.3 Group Hepatitis C Viral Hepatitis (B&C) & respiratory Syncytial 548 Telbivudine N Virus 5.3.3 Group Hepatitis B Protein kinase 549 Temsirolimus N inhibitors 8.1.5 Individual Cancer AIDS/HIV HIV (or Hepatitis with 550 Tenofovir N antiretrovirals 5.3.1 Group some drugs) Tenofovir with AIDS/HIV HIV (or Hepatitis with 551 Emtricitabine N antiretrovirals 5.3.1 Group some drugs) Tenofovir with Emtricitabine and AIDS/HIV HIV (or Hepatitis with 552 Efavirenz N antiretrovirals 5.3.1 Group some drugs) Further entries of combination products required to match Tenofovir with NHSE s/ sheet but all prodducts emtricitabine and AIDS/HIV HIV (or Hepatitis with containing tenofovor are 553 rilpivrine N antiretrovirals 5.3.1 Group some drugs) commissioned by NHSE Immunomodulating 554 Teriflunomide N drugs 8.2.4 Individual multiple sclerosis Osteoporosis in men and Drugs affecting bone juveniles 555 Teriparatide N metabolism 6.6.1 Individual Osteogenesis imperfecta Individual funding Drugs affecting bone http://guidance.nice.org.uk/T 556 Teriparatide C metabolism 6.6.1 Individual Osteoporosis in women Monitored NICE TA161 A161

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 30 of 36 Growth Hormone & growth hormone HIV-associated 557 ? Receptor Antagonist 13.1 Individual lipodystrophy SPS says filing withdrawn. Drugs used in Hyperphenylalaninaemia 558 Tetrahydrobiopterin N Metabolic disorders 9.4.1 Individual (HPA) national list says "for non-Cystic Fibrosis indications" yet only in SPS in combiantion with ivacaftor for CF. Category 559 Tezacaftor N Mucolytics 3.7 Group Cystic Fibrosis changed to NHSE as on V11. Immunomodulating 560 Thalidomide N drugs 8.2.4 Individual Cancer

Licensed indications (Not all blood products are Blood-related products listed in the BNF, but they 561 N except Fibrin Sealants none Group are all excluded from PbR) Thrombomodulin, Individual 562 Recombinant Human C Fibrinolytics 2.10.2 Individual Septic shock (Sepsis) Funding 2017 Individual IL-23 inhibitor, unlikely before 563 Tildrakizumab C Skin Conditions 13.5 Individual Psoriasis Funding 2020 AIDS/HIV HIV (or Hepatitis with 564 Tipranavir N antiretrovirals 5.3.1 Individual some drugs) Management of cystic 565 Tobramycin N Antibacterial Drugs 5.1.4 Individual fibrosis For children transitioning to adult services and becoming a CCG http://gmmmg.nhs.uk/docs/s commissioning responsibility, ubgroups/sbgrp-hcdsg/Child- category is monitored when in Paediatric indications to-adult-services-statement- line with the referenced GMMMG 566 Tocilizumab IV N Cytokine modulators 10.1.3 Group (where adult TA available) amended-post-meeting.pdf guidance. 567 Tocilizumab IV N Cytokine modulators 10.1.3 Group Juvenile arthritis Giant Cell arteritis 568 Tocilizumab IV N Cytokine modulators 10.1.3 Group Takayasu arteritis http://www.nice.org.uk/guida nce/ta375

http://gmmmg.nhs.uk/docs/g NICE TA375 / GM uidance/GMMMG%20RA%2 Harmonised 0Pathway%2022%20april_2 569 Tocilizumab C Cytokine modulators 10.1.3 Group Rheumatoid arthritis Monitored biologics pathway 015.pdf 570 N Cytokine modulators Group Any paediatric use https://www.nice. org.uk/guidance/t a480 http://gmmmg.nh s.uk/docs/guidan ce/GMMMG-RA- https://www.nice.org.uk/guid reference to NICE and GMMMG 571 Tofacitinib C Cytokine modulators 10.1.3 Group Rheumatoid Arthritis Monitored pathway-v4-1.pdf ance/ta480 RA pathway updated Psoriatic arthritis, These are potential future 572 Tofacitinib C Cytokine modulators 10.1.3, 1.5.4 Group ulcerative colitis Individual funding indications

NHS England has stated that it is the responsible commissioner Tolvaptan Vasopressin V2 for this drug only when used in 573 Samsca N receptor antagonist 6.5.2 Individual Hyponatraemia in cancer this indication. Hyponatraemia and other Tolvaptan Vasopressin V2 endocrine uses including 574 Samsca C receptor antagonist 6.5.2 Individual SIADH Individual funding

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 31 of 36 Tolvaptan Vasopressin V2 Autosomal dominant http://www.nice.org.uk/guida New row inserted for this 575 Jinarc C receptor antagonist 6.5.2 Individual polycystic kidney disease Monitored NICE TA358 nce/ta358 indication. CCG commissioned

Allergen SPS says CCG-commissioned 576 Tralokinumab N Immunotherapy 3.4 Group Asthma - severe but on NHSE V11.

Blood-related products 577 Trenonacog alpha N except Fibrin Sealants 2.11 Group Haemophilia B Vasodilator antihypertensive Treprostinil drugs/Pulmanory Pulmonary arterial 578 diethanolamine N Arterial Hypertension 2.5.1 Individual hypertension Vasodilator antihypertensive drugs/Pulmanory Pulmonary arterial 579 Treprostinil sodium N Arterial Hypertension 2.5.1 Individual hypertension Not a new drug. No licensed Drugs used in preparation available in UK; 580 Trientine N Metabolic disorders Individual Wilson's Disease imported.

Licensed indications (Not all blood products are intravenous formulation of listed in the BNF, but they recombinant factor VIII (octocog 581 N Blood related products 2.11 Group are all excluded from PbR) alfa, rFVIII)

SPS suggests this use is NHSE- commissioned. Also used for hereditary orotic aciduria, an Fluorouracil (5-FU) ultra-rare metabolic disorder. 582 Uridine triacetate N* Poisoning 9.8.1 Individual overexposure or toxicity 2019 Drugs affecting the Paediatric indications 583 Ustekinumab N immune response 10.3 / 13.5 Individual (where adult TA available) http://guidance.nice.org.uk/T A180

GMMMG guidance for sequential use: http://gmmmg.nhs.uk/docs/g uidance/GMMMG-Biologics- Drugs affecting the pathway-for-psoriasis-v2- reference to GMMMG pathway 584 Ustekinumab C immune response 13.5 Individual Psoriasis (plaque) Monitored NICE TA180 0.pdf updated http://www.nice.org.uk/guida nce/ta340

http://gmmmg.nhs.uk/docs/g uidance/GMMMG%20AS%2 Drugs affecting the 0PsA%20pathway%20v4%2 585 Ustekinumab C immune response 10.3 Individual Psoriatic arthritis Monitored NICE TA340 0FINAL.pdf

https://www.nice.org.uk/guid ance/ta456 http://gmmmg.nhs.uk/docs/g uidance/Biologics-pathway- Drugs affecting the for-Inflammatory-Bowel- reference to NICE and GMMMG 586 Ustekinumab C immune response 1.5 Individual Crohn's Disease Monitored NICE TA456 Disease-in-Adults-v2-0.pdf pathway updated Drugs affecting the 587 Ustekinumab C immune response 10.3 Individual Any other use Individual funding

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 32 of 36 Drugs used in Trials found for use in dialysis- hypoplastic, Anaemia in chronic kidney dependent patients (NHSE) and haemolytic, and renal disease (non dialysis- non-dialysis-dependent patients 588 Vadadustat C anaemias 9.1 Group dependent) Individual funding (CCG) Drugs used in Trials found for use in dialysis- hypoplastic, Anaemia in chronic kidney dependent patients (NHSE) and haemolytic, and renal disease (dialysis- non-dialysis-dependent patients 589 Vadadustat N anaemias 9.1 Group dependent) (CCG)

Cytomegalovirus CMV retinitis / Prophylaxis 590 Valganciclovir N infection 5.3.2.2 Individual CMV +ve donor transplant Unique delivery system only (thermosensitive mPEG- PLCPPA hydrogel?) 591 Vancomycin C? Antibacterial Drugs 5.1.7 Individual Not in SPS Protein kinase 592 N inhibitors 8.1.5 Individual Thyroid cancer Growth Hormone & growth hormone Somatostatin analogue for Individual 593 Vapreotide C Receptor Antagonist Individual Oesophageal varices Funding Drugs affecting the Paediatric indications 594 Vedolizumab N immune response 1.5.3 Individual (where adult TA available) Drugs affecting the http://www.nice.org.uk/guida 595 Vedolizumab C immune response 1.5.3 Individual Crohn's Disease Monitored NICE TA352 nce/ta352 Drugs affecting the http://www.nice.org.uk/guida 596 Vedolizumab C immune response 1.5.3 Individual Ulcerative colitis Monitored NICE TA342 nce/ta342 Lysosomal Storage 597 Velaglucerase alfa N Disorder Drugs 9.8.1 Group Gaucher's disease Drugs affecting bone 598 Velcalcetide N metabolism 6.5 Individual Hyperparathyroidism Protein kinase 599 Vemurafenib N inhibitors 8.1.5 Individual Melanoma Wet age related macular degeneration (with predominantly classic subfoveal chroidal Subfoveal choroidal neovascularisation http://guidance.nice.org.uk/T 600 Verteporfin C neovascularisation 11.8.2 Individual (CNV)), opthalmology Monitored NICE TA68 A68 Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 601 Vigam N immunoglobulins 14.5.1 Group Neurology Intravenous/subcutane Antibody deficiency ous human normal syndromes, Immunology, 602 Vivaglobin N immunoglobulins 14.5.1 Group Neurology

Licensed indications (Not all blood products are Von Willebrand factor, listed in the BNF, but they 603 recombinant N Blood related products 2.11 Group are all excluded from PbR) For all invasive fungal infections including those Note that treatment of Allergic associated with bronchopulmonary aspergillosis 604 Voriconazole N Antifungals 5.2.1 Individual transplants (ABPA) is CCG-commisisoned. Chronic pulmonary 605 Voriconazole N Antifungals 5.2.1 Individual aspergillosis

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 33 of 36 I think the National list is mixed up: winfuran would have been for treatment of severe uraemic pruritus in patients with end- stage kidney disease on dialysis but the EMA refused a MA on 19/12/13. KP-1461 is an anti HIV drug, the AIDS/HIV development status of which is 606 Winfuran (KP 1461) N* antiretrovirals Individual currently unclear. 607 Ziconotide N Non-opioid analgesics 4.7.1 Individual Severe, chronic pain AIDS/HIV HIV (or Hepatitis with 608 Zidovudine N antiretrovirals 5.3.1 Group some drugs) Zidovudine with AIDS/HIV HIV (or Hepatitis with 609 Lamivudine N antiretrovirals 5.3.1 Group some drugs)

Zidovudine with AIDS/HIV HIV (or Hepatitis with 610 Lamivudine and Abacavir N antiretrovirals 5.3.1 Group some drugs)

Other drugs not listed as PbR exclusions but NHSE commissioned Note: NHSE has been clear that existing GP [=CCG] prescribing of these should NOT be repatriated to NHSE. This section is similar to NHSE's drug list Indications for NHS England drugs list v13 23/03/2018 Commissioner Category CDF = Cancer drugs fund - check with latest version of Prior Approval Commissioning Commissioning Policy No. Drug Name NHSE list PBR Category BNF category Group Indication Category Policy Type Link Comments

Lambert Eaton 3,4 Diaminopyridine N Myasthenic Syndrome Aflibercept N Cancer Cancer Treatment of breast cancer patients with documented taxane Albumin bound paclitaxel N Cancer hypersensitivity Atezolizumab CDF Cancer Cancer new to accord with NHSE V13

Autologous Chondrocyte implantation N Articular cartilage defect new to accord with NHSE V13 New patients only until formal Transplant repatriation Azathioprine N Immunosuppressants immunosuppression only agreed Bendamustine N / CDF Cancer Cancer Blinatumomab N Cancer Cancer new to accord with NHSE V13 Brentuximab N / CDF Cancer Cancer Cabazitaxel N Cancer Cancer N / CDF Cancer Cancer Carfilzomib N Cancer Cancer new to accord with NHSE V13 Consult NHSE guidance / N / CDF Cancer Cancer spreadsheet for individual drugs New patients only until formal Transplant repatriation Ciclosporin N Immunosuppressants immunosuppression only agreed

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 34 of 36 only as per NICE TA117 [i.e. dialysis patients]; otherwise is in Hypercalcaemia and Hyperparathyroidism - Tariff. See Specialist Services Cinacalcet N hypercalciuria dialysis patients only Manual. Clofarabine CDF Cancer Cancer Drugs for mineral bone Colestilan N disorders Adult renal dialysis only Daratumumab CDF Cancer new to accord with NHSE V13 Darbepoetin N Erythropoetins Dialysis-induced anaemia only as per NICE CG 114 Epoetin (all variants) N Erythropoetins Dialysis-induced anaemia only as per NICE CG 114 Eribulin N / CDF Cancer Cancer Drugs for mineral bone Hyperparathyroidism - Etelcalcetide N disorders dialysis patients only new to accord with NHSE V13 Hereditary Factor X (Cogadex) N Blood related products deficiency new to accord with NHSE V12 Protein kinase Ibrutinib N / CDF inhibitors Cancer Protein kinase Idelalisib N inhibitors Cancer Ipilimumab N Cancer Cancer Phosphate binding Lanthanum N agents Adult renal dialysis only Protein kinase N inhibitors Mesenchymal stem cells Acute GvHD and other (e.g. Prochymal®) N indications (BCSH) New patients only until formal Transplant repatriation Mycophenolate mofetil N Immunosuppressants immunosuppression only agreed New patients only until formal Transplant repatriation Mycophenolic acid N Immunosuppressants immunosuppression only agreed Nelarabine CDF Cancer Cancer Nivolumab N / CDF Cancer Cancer Obinutuzumab N / CDF Cancer Cancer Olaparib N Cancer Cancer Olartumumab CDF Cancer Cancer CDF Cancer Cancer Palbociclib N Cancer Cancer N Cancer Cancer Panobinostat N Cancer Cancer Pegaspargase N Cancer Cancer Pegylated liposomal doxorubicin N / CDF Cancer Cancer Pemetrexed N / CDF Cancer Cancer Peptide receptor radionucleotide therapy CDF Cancer Cancer N Cancer Cancer Pixantrone N Cancer Cancer Pomalidomide CDF Cancer Cancer Ponatinib N* Cancer Cancer Endocrinology; non- Protein kinase inhibitors N malignant conditions Radium-223 dichloride N / CDF Cancer Cancer N Cancer Cancer Ribociclib N Cancer Cancer Phosphate binding Sevelamer N agents Adult renal dialysis only

GMMMG PBR Ex Drugs 2017-19 V2 for 18-19 35 of 36 New patients only until formal Transplant repatriation Sirolimus N Immunosuppressants immunosuppression only agreed deaminase deficiency - severe combined Strimvelis N ATMP immunodifieicency New patients only until formal Transplant repatriation Tacrolimus N Immunosuppressants immunosuppression only agreed Talimogene laherparepvec N Cancer Cancer Endocrinology; non- Temozolomide N Cancer malignant conditions CDF Cancer Cancer Trabectedin N Antineoplastic drugs Cancer N Cancer Cancer N Cancer Cancer Trifluridine + tipiracil N Cancer Cancer Venetoclax CDF Cancer Cancer

Notes: • Treatment of severe manifestations of some diseases is NCB commissioned e.g. Severe and / or fistulating Crohn's. Lanreotide / octreotide are CCG commissioned for non-cancer uses • CCGs commission for all patients with autoimmune rheumatic diseases or rare arthropathies where the diagnosis is already established and the manifestations are well-controlled by conventional management and the patient and the rheumatologist are satisfied with treatment response and progress of the disease. • Recommendations for cancer chemotherapy are to be excluded from 1/4/13. However, non-chemotherapy indications for the following will be CCG commissioned if use relates to a non-NHSE service: cladribine, lenalidomide, thalidomide, rilonacept, azacitidine, bevacizumab, bortezomib, cetuximab, protein kinase inhibitors, alemtuzumab. • Drugs for which NHS England is the Commissioner are not necessarily routinely commissioned. • Many drugs for which NHS England is the Commissioner are only commissoned by NHSE when from Specialist Centres; funding for requests outside of specialist centres would fall to CCGs.

For information: [reference A Strategic Framework for Intestinal Failure and Home Parenteral Nutrition Services for Adults in England. National Commissioning Group for Highly Specialised Services April 2008] Type I – this type of Intestinal Failure is short-term, self limiting and often peri-operative in nature. Type I Intestinal Failure is common and these patients are managed successfully in a multitude of healthcare settings, especially surgical wards, including all units which perform major, particularly abdominal surgery. Some patients on high dependency units (HDU) and intensive care units (ICU) will also fall into this category. Type II – Type II IF occurs in metabolically unstable patients in hospital and requires prolonged parenteral nutrition over periods of weeks or months. It is often associated with sepsis, and may be associated with renal impairment. These patients often need the facilities of an Intensive Care or High Dependency Unit for some or much of their stay in hospital. This type of IF is rarer and needs to be managed by a multi-professional specialist intestinal failure team. Effective management of Type II IF can reduce the likelihood of the development of Type III Intestinal Failure. Type III – Type III is a chronic condition requiring long term parenteral feeding. The patient is characteristically metabolically stable but cannot maintain his or her nutrition adequately by absorbing food or nutrients via the intestinal tract. These are, in the main, the group of patients for which Home Parenteral Nutrition (HPN) is indicated.

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