SWL Commissioning Principles for PbR Excluded Drugs / Devices 2020-2021 APPENDIX 1: SWL CCG Commissioned PbR excluded drugs / devices list 2020-2021 (version 1- 23/01/2020 (subject to in-year change - awaiting publication of 2020/21 National Tarif)

Last updated for 2020/21 and approved by SWL Medicines Commissioning Group: 23 01 2020 Added / altered due to changes in 2020/21 National Tariff: currencies and prices (not yet ListsFor latest all 2020-21 version PbR see: excluded www.swlmcg.nhs.uk drugs and devices for which CCGs have commissioning responsibility available- update to follow) PbR excluded drugs/ devices commissioned by NHS England (NHSE) are not included (see Added / altered due to to changes in NHSE commissioning policy 15.0 (compared to v14.1)- http://www.england.nhs.uk/commissioning/spec-services/key-docs) no changes required In this document adults are classified as anyone attending adult services (usually 18 years or over) Devices

Drug/Device type Alternative name PBR Category Indication NICE TA/Policy Management strategy SWL Potentially Notes CCGs prescribed by GPs via shared care Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Abatacept Orencia® Cytokine modulators Juvenile Arthritis (adults): NICE TA373 (Dec 2015) Tick box form- No NHSE is responsible for: -Polyarticular Notification within 2 weeks -Juvenile Arthritis (paediatric) NHS England E03X04 (Jul 2015): E03/P/d biologics for Juvenile Idiopathic Arthritis in Children and Adults Abatacept Orencia® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Juvenile Arthritis (paediatric services) service -Paediatric indications (where adult TA available) Abatacept Orencia® Cytokine modulators Psoriatic Arthritis (adults) NICE TA568 (March 2019)- IFR No terminated Not routinely commissioned Abatacept Orencia® Cytokine modulators Rheumatoid Arthritis - after NICE TA195 (Aug 2010) Tick box form- No failure of anti-TNF (adults) Notification within 2 weeks Abatacept Orencia® Cytokine modulators Rheumatoid Arthritis (adults) NICE TA375 (Jan 2016) Tick box form- No Notification within 2 weeks Abicipar pegol Subfoveal choroidal Wet age-related macular NICE TA due, date TBC IFR (Tick box form- No Not yet licensed in UK neovascularisation degeneration (wet-AMD) Not routinely commissioned until Notification within 2 weeks if (launch plan: 2020) approved by NICE approved by NICE) Biosimilars: Cytokine modulators Ankylosing Spondylitis NICE TA383 (Feb 2016) Tick box form- No Idacio® (adults) Notification within 2 weeks Amgevita® As per Framework Agreement for the supply of Adalimumab Humira® Injection, Reference number: CM/PHR/19/5575 Adalimumab Biosimilars: Cytokine modulators Axial Spondyloarthritis (non- NICE TA383 (Feb 2016) Tick box form- No Idacio® radiographic) (adults) Notification within 2 weeks Amgevita® As per Framework Agreement for the supply of Adalimumab Humira® Injection, Reference number: CM/PHR/19/5575

1 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Adalimumab Biosimilars: Cytokine modulators Crohn's Disease (adults) NICE TA187 (May 2010) Tick box form- No Idacio® Notification within 2 weeks Amgevita® As per Framework Agreement for the supply of Adalimumab Humira® Injection, Reference number: CM/PHR/19/5575 Adalimumab Biosimilars: Cytokine modulators Juvenile Arthritis (adults): NICE TA373 (Dec 2015) Tick box form- No NHSE is responsible for: Idacio® -Polyarticular Notification within 2 weeks -Juvenile Arthritis (paediatric) Amgevita® -Enthesis-related NHS England E03X04 (Jul 2015): E03/P/d biologics for Humira® Juvenile Idiopathic Arthritis in Children and Adults

As per Framework Agreement for the supply of Adalimumab Injection, Reference number: CM/PHR/19/5575

Adalimumab Biosimilars: Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: Idacio® used in CCG commissioned -Behcets syndrome Amgevita® service As per Framework Agreement for -Hidradenitis Suppurativa the supply of Adalimumab -Juvenile Arthritis (paediatric) Humira® Injection, Reference number: -Plaque psoriasis (paediatric) CM/PHR/19/5575 -Paediatric indications (where adult TA available) -Uveitis (adults) Adalimumab Biosimilars: Cytokine modulators Psoriasis (adults) NICE TA146 (Jun 2008) Tick box form- No Idacio® Notification within 2 weeks Amgevita® As per Framework Agreement for the supply of Adalimumab Humira® Injection, Reference number: CM/PHR/19/5575 Adalimumab Biosimilars: Cytokine modulators Psoriatic Arthritis (adults) NICE TA199 (Aug 2010) Tick box form- No Idacio® Notification within 2 weeks Amgevita® As per Framework Agreement for the supply of Adalimumab Humira® Injection, Reference number: CM/PHR/19/5575 Adalimumab Biosimilars: Cytokine modulators Rheumatoid Arthritis - after NICE TA195 (Aug 2010) Tick box form- No Idacio® failure of anti-TNF (adults) Notification within 2 weeks Amgevita® As per Framework Agreement for the supply of Adalimumab Humira® Injection, Reference number: CM/PHR/19/5575

2 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Adalimumab Biosimilars: Cytokine modulators Rheumatoid Arthritis (adults) NICE TA375 (Jan 2016) Tick box form- No Idacio® Notification within 2 weeks Amgevita® As per Framework Agreement for the supply of Adalimumab Humira® Injection, Reference number: CM/PHR/19/5575 Adalimumab Biosimilars: Cytokine modulators Ulcerative Colitis (moderate NICE TA329 (Feb 2015) Tick box form- No Idacio® to severely active) (adults) Notification within 2 weeks Amgevita® As per Framework Agreement for the supply of Adalimumab Humira® Injection, Reference number: CM/PHR/19/5575 Aflibercept Eylea® Subfoveal choroidal Choroidal neovascularisation NICE TA486 (Nov 2017) Tick box form- No neovascularisation (pathological myopia) Notification within 2 weeks Aflibercept Eylea® Subfoveal choroidal Diabetic retinopathy Not routinely commissioned IFR No Not yet licensed in UK neovascularisation (launch plan: TBC) Aflibercept Eylea® Subfoveal choroidal Macular oedema (branch NICE TA409 (Oct 2016) Tick box form- No neovascularisation retinal vein occlusion) Notification within 2 weeks Aflibercept Eylea® Subfoveal choroidal Macular oedema (central NICE TA305 (Feb 2014) Tick box form- No neovascularisation retinal vein occlusion) Local care pathway Notification within 2 weeks Aflibercept Eylea® Subfoveal choroidal Macular oedema (diabetic) NICE TA346 (Jul 2015) Tick box form- No neovascularisation Notification within 2 weeks Aflibercept Eylea® Subfoveal choroidal Other indications used in Not routinely commissioned IFR No NHSE is responsible for: neovascularisation CCG commissioned service -Cancer Aflibercept Eylea® Subfoveal choroidal Wet age-related macular NICE TA294 (Jul 2013) Tick box form- No neovascularisation degeneration (wet-AMD) Local care pathway Notification within 2 weeks Aganirsen Subfoveal choroidal Corneal neovascularisation Not routinely commissioned IFR No Not yet licensed in UK neovascularisation (associated with keratoplasty (launch plan: TBC) rejection) Alicaforsen Camligo® Novel so no group name Pouchitis Not routinely commissioned IFR No Not yet licensed in UK agreed (launch plan: 2021) Alirocumab Praluent® Lipid regulating drugs Dyslipidaemia Not routinely commissioned IFR No Alirocumab Praluent® Lipid regulating drugs Hypercholesterolaemia NICE TA393 (Jun 2016) Tick box form- Yes (primary) and dyslipidaemia Notification within 2 weeks (mixed) Alitretinoin Toctino® Skin Conditions Severe chronic hand eczema NICE TA177 (Aug 2009) Tick box form- No Notification within 2 weeks Alpha-1 antitrypsin Glassia® Drugs used in metabolic Alpha-1 antitrypsin deficiency Not routinely commissioned IFR No Not yet licensed in UK disorders (launch plan: 2021)

Amikacin- liposomal Arikayce® Antibacterial Drugs Nontuberculous Not routinely commissioned IFR No Not yet licensed in UK mycobacterial lung disease (launch plan: 2020) caused by Mycobacterium NHSE is responsible for: Avium Complex (MAC) -only -Cystic fibrosis when delivered via nebulisation/inhalation

3 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Anakinra Kineret® Cytokine modulators Juvenile Arthritis (adults) NHS England E03X04 (Jul Blank Tick Box Form No NHSE is responsible for: 2015): E03/P/d biologics for -Juvenile Arthritis (paediatric) Juvenile Idiopathic Arthritis in Children and Adults Anakinra Kineret® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Adult onset Stills disease service -Cryopyrin Associated Periodic Syndrome (CAPS) -Juvenile Arthritis (paediatric) -Paediatric indications (where adult TA available) -Periodic fevers and autoinflammatory conditions Anakinra Kineret® Cytokine modulators Rheumatoid Arthritis (adults) NICE CG79 (Dec 2015)-not IFR No recommended Not routinely commissioned Andexanet alfa Ondexxya® Oral Anticoagulation reversal - NICE TA due Aug 2020 IFR (Tick box form- No reversal agents to oral factor Xa Not routinely commissioned until Notification within 2 weeks if inhibitors approved by NICE approved by NICE) Anti-pseudomonas Antibacterial Drugs Pseudomonas aeruginosa in Not routinely commissioned IFR No Not licensed in UK aeruginosa IgY ventilated ICU patients (development discontinued) NHSE is responsible for: -Cystic fibrosis Apomorphine Torsion dystonias and Parkinson's Disease Local agreement for St. Notification - indication No Not PbR excluded- local agreement (St. other involuntary George's hospital (movement provided George's hospital only) movements disorder clinic) only: - For homecare use only - Max 20 patients Apremilast Otezla® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Paediatric indications (where adult TA service available) Apremilast Otezla® Cytokine modulators Psoriasis (adults) NICE TA419 (Nov 2016) Tick box form- No Notification within 2 weeks Apremilast Otezla® Cytokine modulators Psoriatic Arthritis (adults) NICE TA433 (Feb 2017) Tick box form- No Notification within 2 weeks Avacincaptad pegol Zimura® Subfoveal choroidal Age-related macular Not routinely commissioned IFR No Not yet licensed in UK neovascularisation degeneration (AMD); (launch plan: 2023) geographic atrophy (advanced dry-type AMD) Avatrombopag Doptelet® Platelet Disorder Drugs Idiopathic Thrombocytopenic Not routinely commissioned IFR No Not yet licensed in UK Purpura (ITP) (adults) (launch plan: 2021) Avatrombopag Doptelet® Platelet Disorder Drugs Thrombocytopenia in patients NICE TA 626 (Jun 2020) Tick box form- No with chronic liver disease Notification within 2 weeks needing a planned invasive procedure (adults)

4 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Baricitinib Olumiant® Immunomodulating drugs Atopic dermatitis (adults) NICE TA due, date TBC IFR (Tick box form- No Not yet licensed in UK Not routinely commissioned until Notification within 2 weeks if (launch plan: 2020) approved by NICE approved by NICE) NHSE is responsible for: -Paediatric indications (where adult TA available) Baricitinib Olumiant® Immunomodulating drugs Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Paediatric indications (where adult TA service available) Baricitinib Olumiant® Immunomodulating drugs Rheumatoid Arthritis (adults) NICE TA466 (Aug 2017) Tick box form- No NHSE is responsible for: Notification within 2 weeks -Paediatric indications (where adult TA available) Bezlotoxumab Zinplava® Antibacterial Drugs Clostridium difficile infection - NICE TA terminated IFR No prevention of recurrence NICE evidence summary ES13 after second-plus episodes (Jun 2017) Botulinum A toxin Botox® Torsion dystonias and Blepharospasm Spasticity after : NICE TA Notification - indication No NHSE is responsible for: Dysport® other involuntary Hemifacial spasm due TBC provided -Focal spasticity in children Xeomin® movements Cervical dystonia (spasmodic -Intravesical use in spinal cord injury torticollis) Commissioned for listed Focal spasticity (adults only), indications Local agreement: incl: -ESH/MCCG/SCCG: Block contract • wrist and hand disability SWL policy review in progress due to upper limb spasticity associated with stroke in adults. • ankle disability due to lower limb spasticity associated with stroke in adults

Botulinum A toxin Botox® Torsion dystonias and Chronic migraine NICE TA260 (Jun 2012) Tick box form- No NHSE is responsible for: other involuntary Notification within 2 weeks -Paediatric indications (where adult TA movements available) Botulinum A toxin Botox® Torsion dystonias and Overactive bladder syndrome Not routinely commissioned IFR / Local agreement No Local agreements: Dysport® other involuntary unless local agreement -CUH/CCCG: Tick box form- Notification Xeomin® movements within 2 weeks SWL policy review in progress -ESH/MCCG/SCCG: Block contract Botulinum A toxin Botox® Torsion dystonias and Severe hyperhidrosis of the See South West London ECI prior approval / Local No Local agreement: Dysport® other involuntary axillae Effective Commissioning agreement -Kingston Hospital: patients started before 1 Xeomin® movements Initiative-Policy 2019-20 April 2011 and on historic list are funded as (https://www.swlondon.nhs.uk/ou per local agreement. rwork/eci ) unless local agreement.

Botulinum A toxin Xeomin® Torsion dystonias and Sialorrhoea NICE TA605 (Oct 2019) Tick box form- No NHSE is responsible for: other involuntary Notification within 2 weeks -Paediatric indications (where adult TA movements available)

5 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Botulinum B toxin Neurobloc® Torsion dystonias and Spasmodic torticollis, and as Not routinely commissioned IFR No other involuntary alternative to Botulinum toxin movements A in presence of antibodies to Botulinum A toxin

Brodalumab Kyntheum® Immunomodulating drugs Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Paediatric indications (where adult TA service available) Kyntheum® Immunomodulating drugs Psoriasis (adults) NICE TA511 (Mar 2018) Tick box form- No NHSE is responsible for: Notification within 2 weeks -Paediatric indications (where adult TA available) Brolucizumab Cytokine modulators Wet age-related macular NICE TA due, date TBC IFR (Tick box form- No degeneration (wet-AMD) Not routinely commissioned until Notification within 2 weeks if approved by NICE approved by NICE) Ilaris® Immunomodulating drugs Cardiovascular (CV) disease - NICE TA suspended IFR No Not licensed in UK prevention of CV events after Not routinely commissioned (launch plan: terminated) (MI) in people with raised high sensitivity C-reactive protein (hsCRP) Canakinumab Ilaris® Immunomodulating drugs Gouty arthritis attacks and NICE TA281 (Apr 2013) IFR No reducing the frequency of (terminated appraisal) - not subsequent attacks (adults) recommended Not routinely commissioned Canakinumab Ilaris® Immunomodulating drugs Juvenile Arthritis (adults) NICE TA302 (Nov 2013) IFR No (terminated appraisal) - no recommendation Not routinely commissioned Canakinumab Ilaris® Immunomodulating drugs Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Juvenile Arthritis (paediatric) service -Cryopyrin associated periodic syndrome Cimzia® Cytokine modulators Ankylosing Spondylitis NICE TA383 (Feb 2016) Tick box form- No (adults) Notification within 2 weeks Certolizumab pegol Cimzia® Cytokine modulators Axial Spondyloarthritis (non- NICE TA383 (Feb 2016) Tick box form- No radiographic) (adults) Notification within 2 weeks Certolizumab pegol Cimzia® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Paediatric indications (where adult TA service available) Certolizumab pegol Cimzia® Cytokine modulators Psoriasis (adults) NICE TA574 (Apr 2019) Tick box form- No Notification within 2 weeks Certolizumab pegol Cimzia® Cytokine modulators Psoriatic Arthritis (adults) NICE TA445 (May 2017) Tick box form- No Notification within 2 weeks Certolizumab pegol Cimzia® Cytokine modulators Rheumatoid Arthritis - after NICE TA415 (Oct 2016) Tick box form- No failure of anti-TNF (adults) Notification within 2 weeks Certolizumab pegol Cimzia® Cytokine modulators Rheumatoid Arthritis (adults) NICE TA375 (Jan 2016) Tick box form- No Notification within 2 weeks

6 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Ciprofloxacin Antibacterial Drugs Bronchiectasis (non-CF Not routinely commissioned IFR No Not licensed in UK (inhalation) related) (adults)- only when (launch plan: terminated) given by inhalation/nebulisation Ciprofloxacin Linhaliq® Antibacterial Drugs Bronchiectasis (non-CF Not routinely commissioned IFR No Not licensed in UK (liposomal) related) (adults)- only when (launch plan: terminated) given by inhalation/nebulisation Oral anticoagulant Anticoagulation reversal - Not routinely commissioned IFR No Not yet licensed in UK reversal agents antidote to oral factor Xa (launch plan: 2023) inhibitors, fondaparinux, low molecular weight and unfractionated heparins Cobitolimod Kappaproct® Drugs affecting the Ulcerative Colitis (adults) Not routinely commissioned IFR No Not yet licensed in UK immune response (launch plan: 2022) NHSE is responsible for: -Paediatric indications (where adult TA available) Collagenase Xiapex® Enzymes Outpatient use only NICE TA459 (Jul 2017) Tick box form- No NHSE is responsible for: clostridium Dupuytren’s contracture Notification within 2 weeks -Paediatric indications (where adult TA histolyticum available) Collagenase Xiapex® Enzymes Outpatient use only Not routinely commissioned IFR No clostridium Peyronie's disease histolyticum Deferasirox Exjade® Drugs used in Myelodysplastic syndrome Not routinely commissioned IFR No NHSE is responsible for: hypoplastic, haemolytic, (MDS) -Iron chelation in thalassaemia and sickle cell and renal anaemias - Iron / Treatment of iron overload for transfused overload and non transfused patients with chronic inherited anaemias [Ref: NHS 16070/P] Deferiprone Ferriprox® Drugs used in Myelodysplastic syndrome Not routinely commissioned IFR No NHSE is responsible for: hypoplastic, haemolytic, (MDS) -Iron chelation in thalassaemia and sickle cell and renal anaemias - Iron / Treatment of iron overload for transfused overload and non transfused patients with chronic inherited anaemias [Ref: NHS 16070/P] Desferrioxamine Drugs used in Myelodysplastic syndrome Not routinely commissioned IFR No NHSE is responsible for: hypoplastic, haemolytic, (MDS) -Iron chelation in thalassaemia and sickle cell and renal anaemias - Iron / Treatment of iron overload for transfused overload and non transfused patients with chronic inherited anaemias [Ref: NHS 16070/P] Dexamethasone Ozurdex® Macular Oedema Macular oedema (branch NICE TA229 (Jul 2011) Tick box form- No intravitreal implant retinal vein occlusion) Local care pathway Notification within 2 weeks Dexamethasone Ozurdex® Macular Oedema Macular oedema (central NICE TA229 (Jul 2011) Tick box form- No intravitreal implant retinal vein occlusion) Local care pathway Notification within 2 weeks Dexamethasone Ozurdex® Macular Oedema Macular oedema (diabetic) NICE TA349 (Jul 2015) Tick box form- No intravitreal implant Notification within 2 weeks 7 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Dexamethasone Ozurdex® Macular Oedema Uveitis (posterior segment, NICE TA460 (Jul 2017) Tick box form- No intravitreal implant non-infectious) Notification within 2 weeks Dibotermin alfa InductOs® Bone morphogenetic Acute tibia fractures (adults) Not routinely commissioned IFR No NHSE is responsible for: protein -Complex spinal surgery DigiFab® Poisoning Digoxin Poisoning Advice from London Poisons Notification - indication No Centre provided On advice of the London Poisons Centre Dimethyl fumarate Skilarence® Immunomodulating drugs Psoriasis (adults) NICE TA475 (Sept 2017) Tick box form- No NHSE is responsible for: Notification within 2 weeks -Multiple scleroris Dupixent® Drugs affecting the Atopic Dermatitis (adults) NICE TA534 (Aug 2018) Tick box form- No NHSE is resonsible for: immune response Notification within 2 weeks -Asthma - Paediatric indications (where adult TA available) Dupilumab Dupixent® Drugs affecting the Nasal polyposis and chronic NICE TA due Jul 2021 IFR (Tick box form- No immune response sinusitis (adults) Not routinely commissioned until Notification within 2 weeks if approved by NICE approved by NICE) Dupilumab Dupixent® Drugs affecting the Other indications (adults) Not routinely commissioned IFR No NHSE is resonsible for: immune response used in CCG commissioned -Asthma service - Paediatric indications (where adult TA available) Soliris® Drugs used in Myasthenia Gravis NICE TA suspended IFR No NHSE is responsible for: hypoplastic, haemolytic, Not routinely commissioned -Atypical haemolytic uremic syndrome (aHUS) and renal anaemias -C3 glomerulopathy (post transplant) -Organ rejection post kidney transplant -Paroxysmal nocturnal haemoglobinuria (PNH).

Eltrombopag Revolade® Platelet Disorder Drugs Idiopathic Thrombocytopenic NICE TA293 (Jul 2013) Tick box form- Prior approval No Purpura (ITP) (adults) Local Care Pathway Eltrombopag Revolade® Platelet Disorder Drugs Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Idiopathic Thrombocytopenic Purpura (ITP) service (children) -Paediatric indications (where adult TA available) Eltrombopag Revolade® Platelet Disorder Drugs Severe aplastic anaemia NICE TA382 (Jan 2016)- IFR No (adults) terminated/ NICE TA suspended Not routinely commissioned Eltrombopag Revolade® Platelet Disorder Drugs Thrombocytopenia Not routinely commissioned IFR No associated with Hepatitis C (adults) Epoprostenol Vasodilator Unlicensed indications used Not routinely commissioned IFR No NHSE is responsible for: antihypertensive drugs/ in CCG commissioned -Pulmonary Arterial Hypertension Pulmonary Arterial services -Vascular disease within specialist centres Hypertension (excluding vascular disease, see notes) Eptinezumab Immunomodulating drugs Migraine prophylaxis (adults) Not routinely commissioned IFR No Not yet licensed in UK (launch plan: 2021) 8 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Eptotermin alfa Osigraft® Bone morphogenetic Acute tibia fractures (adults) Not routinely commissioned IFR No License withdrawn Dec 2015 protein NHSE is responsible for: -Complex spinal surgery Erenumab Aimovig® Immunomodulating drugs Migraine prophylaxis (adults) NICE TA due, date TBC IFR (Tick box form- No Not routinely commissioned until Notification within 2 weeks if approved by NICE approved by NICE) Etanercept Enbrel® Cytokine modulators Ankylosing Spondylitis NICE TA383 (Feb 2016) Tick box form- No (adults) Notification within 2 weeks Biosimilar: Local agreement: Benepali® -Only etanercept biosimilar price Erelzi® is reimbursed regardless of brand used, unless CCG has approved continued use of Enbrel® for individual patients through local process. -Enbrel® is not routinely commissioned for new patients

Etanercept Enbrel® Cytokine modulators Axial Spondyloarthritis (non- NICE TA383 (Feb 2016) Tick box form- No radiographic) (adults) Notification within 2 weeks Biosimilar: Local agreement: Benepali® -Only etanercept biosimilar price Erelzi® is reimbursed regardless of brand used, unless CCG has approved continued use of Enbrel® for individual patients through local process. -Enbrel® is not routinely commissioned for new patients

Etanercept Enbrel® Cytokine modulators Juvenile Arthritis (adults) NICE TA373 (Dec 2015) Tick box form- No NHSE is responsible for: -Polyarticular Notification within 2 weeks -Juvenile Arthritis (paediatric) Biosimilar: -Enthesis-related NHS England E03X04 (Jul Benepali® -Psoriatic 2015): E03/P/d biologics for Erelzi® Juvenile Idiopathic Arthritis in Children and Adults

Local agreement: -Only etanercept biosimilar price is reimbursed regardless of brand used, unless CCG has approved continued use of Enbrel® for individual patients through local process. -Enbrel® is not routinely commissioned for new patients

9 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Etanercept Enbrel® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Plaque psoriasis (paediatric) Biosimilar: service -Juvenile Arthritis (paediatric) Benepali® -Paediatric indications (where adult TA Erelzi® available)

Etanercept Enbrel® Cytokine modulators Psoriasis (adults) NICE TA103 (Jul 2006) Tick box form- No Notification within 2 weeks Biosimilar: Local agreement: Benepali® -Only etanercept biosimilar price Erelzi® is reimbursed regardless of brand used, unless CCG has approved continued use of Enbrel® for individual patients through local process. -Enbrel® is not routinely commissioned for new patients

Etanercept Enbrel® Cytokine modulators Psoriatic Arthritis (adults) NICE TA199 (Aug 2010) Tick box form- No Notification within 2 weeks Biosimilar: Local agreement: Benepali® -Only etanercept biosimilar price Erelzi® is reimbursed regardless of brand used, unless CCG has approved continued use of Enbrel® for individual patients through local process. -Enbrel® is not routinely commissioned for new patients

Etanercept Enbrel® Cytokine modulators Rheumatoid Arthritis - after NICE TA195 (Aug 2010) Tick box form- No failure of anti-TNF (adults) Notification within 2 weeks Biosimilar: Local agreement: Benepali® -Only etanercept biosimilar price Erelzi® is reimbursed regardless of brand used, unless CCG has approved continued use of Enbrel® for individual patients through local process. -Enbrel® is not routinely commissioned for new patients

10 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Etanercept Enbrel® Cytokine modulators Rheumatoid Arthritis (adults) NICE TA375 (Jan 2016) Tick box form- No Notification within 2 weeks Biosimilar: Local agreement: Benepali® -Only etanercept biosimilar price Erelzi® is reimbursed regardless of brand used, unless CCG has approved continued use of Enbrel® for individual patients through local process. -Enbrel® is not routinely commissioned for new patients

Etrolizumab Drugs affecting the Crohn's Disease (adults) Not routinely commissioned IFR No Not yet licensed in UK immune response (launch plan: 2023) NHSE is responsible for: -Paediatric indications (where adult TA available) Drugs affecting the Ulcerative Colitis (adults) Not routinely commissioned IFR No Not yet licensed in UK immune response (launch plan: 2021) NHSE is responsible for: -Paediatric indications (where adult TA available) Evolocumab Repatha SureClick® Lipid regulating drugs Hypercholesterolaemia NICE TA394 (Jun 2016) Tick box form- Yes NHSE is responsible for: (primary) and dyslipidaemia Notification within 2 weeks -Homozygous Familial Hypercholesterolaemia (mixed) Fasinumab Cytokine modulators Osteoarthritis Not routinely commissioned IFR No Not yet licensed in UK (launch plan: 2024) Fidaxomicin Dificlir® Antibacterial Drugs Clostridium difficile NICE evidence summary ESNM1 Notification - indication No (July 12) provided On advice from Consultant On advice from consultant Microbiologist only microbiologist only Filgotinib Drugs affecting the Crohn's Disease (adults) Not routinely commissioned IFR No Not yet licensed in UK immune response (launch plan: 2023) NHSE is responsible for: -Paediatric indications (where adult TA available) Filgotinib Drugs affecting the Psoriatic arthritis (adults) Not routinely commissioned IFR No Not yet licensed in UK immune response (launch plan: 2023) NHSE is responsible for: -Paediatric indications (where adult TA available) Filgotinib Drugs affecting the Rheumatoid Arthritis (adults) NICE TA due, date TBC IFR (Tick box form- No Not yet licensed in UK immune response Not routinely commissioned until Notification within 2 weeks if (launch plan: 2020) approved by NICE approved by NICE) NHSE is responsible for: -Paediatric indications (where adult TA available)

11 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Filgotinib Drugs affecting the Ulcerative Colitis (adults) NICE TA due, date TBC IFR (Tick box form- No Not yet licensed in UK immune response Not routinely commissioned until Notification within 2 weeks if (launch plan: 2023) approved by NICE approved by NICE) NHSE is responsible for: -Paediatric indications (where adult TA available) Fluocinolone Illuvien® Macular Oedema Macular oedema (diabetic) NICE TA301 (Nov 2013) Tick box form- No acetonide Fluocinolone Notification within 2 weeks acetonide intravitreal implant Fluocinolone Illuvien® Macular Oedema Macular oedema (diabetic) in NICE TA613 (Nov 2019)- not IFR No acetonide Fluocinolone phakic eyes recommended acetonide intravitreal implant Fluocinolone Illuvien® Macular Oedema Uveitis (preventing relapse of NICE TA590 (July 2019) Tick box form- No acetonide Fluocinolone recurrent non-infectious Notification within 2 weeks acetonide intravitreal posterior segment uveitis) implant "Special" Poisoning Ethylene glycol and Advice from London Poisons Notification - indication No poisoning - A&E Centre provided On advice of the London Poisons Centre Fostamatinib Tavalisse® Protein kinase inhibitors Thrombocytopenia (adults) NICE TA due Jan 2021 IFR (Tick box form- No Not yet licensed in UK disodium Not routinely commissioned until Notification within 2 weeks if (launch plan: 2020) approved by NICE approved by NICE) Fremanezumab Ajovy® Immunomodulating drugs Migraine prophylaxis (adults) NICE TA631 (Jun 2020) Tick box form- No Not routinely commissioned until Notification within 2 weeks approved by NICE Galcanezumab Emgality® Cytokine modulators Migraine prophylaxis (adults) NICE TA due, date TBC IFR (Tick box form- No Not routinely commissioned until Notification within 2 weeks if approved by NICE approved by NICE) Gantenerumab Hypnotics and anxiolytics Alzheimer's disease Not routinely commissioned IFR No Not yet licensed in UK (launch plan: 2023) Simponi® Cytokine modulators Ankylosing spondylitis NICE TA383 (Feb 2016) Tick box form- No (adults) Notification within 2 weeks Golimumab Simponi® Cytokine modulators Axial Spondyloarthritis (non- NICE TA497 (Jan 2018) Tick box form- No radiographic) (adults) Notification within 2 weeks Golimumab Simponi® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Paediatric indications (where adult TA service avaiilable) Golimumab Simponi® Cytokine modulators Psoriatic Arthritis (adults) NICE TA220 (Apr 2011) Tick box form- No Notification within 2 weeks Golimumab Simponi® Cytokine modulators Rheumatoid Arthritis - after NICE TA225 (Jun 2011) Tick box form- No failure of anti-TNF (adults) Notification within 2 weeks Golimumab Simponi® Cytokine modulators Rheumatoid Arthritis (adults) NICE TA225 (Jun 2011) Tick box form- No NICE TA375 (Jan 2016) Notification within 2 weeks Golimumab Simponi® Cytokine modulators Ulcerative Colitis (moderate NICE TA329 (Feb 2015) Tick box form- No to severely active) (adults) Notification within 2 weeks

12 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Tremfya® Drugs affecting the Psoriasis (adults) NICE TA521 (Jun 2018) Tick box form- No Immune response Notification within 2 weeks Guselkumab Tremfya® Drugs affecting the Psoriatic Arthritis (adults) NICE TA due, date TBC IFR (Tick box form- No Immune response Not routinely commissioned until Notification within 2 weeks if approved by NICE approved by NICE) Oral anticoagulant Reversal of the anticoagulant NICE evidence summary Notification - indication No reversal agents effect of ESNM73, May 2016 provided On advice from consultant haematologist Iloprost Vasodilator Unlicensed indications used Not routinely commissioned IFR No NHSE is responsible for: antihypertensive drugs/ in CCG commissioned -Pulmonary Arterial Hypertension Pulmonary Arterial services -Vascular disease within specialist centres Hypertension (excluding vascular disease, see notes) Imetelstat Protein kinase inhibitors Myelodysplastic syndrome Not routinely commissioned IFR No Not yet licensed in UK (MDS) (launch plan: 2025) NHSE is responsible for: -Cancer

Infliximab Remicade® Cytokine modulators Ankylosing Spondylitis NICE TA383 (Feb 2016) Tick box form- No (adults) Notification within 2 weeks Biosimilars: Local agreement: Flixabi® -Only biosimilar price is Inflectra® reimbursed regardless of brand Remsima® used, unless CCG has approved continued use of Remicade® for individual patients through local process. -Remicade® is not routinely commissioned for new patients

Infliximab Remicade® Cytokine modulators Crohn's Disease (adults) NICE TA187 (May 2010) Tick box form- No Notification within 2 weeks Biosimilars: Local agreement: Flixabi® -Only infliximab biosimilar price is Inflectra® reimbursed regardless of brand Remsima® used, unless CCG has approved continued use of Remicade® for individual patients through local process. -Remicade® is not routinely commissioned for new patients

Infliximab Remicade® Cytokine modulators Juvenile Arthritis (adults) NHS England E03X04 (Jul Blank Tick Box Form No NHSE is responsible for: 2015): E03/P/d biologics for or -Juvenile Arthritis (paediatric) Juvenile Idiopathic Arthritis in Tick box form- Children and Adults Notification within 2 weeks if available)

13 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Infliximab Remicade® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Behcets syndrome Biosimilars: service -Connective tissue disease (interstitial lung Flixabi® disease) Inflectra® -Crohn's disease in children Remsima® -Graft versus host disease -Hidradenitis Suppurativa -Juvenile Arthritis (paediatric) -Paediatric indications (where adult TA available) -Pulmonary sarcoidosis -Renal -Sarcoidosis -Uveitis

Infliximab Remicade® Cytokine modulators Psoriasis (adults) NICE TA134 (Jan 2008) Tick box form- No Notification within 2 weeks Biosimilars: Local agreement: Flixabi® -Only infliximab biosimilar price is Inflectra® reimbursed regardless of brand Remsima® used, unless CCG has approved continued use of Remicade® for individual patients through local process. -Remicade® is not routinely commissioned for new patients

Infliximab Remicade® Cytokine modulators Psoriatic Arthritis (adults) NICE TA199 (Aug 2010) Tick box form- No Notification within 2 weeks Biosimilars: Local agreement: Flixabi® -Only infliximab biosimilar price is Inflectra® reimbursed regardless of brand Remsima® used, unless CCG has approved continued use of Remicade® for individual patients through local process. -Remicade® is not routinely commissioned for new patients

Infliximab Remicade® Cytokine modulators Rheumatoid Arthritis - after NICE TA195 (Aug 2010) Tick box form- No failure of anti-TNF (adults) Notification within 2 weeks Biosimilars: Local agreement: Flixabi® -Only infliximab biosimilar price is Inflectra® reimbursed regardless of brand Remsima® used, unless CCG has approved continued use of Remicade® for individual patients through local process. -Remicade® is not routinely commissioned for new patients

14 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Infliximab Remicade® Cytokine modulators Rheumatoid Arthritis (adults) NICE TA375 (Jan 2016) Tick box form- No Notification within 2 weeks Biosimilars: Local agreement: Flixabi® -Only infliximab biosimilar price is Inflectra® reimbursed regardless of brand Remsima® used, unless CCG has approved continued use of Remicade® for individual patients through local process. -Remicade® is not routinely commissioned for new patients

Infliximab Remicade® Cytokine modulators Ulcerative Colitis (acute NICE TA163 (Dec 2008) Tick box form- No exacerbations) (adults) Notification within 2 weeks Biosimilars: Local agreement: Flixabi® -Only infliximab biosimilar price is Inflectra® reimbursed regardless of brand Remsima® used, unless CCG has approved continued use of Remicade® for individual patients through local process. -Remicade® is not routinely commissioned for new patients

Infliximab Remicade® Cytokine modulators Ulcerative Colitis (moderate NICE TA329 (Feb 2015) Tick box form- No to severely active) (adults) Notification within 2 weeks Biosimilars: Local agreement: Flixabi® -Only infliximab biosimilar price is Inflectra® reimbursed regardless of brand Remsima® used, unless CCG has approved continued use of Remicade® for individual patients through local process. -Remicade® is not routinely commissioned for new patients

Ixekizumab Taltz® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Paediatric indications (where adult TA service avaiilable) Taltz® Cytokine modulators Psoriasis (adults) NICE TA422 (Apr 2017) Tick box form- No Notification within 2 weeks Ixekizumab Taltz® Cytokine modulators Psoriatic Arthritis (adults) NICE TA537 (Aug 2018) Tick box form- No Notification within 2 weeks Ixekizumab Taltz® Cytokine modulators Spondyloarthritis- axial NICE TA due, date TBC IFR (Tick box form- No (adults) Not routinely commissioned until Notification within 2 weeks if approved by NICE approved by NICE) Ketorolac with Omidria® Retinal Intraocular lens replacement Not routinely commissioned IFR No Licensed but not launched Phenylephrine disorders/intraocular lens surgery (launch plan: TBC) replacement surgery

15 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Lampalizumab Subfoveal choroidal Geographic atrophy; Not routinely commissioned IFR No Not licensed in UK neovascularisation secondary to dry age-related (launch plan: terminated) macular degeneration Liothyronine Other endocrine drugs Myxoedema coma Only when administered Notification - indication No intravenously for myxoedema provided coma On advice of consultant endocrinologist Luspatercept Myelodysplastic Myelodysplastic syndrome NICE TA due, date TBC IFR (Tick box form- No NHSE is responsible for: Syndrome (MDS) Not routinely commissioned until Notification within 2 weeks if -Cancer approved by NICE approved by NICE) Lusutrombopag Mulpleta® Platelet Disorder Drugs Thrombocytopenia in patients NICE TA617 (Jan 2020) Tick box form- No with chronic liver disease Notification within 2 weeks needing a planned invasive procedure Masitinib Protein kinase inhibitors Alzheimer's disease Not routinely commissioned IFR No Not licensed in UK (launch plan: 2022) NHSE is responsible for: -Pancreatic cancer/GIST

Mavrilimumab Drugs affecting the Rheumatoid Arthritis (adults) Not routinely commissioned IFR No Not yet licensed in UK Immune response (launch plan: TBC) NHSE is responsible for: -Paediatric indications (where adult TA available) Nucala® Drugs used in metabolic Severe eosinophilic chronic NICE TA due, date TBC IFR (Tick box form- No Not yet licensed in UK disorders- obstructive pulmonary Not routinely commissioned until Notification within 2 weeks if (launch plan: 2022) Mucopolysaccharidosis disease (COPD) approved by NICE approved by NICE) NHSE is responsible for: (9.8.1) - Asthma Nexobrid Novel so no group name Burns Not routinely commissioned IFR No agreed Nitazoxanide Alinia® Viral Hepatitis (B&C) & Treatment of acute Not routinely commissioned IFR No Not yet licensed in UK Respiratory Syncytial uncomplicated influenza (launch plan: 2022) Virus virus infections. NHSE is responsible for: -Hepatitis C Ocriplasmin Jetrea ® Retinal Vitreomacular Traction NICE TA297 (Oct 2013) Tick box form- No disorders/intraocular lens Notification within 2 weeks replacement surgery Octreotide Somatostatin Analogues Prevention of complications Prevention of complications Notification - indication No NHSE is responsible for: following pancreatic surgery following pancreatic surgery provided -Acromegaly (when prescribed in specialist centre) -Cancer -Congential hyperinsulinism Xolair® Allergen Immunotherapy Urticaria- previously treated, NICE TA339 (Sep 2015) Tick box form- No NHSE is responsible for: chronic spontaneous Notification within 2 weeks -Asthma

16 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Parenteral nutrition- Parenteral Nutrition After 14 days (adults) NICE CG32 (Feb 06) Notification - indication No NHSE is responsible for: adults CCGs only commission short See manual for prescribed provided -Parenteral nutrition (home use): periods (usually peri- specialist services 2016/17 -Intestinal failure (see below*) operatively) for less than 28 -Parenteral nutrition (inpatient use): days and parenteral nutrition -Intestinal failure (see below*) of extended duration due to -Inadequate/unsafe enteral feeding circumstances where the primary medical issue is not *NHSE is responsible for: one of sub-optimal bowel Type II Intestinal Failure: metabolically unstable function, i.e. patients who do patients unable to meet nutritional needs via not have Intestinal Failure absorption through the intestines and requiring Type II and III. Examples intravenous nutrition for prolonged periods. include coma patients being managed in ITU, patients Type III intestinal failure: metabolically stable patients requiring prolonged artificial nutritional with significant burns support via IV feeding (parenteral nutrition) affecting the upper GI tract, delivered to them in community. This includes inpatient palliative care for home parenteral nutrition (HPN) products and end-stage oncology patients. associated specialist nursing support for those unable to self-administer intravenous feeds.

Pegbelfermin Non-alcoholic steatohepatitis Responsible commissioner TBC IFR No Not yet licensed in UK (NASH) Not routinely commissioned (launch plan: 2025) Pitolisant Wakix® Hypnotics and anxiolytics Narcolepsy caused by NICE TA due, date TBC IFR (Tick box form- No obstructive sleep apnoea NICE evidence summary ES8 Notification within 2 weeks if (adults) (March 2017) approved by NICE) Not routinely commissioned until approved by NICE Ranibizumab Lucentis® Subfoveal choroidal Choroidal neovascularisation NICE TA298 (Nov 2013) Tick box form- No neovascularisation (pathological myopia) Notification within 2 weeks Ranibizumab Lucentis® Subfoveal choroidal Macular oedema (branch NICE TA283 (May 2013) Tick box form- No neovascularisation retinal vein occlusion) Local care pathway Notification within 2 weeks Ranibizumab Lucentis® Subfoveal choroidal Macular oedema (central NICE TA283 (May 2013) Tick box form- No neovascularisation retinal vein occlusion) Local care pathway Notification within 2 weeks Ranibizumab Lucentis® Subfoveal choroidal Macular oedema (diabetic) NICE TA274 (Feb 2013) Tick box form- No neovascularisation Notification within 2 weeks Ranibizumab Lucentis® Subfoveal choroidal Other indications used in Not routinely commissioned IFR No neovascularisation CCG commissioned service Ranibizumab Lucentis® Subfoveal choroidal Wet age-related macular NICE TA155 (Aug 2008) Tick box form- No neovascularisation degeneration (wet-AMD) Local care pathway Notification within 2 weeks Reltecimod Immunomodulating drugs Septic shock (sepsis) due to Not routinely commissioned IFR No Not yet licensed in UK severe bacterial infections, (launch plan: 2022) initially necrotising soft tissue infection (NSTI) Remestemcel-L Advanced Therapy Drugs affecting the Crohn's Disease (adults) Responsible commissioner TBC IFR No Not yet licensed in UK Medicinal Product immune response Not routinely commissioned (launch plan: TBC) (ATMP) Rexmyelocel-T Advanced Therapy Drugs affecting the Critical limb ischaemia Not routinely commissioned IFR No Not yet licensed in UK Medicinal Product immune response (launch plan: TBC) (ATMP) 17 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Rintatolimod Ampligen® Immunomodulating drugs Chronic fatigue syndrome Not routinely commissioned IFR No Not yet licensed in UK (launch plan: TBC) Skyrizi® Drugs affecting the Psoriasis (adults) NICE TA596 (Aug 2019) Tick box form- No immune response Not routinely commissioned until Notification within 2 weeks approved by NICE Risankizumab Skyrizi® Drugs affecting the Ulcerative Colitis (adults) Not routinely commissioned IFR No Not yet licensed in UK immune response (launch plan: 2024) Risankizumab Skyrizi® Drugs affecting the Psoriatic arthritis (adults) Not routinely commissioned IFR No Not yet licensed in UK immune response (launch plan: 2021) Risankizumab Skyrizi® Drugs affecting the Crohn's Disease (adults) Not routinely commissioned IFR No Not yet licensed in UK immune response (launch plan: 2022) Rituximab Mabthera® Cytokine modulators Autoimmune Haemolytic Not routinely commissioned IFR No Anaemia (AIHA) Biosimilars: Rixathon® Truxima® Rituximab Mabthera® Cytokine modulators Idiopathic Thrombocytopenic Local Care Pathway Tick box form- Prior approval No Purpura (ITP) (adults) Biosimilars: Local agreement: Rixathon® -Only rituximab biosimilar price is Truxima® reimbursed regardless of brand used, unless CCG has approved continued use of Mabthera® for individual patients through local process. -Mabthera® is not routinely commissioned for new patients

Rituximab Mabthera® Cytokine modulators Juvenile Arthritis (adults) NHS England E03X04 (Jul Blank Tick Box Form No NHSE is responsible for: 2015): E03/P/d biologics for or -Juvenile Arthritis (paediatric) Biosimilars: Juvenile Idiopathic Arthritis in Tick box form- Rixathon® Children and Adults Notification within 2 weeks if Truxima® available) Local agreement: -Only rituximab biosimilar price is reimbursed regardless of brand used, unless CCG has approved continued use of Mabthera® for individual patients through local process. -Mabthera® is not routinely commissioned for new patients

18 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Rituximab Mabthera® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -ABO-incompatible kidney transplants Biosimilars: service -ANCA positive vasculitis Rixathon® -Acquired haemophilia Truxima® -Anti-NMDAR autoimmune encephalitis -Cancer -Chronic graft versus host disease -Chronic inflammatory demylinating polyneuropathy -Connective tissue disease (interstitial lung disease) -Cytopenia complicating primary immunodeficiency -Dermatomyositis and polymyositis (adults) -Focal segmental glomerulosclerosis -Graft versus host disease -Haemophilia (acquired) -Immunoglobulin G4 related disease -Juvenile arthritis (paediatric services) -Membranous nephropathy -Myasthenia gravis -Myositis -Nephritis -Neuromyelitis optica -Pemphigus vulgaris and Pemphigoid disease -Primary Sjogren's syndrome (PSS) -SLE -Steroid resistant nephrotic syndrome -Steriod sensitive nephrotic syndrome

Rituximab Mabthera® Cytokine modulators Rheumatoid Arthritis - after NICE TA195 (Aug 2010) Tick box form- No failure of anti-TNF (adults) Notification within 2 weeks Biosimilars: Local agreement: Rixathon® -Only rituximab biosimilar price is Truxima® reimbursed regardless of brand used, unless CCG has approved continued use of Mabthera® for individual patients through local process. -Mabthera® is not routinely commissioned for new patients

Rituximab Mabthera® Cytokine modulators Rheumatoid Arthritis - after NICE TA suspended IFR No failure of conventional Biosimilars: DMARDS (adults) Local care pathway for patients Tick box form- Rixathon® with history of cancer, interstitial Notification within 2 weeks: Truxima® lung disease (ILD) or multiple for patients with history of sclerosis (MS) only cancer, ILD or MS only

19 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Rituximab Mabthera® Cytokine modulators Thrombotic Thromocytopenic Not routinely commissioned IFR No Purpura (TTP) Biosimilars: Rixathon® Truxima® Romiplostim Nplate® Platelet Disorder Drugs Idiopathic Thrombocytopenic NICE TA221 (Apr 2011) Tick box form- Prior approval No NHSE is responsible for: Purpura (ITP) (adults) Local Care Pathway -ITP in children Romosozumab Evenity® Immunomodulating drugs Post-menopausal NICE MTA due, date TBC (non- IFR No osteoporosis bisphosphonates for treating osteoporosis) Not routinely commissioned Roxadustat Drugs used in Anaemia in chronic kidney Not routinely commissioned IFR No Not yet licensed in UK hypoplastic, haemolytic, disease- not dependent on (launch plan: 2021) and renal anaemias dialysis. NHSE is responsible for: -Dialysis-induced anaemia Kevzara® Cytokine modulators Rheumatoid Arthritis (adults) NICE TA485 (Nov 2017) Tick box form- No NHSE is responsible for: Notification within 2 weeks -Paediatric indications (where adult TA available) Cosentyx® Cytokine modulators Ankylosing Spondylitis NICE TA407 (Sep 2016) Tick box form- No (adults) Notification within 2 weeks Secukinumab Cosentyx® Cytokine modulators Axial Spondyloarthritis (non- NICE TA due, date TBC IFR (Tick box form- No radiographic) (adults) Not routinely commissioned until Notification within 2 weeks if approved by NICE approved by NICE) Secukinumab Cosentyx® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responible for: used in CCG commissioned -Paediatric indications service Secukinumab Cosentyx® Cytokine modulators Psoriasis (adults) NICE TA350 (Jul 2015) Tick box form- No Notification within 2 weeks Secukinumab Cosentyx® Cytokine modulators Psoriatic Arthritis (adults) NICE TA455 (May 2017) Tick box form- No Notification within 2 weeks Drugs affecting the Rheumatoid Arthritis (adults) NICE TA suspended IFR No Not licensed in UK immune response Not routinely commissioned (launch plan: terminated) NHSE is responsible for: -Paediatric indications (where adult TA available) Sodium oxybate Xyrem® Hypnotics and anxiolytics Narcolepsy (adults) Not routinely commissioned IFR No NHSE is responsible for: https://www.sps.nhs.uk/wp- -Narcolepsy - paediatric services only content/uploads/2019/10/Sodium- Oxybate-Advisory- Statement_FINAL_v1.6.docx Solanezumab Drugs affecting the Alzheimer's disease Not routinely commissioned IFR No Not licensed in UK immune response (launch plan: terminated) Solriamfetol Sunosi® Hypnotics and anxiolytics Narcolepsy- associated NICE TA due, date TBC IFR (Tick box form- No excessive daytime Not routinely commissioned until Notification within 2 weeks if sleepiness (EDS) (adults) approved by NICE approved by NICE)

20 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Solriamfetol Sunosi® Hypnotics and anxiolytics Obstructive sleep apnoea NICE TA due, date TBC IFR (Tick box form- No syndrome (OSAS)- Not routinely commissioned until Notification within 2 weeks if associated excessive approved by NICE approved by NICE) daytime sleepiness (EDS) (adults) Somapacitan Growth hormone & Growth hormone deficiency Not routinely commissioned IFR No Not yet licensed in UK growth hormone receptor (adults) (launch plan: 2021) antagonist Somatrogon Growth hormone & Growth hormone deficiency Not routinely commissioned IFR No Not yet licensed in UK growth hormone receptor (children and adults) (launch plan: 2021) antagonist Somatropin Growth hormone & Growth hormone deficiency NICE TA64 (Aug 2003) Tick box form- No NHSE is responsible for: (adults) growth hormone receptor (adults) Notification within 2 weeks -Indications falling outside NICE guidance antagonist treated in specialist centres Somatropin Growth hormone & Growth hormone deficiency NICE TA188 (May 2010) Tick box form- Yes NHSE is responsible for: (children) growth hormone receptor Turner Syndrome Notification within 2 weeks -Indications falling outside NICE guidance antagonist Prader-Willi syndrome treated in specialist centres Chronic renal insufficiency Born small for gestational age with subsequent growth failure at 4 years of age or later Short stature homeobox- containing (SHOX) deficiency

Tanezumab Cytokine modulators Cancer pain due to bone Not routinely commissioned IFR No Not yet licensed in UK metastasis (launch plan: 2022) Tanezumab Cytokine modulators Chronic low back pain Not routinely commissioned IFR No Not yet licensed in UK (launch plan: 2022) Tanezumab Cytokine modulators Osteoarthritis NICE TA due, date TBC IFR No Not yet licensed in UK Not routinely commissioned until (launch plan: 2021) approved by NICE Teriparatide Biosimilars: Drugs affecting bone Post-menopausal Not routinely commissioned until Tick box form- No NHSE is responsible for: Terrosa® metabolism osteoporosis approved by NICE Notification within 2 weeks -Male osteoporosis Movymia® -Juvenile osteoporosis -Osteogenesis imperfecta Forsteo®

Thrombomodulin, Recomodulin® Fibrinolytics Severe sepsis with Not routinely commissioned IFR No Not yet licensed in UK Recombinant coagulopathy (launch plan: uncertain) Human NHSE is responsible for: -Pseudoaneurysm Skin Conditions Psoriasis (adults) NICE TA575 (Apr 2019) Tick box form- No Notification within 2 weeks

21 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis RoActemra® Cytokine modulators Juvenile Arthritis (adults) NICE TA373 (Dec 2015) Tick box form- No NHSE is responsible for: -Polyarticular Notification within 2 weeks -Juvenile Arthritis (paediatric) -Systemic NHS England E03X04 (Jul 2015): E03/P/d biologics for Juvenile Idiopathic Arthritis in Children and Adults Tocilizumab RoActemra® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Cytokine release syndrome service -Giant cell arteritis -Juvenile Arthritis (paediatric service) - Stills disease- adult onset -Takayasu arteritis -Paediatric indications (where adult TA available) Tocilizumab RoActemra® Cytokine modulators Rheumatoid Arthritis - after NICE TA247 (Feb 2012) Tick box form- No failure of anti-TNF and/or Notification within 2 weeks rituximab (adults) Tocilizumab RoActemra® Cytokine modulators Rheumatoid Arthritis (adults) NICE TA247 (Feb 2012) Tick box form- No NICE TA375 (Jan 2016) Notification within 2 weeks Tofacitinib Xeljanz® Cytokine modulators Juvenile Arthritis (adults) Not routinely commissioned IFR No Not yet licensed in UK (launch plan: 2021) Tofacitinib Xeljanz® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Paediatric indications (where adult TA service available) Tofacitinib Xeljanz® Cytokine modulators Psoriatic Arthritis (adults) NICE TA543 (Oct 2018) Tick box form- No Notification within 2 weeks Tofacitinib Xeljanz® Cytokine modulators Rheumatoid Arthritis (adults) NICE TA480 (Oct 2017) Tick box form- No Notification within 2 weeks Tofacitinib Xeljanz® Cytokine modulators Ulcerative Colitis (adults) NICE TA547 (Nov 2018) Tick box form- No Notification within 2 weeks Tolvaptan Jinarc® Growth hormone & Polycystic Kidney Disease NICE TA358 (Oct 2015) Tick box form- No NHSE is responsible for: growth hormone receptor Notification within 2 weeks -Hyponatraemia in cancer antagonist Upadacitinib Rinvoq® Drugs affecting the Ankylosing spondylitis Not routinely commissioned IFR No Not yet licensed in UK immune response (adults) (launch plan: 2021) Upadacitinib Rinvoq® Drugs affecting the Axial spondyloarthritis Not routinely commissioned IFR No Not yet licensed in UK immune response (adults) (launch plan: 2023) Upadacitinib Rinvoq® Drugs affecting the Crohn's Disease (adults) Not routinely commissioned IFR No Not yet licensed in UK immune response (launch plan: 2023) Upadacitinib Rinvoq® Drugs affecting the Dermatitis (adults) NICE TA due, date TBC IFR (Tick box form- No Not yet licensed in UK immune response Not routinely commissioned until Notification within 2 weeks if (launch plan: 2021) approved by NICE approved by NICE) Upadacitinib Rinvoq® Drugs affecting the Psoriatic Arthritis (adults) NICE TA due, date TBC IFR No Not yet licensed in UK immune response Not routinely commissioned until (launch plan: 2021) approved by NICE Upadacitinib Rinvoq® Drugs affecting the Ulcerative Colitis (adults) Not routinely commissioned IFR No Not yet licensed in UK immune response (launch plan: 2023)

22 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Upadacitinib Rinvoq® Drugs affecting the Rheumatoid Arthritis (adults) NICE TA due, date TBC IFR (Tick box form- No immune response Not routinely commissioned until Notification within 2 weeks if approved by NICE approved by NICE) Stelara® Cytokine modulators Crohn's Disease (adults) NICE TA456 (Jul 2017) Tick box form- No Notification within 2 weeks Ustekinumab Stelara® Cytokine modulators Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: used in CCG commissioned -Plaque psoriasis (paediactric) service -Paediatric indications (where adult TA available) Ustekinumab Stelara® Cytokine modulators Psoriasis (adults) NICE TA180 (Sep 2009) Tick box form- No NHSE is responsible for: Notification within 2 weeks -Plaque psoriasis (paediactric)

23 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Ustekinumab Stelara® Cytokine modulators Psoriatic Arthritis (adults) NICE TA340 (Jun 2015) Tick box form- No Notification within 2 weeks Ustekinumab Stelara® Cytokine modulators Ulcerative Colitis (adults) NICE TA633 (Jun 2020) Tick box form- No Notification within 2 weeks Vadadustat Drugs used in Anaemia in chronic kidney Not routinely commissioned IFR No Not yet licensed in UK hypoplastic, haemolytic, disease- not dependent on (launch plan: 2022) and renal anaemias dialysis. NHSE is responsible for: -Dialysis-induced anaemia Valbenazine Ingrezza® Torsion dystonias and Tardive dyskinesia Not routinely commissioned IFR No Not licensed in UK other involuntary (launch plan: uncertain) movements Vapreotide Growth hormone & Oesophageal varices Not routinely commissioned IFR No Not licensed in UK growth hormone receptor (no known launch plans) antagonist Entyvio® Drugs affecting the Crohn's Disease (adults) NICE TA352 (Aug 2015) Tick box form- No immune response Notification within 2 weeks Vedolizumab Entyvio® Drugs affecting the Other indications (adults) Not routinely commissioned IFR No NHSE is responsible for: immune response used in CCG commissioned -Paediatric indications (where adult TA service available) Vedolizumab Entyvio® Drugs affecting the Ulcerative Colitis (moderate NICE TA342 (Jun 2015) Tick box form- No immune response to severely active) (adults) Notification within 2 weeks Verteporfin Visudyne® Subfoveal choroidal Wet age-related macular NICE NG82 (Jan 2018) IFR No Photodynamic Therapy neovascularisation degeneration (wet-AMD) - Not recommended alone for late wAMD - Not recommended as adjunct to anti-VEGF as first-line treatment for late wAMD - Only recommended as adjunct to anti-VEGF as second-line treatment in late wAMD in context of

Not routinely commissioned

Voclosporin Drugs affecting the Dry eye syndrome (adults) Not routinely commissioned IFR No Not yet licensed in UK immune response (launch plan: 2024) Voclosporin Voclera® Drugs affecting the Lupus nephritis (adults) Responsible commissioner TBC IFR No Not yet licensed in UK immune response Not routinely commissioned (launch plan: 2022) Biological mesh, Device Notification No Synthetic equivalents included. Includes including synthetic consumables specifically used for the equivalents deployment of the device Consumables Device Notification No Includes consumables specifically used for associated with per the deployment of the device oral single operator cholangioscope Continuous glucose Continuous Glucose Type 1 diabetes NICE NG17 & NG3 Tick box form- No Includes consumables specifically used for monitoring systems Monitoring Systems Local policy (in development) Notification within 2 weeks if the deployment of the device (adults) local policy approved

24 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis Continuous glucose Continuous Glucose Type 1 diabetes NICE NG18 Tick box form- No Includes consumables specifically used for monitoring systems Monitoring Systems Local policy (in development) Notification within 2 weeks if the deployment of the device (children) local policy approved Insulin pump Mylife Ypsopump® Insulin pumps and pump Type 1 diabetes NICE TA151 (Jul 2008) Tick box form- Insulin only (not Includes consumables specifically used for therapy (adults) Accucheck Insight® consumables Local policy Notification within 2 weeks pump or the deployment of the device consumables) A6 Touch Care® Accucheck Combo® Omnipod®

Tandem T-Slim® Dana R® Kaleido pump® Dana RS®

Consumables only for: Minimed 640G® Minimet 670G® Paradigm Veo®

Insulin pump Mylife Ypsopump® Insulin pumps and pump Type 1 diabetes NICE TA151 (Jul 2008) Tick box form- Insulin only (not Includes consumables specifically used for therapy (children) Accucheck Insight® consumables Local policy Notification within 2 weeks pump or the deployment of the device consumables) A6 Touch Care® Accucheck Combo® Omnipod®

Tandem T-Slim® Dana R® Kaleido pump® Dana RS®

Consumables only for: Minimed 640G® Minimet 670G® Paradigm Veo®

Intracardiac Device Single-chamber ventricular NICE IPG626 IFR No Includes consumables that are required pacemaker system pacing Not routinely commissioned until uniquely for the deployment of the device SWL commissioning policy agreed

25 of 26 Abaloparatide Eladynos® Drugs affecting bone Post-menopausal NICE TA due, date TBC IFR (Tick box form- No Not licensed in UK metabolism osteoporosis Not routinely commissioned until Notification within 2 weeks if (launch plan: terminated) approved by NICE approved by NICE) NHSE is responsible for: - Male osteoporosis - Juvenile osteoporosis

Points to Note: NHS England is responsible for any drug approved by NICE for adult conditions which is used for children at specialised paediatric centres Any new drug that is added to a fully excluded category or sub-category in the BNF will still be excluded but may not necessarily be included on this list Inclusion on the PbR excluded drug / device list does not mean the drug must be funded by commissioners Drugs listed might be considered PbR excluded when used 'off label', however CCGs may want to consider these as IFR funding requests OPCS4 codes for high cost drugs are NOT directly related to the PbR drug exclusion list. These codes relate to ongoing work to 'unbundle' the tariff

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