Appendix 1: EoE CCG Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices

Transcription

1 Appendix 1: East of England () CCG Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2018 v1 High cost drugs excluded from the National Tariff are not commissioned by Clinical Commissioning Groups (CCGs) unless the drugs and indications have approval through local processes. The tables in Appendix 1 summarise the policy on the commissioning of drugs and devices (which include drugs). It is coded by a "traffic light" scheme as follows: Not commissioned. Where provider Trusts prescribe this treatment the funding responsibility lies with the provider and not the commissioner. Approved for use in line with or where NICE has been converted into a locally agreed protocol or CCG policy. Notification or individual or group prior approval required using proforma as per contract. Clinical evidence of outcomes may be requested by CCGs (in line with local contracts). Funding will not be authorised for patients who do not meet agreed criteria. Approved for use in line with locally agreed guidance only. Prior approval, notification proformas or electronic Blueteq forms should be completed. s with other minimum dataset information must be provided on back up data to invoices. NHSE commissioning responsibility. CCGs should not consider funding requests for these drugs in these indications / group of patients. For drugs or indications where NHS England is the the current version of the NHS England drug list should be refered to for the commissioning position, this is located at :- Please note that the enclosed information reflects the current commissioning arrangements. These arrangements are subject to change in year if commissioning responsibility for particular drugs or services change between mid Essex CCG and the NHSE and / or new local drug policies are introduced or new NICE guidance is published. The main reference sources used to produce this document were: 1. National tariff payment system 2017/18 and 2018/19, Annex A The national prices and national tariff workbook, High cost drugs and devices available at 2. East of England Priorities Advisory Commmittee (PAC) recommendations available at: 3. National Institute for Health and Care Excellence (NICE) Guidance available at 4. UKMi Prescribing Outlook New Medicines September 2017 available from Specialist Pharmacy Services 5. UKMi New Drugs Online available from Specialist Pharmacy Services 6. s for NHS England drugs list v13 published April 2018 available at

2 Appendix 1: East of England () CCG Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices High cost drugs excluded from the National Tariff are not commissioned by Clinical Commissioning Groups (CCGs) unless the drugs and indications have approval through local processes. Please note that the enclosed information reflects the current commissioning arrangements. These arrangements are subject to change in year if commissioning responsibility for particular drugs or services change between xxxccg and the NHSE and / or new local drug policies are introduced or new NICE guidance is published. The tables in Appendix 1 summarise the policy on the commissioning of drugs and devices (which include drugs). It is coded by a "traffic light" scheme as follows: Not commissioned. Where provider Trusts prescribe this treatment the funding responsibility lies with the provider and not the commissioner. Approved for use in line with or where NICE has been converted into a locally agreed protocol or CCG policy. Notification or individual or group prior approval required using proforma or electronic Blueteq forms as per contract. Clinical evidence of outcomes may be requested by CCGs (in line with local contracts). Funding will not be authorised for patients who do not meet agreed criteria. Approved for use in line with locally agreed guidance only. Prior approval, notification proformas or electronic Blueteq forms should be completed. s with other minimum dataset information must be provided on back up data to invoices. NHSE commissioning responsibility. CCGs should not consider funding requests for these drugs in these indications / group of patients. For drugs or indications where NHS England is the the current version of the NHS England drug list should be refered to for the commissioning position, this is located at :- Drug name BNF section Category Licensed / s agreed Is this commissioned? Page 2 of 41

3 Drug name BNF section Category Licensed / s agreed Is this commissioned? Abaloparatide Analogue of human Osteoporosis- postmenopausal parathyroid hormonerelated protein NICE ID882 suspended Transdermal patch predicted UK launch Male and juvenile osteoporosis is NHSE commissioning responsibility. Abatacept Cytokine modulators Rheumatoid arthritis after failure of anti- TNF NICE TA195, August 2010 criteria TA195. CCG commission adults only. GP prescribing Abatacept Cytokine modulators Rheumatoid Arthritis NICE TA375 not previously treated January 2016 with DMARDs or after conventional DMARDs only have failed TA375 criteria CCG commission adults only. GP prescribing NICE TA 375 replaced NICE TA 280 Abatacept Cytokine modulators Polyarticular juvenile idiopathic arthritis (2nd line only). Un use in adults. NICE TA373 December 2015 TA373 criteria. CCG commision adults only. GP prescribing Page 3 of 41

4 Drug name BNF section Category Licensed / s agreed Is this commissioned? Abatacept Cytokine modulators Active psoriatic arthritis after DMARDs NICE ID933 Due July 2018 only. GP prescribing Abatacept Cytokine modulators All other indications, or un. NHS England is responsible use. Adalimumab or Cytokine modulators Psoriasis NICE TA146, June 2008 criteria TA146. only. GP prescribing for plaque psoriasis NICE TA 455, paediatric use (of adult TAs), uveitis (NICE TA 460) and Hidradenitis Suppurativa (NICE TA 392) and Bechet's syndrome. Adalimumab or Cytokine modulators Crohn's Disease NICE TA187, May 2010 TA187 only. GP prescribing for plaque psoriasis NICE TA 455, paediatric use (of adult TAs), uveitis (NICE TA 460) and Hidradenitis Suppurativa (NICE TA 392) and Bechet's syndrome. Page 4 of 41

5 Drug name BNF section Category Licensed / s agreed Is this commissioned? Adalimumab or Cytokine modulators Psoriatic Arthritis NICE TA199, August 2010 criteria TA199. only. GP prescribing for plaque psoriasis NICE TA 455, paediatric use (of adult TAs), uveitis (NICE TA 460) and Hidradenitis Suppurativa (NICE TA 392) and Bechet's syndrome. Adalimumab or Cytokine modulators Moderate to severe active ulcerative colitis after the failure of conventional therapy NICE TA329 February 2015 criteria TA329 only. GP prescribing for plaque psoriasis NICE TA 455, paediatric use (of adult TAs), uveitis (NICE TA 460) and Hidradenitis Suppurativa (NICE TA 392) and Bechet's syndrome. Adalimumab or Cytokine modulators Rheumatoid arthritis NICE TA375 January 2016 or TA195 August criteria TA375 or TA195. only. GP prescribing for plaque psoriasis NICE TA 455, paediatric use (of adult TAs), uveitis (NICE TA 460) and Hidradenitis Suppurativa (NICE TA 392) and Bechet's syndrome. Page 5 of 41

6 Drug name BNF section Category Licensed / s agreed Is this commissioned? Adalimumab or Cytokine modulators Ankylosing spondylitis NICE TA383 February 2016 criteria TA383. only. GP prescribing for plaque psoriasis NICE TA 455, paediatric use (of adult TAs), uveitis (NICE TA 460) and Hidradenitis Suppurativa (NICE TA 392) and Bechet's syndrome. Adalimumab or Cytokine modulators Axial spondyloarthritis (non- radiographic) NICE TA383 February 2016 TA383 only. GP prescribing for plaque psoriasis NICE TA 455, paediatric use (of adult TAs), uveitis (NICE TA 460) and Hidradenitis Suppurativa (NICE TA 392) and Bechet's syndrome. Adalimumab or Cytokine modulators Polyarticular juvenile idiopathic arthritis NICE TA373 December 2015 TA373 criteria. only. GP prescribing for plaque psoriasis NICE TA 455, paediatric use (of adult TAs), uveitis (NICE TA 460) and Hidradenitis Suppurativa (NICE TA 392) and Bechet's syndrome. Adalimumab or Cytokine modulators All other indications, or un. NHS England is responsible use of relevant adult TAs. Page 6 of 41

7 Drug name BNF section Category Licensed / s agreed Is this commissioned? Afamelanotide Skin conditions Prevention of phototoxicity in erythropoietic protoporphyria (EPP). NICE ID927 due May 2018 Predicted UK launch 2018 Aflibercept Subfoveal choroidal neovascularisation Aflibercept Subfoveal choroidal neovascularisation Aflibercept Subfoveal choroidal neovascularisation Aflibercept Subfoveal choroidal neovascularisation Aflibercept Subfoveal choroidal neovascularisation Aflibercept Subfoveal choroidal neovascularisation Neovascular (wet) age-related macular degeneration. Macular oedema, secondary to CRVO Diabetic Macular Oedema Macular oedema, secondary to BRVO Choroidal neovascularisation All other indications, or un. NICE TA294, July 2013 NICE TA305, February 2014 NICE TA346 July 2015 NICE TA409 September 2016 NICE TA486 November 2017 TA294. TA305 TA346 TA409 TA486 NHSE is responsible commissioner for cancer indications. NHSE is responsible commissioner for cancer indications. NHSE is responsible commissioner for cancer indications. NHSE is responsible commissioner for cancer indications. NHSE is responsible commissioner for cancer indications. NHSE is responsible commissioner for cancer indications. Aganirsen No BNF category. Antisense oligonucleotide against the insulin receptor substrate-1 (IRS-1) given topically as eye drops Corneal neovascularisation (CoNV) - associated with keratoplasty rejection. Launch planned for 2019 Page 7 of 41

8 Drug name BNF section Category Licensed / s agreed Is this commissioned? Alirocumab 2.12 Lipid-regulating drugs Hypercholesterolaemi a, familial and nonfamilial (3rd line) NICE TA 393 June 2016 TA393 and PAC recommendations. Alitretinoin Skin conditions Severe chronic hand eczema Allogenic mesenchymal stem cells injection Cx601 (Alofisel) Amikacin Liposomal inhalation Allogenic mesenchymal stem cells Perianal fistula, complex and refractory to conventional and/or biologic agents in adults with Crohn s disease Aminoglycosides Nontuberculous mycobacterial lung infection NICE TA177, August 2009 expected TA177. Adults only. GP prescribing expected. NHS England responsible commissioner for use in CF Anakinra Cytokine modulators Rheumatoid arthritis NICE TA72, November 2003 (replaced by NICE CG79, February 2010), not recommended NHS England responsible commissioner for adult specialised autoinflammatory disease, paediatric use, Cropyrin associated periodic syndrome, juvenile idiopathic arthritis (un indication). Apremilast Cytokine modulators Psoriasis NICE TA419 November 2016 TA419. only. GP prescribing Apremilast Cytokine modulators Psoriatic arthritis unresponsive to DMARDs NICE TA433 February 2017 TA433. only. GP prescribing Page 8 of 41

9 Drug name BNF section Category Licensed / s agreed Is this commissioned? Apremilast Cytokine modulators Psoriatic arthritis in DMARD naive or biologic agent-naive patients anticipated Launch due NHS England responsible use Apremilast Cytokine modulators Ankylosing Spondylitis AR101 oral, Oral immunotherapy Peanut sensitivity Aimmune therapeutics Autologous stem cells injection [C- Cure] Autologous stem cells, bone marrowderived, mesenchymal, given by intramyocardial injection, first-inclass. ATMP. Heart failure, chronic, advanced, refractory, secondary to ischaemic heart disease. anticipated anticipated anticipated Predicted launch 2019 UK availability 2019 Predicte launch date Likely to be NHSE. Avatrombopag Platelet disorder drugs Avatrombopag Platelet disorder drugs Aztreonam Lysine nebuliser solution ITP first line Thrombocytopenia associated with liver disease, pre-surgical procedure Antibacterial drugs Cystic Fibrosis NHSE commissioning policy for CF. In line with NHSE NHSE Policies for CF Policy Ref: A01/P/b Dec 2014 and Policy Ref: 16001/P July 2016 Launch due 2019 Predicted UK launch 2018 Only excluded when given by nebulisation / inhalation. NHS England responsible commissioner for use in CF. GP prescribing not expected Aztreonam Lysine nebuliser solution Antibacterial drugs Bronchiectasis Bronchiectasis only in line with Local Policies Only excluded when given by nebulisation / inhalation. NHS England responsible commissioner for use in CF Page 9 of 41

10 Drug name BNF section Category Licensed / s agreed Is this commissioned? Baricitinib Cytokine modulators Moderate to severe active rheumatoid arthritis not responding to, or who are intolerant to one or more DMARDs. NICE TA466 August 2017 TA466. only. GP prescribing Benralizumab Interleukin-5 receptor (IL-5R) monoclonal antibody that depletes eosinophils and neutralises IL-5. COPD, moderate-tovery severe with a history of exacerbations. anticipated Predicted UK launch date NHS England resonsible commissioner for asthma indication. Botulinum Toxin A Prophylaxis of migraine Migraine prophylaxis NICE TA260, June 2012 TA260 GP prescribing expected Botulinum Toxin A Essential tremor, chorea, tics and related disorders Spasticity (after stroke) where there is a dynamic spastic component (as opposed to contracture) and there are anticipated functional gains in line with Royal College of Physician guidance. Spasticity (after stroke) - botulinum toxin type A [ID768] - In development [GID-TAG499] Expected publication date: TBC In line with PAC recommendations Page 10 of 41

11 Drug name BNF section Category Licensed / s agreed Is this commissioned? Botulinum Toxin A Essential tremor, chorea, tics and related disorders Chronic anal fissure, severe blepharospasm, hemifacial spasm, cervical dystonia (spasmodic torticollis), focal spasticity in upper and lower limb in adults (causes other than stroke), hyperhidrosis of the axillae, dysphagia caused by achalasia and overactive bladder. anticipated In line with PAC recommendations. GP prescribing expected.nhs England is for focal spasticity in children. Treatment of spasticity in paediatric cerebral palsy is commissioned by NHSE at specialist centres only. Intravesical use in spinal injury commissioned by NHSE. Page 11 of 41

12 Drug name BNF section Category Licensed / s agreed Is this commissioned? Botulinum Toxin A Essential tremor, chorea, tics and related disorders Chronic sialorrhoea in adults and children, associated with neurological conditions such as cerebral palsy (CP), Parkinson s disease (PD), stroke and traumatic brain injury (TBI) (licence extension). anticipated COMMISSIOINED License extension expected GP prescribing expected.nhs England is for focal spasticity in children. Treatment of spasticity in paediatric cerebral palsy is commissioned by NHSE at specialist centres only. Intravesical use in spinal injury commissioned by NHSE. Botulinum Toxin A Essential tremor, chorea, tics and related disorders Laryngeal dystonia (spasmodic dystonia), anticipated hydradenitis suppurative, mechanical neck disorders, correction of strabismus (squint) in paediatrics, dysphagia (causes other than achalasia), Raynaud s Disease, Massateric Hypertrophy. COMMISSIOINED In line with negative PAC recommendations Botulinum Toxin A Essential tremor, chorea, tics and related disorders All other indications, or un. Page 12 of 41

13 Drug name BNF section Category Licensed / s agreed Is this commissioned? Botulinum Toxin B Torsion, dystonias Spasmodic torticollis and other involuntary (Cervical dystonia) movements anticipated In patients resistant to Botulinum Toxin A for cervical dystonia. Brodalumab Drugs affecting the immune response Plaque psoriasis, moderate-to-severe. NICE TA511 March 2018 TA511 only. GP prescribing Brolucizumab Cytokine modulators Neovascular (wet) age-related macular degeneration (AMD) Canakinumab Secondary prevention of cardiovascular events in post myocardial infarction patients with elevated high sensitivity C- reactive protein (licence extension). NICE (ID1362) TBC Predicted UK launch Enema formulation. Predicted UK availability NHSE are the responsible commisioners for juvenile arthritis in paediatrics. Certolizumab Pegol Cytokine modulators Rheumatoid Arthritis after conventional DMARDs only have failed NICE TA375 January 2016 TA375 only. GP prescribing Certolizumab Pegol Cytokine modulators Ankylosing spondylitis NICE TA 383, February 2016 TA383. only. GP prescribing Page 13 of 41

14 Drug name BNF section Category Licensed / s agreed Is this commissioned? Certolizumab Pegol Cytokine modulators Axial spondyloarthritis (non radiographic) NICE TA 383, February 2016 TA383. only. GP prescribing Certolizumab Pegol Cytokine modulators Rheumatoid arthritis after TNF inhibitor NICE TA415 Oct 2016 TA415 only. GP prescribing Certolizumab Pegol Cytokine modulators Active psoriatic arthritis after DMARDs NICE TA445 May 2017 TA445 only. GP prescribing Certolizumab Pegol Certolizumab Pegol Cytokine modulators Early progressive rheumatoid arthritis, untreated by DMARDs Cytokine modulators Moderate to severe plaque psoriasis Negative NICE TA375, January 2016 NICE (ID1232) TBC COMISSIONED NHS England is responsible use. NHS England is responsible use. Certolizumab Pegol Cytokine modulators All other indications, or un. COMISSIONED NHS England is responsible use. Page 14 of 41

15 Drug name BNF section Category Licensed / s agreed Is this commissioned? Cobitolimod DNA-based immunomodulatory sequence (DIMS) targeting the toll-like receptor 9 (TLR9) given intracolonically Ulcerative colitis (UC) refractory, 3rd line COMISSIONED Launch plans NHSE is for paediatric indications where adult TAs available. Colistimethate sodium powder (Promixin ) /injection for nebulisation Antibacterial drugs Cystic Fibrosis NHSE Policy - Inhaled Therapy For Adults And Children With Cystic Fibrosis Policy Ref: A01/P/b Dec 2014 NHSE responsibility, but GPs may prescribe for existing patients. No GP prescribing for new patients. Only excluded when given by nebulisation/inhalation. Colistimethate sodium dry powder for inhalation (Colobreathe ) Antibacterial drugs Cystic Fibrosis NICE TA276, March NHSE Policy - Inhaled Therapy For Adults And Children With Cystic Fibrosis Policy Ref: A01/P/b Dec 2014 No GP prescribing of Colobreathe as Patient Access Scheme not available in primary care. Only excluded when given by nebulisation/inhalation. Collagenase Enzymes Peyronie's disease (PsD).. Only excluded from tariff when used in outpatients Collagenase Enzymes Dupuytren's Contracture NICE TA459 July 2017 TA459 Only excluded from tariff when used in outpatients Page 15 of 41

16 Drug name BNF section Category Licensed / s agreed Is this commissioned? Deferasirox Iron overload Anaemia related to chronic iron overload for myelodysplastic syndrome only PAC recommendation (not recommended) NHS England responsible commissioner for hypoplastic, haemolytic and renal anaemias - iron overload, thalassemia and sickle cell disease. NHSE routinely commissioned in combination when dual therapy required. Deferiprone Iron overload Anaemia related to chronic iron overload for myelodysplastic syndrome only PAC recommendation (not recommended) NHS England responsible commissioner for hypoplastic, haemolytic and renal anaemias - iron overload, thalassemia and sickle cell disease. NHSE routinely commissioned in combination when dual therapy required. Desferrioxamine Iron overload Anaemia related to chronic iron overload for myelodysplastic syndrome only PAC recommendation (not recommended) NHS England responsible commissioner for hypoplastic, haemolytic and renal anaemias - iron overload, thalassemia and sickle cell disease. NHSE routinely commissioned in combination when dual therapy required. Dexamethasone intravitreal implant Dexamethasone intravitreal implant Dexamethasone intravitreal implant Macular oedema Macular oedema secondary to retinal vein occlusion Macular oedema Diabetic Macular Oedema Macular oedema Non-infectious uveitis (unilateral) NICE TA229, July NICE TA349 July 2015 NICE TA460 July 2017 TA229. TA349 TA460 criteria. Page 16 of 41

17 Drug name BNF section Category Licensed / s agreed Is this commissioned? Dibotermin alfa Bone morphogenetic protein Acute tibia fractures Only in line with Local Policies (PAC policy) NHS England responsible commissioner for complex spinal surgery NHSE policy Digoxin immune fab Poisoning Life-threatening digoxin toxicity. National Poisons Centre Guidelines. Only commissioned in line with National Poison Centres guidelines. Local Commissioner to be notified / invoiced when used. Available on named patient basis only in hospitals. Dimethyl fumarate Preparations for psoriasis Moderate to severe plaque psoriasis NICE TA475 September 2017 TA475 NHS England is responsible commissioner for Multiple Sclerosis. Dupilumab injection 13 Anti-interleukin -4 and -13 receptor monoclonal antibody Atopic dermatitis, moderate-to-severe. NICE ID1048 No due August 2018 Made available via EAMS, now. NHS England for asthma indication. Eculizumab 10 Recombinant humanised monoclonal antibody. First in class, given by i.v. infusion. Myasthenia Gravis NICE ID1064 Due (MG), generalised, May 2018 but refractory, in patients currently who are antiacetylcholine receptor suspended antibody-positive NHS England is responible commissioner for Atypical haemolytic uremic syndrome (ahus), Paroxysmal nocturnal haemoglobinuria (PNH), organ rejection post kidney transplant, C3 glomerulopathy post transplant Eltrombopag Platelet disorder drugs Chronic idiopathic thrombocytopenic purpura (ITP) NICE TA293, July 2013 TA293. GP prescribing expected. NHS England are the responsible commissioner for use in paediatrics Page 17 of 41

18 Drug name BNF section Category Licensed / s agreed Is this commissioned? Eltrombopag Platelet disorder drugs Thrombocytopenia in adult patients with chronic hepatitis C virus infection GP prescribing expected.pac recommendations published Sept NHS England are the responsible commissioner for use in paediatrics Eltrombopag Platelet disorder drugs Severe aplastic anaemia (SAA) refractory immunosuppressive therapy NICE TA382 terminated appraisal, January NICE unable to make a recommendation... NHS England are the for use in paediatrics. Eltrombopag Platelet disorder drugs Untreated severe aplastic anaemia NICE ID1198 suspended.. Un indication. NHS England are the responsible commissioner for use in paediatrics. Erenumab Humanised monoclonal antibody that inhibits calcitonin generelated peptide (CGRP) Migraine, prevention in adults. NICE ID1188 due January 2019 UK launch 2018 Etanercept or Cytokine modulators Rheumatoid Arthritis NICE TA375 January 2016 or TA195 August criteria TA375 or TA195. only, GP prescribing for paediatric use as per TA455 or adult TAs (TA103, TA130, TA143, TA199) Page 18 of 41

19 Drug name BNF section Category Licensed / s agreed Is this commissioned? Etanercept or Cytokine modulators Ankylosing spondylitis NICE TA383 February 2016 TA383 only, GP prescribing for paediatric use as per TA455 or adult TAs (TA103, TA130, TA143, TA199) Etanercept or Cytokine modulators Axial spondyloarthritis (non radiographic) NICE TA383 February 2016 TA383 only, GP prescribing for paediatric use as per TA455 or adult TAs (TA103, TA130, TA143, TA199) Etanercept or Cytokine modulators Psoriatic Arthritis NICE TA199, August 2010 TA199. only, GP prescribing for paediatric use as per TA455 or adult TAs (TA103, TA130, TA143, TA199) Etanercept or Cytokine modulators Psoriasis NICE TA103, July 2006 TA103. only, GP prescribing for paediatric use as per TA455 or adult TAs (TA103, TA130, TA143, TA199) Page 19 of 41

20 Drug name BNF section Category Licensed / s agreed Is this commissioned? Etanercept or Cytokine modulators Polyarticular juvenile idiopathic arthritis or Enthesitis-related JIA or Psoriatic JIA. Un use in adults. NICE TA373 Dec 2015 TA373 criteria. only, GP prescribing for paediatric use as per TA455 or adult TAs (TA103, TA130, TA143, TA199) Etanercept or Cytokine modulators All other indications, or un. NHS England is responsible use. Etrolizumab Monoclonal antibody Ulcerative colitis (UC) naive to TNF inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment Predicted launch NHS England is responsible use (where adult TA available) Etrolizumab Monoclonal antibody Crohn's disease, moderate-to-severe after steroids, immunosuppressants and anti-tnf therapy Predicted launch NHS England is responsible use (where adult TA available) Evolocumab 2.12 PCSK9 Monoclonal Antibody Inhibitor Hyperlipidaemia and mixed dyslipidaemia NICE TA394, June TA394 and PAC recommendations CCG commission Primary non-familial hypercholesterolaemia or mixed dyslipidaemia. NHSE is for Homozygous familial hypercholesterolemia Page 20 of 41

21 Drug name BNF section Category Licensed / s agreed Is this commissioned? Evolocumab 2.12 PCSK9 Monoclonal Antibody Inhibitor Prevention of cardiovascular events in patients at high risk for a recurrent event (licence extension). License extension predcited 2018 Fasinumab 10 Inhibits nerve growth factor (NGF), a neurotrophin stimulated by paincausing injury and inflammation. Given by monthly s.c. injection. Pain due to osteoarthritis. Predicted UK launch Secondary care initiated, primary care continuation. Filgotinib JAK inhibitor Rheumatoid arthritis (RA), moderate-tosevere Predicted UK launch NHS England is responsible use where adult TA available. Filgotinib JAK inhibitor Ulcerative colitis (UC) Predicted UK launch NHS England is responsible use where adult TA available. Fluocinolone acetonide intravitreal implant Fluocinolone acetonide intravitreal implant Macular oedema Chronic diabetic macular oedema Corticosteroid implant Non-infectious posterior uveitis that is sight threatening, second-line (licence extension). NICE TA301, November 2013 TA301. Predicted launch 2019 Page 21 of 41

22 Drug name BNF section Category Licensed / s agreed Is this commissioned? Fomepizole Poisoning Poisoning National Poisons Centre Guidelines Only commissioned in line with National Poison Centres guidelines. Local Commissioner to be notified when used. Galcanezumab 4 Monoclonalantibody, calcitonin gene-related peptide antagonist Prevention of chronic or episodic migraine. Golimumab Cytokine modulators Psoriatic Arthritis NICE TA220, April 2011 TA220. Predicted launch only, GP prescribing Golimumab Cytokine modulators Rheumatoid arthritis NICE TA375 Jan 2016 or TA225 June 2011 TA375 or TA225 only, GP prescribing Golimumab Cytokine modulators Moderate to severe ulcerative colitissecond line NICE TA329 Feb 2015 TA329 only, GP prescribing Golimumab Cytokine modulators Ankylosing spondylitis NICE TA383 February 2016 TA383 only, GP prescribing Golimumab Cytokine modulators Axial spondyloarthritis (non-radiographic) NICE TA497 January 2018 TA497 only, GP prescribing Page 22 of 41

23 Drug name BNF section Category Licensed / s agreed Is this commissioned? Golimumab Cytokine modulators All other indications, or un. NHS England is responsible use. Guselkumab Drugs affecting the immune response. ICES13 injection; 7 Autologous myoblast cell-based therapy, given by intrasphincter muscle injection. ATMP. Plaque psoriasis, moderate-to-severe Stress urinary incontinence second-line, in women. NICE ID1075 due June 2018 Predicted launch 2018 Predicted launch 2020 Iloprost Vasodilator antihypertensive drugs/pulmanory Arterial Hypertension Critical limb ischaemia NHSE commissioned when used for pulmonary arterial hypertension at specialist centres. Infliximab or Cytokine modulators Crohn's Disease NICE TA187, May 2010 TA187 only, GP prescribing for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome. Infliximab or Cytokine modulators Rheumatoid Arthritis NICE TA375 Jan 2016 or TA195 Aug TA375 or TA195. only, GP prescribing for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets Page 23 of 41

24 Drug name BNF section Category Licensed / s agreed Is this commissioned? Infliximab or Infliximab or Infliximab or Cytokine modulators Psoriatic Arthritis NICE TA199, August Cytokine modulators Psoriasis (adults) NICE TA134, January Cytokine modulators Ulcerative Colitis (acute exacerbations) NICE TA163, December 2008 TA199. TA134. TA163. only, GP prescribing for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome. only, GP prescribing for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome. only, GP prescribing for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome. Page 24 of 41

25 Drug name BNF section Category Licensed / s agreed Is this commissioned? Infliximab or Cytokine modulators Ulcerative Colitis - 2nd line for moderate to severely active NICE TA329 Feb 2015 TA329 only, GP prescribing for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome. Infliximab or Infliximab or Infliximab or Cytokine modulators Ankylosing spondylitis NICE TA383 February Cytokine modulators JIA (un indication) Patient currently responding to treatment Cytokine modulators Axial spondyloarthritis Not considered in (non- radiographic). NICE TA383 Un indication. February If treatment is started with the least expensive infliximab product in line with NICE TA383 Continuation and discontinuation in line with NHSE policy EO3X04. No initiation in adults only, GP prescribing for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets only, GP prescribing for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis only, GP prescribing for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome. Page 25 of 41

26 Drug name BNF section Category Licensed / s agreed Is this commissioned? Infliximab or Infliximab or Cytokine modulators Ulcerative Colitis (Sub-acute manifestations) Cytokine modulators All other indications, or un. NICE TA329 Feb 2015 Not recommended only, GP prescribing for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome. only, GP prescribing for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome. Ixekizumab Humanized anti interleukin-17 monoclonal antibody Moderate to severe plaque psoriasis NICE TA442 April 2017 TA329 Adults only, GP prescribing expected. It is anticipated NHS England is Ixekizumab Humanized anti interleukin-17 monoclonal antibody Active psoriatic arthritis after DMARDs NICE ID1194 due October 2018 Now Ixekizumab Humanized anti interleukin-17 monoclonal antibody Ankylosing spondylitis Predicted UK launch Page 26 of 41

27 Drug name BNF section Category Licensed / s agreed Is this commissioned? Ixekizumab Humanized anti interleukin-17 monoclonal antibody Radiographic and non-nradiographic axial NICE guidance spondyloarthritis, in biological DMARDnaive or TNF-inhibitorexperienced adults Lampalizumab 11 Humanised monoclonal antibody Lanreotide Somatostatin Analogues Geographic atrophy associated with dry age-related macular degeneration. Non cancer indications. Only in line with Local Policies Predicted launch Intravitreal injection NHS England is respnsible commissioner for cancer indications and congenital hyperinsulinism and for acromegaly but only when prescribed in a specialist centre. Levofloxacin Solution for Inhalation Antibacterial drugs Chronic pulmonary infections due to Pseudomonas aeruginosa in adults with CF Lomitapide 2.12 Lipid-regulating drugs Hypercholesterolaemi a, homozygous familial (HoFH). On NICE scoping horizon. No ID number or date NHSE. Only excluded when given by nebulisation / inhalation - not commissioned NHSE commissioned for homozygous familial in specialist centres. Page 27 of 41

28 Drug name BNF section Category Licensed / s agreed Is this commissioned? Mannitol 3.7 Mucolytics Cystic Fibrosis NICE TA266 November 2012 NHSE Policy - Inhaled Therapy For Adults And Children With Cystic Fibrosis Policy Ref: A01/P/b Dec NHS England A01/P/b NHSE. Only excluded when given by nebulisation / inhalation. GP prescribing not expected. Mannitol 3.7 Mucolytics s other than cystic fibrosis. Masitinib Protein tyrosine Moderate Crohn s kinase inhibitor disease in patients intolerant or with an unsatisfactory response to, immunosuppressive drugs and/or TNFinhibitors Predicted launch unknown. NHSE responsible for paediatric cancer/gist, motor neurone disease, asthma. Masitinib Protein tyrosine kinase inhibitor Mild to moderate Alzheimer's disease - adjunct Predicted UK launch NHSE responsible for paediatric cancer/gist, motor neurone disease, asthma. Page 28 of 41

29 Drug name BNF section Category Licensed / s agreed Is this commissioned? Mepolizumab Fully humanised IgG monoclonal antibody specific for interleukin 5 Chronic obstructive pulmonary disease NICE ID1327 publication date TBC Predicted launch NHS England responsible commissioner for asthma indication.eosinophilic Granulomatosis with Polyangiitis (Churg Strauss syndrome) - NHSE likely to be responsible commissioners. Ocriplasmin Retinal disorders Vitreomacular traction including those associated with macular holes. Octreotide Somatostatin Analogues Omalizumab Allergen Immunotherapy Pegaptanib Subfoveal choroidal neovascularisation Non cancer indications Previously treated chronic spontaneous urticaria Neovascular (wet) age-related macular degeneration Pegpleranib Retinal disorders Neovascular (wet) age-related macular degeneration (AMD), in combination with Phenylephrine with Ketorolac Retinal disorders / intraocular lens replacement surgery Intraocular lense replacement surgery NICE TA297 Oct 2013 NICE TA339 June 2015 Negative NICE TA155, August 2008 TA297 Only in line with Local Policies TA339 GP prescribing recommended. NHS England responsible commissioner for cancer, congenital hyperinsulinaemia and acromegaly but only when prescribed in a specialist centre. NHS England responsible for asthma indication Launch predicted 2018 Ranibizumab Neovascularisation Neovascular (wet) age-related macular degeneration NICE TA155, August 2008 TA155. GP prescribing expected. Page 29 of 41

30 Drug name BNF section Category Licensed / s agreed Is this commissioned? Ranibizumab Neovascularisation Diabetic Macular Oedema Ranibizumab Neovascularisation Macular oedema (retinal vein occlusion) Ranibizumab Neovascularisation CNV due to pathological myopia Ranibizumab injection Ranibizumab injection Neovascularisation Visual impairment due to choroidal neovascularisation (CNV) other than due to wet age-related macular degeneration, or pathologic myopia Neovascularisation All other indications, or un. NICE TA274, Feb 2013 NICE TA283, May 2013 NICE TA298, November 2013 In line with TA274. In line with TA283. In line with TA298. GP prescribing expected. GP prescribing expected. GP prescribing expected. License extension predicted 2017 Risankizumab Humanised IgG1 Monoclonal antibody Chronic plaque psoriasis moderatesevere anticipated Predicted UK launch 2019 Page 30 of 41

31 Drug name BNF section Category Licensed / s agreed Is this commissioned? Rituximab or Rituximab or Cytokine modulators Rheumatoid Arthritis after failure of TNF inhibitor Cytokine modulators Rheumatoid arthritis (first line) NICE TA195, Aug 2010 TA195. Only in line with Local Policies NHS England responsible commissioner for ANCApositive vasculitis, cancer, haemophilia, paediatric indications, graft vs host disease, SLE, myositis, neuromyelitis optica, renal disease and transplants indications, PSS, polyneuropathy, connective tisse/interstitial lung disease, immunodeficiency, immunogloblin related, pemphigus vulgaris/pemphigoid disease. Rituximab or Cytokine modulators ITP Only in line with Local Policies Page 31 of 41

32 Drug name BNF section Category Licensed / s agreed Is this commissioned? Rituximab or Cytokine modulators Refractory vasculitis Rituximab or Cytokine modulators JIA (un indication) Patient currently responding to treatment,transition ed from the NHS England paediatric service Continuation and discontinuation in line with NHSE policy EO3X04. No initiation in adults Rituximab or Cytokine modulators All other indication, or un. Romiplostim Platelet Disorder Drugs ITP NICE TA221 April 2011 TA221. GP prescribing expected. Local Commissioner. NHSE for paediatric ITP. Romosozumab Humanised monoclonal antibody, sclerostin inhibitor Osteoporosis in men and postmenopausal women Sarilumab No BNF category Cytokine modulators Moderately to severely active rheumatoid arthritis (RA) second line to DMARDs. anticipated NICE TA485 November 2017 TA485. Adults only. GP prescribing expected. NHS England responsible use but do not commission as un indication. Page 32 of 41

33 Drug name BNF section Category Licensed / s agreed Is this commissioned? Secukinumab Cytokine modulators Chronic plaque psoriasis moderatesevere after failed conventional therapies NICE TA350 July 2015 TA350 Adults only. GP prescribing expected. NHS England responsible use but do not commission as un indication. Secukinumab Cytokine modulators Ankylosing spondylitis NICE TA407 after treatment with September 2016 non-steroidal antiinflammatory drugs or TNF-alpha inhibitors TA407 Adults only. GP prescribing expected. NHS England responsible use but do not commission as un indication. Secukinumab Cytokine modulators Psoriatic arthritis, second line NICE TA455 May 2017 TA407 Adults only. GP prescribing expected. NHS England responsible use but do not commission as un indication. Secukinumab Cytokine modulators Axial - spondyloarthritis (nonradiographical) Secukinumab Cytokine modulators All other indications, or un. UK launch plans unknown. Serelaxin 2 Recombinant form of human relaxin-2 hormone Acute heart failure. NICE ID673 suspended Predicted UK launch 2018 Siltuximab Cytokine modulators Castleman s disease Page 33 of 41

34 Drug name BNF section Category Licensed / s agreed Is this commissioned? Sodium oxybate 4.1 Hypnotics and anxiolytics Somatropin (adults) Growth Hormone or Growth Hormone Receptor Antagonist Narcolepsy with cataplexy (adults) NICE approved uses only NICE TA64 August 2013 PAC policy - Low priority and not routinely funded. Existing patients may continue until they or their clinician discontinue. TA64 NHS England is responsible use. Local Commissioner Somatropin (children) Growth Hormone or Growth Hormone Receptor Antagonist Its within the SPS document NICE TA188, May 2010 TA188 and PAC recommendations. Local Commissioner and GOSH NB: Shared care arrangements with GPs in place. Tanezumab 4.7 Nerve growth factor inhibitor Osteoarthritis Teriparatide Drugs affecting bone metabolism Secondary prevention of osteoporotic fragility fractures expected. NICE TA161 Jan Predicted launch 2019 Notification or Prior GP prescribing TA161 guidance or Approval required use expected. Local Commissioner. ID901 locally agreed proforma or Blueteq review in progress no due protocols. date needs updating. NHSE for male and juvenile osteoporosis. Teriparatide Drugs affecting bone metabolism Thrombomodulin, Recombinant Human 2 Fibrinolytic. Recombinant human thrombomodulin Treatment of osteoporosis associated with glucocorticoids Septic shock (Sepsis) - with disseminated intravascular coagulation (DIC) RECOMMENDED RECOMMENDED RECOMMENDED RECOMMENDED Launch plans 2019 Page 34 of 41

35 Drug name BNF section Category Licensed / s agreed Is this commissioned? Tildrakizumab 13 Human interleukin- 23 antagonist Tobramycin (Tobi / Bramitob ) nebuliser solution Plaque psoriasis, moderate-to-severe, in adults who are candidates for systemic therapy. NICE ID1060 No due date Antibacterial Drugs Cystic Fibrosis NHSE Policy - Inhaled Therapy For Adults And Children With Cystic Fibrosis Policy Ref: A01/P/b Predicted launch NHSE likely to be s NHSE responsibility, but GPs may prescribe for existing patients. No GP prescribing for new patients. Only excluded when given by nebulisation / inhalation. Tobramycin (Tobi Podhaler) dry powder for inhalation Antibacterial Drugs Cystic Fibrosis NICE TA276, March NHSE Policy - Inhaled Therapy For Adults And Children With Cystic Fibrosis Policy Ref: A01/P/b No GP prescribing of Tobi Podhaler as Patient Access Scheme not available in primary care. Only excluded when given by nebulisation / inhalation. Tocilizumab Cytokine modulator Rheumatoid Arthritis NICE TA247 Feb 2012 or TA 375 Jan TA247 or TA Adults only. GP prescribing expected. NHS England is responsible use, paediatric juvenile arthritis (NICE TA 373 and TA238) Takayasu arteritis and Giant cell arteritis. Tocilizumab Cytokine modulators Polyarticular juvenile idiopathic arthritis NICE TA373 Dec 2015 TA373 criteria. Continuation in young adults tranisitioning from NHS England paeds service Adults only. GP prescribing expected. NHS England is responsible use, paediatric juvenile arthritis (NICE TA 373 and TA238) Takayasu arteritis and Giant cell arteritis. Page 35 of 41

36 Drug name BNF section Category Licensed / s agreed Is this commissioned? Tocilizumab Cytokine modulator All other indications, or un. Adults only. GP prescribing expected. NHS England is responsible use, paediatric juvenile arthritis (NICE TA 373 and TA238) Takayasu arteritis and Giant cell arteritis. Tofacitinib Cytokine modulator Rheumatoid arthritis, moderate-to-severe, in patients not responding to DMARDs. NICE TA480 October 2017 TA480 It is anticipated that NHSE is Tofacitinib Cytokine modulator Psoriatic arthritis second-line following failure of conventional DMARDs, third-line following failure of biological DMARDs NICE ID1220 Due December 2018 Predicted UK lanch It is anticipated that NHSE is Tofacitinib Cytokine modulator Moderate-to-severe active ulcerative colitis in adults, following failure of conventional therapy. NICE ID1218 No due date Predicted UK lanch It is anticipated that NHSE is Tofacitinib Cytokine modulator Rheumatoid arthritis moderate-to-severe, methotrexate-naïve Predicted UK lanch It is anticipated that NHSE is Page 36 of 41

37 Drug name BNF section Category Licensed / s agreed Is this commissioned? Tolvaptan Vasopressin V2- receptor antagonist Autosomal dominant polycystic kidney disease, stage 2 or 3, rapidly progressing NICE TA358 October 2015 TA358. NHSE responsible for commissioning in hyponatraemia in cancer patients requiring chemotherapy. Tolvaptan Vasopressin V2- receptor antagonist Tolvaptan Vasopressin V2- receptor antagonist Hyponatraemia due to syndrome of inappropriate antidiuretic hormone secretion (SIADH) in patients Hyponatraemia who do from not other causes and other endocrine uses NHSE responsible for commissioning in hyponatraemia in cancer patients requiring chemotherapy. NHSE responsible for commissioning in hyponatraemia in cancer patients requiring chemotherapy. Tolvaptan Vasopressin V2- receptor antagonist All other indications, or un. NHSE responsible for commissioning in hyponatraemia in cancer patients requiring chemotherapy. Upadacitinib 10 Janus kinase (JAK) inhibitor Rheumatoid arthritis (RA) with inadequate response to either methotrexate or TNF inhibitors expected. ABT-494 oral. Predicted launch Not yet on MHSE indications list. Ustekinumab Drugs affecting the immune response Psoriasis moderate to severe NICE TA180, Sept 2009 TA180. Adults only. GP prescribing expected. NHSE is for NICE TA455 for paediatric indications of adult TAs. Page 37 of 41

38 Drug name BNF section Category Licensed / s agreed Is this commissioned? Ustekinumab Drugs affecting the immune response Psoriatic arthritis NICE TA340 June 2015 TA340 Adults only. GP prescribing expected. NHSE is for NICE TA455 for paediatric indications of adult TAs. Ustekinumab Drugs affecting the immune response Ustekinumab for moderately to severely active Crohn s disease after previous treatment TA456 July 2017 TA456. Adults only. GP prescribing expected. NHSE is for NICE TA455 for paediatric indications of adult TAs. Ustekinumab Drugs affecting the immune response Radiographic axial spondyloarthritis in adults with an inadequate response to DMARDs and/or TNF-antagonist Predicted UK launch NHSE is responsible use. Ustekinumab Drugs affecting the immune response Ulcerative colitis, moderate-to-severe active disease, second-line Predicted NHSE is for paediatric indications. Ustekinumab Drugs affecting the immune response All other indications, and un. NHSE is responsible indications. Vadadustat 9 Hypoxia-inducible factor-prolyl hydroxylase (HIF- PH) inhibitor Anaemia in chronic kidney disease, dialysed and nondialysed patients - first line anticipated Page 38 of 41

39 Drug name BNF section Category Licensed / s agreed Is this commissioned? Valbenazine 4 Vesicular monoamine transporter-2 inhibitor Vedolizumab Drugs affecting the immune response Tardive dyskinesia in adults Moderate to severe ulcerative colitis - second line after conventional therapy or TNF inhibitor anticipated NICE TA342 June 2015 TA342 and locally agreed patient pathway UK launch 2018 NHS England is responsible use. GP prescribing expected. Vedolizumab Drugs affecting the immune response Crohn's disease second line after conventional therapy and TNF inhibitors NICE TA352 Aug 2015 TA352 NHS England is responsible use. GP prescribing expected. Vedolizumab Drugs affecting the immune response All other indications, and un. Verteporfin Subfoveal choroidal neovascularisation Photodynamic therapy for wet agerelated degeneration. Fibrin sealants Blood-related products Haemostatic / tissue glue. No longer a high cost drug excluded from tariff. Part of HRG procedure tariff. Products include Evicel, Tisseel Lyo, Tisseel Ready to use, Artiss solution for sealant, deep frozen. Page 39 of 41

40 Overriding Principals: The principle underpinning the Manual for prescribed services is that the determination of specialised is principally related to the complexity of the patient and not necessarily the procedure. This is reflected in the split of specialised centres vs other centres undertaking the same procedure. Principal 1 - The commissioning body which holds the specific device funding for a particular provider is responsible for payment to that provider until the funding is transferred. This is based on the East of England Rebasing Exercise plus any subsequent transfers. It is possible that NHS England may fund a specific device with one provider and CCGs fund the same device at a different provider. Principal 2 - In line with the original Errata guidance (see below), a device is only the responsibility of NHS England if the device is on the list and it is part of a specialised spell. The provider will also need to hold a contract with NHS England for the devices to be classified as specialised. Any exceptions to this principal will be clearly marked in Comments/ High Cost Devices and Listed Procedures 2017/18 and 2018/19 Return to contents E: This sheet lists excluded devices and the for information only. It does not provide information on whether a device is commissioned or not commissioned. Advice on commissioning status of non NHSE devices should be sought from the responsible CCG. Devices: Key: Amended for 2017/19 national tariff proposals Removed from list CCG is Device 3 dimensional mapping and linear ablation catheters used for complex cardiac ablation procedures Aneurysm coils Bespoke orthopaedic prostheses Biological mesh, including synthetic equivalents Bone Anchored Hearing Aids Bone Growth Stimulators Carotid, iliac and renal stents Lengthing nails for Limb Reconstruction and Circular external fixator frame Consumables associated with per oral single operator cholangioscope Deep brain, vagal, sacral, spinal cord and occipital nerve stimulators Devices used in connection with pulmonary artery banding Drug-eluting peripheral angioplasty balloon Endovascular stent graft Flow diverters for intracranial aneurysms ICD (Implantable Cardioverter-Defibrillator) ICD with CRT (Cardiac Resynchronisation Therapy) capability Insulin pumps and pump consumables Intracranial stents Intrathecal drug delivery pumps Maxillofacial bespoke prostheses Occluder, Vascular, Appendage and Septal devices Pacemaker extraction sheaths Percutaneous valve repair and replacement devices Peripheral vascular stents Radiofrequency, cryotherapy and microwave ablation probes and catheters Rib Fixation Plates Comments/ Responsible Commissioner NHSE Separated aneurysm coils and flow diverters for intracranial aneurysms NHSE Bespoke prostheses designed and manufactured for individual patients plus modular limb salvage replacemnhse Synthetic equivalents included CCG NHSE CCG Includes embolic protection devices NHSE NHSE CCG NHSE NHSE NHSE Includes aortic stent grafts NHSE NHSE NHSE NHSE CCG (in some CCGs Paeds may be NHSE) NHSE NHSE NHSE NHSE CCG Includes devices for TAVI NHSE Includes peripheral vascular drug eluting stents NHSE Except where used for complex Gastrointestinal Tract Endoscopy procedures NHSE NHSE Procedures Procedure When to exclude Local Grouper processing SUS National Tariff processing Head and Neck Reconstructive Surgery~ Pre-Processing at episode Do not run through grouper Episodes need to be processed using '=' exclusion