Appendix 1: East of England (EoE) CCG Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2019-20

High cost drugs excluded from the 2019-20 National Tariff are not commissioned by EoE 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 Mid and South Essex CCGs and NHSE and / or new local drug policies are introduced or new NICE guidance is published. Any drug and/or a specific indication not listed within the appendix is designated as NOT COMMISSIONED. 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 NICE Guidance or where NICE has been converted into a locally agreed protocol or EoE 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. Indications 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 responsible commissioner the current version of the NHS England drug list should be refered to for the commissioning position, this is located at :- http://www.england.nhs.uk/commissioning/spec-services/key-docs/

Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Abatacept 10.1.3 Cytokine modulators Rheumatoid arthritis NICE TA195, In line with NICE Complete proforma CCGs commission adults after failure of anti- August 2010 criteria TA195. (using agreed local only. GP prescribing NOT expected. NHS England is TNF systems) responsible commissioner for paediatric use.

Page 1 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Abatacept 10.1.3 Cytokine modulators Rheumatoid Arthritis NICE TA375 In line with NICE Complete proforma CCGs commission adults not previously treated January 2016 TA375 criteria (using agreed local only. GP prescribing NOT expected. NHS England is with DMARDs or after systems) responsible commissioner conventional for paediatric use. NICE TA DMARDs only have 375 replaced NICE TA 280 failed

Abatacept 10.1.3 Cytokine modulators Polyarticular juvenile NICE TA373 In line with NICE Complete proforma CCG commision adults only. idiopathic arthritis December 2015 TA373 criteria. (using agreed local GP prescribing NOT expected. NHS England is (2nd line only). systems) responsible commissioner Unlicensed use in for paediatric use. adults.

Abatacept 10.1.3 Cytokine modulators Active psoriatic NICE TA568 NOT NOT COMMISSIONED NICE appraisal terminated arthritis after Terminated COMMISSIONED because the manufacturer does not intend to launch DMARDs appraisal March Abatacept for this indication 2019 in the UK

Abatacept 10.1.3 Cytokine modulators All other indications, NOT NOT COMMISSIONED licensed or COMMISSIONED unlicensed.

Adalimumab or 13.5.3 Cytokine modulators Psoriasis NICE TA146, June In line with NICE Complete proforma CCG commission Adults licensed 2008 criteria TA146. (using agreed local only. GP prescribing NOT expected. NHS England is biosimilar systems) responsible commissioner 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 2 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Adalimumab or 1.5.3 Cytokine modulators Crohn's Disease NICE TA187, May In line with NICE Complete proforma CCG commission Adults licensed 2010 TA187 (using agreed local only. GP prescribing NOT expected. NHS England is biosimilar systems) responsible commissioner 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 10.1.3 Cytokine modulators Psoriatic Arthritis NICE TA199, In line with NICE Complete proforma CCG commission Adults licensed August 2010 criteria TA199. (using agreed local only. GP prescribing NOT expected. NHS England is biosimilar systems) responsible commissioner 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 1.5.3 Cytokine modulators Moderate to severe NICE TA329 In line with NICE Complete proforma CCG commission Adults licensed active ulcerative February 2015 criteria TA329 (using agreed local only. GP prescribing NOT expected. NHS England is biosimilar colitis after the failure systems) responsible commissioner of conventional for plaque psoriasis NICE therapy TA 455, paediatric use (of adult TAs), uveitis (NICE TA 460) and Hidradenitis Suppurativa (NICE TA 392) and Bechet's syndrome.

Page 3 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Adalimumab or 10.1.3 Cytokine modulators Rheumatoid arthritis NICE TA375 In line with NICE Complete proforma CCG commission Adults licensed January 2016 or criteria TA375 or (using agreed local only. GP prescribing NOT expected. NHS England is biosimilar TA195 August TA195. systems) responsible commissioner 2010. 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 10.1.3 Cytokine modulators Ankylosing spondylitis NICE TA383 In line with NICE Complete proforma CCG commission Adults licensed February 2016 criteria TA383. (using agreed local only. GP prescribing NOT expected. NHS England is biosimilar systems) responsible commissioner 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 10.1.3 Cytokine modulators Axial spondyloarthritis NICE TA383 In line with NICE Complete proforma CCG commission Adults licensed (non- radiographic) February 2016 TA383 (using agreed local only. GP prescribing NOT expected. NHS England is biosimilar systems) responsible commissioner 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 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Adalimumab or 10.1.3 Cytokine modulators Polyarticular juvenile NICE TA373 In line with NICE Complete proforma CCG commission Adults licensed idiopathic arthritis December 2015 TA373 criteria. (using agreed local only. GP prescribing NOT expected. NHS England is biosimilar systems) responsible commissioner 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 1.5.3 10.1.3 13.5.3 Cytokine modulators All other indications, No NICE guidance NOT NOT COMMISSIONED NHS England is responsible licensed licensed or anticipated. COMMISSIONED commissioner for paediatric use of relevant adult TAs. biosimilar unlicensed.

Andexanet alfa Factor Xa inhibitor Reversal of Factor Xa NICE ID1101 In NOT NOT COMMISSIONED Predicted UK launch 2019 antidote inhibition development [GID- COMMISSIONED TA10440] Publication date TBC Afamelanotide Skin conditions Prevention of NICE ID927 In NOT NOT COMMISSIONED phototoxicity in development [GID- COMMISSIONED erythropoietic HST10009] protoporphyria (EPP). Publications date TBC

Aflibercept 11.8.2 Subfoveal choroidal Neovascular (wet) NICE TA294, July In line with NICE Complete proforma NHSE is responsible neovascularisation age-related macular 2013 TA294. (using agreed local commissioner for cancer indications. degeneration. systems) Aflibercept 11.8.2 Subfoveal choroidal Macular oedema, NICE TA305, In line with NICE Complete proforma NHSE is responsible neovascularisation secondary to CRVO February 2014 TA305 (using agreed local commissioner for cancer indications. systems) Aflibercept 11.8.2 Subfoveal choroidal Diabetic Macular NICE TA346 July In line with NICE Complete proforma NHSE is responsible neovascularisation Oedema 2015 TA346 (using agreed local commissioner for cancer indications. systems)

Page 5 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Aflibercept 11.8.2 Subfoveal choroidal Macular oedema, NICE TA409 In line with NICE Complete proforma NHSE is responsible neovascularisation secondary to BRVO September 2016 TA409 (using agreed local commissioner for cancer indications. systems) Aflibercept 11.8.2 Subfoveal choroidal Choroidal NICE TA486 In line with NICE Complete proforma NHSE is responsible neovascularisation neovascularisation November 2017 TA486 (using agreed local commissioner for cancer indications. systems) Aflibercept 11.8.2 Subfoveal choroidal All other indications, No NICE guidance NOT NOT COMMISSIONED NHSE is responsible neovascularisation licensed or anticipated. COMMISSIONED commissioner for cancer indications. unlicensed.

Alirocumab 2.12 Lipid-regulating Primary NICE TA 393 June In line with NICE Complete proforma drugs hypercholesterolaemi 2016 TA393 and EoE (using agreed local a (heterozygous PAC systems) familiar and non- recommendations. familiar) and mixed dyslipidaemia 2.12 Lipid-regulating Homozygous familial No NICE guidance NOT NOT COMMISSIONED drugs hypercholesterolaemi expected COMMISSIONED a

Alitretinoin 13.5.1 Skin conditions Severe chronic hand NICE TA177, In line with NICE Complete proforma Adults only. GP prescribing eczema August 2009 TA177. (using agreed local NOT expected. systems) Darvadstrocel Allogenic Perianal fistula, NICE TA556 Jan NOT NOT COMMISSIONED (Alofisel) mesenchymal stem complex and 2019, not COMMISSIONED cells refractory to recommended conventional and/or biologic agents in adults with Crohn’s disease. Amikacin 5.1.4 Aminoglycosides Nontuberculous No NICE guidance NOT NOT COMMISSIONED NHS England responsible Liposomal mycobacterial lung anticipated. COMMISSIONED commissioner for use in CF inhalation infection

Page 6 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Anakinra 10.1.3 Cytokine modulators Rheumatoid arthritis NICE TA72, NOT NOT COMMISSIONED NHS England responsible November 2003 COMMISSIONED commissioner for juvenile arthritis - paediatric, adult (replaced by NICE onset Stills disease, CG79, February cropyrin associated periodic 2010), not syndrome, Stills disease, recommended periodic fevers and autoinflammatory conditions.

Andexanet alfa 2.8.4 Factor Xa inhibitor Oral anticoagulant NICE ID1101 GID- NOT NOT COMMISSIONED antidote reversal agents TA10440 in COMMISSIONED development. Expected publication date March 2020 Apremilast 10.1.3 Cytokine modulators Psoriasis NICE TA419 In line with NICE Complete proforma CCG commission Adults November 2016 TA419. (using agreed local only. GP prescribing NOT expected. systems)

Apremilast 10.1.3 Cytokine modulators Psoriatic arthritis NICE TA433 In line with NICE Complete proforma CCG commission Adults unresponsive or February 2017 TA433. (using agreed local only. GP prescribing NOT expected. intolerant to DMARDs systems)

Avatrombopag 9.1.4 Platelet disorder ITP first line No NICE guidance NOT NOT COMMISSIONED Predicted UK launch 2019. drugs anticipated. COMMISSIONED Avatrombopag 9.1.4 Platelet disorder Thrombocytopenia NICE ID1520 In NOT NOT COMMISSIONED Predicted UK launch 2019. drugs associated with liver development [GID- COMMISSIONED disease, pre-surgical TA10444] procedure. Publication expected Feb 2020

Page 7 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Aztreonam 5.1.2.3 Antibacterial drugs Cystic Fibrosis NHSE In line with NHS NHS England Only excluded when given Lysine nebuliser commissioning England Policies for by nebulisation / inhalation. NHS England responsible solution policy for CF. CF commissioner for use in CF. Policy Ref: A01/P/b GP prescribing not Dec 2014 and expected. Policy Ref: 16001/P July 2016 Aztreonam 5.1.2.3 Antibacterial drugs Bronchiectasis Bronchiectasis only GPs prescribe for NOT COMMISSIONED Only excluded when given Lysine nebuliser in line with Local patients subject to by nebulisation / inhalation. NHS England responsible solution Policies local commissioner commissioner for use in CF agreement.

Baricitinib 10.1.3 Cytokine modulators Moderate to severe NICE TA466 In line with NICE Complete proforma CCG commission Adults active rheumatoid August 2017 TA466. (using agreed local only. GP prescribing NOT expected. arthritis adult patients systems) who have responded inadequately to intensive therapy with a combination of Bezlotoxumab Human monoclonal Prevention of NICE ID1068 In NOT NOT COMMISSIONED antibody recurrence development [GID- COMMISSIONED of Clostridium TA10178] difficile infection Suspended

Botulinum Toxin 4.7.4.2 Prophylaxis of Migraine prophylaxis NICE TA260, June In line with NICE Complete proforma GP prescribing NOT A migraine 2012 TA260 (using agreed local expected systems)

Page 8 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Botulinum Toxin 4.9.3 Essential tremor, Spasticity (after Spasticity (after In line with PAC Complete proforma GP prescribing NOT A chorea, tics and stroke) where there is stroke) - botulinum recommendations (using agreed local expected related disorders a dynamic spastic toxin type A [ID768] systems) component (as - In development opposed to [GID-TAG499] contracture) and Expected there are anticipated publication date: functional gains in TBC line with Royal College of Physician guidance. Botulinum Toxin 4.9.3 Essential tremor, Hypersalivation NICE ID1150 In In line with PAC NOT COMMISSIONED GP prescribing NOT A chorea, tics and associated with development [GID- recommendations. expected related disorders neurological TA10296] conditions (including Publication Hirschsprung's expected October disease). 2019

Page 9 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Botulinum Toxin 4.9.3 Essential tremor, Chronic anal fissure, No NICE guidance In line with PAC Complete proforma GP prescribing NOT A chorea, tics and severe anticipated recommendations. (using agreed local expected.NHS England is responsible commissioner related disorders blepharospasm, systems) for focal spasticity in hemifacial spasm, children. Treatment of cervical dystonia spasticity in paediatric (spasmodic cerebral palsy is torticollis), focal commissioned by NHSE at specialist centres only. spasticity in upper Intravesical use in spinal and lower limb in injury commissioned by adults (causes other NHSE. than stroke), hyperhidrosis of the axillae, dysphagia caused by achalasia and overactive bladder.,

Page 10 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Botulinum Toxin 4.9.3 Essential tremor, Chronic sialorrhoea in No NICE guidance NOT NOT COMMISSIONED License extension expected A chorea, tics and adults and children, anticipated COMMISSIOINED 2019. GP prescribing NOT expected.NHS England is related disorders associated with responsible commissioner neurological for focal spasticity in conditions such as children. Treatment of cerebral palsy (CP), spasticity in paediatric Parkinson’s disease cerebral palsy is commissioned by NHSE at (PD), stroke and specialist centres only. traumatic brain injury Intravesical use in spinal (TBI) (licence injury commissioned by extension). NHSE.

Botulinum Toxin 4.9.3 Essential tremor, Laryngeal dystonia No NICE guidance NOT NOT COMMISSIONED In line with negative PAC A chorea, tics and (spasmodic dystonia), anticipated COMMISSIOINED recommendations related disorders hydradenitis suppurative, mechanical neck disorders, correction of strabismus (squint) in paediatrics, dysphagia (causes other than achalasia), Raynaud’s Disease, Massateric Hypertrophy.

Botulinum Toxin 4.9.3 Essential tremor, All other indications, NOT NOT COMMISSIONED A chorea, tics and licensed or COMMISSIONED related disorders unlicensed.

Page 11 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Botulinum Toxin 4.9.3 Torsion, dystonias Spasmodic torticollis No NICE guidance In patients resistant NOT COMMISSIONED B and other involuntary (Cervical dystonia) anticipated to Botulinum Toxin movements A for cervical dystonia.

Brodalumab 13.5.3 Drugs affecting the Plaque psoriasis, NICE TA511 In line with NICE Complete proforma CCG commission Adults immune response moderate-to-severe. March 2018 TA511 (using agreed local only. GP prescribing NOT expected. systems) 10.1.3 Cytokine modulators Neovascular (wet) NICE ID1254 NOT NOT COMMISSIONED Predicted UK launch 2020. age-related macular Proposed [GID- COMMISSIONED degeneration (AMD) TA10455] Publication date TBC Cannabidiol Cannabinoids Seizures associated NICE ID1211[GID- NOT NOT COMMISSIONED Dravet/Lennox Gastaut with Dravet syndrome TA10274] Expected COMMISSIONED syndrome is NHS England specialised service publication date: December 2019

Cannabidiol Cannabinoids Seizures associated NICE ID1308[GID- NOT NOT COMMISSIONED Dravet/Lennox Gastaut with Lennox - TA10410] Expected COMMISIONED syndrome is NHS England specialised service Gastautsyndrome publication date: December 2019

Cannabidiol Cannabinoids All other indications No NICE guidance NOT NOT COMMISSIONED Dravet/Lennox Gastaut expected. COMMISSIONED syndrome is NHS England specialised servise

Caplacizumab Anti-von Willebrand Acquired thrombotic NICE ID1185 In NOT NOT COMMISSIONED factor (vWF) thrombocytopenic development [GID- COMMISSIONED nanobody purpura (aTTP) TA10361] Publication date August 2019

Page 12 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Certolizumab 10.1.3 Cytokine modulators Rheumatoid Arthritis NICE TA375 In line with NICE Complete proforma CCG commission Adults Pegol not previously treated January 2016 TA375 (using agreed local only. GP prescribing NOT expected. with DMARDs or after systems) conventional DMARDs only have failed

Certolizumab 10.1.3 Cytokine modulators Ankylosing spondylitis NICE TA383, In line with NICE Complete proforma CCG commission Adults Pegol February 2016 TA383. (using agreed local only. GP prescribing NOT expected. systems) Certolizumab 10.1.3 Cytokine modulators Axial spondyloarthritis NICE TA383, In line with NICE Complete proforma CCG commission Adults Pegol (non radiographic) February 2016 TA383. (using agreed local only. GP prescribing NOT expected. systems)

Certolizumab 10.1.3 Cytokine modulators Rheumatoid arthritis NICE TA415 Oct In line with NICE Complete proforma CCG commission Adults Pegol after TNF inhibitor 2016 TA415 (using agreed local only. GP prescribing NOT expected. systems) Certolizumab 10.1.3 Cytokine modulators Active psoriatic NICE TA445 May In line with NICE Complete proforma CCG commission Adults Pegol arthritis after 2017 TA445 (using agreed local only. GP prescribing NOT expected. DMARDs systems) Certolizumab 10.1.3 Cytokine modulators Early progressive Negative NICE NOT NOT COMISSIONED Pegol rheumatoid arthritis, TA375, January COMMISSIONED untreated by 2016 DMARDs

Page 13 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Certolizumab 10.1.3 Cytokine modulators Moderate to severe NICE TA 574 April In line with NICE Complete proforma CCG commission Adults GP Pegol plaque psoriasis 2019 TA 574 (using agreed local prescribing NOT expected systems) Certolizumab 10.1.3 Cytokine modulators All other indications, No NICE guidance NOT NOT COMISSIONED Pegol licensed or anticipated. COMMISSIONED unlicensed.

Colistimethate 5.1.7 Antibacterial drugs Cystic Fibrosis NHSE Policy - NHS England Only excluded when given sodium powder Inhaled Therapy by nebulisation/inhalation. for nebulisation For Adults And Children With Cystic Fibrosis Policy Ref: A01/P/b Dec 2014

Colistimethate 5.1.8 Antibacterial drugs Cystic Fibrosis NICE TA276, NHSE Policy - No GP prescribing of Only excluded when given sodium dry March 2013. Inhaled Therapy Colobreathe® as Patient by nebulisation/inhalation. powder for For Adults And Access Scheme not inhalation Children With available in primary (Colobreathe®) Cystic Fibrosis care. Policy Ref: A01/P/b Dec 2014

Collagenase 10.1.3 Enzymes Peyronie's disease No NICE guidance NOT NOT COMMISSIONED. (PsD) anticipated. COMMISSIONED. Collagenase 10.1.3 Enzymes Dupuytren's NICE TA459 July In line with NICE Complete proforma Only excluded from tariff Contracture 2017 TA459 (using agreed local when used in outpatients systems) Deferasirox 9.1.3 Iron overload Anaemia related to PAC Only in line with NOT COMMISSIONED NHS England responsible chronic iron overload recommendation Local Policies commissioner for hypoplastic, haemolytic and for myelodysplastic (not recommended) renal anaemias - iron syndrome only overload, thalassemia and sickle cell disease. NHSE routinely commissioned in combination when dual therapy required.

Page 14 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Deferiprone 9.1.3 Iron overload Anaemia related to PAC Only in line with NOT COMMISSIONED NHS England responsible chronic iron overload recommendation Local Policies commissioner for hypoplastic, haemolytic and for myelodysplastic (not recommended) renal anaemias - iron syndrome only overload, thalassemia and sickle cell disease. NHSE routinely commissioned in combination when dual therapy required.

Desferrioxamine 9.1.3 Iron overload Anaemia related to PAC Only in line with NOT COMMISSIONED NHS England responsible chronic iron overload recommendation Local Policies commissioner for hypoplastic, haemolytic and for myelodysplastic (not recommended) renal anaemias - iron syndrome only overload, thalassemia and sickle cell disease. NHSE routinely commissioned in combination when dual therapy required.

Dexamethasone 11.4.1 Macular oedema Macular oedema NICE TA229, July In line with NICE Complete proforma intravitreal secondary to retinal 2011. TA229. (using agreed local implant vein occlusion. systems) Dexamethasone 11.4.1 Macular oedema Diabetic Macular NICE TA349 July In line with NICE Complete proforma intravitreal Oedema 2015 TA349 (using agreed local implant systems) Dexamethasone 11.4.2 Macular oedema Non-infectious uveitis NICE TA460 July In line with NICE Complete proforma intravitreal (unilateral) 2017 TA460 criteria. (using agreed local implant systems) Dibotermin alfa Bone morphogenetic Acute tibia fractures No NICE guidance Only in line with Complete proforma NHS England responsible protein anticipated. Local Policies (PAC (using agreed local commissioner for complex spinal surgery NHSE policy policy) systems) 16063.

Page 15 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Digoxin immune 2.1.1 Poisoning Life-threatening National Poisons Only commissioned Local Commissioner to Available on named patient fab digoxin toxicity. Centre Guidelines. in line with National be notified / invoiced basis only in hospitals. Poison Centres when used. guidelines.

Dimethyl 13.5.2 Preparations for Moderate to severe NICE TA475 In line with NICE Complete proforma NHS England is responsible fumarate psoriasis plaque psoriasis September 2017 TA475 (using agreed local commissioner for Multiple Sclerosis. systems) Dupilumab 13 Anti-interleukin -4 Moderate-to-severe TA534 August 2018 In line with NICE Complete proforma NHS England responsible injection and -13 receptor atopic dermatitis TA534 (using agreed local commissioner for asthma indication. systems)

Dupilumab 13 Anti-interleukin -4 Severe asthma NICE [GID- NOT NOT COMMISSIONED UK launch plans unknown. injection and -13 receptor TA10276] COMMISSIONED monoclonal antibody Publication date July 2020 Dupilumab 13 Anti-interleukin -4 Nasal cronic NICE ID1179 NOT NOT COMMISSIONED Predicted launch 2020 injection and -13 receptor rhinosinusitis with Proposed [GID- COMMISSIONED monoclonal antibody nasal polyps TA10450] Publication date TBC Eculizumab 10 Recombinant Relapsing NICE ID1271 NOT NOT COMMISSIONED NHS England is responsible humanised neromyelitis optica Proposed [GID- COMMISSIONED commissioner for Atypical haemolytic uremic monoclonal TA10469] Expected syndrome (aHUS), antibody. publication date: Paroxysmal nocturnal TBC haemoglobinuria (PNH), , C3 glomerulopathy post transplant

Page 16 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Eculizumab 10 Recombinant Myasthenia Gravis NICE ID1064 Due NOT NOT COMMISSIONED NHS England is responsible humanised (MG), generalised, May 2018 but COMMISSIONED commissioner for Atypical haemolytic uremic monoclonal refractory, in patients currently syndrome (aHUS), antibody. who are anti- suspended Paroxysmal nocturnal acetylcholine receptor haemoglobinuria (PNH), , antibody-positive C3 glomerulopathy post transplant

Eltrombopag 9.1.4 Platelet disorder Chronic idiopathic NICE TA293, July In line with NICE Complete proforma GP prescribing NOT drugs thrombocytopenic 2013 TA293. (using agreed local expected. NHS England are the responsible purpura (ITP) systems) commissioner for use in paediatrics

Eltrombopag 9.1.4 Platelet disorder Thrombocytopenia in No NICE guidance Only in line with NOT COMMISSIONED GP prescribing NOT drugs adult patients with anticipated. Local Policies/PAC expected.PAC recommendations published chronic hepatitis C recommendations. Sept 2014. virus infection

Eltrombopag 9.1.4 Platelet disorder Severe aplastic NICE TA382 NOT NOT COMMISSIONED. drugs anaemia (SAA) terminated COMMISSIONED. refractory appraisal, January immunosuppressive 2016. NICE unable therapy to make a recommendation.

Eltrombopag 9.1.4 Platelet disorder Untreated severe NICE ID1198 NOT NOT COMMISSIONED. Unlicensed indication. drugs aplastic anaemia suspended COMMISSIONED.

Page 17 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Erenumab Humanised Migraine, prevention NICE ID1188 [GID- NOT NOT COMMISSIONED monoclonal antibody in adults. TA10302] Expected COMMISSIONED that inhibits publication date: calcitonin gene- July 2019 related peptide (CGRP)

Erythropoietins 9.1.3 Drugs used in renal No NICE guidance NHS England NHS England Only excluded when used in anaemias anticipated. Hypoplastic, conjunction with renal dialysis. NHS England is the haemolytic and renal responsible commissioner anaemias for dialysis induced anaemia. Etanercept or 10.1.3 Cytokine modulators Rheumatoid Arthritis NICE TA375 In line with NICE Complete proforma CCG commission Adults licensed January 2016 or criteria TA375 or (using agreed local only, GP prescribing NOT expected. biosimilar TA195 August TA195. systems) 2010. Etanercept or 10.1.3 Cytokine modulators Ankylosing spondylitis NICE TA383 In line with NICE Complete proforma CCG commission Adults licensed February 2016 TA383 (using agreed local only, GP prescribing NOT expected. biosimilar systems) Etanercept or 10.1.3 Cytokine modulators Axial spondyloarthritis NICE TA383 In line with NICE Complete proforma CCG commission Adults licensed (non radiographic) February 2016 TA383 (using agreed local only, GP prescribing NOT expected. , TA143, TA199) biosimilar systems) Etanercept or 10.1.3 Cytokine modulators Psoriatic Arthritis NICE TA199, In line with NICE Complete proforma CCG commission Adults licensed August 2010 TA199. (using agreed local only, GP prescribing NOT expected. biosimilar systems) Etanercept or 10.1.3 Cytokine modulators Psoriasis NICE TA103, July In line with NICE Complete proforma CCG commission Adults licensed 2006 TA103. (using agreed local only, GP prescribing NOT expected. biosimilar systems)

Page 18 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Etanercept or 10.1.3 Cytokine modulators Polyarticular juvenile NICE TA373 Dec In line with NICE Complete proforma CCG commission Adults licensed idiopathic arthritis or 2015 TA373 criteria. (using agreed local only, GP prescribing NOT expected. NHS England is biosimilar Enthesitis-related JIA systems) responsible commissioner or Psoriatic JIA. for paediatric use as per Unlicensed use in NHS ENGLAND CLINICAL adults. COMMISSIONING POLICY: E03/P/d; TA 373

Etanercept or 10.1.3 Cytokine modulators All other indications, No NICE guidance NOT NOT COMMISSIONED NHS England is responsible licensed licensed or anticipated. COMMISSIONED commissioner for paediatric use. biosimilar unlicensed.

Evolocumab 2.12 PCSK9 Monoclonal Primary NICE TA394, June In line with NICE Complete proforma CCG commission Primary Antibody Inhibitor hypercholesterolaemi 2016. TA394 and EoE (using agreed local non-familial hypercholesterolaemia or a (heterozygous PAC systems) mixed dyslipidaemia. NHSE familiar and non- recommendations is responsible commissioner familiar) and mixed for Homozygous familial dyslipidaemia hypercholesterolemia

Evolocumab 2.12 PCSK9 Monoclonal Prevention of No NICE guidance To be confirmed To be confirmed Antibody Inhibitor cardiovascular events anticipated. in patients with established atherosclerotic cardiovascular disease. Fidaxomicin 5.1.7 Antibacterials C. difficile associated NOT NOT COMMISSIONED diarrhoea (CDAD) in COMMISSIONED adults

Page 19 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Fidaxomicin 5.1.8 Antibacterials C. difficile associated NOT NOT COMMISSIONED License extension expected diarrhoea (CDAD) in COMMISSIONED 2020. children

Fluocinolone 11.4.1 Macular oedema Chronic diabetic NICE TA301, In line with NICE Complete proforma acetonide macular oedema November 2013 TA301. (using agreed local intravitreal Under review NICE systems) implant ID1421 In development [GID- TA10379] Publication date TBC Fluocinolone 11.4.2 Corticosteroid Non-infectious NICE ID1039 In NOT NOT COMMISSIONED acetonide implant posterior uveitis that development [GID- COMMISSIONED intravitreal is sight threatening, TA10368] implant second-line. Publication date TBC Fomepizole Poisoning Poisoning National Poisons Only commissioned Local Commissioner to Centre Guidelines in line with National be notified when used. Poison Centres guidelines.

Fremanezumab Humanised Episodic and chronic NICE ID1368 In NOT NOT COMMISSIONED monoclonal antibody migraine prevention development [GID- COMMISSIONED that inhibits in adults. TA10339]. calcitonin gene- Publication date related peptide TBC (CGRP). Humanised Episodic cluster No NICE guidance NOT NOT COMMISSIONED monoclonal antibody headache in adults, anticipated. COMMISSIONED that inhibits prevention (licence calcitonin gene- extension). related peptide

Page 20 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Galcanezumab 4 Monoclonal- Prevention of chronic NICE ID1372. NOT NOT COMMISSIONED antibody, calcitonin or episodic migraine. Proposed [GID- COMMISSIONED gene-related peptide TA10454] antagonist Publication date TBC 4 Monoclonal- Prevention of cluster NICE ID1212. NOT NOT COMMISSIONED antibody, calcitonin headache Proposed [GID- COMMISSIONED gene-related peptide TA10425] antagonist Publication date TBC Golimumab 10.1.3 Cytokine modulators Psoriatic Arthritis NICE TA220 April In line with NICE Complete proforma CCG commission Adults 2011 TA220. (using agreed local only, GP prescribing NOT expected. systems) Golimumab 10.1.3 Cytokine modulators Rheumatoid arthritis NICE TA375 Jan In line with NICE Complete proforma CCG commission Adults 2016 or TA225 TA375 or TA225 (using agreed local only, GP prescribing NOT expected. June 2011 systems) Golimumab 1.5.3 Cytokine modulators Moderate to severe NICE TA329 Feb In line with NICE Complete proforma CCG commission Adults ulcerative colitis- 2015 TA329 (using agreed local only, GP prescribing NOT expected. second line systems) Golimumab 10.1.3 Cytokine modulators Ankylosing spondylitis NICE TA383 In line with NICE Complete proforma CCG commission Adults February 2016 TA383 (using agreed local only, GP prescribing NOT expected. systems) Golimumab 10.1.3 Cytokine modulators Axial spondyloarthritis NICE TA497 In line with NICE Complete proforma CCG commission Adults (non-radiographic) January 2018 TA497 (using agreed local only, GP prescribing NOT expected.. systems)

Golimumab 10.1.3 Cytokine modulators All other indications, NOT NOT COMMISSIONED licensed or COMMISSIONED unlicensed.

Guselkumab 13.5.3 Drugs affecting the Plaque psoriasis, NICE TA521 June In line with NICE Complete proforma CCG commission Adults immune response. moderate-to-severe 2018 TA521 (using agreed local only, GP prescribing NOT expected.. systems)

Page 21 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Idarucizumab 2.8.4 Oral anticoagulant Reversal agent for No NICE guidance Local Commissioner to reversal agents dabigatran anticipated. be notified / invoiced when used. Iloprost 2.5.1 Vasodilator Critical limb No NICE guidance Only in line with NOT COMMISSIONED NHSE commissioned when antihypertensive ischaemia anticipated. Local Policies used for pulmonary arterial hypertension at specialist drugs/Pulmanory centres. Arterial Hypertension

Infliximab or 1.5.3 Cytokine modulators Crohn's Disease NICE TA187, May In line with NICE Complete proforma CCG commission Adults licensed 2010 TA187 (using agreed local only, GP prescribing NOT expected. NHS England is biosimilar systems) responsible commissioner for paediatric use.

Infliximab or 10.1.3 Cytokine modulators Rheumatoid Arthritis NICE TA375 Jan In line with NICE Complete proforma CCG commission Adults licensed 2016 or TA195 Aug TA375 or TA195. (using agreed local only, GP prescribing NOT expected. biosimilar 2010. systems)

Infliximab or 10.1.3 Cytokine modulators Psoriatic Arthritis NICE TA199, In line with NICE Complete proforma CCG commission Adults licensed August 2010 TA199. (using agreed local only, GP prescribing NOT expected. biosimilar systems)

Page 22 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Infliximab or 13.5.3 Cytokine modulators Psoriasis (adults) NICE TA134, In line with NICE Complete proforma CCG commission Adults licensed January 2008 TA134. (using agreed local only, GP prescribing NOT expected. biosimilar systems)

Infliximab or 1.5.3 Cytokine modulators Ulcerative Colitis NICE TA163, In line with NICE Complete proforma CCG commission Adults licensed (acute exacerbations) December 2008 TA163. (using agreed local only, GP prescribing NOT expected. biosimilar systems) Infliximab or 1.5.3 Cytokine modulators Ulcerative Colitis - NICE TA329 Feb In line with NICE Complete proforma CCG commission Adults licensed 2nd line for moderate 2015 TA329 (using agreed local only, GP prescribing NOT expected. biosimilar to severely active systems)

Infliximab or 10.1.3 Cytokine modulators Ankylosing spondylitis NICE TA383 If treatment is Complete proforma CCG commission Adults licensed February 2016 started with the (using agreed local only, GP prescribing NOT expected. biosimilar least expensive systems) infliximab product in line with NICE TA383

Infliximab or 10.1.3 Cytokine modulators JIA (unlicensed Patient currently Continuation and Complete proforma CCG commission Adults biosimilar indication) responding to discontinuation in (using agreed local only, GP prescribing NOT expected. NHS England is treatment. line with NHSE systems) responsible commissioner policy E03/P/d for paediatric use. (EO3X04). No initiation in adults

Infliximab or 10.1.3 Cytokine modulators Axial spondyloarthritis Not considered in NOT NOT COMMISSIONED licensed (non- radiographic). NICE TA383 COMMISSIONED biosimilar Unlicensed indication. February 2016.

Page 23 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Infliximab or 1.5.3 Cytokine modulators Ulcerative Colitis NICE TA329 Feb NOT NOT COMMISSIONED licensed (Sub-acute 2015 Not COMMISSIONED biosimilar manifestations) recommended

Infliximab or 1.5.3 10.1.3 Cytokine modulators All other indications, NOT NOT COMMISSIONED licensed 13.5.3 licensed or COMMISSIONED biosimilar unlicensed.

Ixekizumab 13.4.2 Humanized Plaque psoriasis NICE TA442 April In line with NICE Complete proforma Adults only, GP prescribing anti–interleukin-17 2017 TA 442 (using agreed local NOT expected. monoclonal antibody systems)

Ixekizumab 10.1.3 Humanized Psoriatic arthritis NICE TA537 In line with NICE Complete proforma Adults only, GP prescribing anti–interleukin-17 August 2018 TA537 (using agreed local NOT expected. monoclonal antibody systems)

Ixekizumab 10.1.3 Humanized Axial spondyloarthritis NICE ID1532 [GID- NOT NOT COMMISSIONED Predicted UK launch 2020 anti–interleukin-17 after NSAIDs TA10458] Expected COMMISSIONED monoclonal antibody publication date: TBC

Page 24 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Ketorolac with Retinal Intraocular lens No NICE guidance NOT NOT COMMISSIONED Licensed. UK launch plans Phenylephrine disorders/intraocular replacement surgery anticipated. COMMISSIONED not known. lens replacement surgery Lanreotide 8.3.4.3 Somatostatin Cancer, acromegaly. No NICE guidance NHS England NHS England NHS England is responsible Analogues anticipated. commissioner for cancer indications and congenital hyperinsulinism and for acromegaly but only when prescribed in a specialist centre.

Levofloxacin 5.1.2 Antibacterial drugs Chronic pulmonary No NICE guidance NOT NOT COMMISSIONED Only excluded when given Solution for infections due to anticipated. COMMISSIONED by nebulisation / inhalation. NHS England is the Inhalation Pseudomonas responsible commissioner aeruginosa in adults for cystic fibrosis only when with CF prescribed in a specialist centre.

Liothyronine Other endocrine Myxoedema coma No NICE guidance TBC TBC injection drugs anticipated. Liothyronine Other endocrine Thyroid replacement No NICE guidance TBC TBC Unlicensed indication. injection drugs in patients who are anticipated. long term nil by mouth. Liothyronine Other endocrine Management of No NICE guidance TBC TBC Unlicensed indication. injection drugs organ donor patients anticipated. post brain death.

Lusutrombopag Platelet Disorder Thrombocytopenia in NICE ID1520 In NOT NOT COMMISSIONED Licensed but not launched. Drugs adults with chronic development [GID- COMMISSIONED liver disease prior to TA10444] elective procedures Publication expected Feb 2020

Page 25 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Mannitol 3.7 Mucolytics Cystic Fibrosis NICE TA266 NHSE Policy - NHS England NHSE. Only excluded when November 2012 Inhaled Therapy given by nebulisation / inhalation. GP prescribing For Adults And not expected. Children With Cystic Fibrosis Policy Ref: A01/P/b Dec 2014. GPs prescribe for patients subject to local commissioner agreement.

Mannitol 3.7 Mucolytics Indications other than No NICE guidance NOT NOT COMMISSIONED cystic fibrosis. anticipated. COMMISSIONED Mepolizumab Fully humanised IgG Chronic obstructive NICE ID1327 NOT NOT COMMISSIONED Predicted launch date monoclonal antibody pulmonary disease publication date COMMISSIONED unknown. NHS England responsible commissioner specific for TBC for asthma interleukin 5 indication.Eosinophilic Granulomatosis with Polyangiitis (Churg Strauss syndrome) - NHSE likely to be responsible commissioners.

Mexiletine Neuromuscular Non-dystrophic NHS England NHS England Excluded HCD for disorders myotona neuromuscular disorder only. NHS England is responsible commissioner for neuromuscular disorder.

Ocriplasmin 11.8.2 Retinal disorders Vitreomacular traction NICE TA297 Oct In line with NICE Complete proforma GP prescribing NOT including those 2013 TA297 (using agreed local recommended. associated with systems) macular holes.

Page 26 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Octreotide 8.3.4.3 Somatostatin Non cancer Only in line with Complete proforma NHS England responsible Analogues indications Local Policies (using agreed local commissioner for cancer, congenital systems) hyperinsulinaemia and acromegaly but only when prescribed in a specialist centre. Omalizumab 3.4.2 Allergen Previously treated NICE TA339 June In line with NICE Complete proforma NHS England responsible Immunotherapy chronic spontaneous 2015 TA339 (using agreed local for asthma indication urticaria systems) Pitolisant 4.1.1 Hypnotics and Narcolepsy with or No NICE guidance NOT NOT COMMISSIONED anxiolytics without cataplexy anticipated. COMMISSIONED

Pitolisant 4.1.1 Hypnotics and Obstructive sleep NICE ID1065 [GID- NOT NOT COMMISSIONED anxiolytics apnoea TA10385] Expected COMMISIONED publication date: TBC 11.8.2 Neovascularisation Neovascular (wet) NICE TA155, In line with NICE Complete proforma GP prescribing NOT age-related macular August 2008 TA155. (using agreed local expected. degeneration systems) Ranibizumab 11.8.2 Neovascularisation Diabetic Macular NICE TA274, Feb In line with TA274. Complete proforma GP prescribing NOT Oedema 2013 (using agreed local expected. systems) Ranibizumab 11.8.2 Neovascularisation Macular oedema NICE TA283, May In line with TA283. Complete proforma GP prescribing NOT (retinal vein 2013 (using agreed local expected. occlusion) systems) Ranibizumab 11.8.2 Neovascularisation CNV due to NICE TA298, In line with TA298. Complete proforma GP prescribing NOT pathological myopia November 2013 (using agreed local expected. systems) Ranibizumab 11.8.3 Neovascularisation Moderately-severe to No NICE guidance NOT NOT COMMISSIONED Licensed extension severe non- anticipated. COMMISSIONED predicted 2019 proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) 2019

Page 27 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Ranibizumab 11.8.2 Neovascularisation All other indications, NOT NOT COMMISSIONED injection licensed or COMMISSIONED unlicensed.

Risankizumab Humanised IgG1 Chronic plaque ID1398 In NOT NOT COMMISSIONED Monoclonal antibody psoriasis moderate- development [GID- COMMISSIONED severe TA10349] Expected publication August 2019

Rituximab or 10.1.3 Cytokine modulators Rheumatoid Arthritis NICE TA195, Aug In line with NICE Complete proforma NHS England responsible licensed after failure of TNF 2010 TA195. (using agreed local commissioner for ANCA- positive vasculitis, cancer, biosimilar inhibitor systems) 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, Rituximab or 10.1.3 Cytokine modulators Rheumatoid arthritis No NICE guidance Only in line with Complete proforma pemphigus licensed (first line) anticipated. Local Policies (using agreed local vulgaris/pemphigoid biosimilar systems) disease.

Rituximab or 10.1.3 Cytokine modulators ITP No NICE guidance Only in line with Complete proforma licensed anticipated. Local Policies (using agreed local biosimilar systems)

Page 28 of 38 NHS England responsible commissioner for ANCA- positive 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.

Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Rituximab or 10.1.3 Cytokine modulators Refractory vasculitis Only in line with Complete proforma licensed Local Policies (using agreed local biosimilar systems)

Rituximab or 10.1.3 Cytokine modulators JIA (unlicensed Patient currently Continuation and Complete proforma biosimilar indication) responding to discontinuation in (using agreed local treatment,transition line with NHSE systems) ed from the NHS policy E03/P/d England paediatric (EO3X04). No service initiation in adults

Rituximab or 10.1.3 Cytokine modulators All other indication, NOT NOT COMMISSIONED licensed licensed or COMMISSIONED biosimilar unlicensed. Romiplostim 9.1.4 Platelet Disorder ITP NICE TA221 April In line with NICE Complete proforma GP prescribing NOT Drugs 2011 TA221. (using agreed local expected. NHS England are the responsible systems) commissioner for use in paediatrics Humanised Osteoporosis in men Non- NOT NOT COMMISSIONED monoclonal and postmenopausal bisphosphonates COMMISSIONED antibody, sclerostin women for treating inhibitor osteoporosis NICE ID901 In development [GID- TA10072] Expected publication September 2019

Sarilumab No BNF category Cytokine modulators Moderately to NICE TA485 In line with NICE Complete proforma Adults only. GP prescribing severely active November 2017 TA485. (using agreed local NOT expected. rheumatoid arthritis systems) (RA)

Page 29 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Secukinumab 10.1.3 Cytokine modulators Chronic plaque NICE TA350 July In line with NICE Complete proforma Adults only. GP prescribing psoriasis moderate- 2015 TA350 (using agreed local NOT expected. NHS England responsible severe after failed systems) commissioner for paediatric conventional use but do not commission therapies as unlicensed indication.

Secukinumab 10.1.3 Cytokine modulators Ankylosing spondylitis NICE TA407 In line with NICE Complete proforma Adults only. GP prescribing after treatment with September 2016 TA407 (using agreed local NOT expected. NHS England responsible non-steroidal anti- systems) commissioner for paediatric inflammatory drugs or use but do not commission TNF-alpha inhibitors as unlicensed indication.

Secukinumab Cytokine modulators Psoriatic arthritis, NICE TA455 May In line with NICE Complete proforma Adults only. GP prescribing second line 2017 TA407 (using agreed local NOT expected. NHS England responsible systems) commissioner for paediatric use but do not commission as unlicensed indication.

Secukinumab 10.1.3 Cytokine modulators Axial - NICE ID1419 NOT NOT COMMISSIONED Predicted UK launch 2020 spondyloarthritis (non- Proposed [GID- COMMISSIONED radiographic) TA10457] Publication date TBC Secukinumab Cytokine modulators All other indications, NOT NOT COMMISSIONED licensed or COMMISSIONED unlicensed.

Siltuximab 10.1.3 Cytokine modulators Castleman’s disease No NICE guidance NOT NOT COMMISSIONED anticipated. COMMISSIONED

Page 30 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Sodium oxybate 4.1 Hypnotics and Narcolepsy with EoE PAC policy - NOT COMMISSIONED NHS England is responsible anxiolytics cataplexy (adults) Low priority and not commissioner for paediatric use. routinely funded. Existing patients may continue until they or their clinician discontinue. Solriamfetol 4.1 Hypnotics and Obstructive sleep ID1499 Proposed NOT NOT COMMISSIONED Predicted UK launch 2020 anxiolytics apnoea syndrome [GID-TA10430] COMMISSIONED (OSAS)-associated Publication date excessive daytime TBC sleepiness (EDS)

Somatropin 6.5.1 Growth Hormone or Adults with growth NICE TA64 August In line with NICE Complete proforma Local Commissioner (adults) Growth Hormone hormone deficiency 2013 TA64 (using agreed local Receptor Antagonist systems)

Somatropin 6.5.1 Growth Hormone or Growth failure in NICE TA188, May In line with NICE Complete proforma Local Commissioner and (children) Growth Hormone children 2010 TA188 and EoE (using agreed local GOSH NB: Shared care arrangements with GPs in Receptor Antagonist PAC systems) place. recommendations Teriparatide 6.6.1 Drugs affecting bone Secondary prevention NICE TA161 Jan In line with NICE Complete proforma GP prescribing NOT metabolism of osteoporotic 2011. Note: NICE TA161 guidance or (using agreed local expected. Local Commissioner. NHSE fragility fractures in review Non- locally agreed systems) responsible commissioner postmenopausal bisphosphonates protocols. for male and juvenile women. for treating osteoporosis. osteoporosis [ID901] In development [GID- TA10072] September 2019

Page 31 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Teriparatide 6.6.1 Drugs affecting bone Treatment of No NICE guidance NOT NOT COMMISSIONED metabolism osteoporosis anticipated. COMMISSIONED associated with glucocorticoids Tildrakizumab 13 Human interleukin- Chronic plaque NICE TA575, April In line with NICE Complete proforma 23 antagonist psoriasis in adults, 2019 TA575 (using agreed local moderate-to-severe systems)

Tobramycin 5.1.4 Antibacterial Drugs Cystic Fibrosis NHSE Policy - NHS England Only excluded when given (Tobi® / Inhaled Therapy commissioning by nebulisation / inhalation. Bramitob®) For Adults And responsibility. No GP nebuliser solution Children With prescribing Cystic Fibrosis Policy Ref: A01/P/b

Tobramycin 5.1.5 Antibacterial Drugs Cystic Fibrosis NICE TA276, NHSE Policy - No GP prescribing of Only excluded when given (Tobi® Podhaler) March 2013. Inhaled Therapy Tobi® Podhaler as by nebulisation / inhalation. dry powder for For Adults And Patient Access Scheme inhalation Children With not available in primary Cystic Fibrosis care. NHS England Policy Ref: A01/P/b commissioning responsibility.

Tocilizumab 10.1.3 Cytokine modulator Rheumatoid Arthritis NICE TA247 Feb In line with NICE Complete proforma Adults only. GP prescribing 2012 or TA 375 Jan TA247 or TA375 (using agreed local NOT expected. NHS England is responsible 2016 systems) commissioner for paediatric use, paediatric juvenile arthritis (NICE TA 373 and TA238) Takayasu arteritis and Giant cell arteritis.

Page 32 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Tocilizumab 10.1.3 Cytokine modulators Polyarticular juvenile NICE TA373 Dec In line with NICE Complete proforma Adults only. GP prescribing idiopathic arthritis 2015 TA373 criteria and (using agreed local NOT expected. NHS England is responsible continuation in systems) commissioner for paediatric young adults use, paediatric juvenile tranisitioning from arthritis (NICE TA 373 and NHS England TA238) Takayasu arteritis paeds service and Giant cell arteritis.

Tocilizumab 10.1.3 Cytokine modulator All other indications, No NICE guidance NOT NOT COMMISSIONED Adults only. GP prescribing licensed or anticipated. COMMISSIONED NOT expected. NHS England is responsible unlicensed. commissioner for paediatric use, paediatric juvenile arthritis (NICE TA 373 and TA238) Takayasu arteritis and Giant cell arteritis.

Tofacitinib 10.3.1 Cytokine modulator Rheumatoid arthritis, NICE TA480 In line with NICE Complete proforma Adults only. GP prescribing moderate-to-severe, October 2017 TA480 (using agreed local not expected. in patients not systems) responding to DMARDs or methotrexate. Tofacitinib 10.3.1 Cytokine modulator Psoriatic arthritis NICE TA543 In line with NICE Complete proforma Adults only. GP prescribing second-line following October 2018 TA543 (using agreed local not expected failure of conventional systems) DMARDs, third-line following failure of biological DMARDs

Page 33 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Tofacitinib 10.3.1 Cytokine modulator Moderate-to-severe NICE TA547 In line with NICE Complete proforma Adults only. GP prescribing active ulcerative November 2018 TA547 (using agreed local not expected colitis in adults, systems) following failure of conventional therapy.

Tolvaptan 6.5.2 Vasopressin V2- Autosomal dominant NICE TA358 In line with NICE Complete proforma NHSE responsible for receptor antagonist polycystic kidney October 2015 TA358. (using agreed local commissioning in hyponatraemia in cancer disease, stage 2 or 3, systems) patients requiring rapidly progressing chemotherapy.

Tolvaptan 6.5.2 Vasopressin V2- Hyponatraemia due No NICE guidance In line with PAC NOT COMMISSIONED NHSE responsible for receptor antagonist to syndrome of anticipated. recommendations. commissioning in hyponatraemia in cancer inappropriate patients requiring antidiuretic hormone chemotherapy. secretion (SIADH) in patients who do not require Tolvaptan 6.5.2 Vasopressin V2- Hyponatraemiachemotherapy. from No NICE guidance Only in line with NOT COMMISSIONED NHSE responsible for receptor antagonist other causes and anticipated. Local Policies commissioning in hyponatraemia in cancer other endocrine uses patients requiring chemotherapy.

Tolvaptan 6.5.2 Vasopressin V2- All other indications, NOT NOT COMMISSIONED NHSE responsible for receptor antagonist licensed or COMMISSIONED commissioning in hyponatraemia in cancer unlicensed. patients requiring chemotherapy.

Upadacitinib 10 Janus kinase (JAK) Rheumatoid arthritis NICE ID1400 NOT NOT COMMISSIONED Predicted launch 2020. It is inhibitor (RA) with inadequate Proposed [GID- COMMISSIONED anticipated that NHSE is responsible commissioner response to either TA10389] for paediatric use. methotrexate or TNF Publication date inhibitors March 2020

Page 34 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Ustekinumab 13.5.3 Drugs affecting the Psoriasis moderate to NICE TA180, Sept In line with NICE Complete proforma Adults only. GP prescribing immune response severe 2009 TA180. (using agreed local NOT expected. systems)

Ustekinumab 10.1.3 Drugs affecting the Psoriatic arthritis NICE TA340 June In line with NICE Complete proforma Adults only. GP prescribing immune response 2015 TA340 (using agreed local NOT expected. systems)

Ustekinumab 1.5.3 Drugs affecting the Ustekinumab for TA456 July 2017 In line with NICE Complete proforma Adults only. GP prescribing immune response moderately to TA456. (using agreed local NOT expected. severely active systems) Crohn’s disease after previous treatment

Ustekinumab 13.5.3 Drugs affecting the Ulcerative colitis, NICE ID1511 In NOT NOT COMMISSIONED immune response moderate-to-severe development [GID- COMMISSIONED active disease, TA10434] Expected second-line publication March 2020

Ustekinumab 13.5.3 Drugs affecting the All other indications, NOT NOT COMMISSIONED immune response licensed and COMMISSIONED unlicensed.

Valbenazine 4 Vesicular Tardive dyskinesia in No NICE guidance NOT NOT COMMISSIONED Launch date not known. monoamine adults anticipated COMMISSIONED transporter-2 inhibitor

Page 35 of 38 Drug name BNF section Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes Indication for funding across What is required for EoE funding approval?

Vedolizumab 1.5.3 Drugs affecting the Moderate to severe NICE TA342 June In line with NICE Complete proforma Adults only. GP prescribing immune response ulcerative colitis - 2015 TA342 and locally (using agreed local not expected second line after agreed patient systems) conventional therapy pathway or TNF inhibitor

Vedolizumab 1.5.3 Drugs affecting the Crohn's disease NICE TA352 Aug In line with NICE Complete proforma Adults only. GP prescribing immune response second line after 2015 TA352 (using agreed local not expected conventional therapy systems) and TNF inhibitors

Vedolizumab 13.5.3 Drugs affecting the All other indications, NOT NOT COMMISSIONED immune response licensed and COMMISSIONED unlicensed.

Verteporfin 11.8.2 Subfoveal choroidal Photodynamic NICE guideline In line with NG82. NOT COMMISSIONED neovascularisation therapy for wet age- [NG82] Jan 2018 related degeneration. (replaces NICE TA68, September 2003)

Page 36 of 38 High cost devices and listed procedures 2019/20 Return to contents

Device Comments/Notes 3 dimensional mapping and linear ablation catheters used for complex cardiac ablation procedures Includes consumables that are required uniquely for the deployment of the device Aneurysm coils Separated aneurysm coils and flow diverters for intracranial aneurysms. Includes consumables that are required uniquely for the deployment of the device Bespoke prostheses designed and manufactured for individual patients plus modular limb salvage replacements for femur or shoulder (non CE marked). Includes Bespoke orthopaedic prostheses consumables that are required uniquely for the deployment of the device Biological mesh, including synthetic equivalents Synthetic equivalents included. Includes consumables that are required uniquely for the deployment of the device Bone Anchored Hearing Aids and Middle Ear Implants Includes consumables that are required uniquely for the deployment of the device Bone Growth Stimulators Includes consumables that are required uniquely for the deployment of the device Carotid, iliac and renal stents Includes embolic protection devices. Includes consumables that are required uniquely for the deployment of the device Lengthing nails for Limb Reconstruction and Circular external fixator frame Includes consumables that are required uniquely for the deployment of the device Consumables associated with per oral single operator cholangioscope Includes consumables that are required uniquely for the deployment of the device Includes Lumbar Multifidus Restorative Neurostimulator and Spinal cord stimulator (patient remote controller). Includes consumables that are required uniquely for the Deep brain, vagal, sacral, spinal cord and occipital nerve stimulators deployment of the device Devices used in connection with pulmonary artery banding Includes consumables that are required uniquely for the deployment of the device Drug-eluting peripheral angioplasty balloon Includes consumables that are required uniquely for the deployment of the device Includes aortic stent grafts, endovascular fixation devices for endovascular stent grafts and trans-jugular intrahepatic port-systemic shunt (TIPSS). Includes consumables Endovascular stent graft that are required uniquely for the deployment of the device Flow diverters for intracranial aneurysms Includes consumables that are required uniquely for the deployment of the device ICD (Implantable Cardioverter-Defibrillator) Includes consumables that are required uniquely for the deployment of the device ICD with CRT (Cardiac Resynchronisation Therapy) capability Includes consumables that are required uniquely for the deployment of the device Insulin pumps and pump consumables Includes consumables that are required uniquely for the deployment of the device Intracranial stents Includes consumables that are required uniquely for the deployment of the device Intrathecal drug delivery pumps Includes consumables that are required uniquely for the deployment of the device Maxillofacial bespoke prostheses Includes consumables that are required uniquely for the deployment of the device Occluder, Vascular, Appendage and Septal devices Includes consumables that are required uniquely for the deployment of the device Percutaneous valve repair and replacement devices Includes devices for TAVI. Includes consumables that are required uniquely for the deployment of the device Peripheral vascular stents Includes peripheral vascular drug eluting stents. Includes consumables that are required uniquely for the deployment of the device Radiofrequency, cryotherapy and microwave ablation probes and catheters Except where used for complex Gastrointestinal Tract Endoscopy procedures. Includes consumables that are required uniquely for the deployment of the device Rib Fixation Plates Includes consumables that are required uniquely for the deployment of the device Continuous Glucose Monitoring Systems Includes consumables that are required uniquely for the deployment of the device Liquid Embolic Includes consumables that are required uniquely for the deployment of the device Irreversible electroporation probes Includes consumables that are required uniquely for the deployment of the device Intracardiac pacemaker system Includes consumables that are required uniquely for the deployment of the device Wireless CRT-P (Cardiac Resynchronisation Therapy-Pacemaker) system Includes consumables that are required uniquely for the deployment of the device Note: the presence of devices on the above list does not automatically mean that commissioners will commission them. Some may be subject to prior approval

Procedures

Procedure When to exclude Local grouper processing SUS national tariff processing Head and Neck Reconstructive Surgery~ Pre-Processing at episode level Do not run through grouper Episodes need to be processed using '=' exclusion Intracranial Telemetry% Pre-Processing at episode level Spells containing an episode with OPCS Code A111 or A112 Episodes need to be processed using '=' exclusion

ICD10 primary diagnosis one of: S321, S3210, S3211, S322, S3220, S3221, S323, S3230, S3231, S324, S325, S3250, S3251, S328 And OPCS code of Z75*, Z841 or Z842 Pelvic Reconstructions Pre-Processing at episode level And either Episodes need to be processed using '=' exclusion 1. OPCS code of W195, W196, W198, W208, W209, W213, W214, W232, W236, W245, W248, W654, W655 or W677 OR 2. OPCS code of (W211, W212, W215, W218 or W219) and W281

PETCT (outpatient and direct access only) Post-Processing HRGs RN01A/B/C, RN02A/B and RN03A/B are excluded The unbundled HRG will not have a mandatory tariff set

ICD10 (any position) diagnosis of: C40, C41, C47, C48, C49, or C79.5 Soft Tissue Sarcoma Pre-Processing at episode level And OPCS primary procedure code is not missing and is not a Episodes need to be processed using '=' exclusion chapter X code, for example W052 "Implantation massive endoprosthetic replacement of bone".

~Surgery for the excision of and reconstruction for, upper aerodigestive tract, skull base, salivary and thyroid gland malignancies and non-malignancies % including any subsequent cortical mapping and epilepsy surgery

Tests Molecular Diagnostic tests - NRAS/KRAS testing, BRAF Testing, KIT testing, ALK Testing (1), ALK Testing (2), Oncotype DX, PD-L1 EndoPredict and Prosigna Prevention of cardiovascular events in patients with established atherosclerotic cardiovascular disease.