Appendix 1: Mid and South Essex CCGs Collaboration Commissioners list of indications that may be commissioned for excluded drugs and devices 2021/2022 v1 High cost drugs excluded from the 2021/2022 National Tariff are not commissioned by Mid and South Essex Clinical Commissioning Groups (CCGs) unless the drugs and indications have approval through local processes.

The table in Appendix 1 summarise the policy on the commissioning of drugs and devices. It is coded by a "traffic light" scheme as follows:

Any drug and/or indication (licensed or unlicensed use) not listed In Appendix 1 is designated as NOT COMMISSIONED

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. 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. 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 :- https://www.england.nhs.uk/commissioning/spec- services/key-docs/

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 the NHS England 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 2020 2021 Annex A: The National Tariff and national prices workbook, High cost drugs and devices available at https://improvement.nhs.uk/resources/national‐tariff/ 2. East of England Priorities Advisory Commmittee (PAC) recommendations available at: http://www.prescqipp.info/ 3. National Institute for Health and Care Excellence (NICE) Guidance available at www.nice.org.uk. 4. UKMi Prescribing Outlook 2020 available from Specialist Pharmacy Services https://www.sps.nhs.uk/articles/prescribing‐outlook‐2020/ 5. UKMi New Drugs Online available from Specialist Pharmacy Services https://www.sps.nhs.uk/ 6. Indications for NHS England drugs list v15 published April 2020 available at https://www.england.nhs.uk/commissioning/spec‐services/key‐docs

Version 1 April 2021 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 High cost drugs excluded from the 2021-22 National Tariff are not commissioned by Mid and South Essex 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 the NHS England and/or new local drug policies are introduced or new NICE guidance is published.

Any drug and/or indication (licensed or unlicensed use) not listed In Appendix 1 is designated as NOT COMMISSIONED

The table in Appendix 1 summarise the policy on the commissioning of drugs and devices. 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.

NHS England 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 : https://www.england.nhs.uk/commissioning/spec-services/key-docs/

Version 1 April 2021 Page 2 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

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

Abatacept 10.1.3 Cytokine Rheumatoid Arthritis NICE TA375 In line with NICE Complete proforma CCG commission adults modulators not previously treated January 2016. TA375. (using agreed local only. GP prescribing NOT expected. NHS England is with DMARDs or after (partial review of systems) responsible commissioner conventional TA375, NICE for paediatric use. NICE DMARDs only have ID2710. TA375 replaced NICE failed In development TA280 [GID-TA10586] Abatacept 10.1.3 Cytokine Polyarticular juvenile NICE TA373 In line with NICE Complete proforma CCG commision adults only. modulators idiopathic arthritis December 2015 TA373. (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 Active psoriatic NICE TA568 NOT NOT COMMISSIONED modulators arthritis after March 2019 COMMISSIONED DMARDs Terminated appraisal.

Abrocitinib JAK inhibitor Moderate to severe No NICE NOT NOT COMMISSIONED UK availability 2021 atopic dermatitis, in guidance COMMISSIONED adults anticipated. Actoxumab Monoclonal Prevention of No NICE NOT NOT COMMISSIONED Not licensed yet antibodies. No BNF recurrence guidance COMMISSIONED category of Clostridium anticipated. difficile infection

Version 1 April 2021 Page 3 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Adalimumab or 13.5.3 Cytokine Psoriasis NICE TA146 In line with NICE Complete proforma CCG commission Adults biosimilar modulators June 2008 TA146. (using agreed local only. GP prescribing NOT expected. NHS England is systems) responsible commissioner for plaque psoriasis in children 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 Crohn's Disease NICE TA187 May In line with NICE Complete proforma CCG commission Adults biosimilar modulators 2010 TA187 (using agreed local only. GP prescribing NOT expected. NHS England is systems) responsible commissioner for plaque psoriasis in children 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 Psoriatic Arthritis NICE TA199, In line with NICE Complete proforma CCG commission Adults biosimilar modulators August 2010 TA199. (using agreed local only. GP prescribing NOT expected. NHS England is systems) responsible commissioner for plaque psoriasis in children NICE TA 455, paediatric use (of adult TAs), uveitis (NICE TA 460) and Hidradenitis Suppurativa (NICE TA 392) and Bechet's syndrome.

Version 1 April 2021 Page 4 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Adalimumab or 1.5.3 Cytokine Moderate to severe NICE TA329 In line with NICE Complete proforma CCG commission Adults biosimilar modulators active ulcerative February 2015 criteria TA329 (using agreed local only. GP prescribing NOT expected. NHS England is colitis after the failure systems) responsible commissioner of conventional for plaque psoriasis in therapy children 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 Rheumatoid arthritis NICE TA375 In line with NICE Complete proforma CCG commission Adults biosimilar modulators January 2016. criteria TA375 or (using agreed local only. GP prescribing NOT expected. NHS England is (partial review of TA195. systems) responsible commissioner TA375, NICE for plaque psoriasis in ID2710. children NICE TA 455, In development paediatric use (of adult [GID-TA10586] TAs), uveitis (NICE TA 460) and Hidradenitis Expected Suppurativa (NICE TA 392) publication date: and Bechet's syndrome. TBC

Adalimumab or 10.1.3 Cytokine Ankylosing spondylitis NICE TA383 In line with NICE Complete proforma CCG commission Adults biosimilar modulators February 2016 TA383. (using agreed local only. GP prescribing NOT expected. NHS England is systems) responsible commissioner for plaque psoriasis in children NICE TA 455, paediatric use (of adult TAs), uveitis (NICE TA 460) and Hidradenitis Suppurativa (NICE TA 392) and Bechet's syndrome.

Version 1 April 2021 Page 5 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Adalimumab or 10.1.3 Cytokine Axial spondyloarthritis NICE TA383 In line with NICE Complete proforma CCG commission Adults biosimilar modulators (non- radiographic) February 2016 TA383 (using agreed local only. GP prescribing NOT expected. NHS England is systems) responsible commissioner for plaque psoriasis in children 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 Polyarticular juvenile NICE TA373 In line with NICE Complete proforma CCG commission Adults biosimilar modulators idiopathic arthritis December 2015 TA373. (using agreed local only. GP prescribing NOT expected. NHS England is systems) responsible commissioner for plaque psoriasis in children NICE TA 455, paediatric use (of adult TAs), uveitis (NICE TA 460) and Hidradenitis Suppurativa (NICE TA 392) and Bechet's syndrome.

Afamelanotide Skin conditions Prevention of NICE ID927 In NOT NOT COMMISSIONED Predicted UK launch TBC phototoxicity in development COMMISSIONED confirmed pending NICE appeal. Likely NHS England erythropoietic [GID-HST10009] commissioning protoporphyria (EPP). Publications date responsibility TBC. Original FAD negative. 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)

Version 1 April 2021 Page 6 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

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) 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) Alicaforsen 1.05 Inhibition of ICAM-1 Ulcerative colitis No NICE NOT NOT COMMISSIONED production guidance COMMISSIONED anticipated. Alirocumab 2.12 Lipid-regulating Primary NICE TA 393 In line with NICE Complete proforma drugs hypercholesterolaemi June 2016 TA393 and EoE PAC (using agreed local a (heterozygous recommendations. systems) familial and non- familial) or mixed dyslipidaemia. Alirocumab 2.12 Lipid-regulating Cardiovascular event No NICE NOT NOT COMMISSIONED drugs reduction in patients guidance COMMISSIONED with established expected atherosclerotic cardiovascular disease. 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)

Amikacin 5.1.4 Aminoglycosides Nontuberculous No NICE NOT NOT COMMISSIONED NHS England responsible Liposomal mycobacterial lung guidance COMMISSIONED commissioner for use in CF inhalation infection anticipated.

Version 1 April 2021 Page 7 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Anakinra 10.1.3 Cytokine Rheumatoid arthritis NICE TA72, NOT NOT COMMISSIONED NHS England responsible modulators November 2003 COMMISSIONED commissioner for adult specialised (replaced by autoinflammatory disease, NICE CG79, paediatric use, Cropyrin February 2010), associated periodic not syndrome, Stills disease recommended (juvenile idiopathic arthritis).

Andexanet alfa Factor Xa inhibitor Reversal of Factor Xa NICE ID1101. In NOT NOT COMMISSIONED antidote inhibition development COMMISSIONED [GID-TA10440] Publication date TBC

Apremilast 10.1.3 Cytokine Psoriasis NICE TA419 In line with NICE Complete proforma CCG commission Adults modulators November 2016 TA419. (using agreed local only. GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use.

Apremilast 10.1.3 Cytokine Psoriatic arthritis NICE TA433 In line with NICE Complete proforma CCG commission Adults modulators unresponsive to February 2017 TA433. (using agreed local only. GP prescribing NOT expected. NHS England is DMARDs systems) responsible commissioner for paediatric use.

Avatrombopag 9.1.4 Platelet disorder Avatrombopag for NICE TA626 In line with NICE Complete proforma drugs treating June 2020 TA626 (using agreed local thrombocytopenia in systems) people with chronic liver disease needing a planned invasive procedure Avatrombopag 9.1.4 Platelet disorder ITP first line No NICE NOT NOT COMMISSIONED Predicted UK launch 2019. drugs guidance COMMISSIONED anticipated.

Version 1 April 2021 Page 8 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Aztreonam Lysine 5.1.2.3 Antibacterial drugs Cystic Fibrosis NHSE In line with NHSE NHSE responsibility Only excluded when given nebuliser solution commissioning Policies for CF by nebulisation / inhalation. NHS England responsible policy for CF Policy Ref: A01/P/b commissioner for use in CF Dec 2014 and Policy Ref: 16001/P July 2016

Aztreonam Lysine 5.1.2.3 Antibacterial drugs Bronchiectasis Bronchiectasis NOT NOT COMMISSIONED Only excluded when given nebuliser solution only in line with COMMISSIONED by nebulisation / inhalation. NHS England responsible Local Policies commissioner for use in CF

Baricitinib 10.1.3 Cytokine Moderate to severe NICE TA466 In line with NICE Complete proforma CCG commission Adults modulators active rheumatoid August 2017 TA466. (using agreed local only. GP prescribing NOT expected. NHS England is arthritis not to, or who systems) responsible commissioner are intolerant to one for paediatric use. or more DMARDs.

Baricitinib 10.1.4 Cytokine Atopic dermatitis in NICE TA681 In line with NICE Complete proforma CCG commission Adults modulators adults. Moderate to March 2021 TA681 (using agreed local only. GP prescribing NOT expected. severe. systems)

Benralizumab Interleukin-5 COPD, moderate-to- No NICE NOT NOT COMMISSIONED UK launch plans uncertain. receptor (IL-5R) very severe with a guidance COMMISSIONED NHS England repsonsible for severe eosinophilic monoclonal history of anticipated asthma indication NICE TA antibody. exacerbations. 565

Bevacizumab anti VEGF Juxtafoveal Local policy NOT NOT COMMISSIONED NHSE are the responsible (Avastin) monoclonal telangiecstasis COMMISSIONED commissioners for cancer indications and antibody neurofibromatosis

Version 1 April 2021 Page 9 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Bevacizumab anti VEGF wet aged-related Local policy (PAC NOT NOT COMMISSIONED NHSE are the responsible (Avastin) monoclonal macular degeneration statement) COMMISSIONED commissioners for cancer indications and antibody neurofibromatosis Bevacizumab Anti VEGF Wet aged-related No specific NICE NOT NOT COMMISSIONED Predicted launch date 2021 biosimilar (ONS- monoclonal macular degeneration guidance COMMISSIONED 5010) antibody anticipated - would expect to follow NICE TA155 Bezlotoxumab Human monoclonal Prevention of NICE TA601, NOT NOT COMMISSIONED antibody recurrence September 2019 COMMISSIONED of Clostridium Terminated difficile infection appraisal. Bimekizumab Human monoclonal Moderate to severe NICE [ID2692] NOT NOT COMMISSIONED antibody chronic plaque Proposed [GID- COMMISSIONED psoriasis TA10649] - Publication date September 2021

Deucravacitinib Tyrosine kinase 2 Moderate to severe No NICE NOT NOT COMMISSIONED UK Launch 2022 inhibtor chronic plaque guidance COMMISSIONED psoriasis anticipated Botulinum Toxin A 4.7.4.2 Prophylaxis of Migraine prophylaxis NICE TA260, In line with NICE Complete proforma GP prescribing NOT migraine June 2012 TA260 (using agreed local expected systems) Botulinum Toxin A 4.9.3 Essential tremor, Chronic sialorrhoea NICE TA 605, In line with NICE Complete proforma License extension for use in (Xeomin®) chorea, tics and (excessive salivation October 2019 TA605 (using agreed local children TBC - UK availability 2021 related disorders and drooling) caused systems) by neurological conditions in adults

Version 1 April 2021 Page 10 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Botulinum Toxin A 4.9.3 Essential tremor, Spasticity (after NICE ID768 - In In line with PAC Complete proforma NHS England is responsible chorea, tics and stroke) where there is development recommendations (using agreed local commissioner for focal spasticity in children. related disorders a dynamic spastic [GID-TAG499] - systems) Treatment of spasticity in component (as expected paediatric cerebral palsy is opposed to publication date commissioned by NHSE at contracture) and TBC specialist centres only. there are anticipated Intravesical use in spinal injury commissioned by functional gains in line NHSE. with Royal College of Physician guidance.

Version 1 April 2021 Page 11 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Botulinum Toxin A 4.9.3 Essential tremor, Chronic anal fissure, No NICE In line with PAC Complete proforma GP prescribing NOT chorea, tics and severe guidance recommendations. (using agreed local expected.NHS England is responsible commissioner related disorders blepharospasm, anticipated systems) for focal spasticity in hemifacial spasm, children. Treatment of cervical dystonia spasticity in paediatric (spasmodic torticollis) cerebral palsy is in adults, focal commissioned by NHSE at specialist centres only. spasticity in adults, Intravesical use in spinal hyperhidrosis of the injury commissioned by axillae, palmar or NHSE. craniofacial, dysphagia caused by achalasia, Hirschsprung’s disease, overactive bladder, spasticity treatment in paediatric cerebral palsy when not in specialist centres, Masseteric hypertrophy and Temporomandibular Disorders.

Version 1 April 2021 Page 12 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Botulinum Toxin A 4.9.3 Essential tremor, Chronic sialorrhoea in No NICE NOT NOT COMMISSIONED Not commissionined in line chorea, tics and children with cerebral guidance COMMISSIONED with negative PAC recommendations. related disorders palsy, laryngeal anticipated dystonia (spasmodic dystonia), hydradenitis suppurative, plantar hyperhidrosis, mechanical neck disorders, correction of strabismus (squint) in paediatrics, dysphagia (causes other than achalasia), Raynaud’s Disease.

Brimapitide 12 Protein kinase Acute sensorineural No NICE NOT NOT COMMISSIONED Predicted UK launch 2023 inhibitors hearing loss (ASNHL) guidance COMMISSIONED anticipated. Brodalumab 13.5.3 Drugs affecting the Moderate to severe NICE TA511 In line with NICE Complete proforma CCG commission Adults immune response plaque psoriasis March 2018 TA511 (using agreed local only. GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use.

Brolucizumab 10.1.3 Cytokine Wet aged-related NICE TA672 In line with NICE Complete proforma CCG commission Adults modulators macular degeneration February 2021 TA672 (using agreed local only. GP prescribing NOT expected systems)

Version 1 April 2021 Page 13 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Cannabidiol Cannabinoids All indications No NICE NOT NOT COMMISSIONED Cannabidiol with clobazam guidance COMMISSIONED as an option for treating seizures associated with anticipated Dravet syndrome (NICE TA 614) and Lennox-Gastaut syndrome (NICE TA 615) in people aged 2 years and older commissioned by NHS England.

Certolizumab 10.1.3 Cytokine Rheumatoid Arthritis NICE TA375 In line with NICE Complete proforma CCG commission Adults Pegol modulators not previously treated January 2016. TA375 (using agreed local only. GP prescribing NOT expected. NHS England is with DMARDs or after (partial review of systems) responsible commissioner conventional TA375, NICE for paediatric use. DMARDs only have ID2710. failed In development [GID-TA10586] Expected publication date: TBC Certolizumab 10.1.3 Cytokine Ankylosing spondylitis NICE TA383, In line with NICE Complete proforma CCG commission Adults Pegol modulators February 2016 TA383. (using agreed local only. GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use.

Certolizumab 10.1.3 Cytokine Axial spondyloarthritis NICE TA383, In line with NICE Complete proforma CCG commission Adults Pegol modulators (non radiographic) February 2016 TA383. (using agreed local only. GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use.

Certolizumab 10.1.3 Cytokine Rheumatoid arthritis NICE TA415 Oct In line with NICE Complete proforma CCG commission Adults Pegol modulators after TNF inhibitor 2016 TA415 (using agreed local only. GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use.

Version 1 April 2021 Page 14 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Certolizumab 10.1.3 Cytokine Active psoriatic NICE TA445 May In line with NICE Complete proforma CCG commission Adults Pegol modulators arthritis after 2017 TA445 (using agreed local only. GP prescribing NOT expected. NHS England is DMARDs systems) responsible commissioner for paediatric use.

Certolizumab 10.1.3 Cytokine Moderate to severe NICE TA574 April In line with NICE Complete proforma CCG commission Adults Pegol modulators plaque psoriasis 2019 TA574 (using agreed local only. GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use.

Cobitolimod DNA-based Ulcerative colitis (UC) No NICE NOT NOT COMMISSIONED No predicted launch date. immunomodulatory refractory, 3rd line guidance COMMISSIONED sequence given anticipated. intracolonically Colistimethate 5.1.7 Antibacterial drugs Cystic Fibrosis NICE TA276 NHSE Policy -Inhaled NHSE responsibility Only excluded when given sodium powder for March 2013 Therapy For Adults by nebulisation/inhalation. nebulisation And Children With Cystic Fibrosis Policy Ref: A01/P/b Dec 2014

Colistimethate 5.1.7 Antibacterial drugs Cystic Fibrosis NICE TA276, NHSE Policy -Inhaled No GP prescribing as Only excluded when given sodium dry powder March 2013. Therapy For Adults Patient Access Scheme by nebulisation/inhalation. for inhalation And Children With not available in primary (Colobreathe®) Cystic Fibrosis Policy care. Ref: A01/P/b Dec 2014

Version 1 April 2021 Page 15 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Colistimethate 5.1.7 Antibacterial drugs Non-cystic fibrosis NO NICE NOT NOT COMMISSIONED UK availability 2021. Local inhaled (promixin) (CF) related guidance COMMISSIONED policies may be in place. bronchiectasis - first- anticipated line in patients colonised with Pseudomonas aeruginosa

Collagenase 10.1.3 Enzymes Peyronie's disease No NICE NOT NOT COMMISSIONED Only excluded from tariff (PsD) guidance COMMISSIONED when used in outpatients. Collagenase clostridium anticipated. histolyticum (Xiapex) is no longer available in the UK. Collagenase 10.1.3 Enzymes Dupuytren's NICE TA459 NOT NOT COMMISSIONED Collagenase clostridium Contracture withdrawn COMMISSIONED histolyticum (Xiapex) is no longer available in the UK. Deferasirox 9.1.3 Iron overload Anaemia related to PAC Only in line with Local NOT COMMISSIONED NHS England responsible chronic iron overload recommendation Policies commissioner for hypoplastic, haemolytic and for myelodysplastic (not renal anaemias - iron syndrome only recommended) overload, thalassemia and sickle cell disease. NHSE routinely commissioned in combination when dual therapy required.

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

Version 1 April 2021 Page 16 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

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

Dexamethasone 11.4.1 Corticosteroid Macular oedema NICE TA229, July In line with NICE Complete proforma intravitreal implant secondary to retinal 2011. TA229. (using agreed local vein occlusion. systems) Dexamethasone 11.4.1 Corticosteroid Diabetic Macular NICE TA349 July In line with NICE Complete proforma intravitreal implant Oedema 2015 TA349 (using agreed local systems) Dexamethasone 11.4.2 Corticosteroid Non-infectious uveitis NICE TA460 July In line with NICE Complete proforma intravitreal implant (unilateral) 2017 TA460 criteria. (using agreed local systems) Dexamethasone Corticosteroid Occular inflammation NICE ID1154 NOT NOT COMMISSIONED intracanalicular and pain following Proposed [GID- COMMISSIONED insert cataract surgery TA10198] Date: TBC

Dibotermin alfa Bone Acute tibia fractures No NICE Only in line with Local Complete proforma NHS England responsible morphogenetic guidance Policies (PAC policy) (using agreed local commissioner for complex spinal surgery NHSE policy protein anticipated. systems) 16063. Digoxin immune 2.1.1 Poisoning Life-threatening National Poisons Only commissioned in Local Commissioner to Available on named patient fab digoxin toxicity. Centre line with National be notified / invoiced basis only in hospitals. Guidelines. Poison Centres when used. guidelines. Dimethyl fumarate 13.5.2 Preparations for Moderate to severe NICE TA475 In line with NICE Complete proforma NHS England is responsible psoriasis plaque psoriasis September 2017 TA475 (using agreed local commissioner for Multiple Sclerosis. systems)

Version 1 April 2021 Page 17 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Dupilumab 13 Anti-interleukin -4 Atopic dermatitis, NICE TA534 In line with NICE Complete proforma NHS England responsible injection and -13 receptor moderate-to-severe. August 2018 TA534 (using agreed local commissioner for asthma and paediatric dermatitis monoclonal systems) indications. antibody Dupilumab 13 Anti-interleukin -4 Nasal polyposis and NICE TA648 NOT NOT COMMISSIONED Predicted launch 2020 injection and -13 receptor chronic sinusitis in September 2020 COMMISSIONED monoclonal adults Terminated antibody appraisal Eculizumab 10 Recombinant Myasthenia Gravis NICE TA636 NOT NOT COMMISSIONED NHS England is responible humanised (MG), generalised, June 2020 COMMISSIONED commissioner for Atypical haemolytic uremic monoclonal refractory, in patients Terminated syndrome (AHUS), antibody. who are anti- appraisal Paroxysmal nocturnal acetylcholine receptor haemoglobinuria (PNH), antibody-positive organ rejection post kidney transplant, C3 glomerulopathy post transplant. Eltrombopag 9.1.4 Platelet disorder Chronic idiopathic NICE TA648 In line with NICE Complete proforma GP prescribing NOT drugs thrombocytopenic September 2020 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 NOT NOT COMMISSIONED GP prescribing NOT drugs adult patients with guidance COMMISSIONED expected.PAC recommendations published chronic hepatitis C anticipated. Sept 2014. NHS England virus infection are the responsible commissioner for use in paediatrics.

Eltrombopag 9.1.4 Platelet disorder Severe aplastic NICE TA382 NOT NOT COMMISSIONED NHS England are the drugs anaemia (SAA) January 2016 COMMISSIONED responsible commissioner for use in paediatrics refractory Terminated immunosuppressive appraisal therapy

Version 1 April 2021 Page 18 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Eptinezumab 4.7.4.2 Immunomodulating Migraine prophylaxis NICE [ID3803] NOT NOT COMMISSIONED Predicted UK launch 2022 drugs Proposed [GID- COMMISSIONED TA10677] Date TBC

Erythropoietins 9.1.3 Drugs used in renal Pre-dialysis No NICE Only in line with Local Complete proforma anaemias guidance Policies (using agreed local anticipated. systems) Erenumab Humanised Migraine, prevention NICE TA682 In line with NICE Complete proforma CCG commission Adults monoclonal in adults. March 2021 TA682 (iusing agreed local only, GP prescribing NOT expected antibody that systems) inhibits calcitonin gene-related peptide (CGRP)

Etanercept or 10.1.3 Cytokine Rheumatoid Arthritis NICE TA195 In line with NICE Complete proforma CCG commission Adults biosimilar modulators August 2010 or criteria TA375 or (using agreed local only, GP prescribing NOT expected. NHS England is NICE TA375 TA195. systems) responsible commissioner January 2016. for paediatric use as per (partial review of TA455 or adult TAs (TA103, TA375, NICE TA130, TA143, TA199) ID2710. In development [GID-TA10586] Expected publication date: TBC

Version 1 April 2021 Page 19 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Etanercept or 10.1.3 Cytokine Ankylosing spondylitis NICE TA383 In line with NICE Complete proforma CCG commission Adults biosimilar modulators February 2016 TA383 (using agreed local only, GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use as per TA455 or adult TAs (TA103, TA130, TA143, TA199)

Etanercept or 10.1.3 Cytokine Axial spondyloarthritis NICE TA383 In line with NICE Complete proforma CCG commission Adults biosimilar modulators (non radiographic) February 2016 TA383 (using agreed local only, GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use as per TA455 or adult TAs (TA103, TA130, TA143, TA199)

Etanercept or 10.1.3 Cytokine Psoriatic Arthritis NICE TA199, In line with NICE Complete proforma CCG commission Adults biosimilar modulators August 2010 TA199. (using agreed local only, GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use as per TA455 or adult TAs (TA103, TA130, TA143, TA199)

Etanercept or 10.1.3 Cytokine Psoriasis NICE TA103, July In line with NICE Complete proforma CCG commission Adults biosimilar modulators 2006 TA103. (using agreed local only, GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use as per TA455 or adult TAs (TA103, TA130, TA143, TA199)

Version 1 April 2021 Page 20 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Etanercept or 10.1.3 Cytokine Polyarticular juvenile NICE TA373 Dec In line with NICE Complete proforma CCG commission Adults biosimilar modulators idiopathic arthritis or 2015 TA373. (using agreed local only, GP prescribing NOT expected. NHS England is Enthesitis-related JIA systems) responsible commissioner or Psoriatic JIA. for paediatric use as per Unlicensed use in TA455 or adult TAs (TA103, adults. TA130, TA143, TA199)

Etrolizumab Monoclonal Ulcerative colitis (UC) NICE [ID3827] NOT NOT COMMISSIONED Predicted launch 2021. NHS antibody naive to TNF Proposed [GID- COMMISSIONED England is responsible commissioner for paediatric inhibitors and TA10717] use. refractory to or Expected intolerant of prior publication date: immunosuppressant TBC and/or corticosteroid treatment Etrolizumab Monoclonal Crohn's disease, No NICE NOT NOT COMMISSIONED Predicted launch 2023. NHS antibody moderate-to-severe guidance COMMISSIONED England is responsible commissioner for paediatric after steroids, anticipated. use. immunosuppressants and anti-TNF therapy Evolocumab 2.12 PCSK9 Monoclonal Hyperlipidaemia and NICE TA394, In line with NICE Complete proforma CCG commission Primary Antibody Inhibitor mixed dyslipidaemia June 2016. TA394 and EoE PAC (using agreed local non-familial hypercholesterolaemia or recommendations systems) mixed dyslipidaemia. NHSE is responsible commissioner for Homozygous familial hypercholesterolemia

Fasinumab 10 Inhibits nerve Osteoarthritis. No NICE NOT NOT COMMISSIONED Predicted UK launch 2024. growth factor guidance COMMISSIONED Secondary care initiated, primary care continuation. (NGF). anticipated. Phase III clinical trial (SPS) April 2020.

Version 1 April 2021 Page 21 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Fidaxomicin 5.1.8 Antibacterials C. difficile associated No NICE NOT NOT COMMISSIONED Predicted UK launch for (Dificlir) diarrhoea (CDAD) guidance COMMISSIONED granules for oral suspension in 2021 anticipated. Filgotinib JAK inhibitor Rheumatoid arthritis NICE TA676 In line with NICE Complete proforma CCG commission Adults (RA), moderate-to- February 2021 TA676 (using agreed local only, GP prescribing NOT expected. severe systems) Filgotinib JAK inhibitor Ulcerative colitis (UC) NICE ID3736 NOT NOT COMMISSIONED Predicted UK launch 2020. Proposed GID- COMMISSIONED NHS England is responsible commissioner for paediatric TA10600 use. Publication date Filgotinib JAK inhibitor Crohn's disease NoD NICE b 2021 NOT NOT COMMISSIONED Predicted UK launch 2020. guidance COMMISSIONED NHS England is responsible commissioner for paediatric anticipated. use.

Fluocinolone 11.4.1 Macular oedema Chronic diabetic NICE TA301, In line with NICE Complete proforma acetonide macular oedema after November 2013 TA301. (using agreed local intravitreal implant an inadequate systems) response to prior therapy

Fluocinolone 11.4.1 Corticosteroid Recurrent non NICE TA590 July In line with NICE Complete proforma acetonide implant infectious uveitis 2019 TA590 (using agreed local intravitreal implant systems) Fluocinolone 11.4.1 Corticosteroid Chronic diabetic NICE TA613 NOT NOT COMMISSIONED acetonide implant macular oedema in November 2019 COMMISSIONED intravitreal implant phakic eyes after an Negative inadequate response appraisal to previous therapy

Version 1 April 2021 Page 22 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Fomepizole Poisoning Poisoning National Poisons Only commissioned in Local Commissioner to Centre line with National be notified / invoiced Guidelines Poison Centres when used. guidelines.

Fostamatinib Antihemorrhagics, Persistent or chronic NICE ID1087 NOT NOT COMMISSIONED other systemic immune Proposed [GID- COMMISSIONED haemostatics. thrombocytopenia TA10387] Negative FAD. Expected publication date TBC Fremanezumab Humanised Prevention of NICE TA631 In line with NICE Complete proforma monoclonal migraine June 2020 TA631 (using agreed local antibody that systems) inhibits calcitonin gene-related peptide (CGRP).

Galcanezumab 4 Monoclonal- Prevention of chronic NICE TA659 In line with TA659 Complete proforma antibody, calcitonin or episodic migraine. November 2020 (using agreed local gene-related systems) peptide antagonist Galcanezumab 4 Monoclonal- Prevention of cluster NICE ID1212 In NOT NOT COMMISSIONED Launch date not known. antibody, calcitonin headache development COMMISSIONED gene-related [GID-TA10425] - peptide antagonist TA suspended Golimumab 10.1.3 Cytokine Psoriatic Arthritis NICE TA220 April In line with NICE Complete proforma CCG commission Adults modulators 2011 TA220. (using agreed local only, GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use.

Version 1 April 2021 Page 23 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Golimumab 10.1.3 Cytokine Rheumatoid arthritis NICE TA225 In line with NICE Complete proforma CCG commission Adults modulators June 2011 or TA375 or TA225 (using agreed local only, GP prescribing NOT expected. NHS England is NICE TA375 systems) responsible commissioner January 2016 for paediatric use. (partial review of TA375, NICE ID2710. In development [GID-TA10586] Expected publication date: TBC Golimumab 1.5.3 Cytokine Moderate to severe NICE TA329 Feb In line with NICE Complete proforma CCG commission Adults modulators ulcerative colitis- 2015 TA329 (using agreed local only, GP prescribing NOT expected. NHS England is second line systems) responsible commissioner for paediatric use.

Golimumab 10.1.3 Cytokine Ankylosing spondylitis NICE TA383 In line with NICE Complete proforma CCG commission Adults modulators February 2016 TA383 (using agreed local only, GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use.

Golimumab 10.1.3 Cytokine Axial spondyloarthritis NICE TA497 In line with NICE Complete proforma CCG commission Adults modulators (non-radiographic) January 2018 TA497 (using agreed local only, GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use.

Guselkumab 13.5.3 Drugs affecting the Plaque psoriasis, NICE TA521 In line with NICE Complete proforma immune response. moderate-to-severe June 2018 TA521 (using agreed local systems)

Version 1 April 2021 Page 24 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Guselkumab 13.5.3 Drugs affecting the active psoriatic NICE [ID1658] In NOT NOT COMMISSIONED immune response. arthritis after development COMMISSIONED inadequate response [GID-TA10561] to DMARDs Expected publication date: June 2021

Idarucizumab 2.8.4 Oral anticoagulant Reversal agent for Only in line with Local Complete proforma reversal agents dabigatran Policies (using agreed local systems)

ICES13 injection 7 Autologous Stress urinary No NICE NOT NOT COMMISSIONED UK launch plans uncertain myoblast cell- incontinence – guidance COMMISSIONED based therapy, second-line, in anticipated. given by intra- women. sphincter muscle injection. ATMP.

Iloprost 2.5.1 Vasodilator Critical limb No NICE Only in line with Local NOT COMMISSIONED NHSE commissioned when antihypertensive ischaemia guidance Policies used for pulmonary arterial hypertension at specialist drugs/Pulmanory anticipated. centres. Arterial Hypertension Infliximab IV or 1.5.3 Cytokine Crohn's Disease NICE TA187, In line with NICE Complete proforma CCG commission Adults biosimilar modulators May 2010 TA187 (using agreed local only, GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome.

Version 1 April 2021 Page 25 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Infliximab IV or 10.1.3 Cytokine Rheumatoid Arthritis NICE TA195 In line with NICE Complete proforma CCG commission Adults biosimilar modulators August 2010 or TA375 or TA195. (using agreed local only, GP prescribing NOT expected. NHS England is NICE TA375 systems) responsible commissioner January 2016 for paediatric use, (partial review of uveitis,connective tissue, TA375, NICE interstital lung disease, graft ID2710. versus host, renal, sarcoidosis, hidadentis In development suppurativa and Bechets [GID-TA10586] syndrome. Expected publication date: TBC

Infliximab IV or 10.1.3 Cytokine Psoriatic Arthritis NICE TA199, In line with NICE Complete proforma CCG commission Adults biosimilar modulators August 2010 TA199. (using agreed local only, GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome.

Infliximab or 13.5.3 Cytokine Psoriasis (adults) NICE TA134, In line with NICE Complete proforma CCG commission Adults biosimilar modulators January 2008 TA134. (using agreed local only, GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome.

Version 1 April 2021 Page 26 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Infliximab IV or 1.5.3 Cytokine Ulcerative Colitis NICE TA163, In line with NICE Complete proforma CCG commission Adults biosimilar modulators (acute exacerbations) December 2008 TA163. (using agreed local only, GP prescribing NOT expected. NHS England is systems) responsible commissioner for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome.

Infliximab or 1.5.3 Cytokine Ulcerative Colitis - NICE TA329 Feb In line with NICE Complete proforma CCG commission Adults biosimilar modulators 2nd line for moderate 2015 TA329 (using agreed local only, GP prescribing NOT expected. NHS England is to severely active systems) responsible commissioner for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome.

Infliximab IV or 10.1.3 Cytokine Ankylosing spondylitis NICE TA383 If treatment is started Complete proforma CCG commission Adults biosimilar modulators February 2016 with the least (using agreed local only, GP prescribing NOT expected. NHS England is expensive infliximab systems) responsible commissioner product in line with for paediatric use, NICE TA383 uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome.

Version 1 April 2021 Page 27 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Infliximab IV or 10.1.3 Cytokine Diarrhoea or colitis Local policy (PAC Only in line with Local Complete proforma GP prescribing NOT biosimilar modulators associated with statement) Policies (PAC policy) (using agreed local expected.PAC recommendations published Immune Checkpoint systems) July 2019. NHS England are Inhibitor (unlicensed the responsible indication) commissioner for use in paediatrics.

Infliximab IV or 10.1.3 Cytokine modulatorsJIA (unlicensed Patient currently Continuation and Complete proforma CCG commission Adults biosimilar indication) responding to discontinuation in line (using agreed local only, GP prescribing NOT expected. NHS England is treatment. with NHSE policy systems) responsible commissioner E03/P/d (EO3X04). for paediatric use, No initiation in adults uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome.

Infliximab 13.5.3 Drugs affecting the Subcutaenous No NICE NOT NOT COMMISSIONED subcutaenous immune response injection. Licensed guidance COMMISSIONED injection indications - anticipated gastroenterologic and rheumatologic conditions. Infliximab IV or 10.1.3 Cytokine Axial spondyloarthritis Not considered in NOT NOT COMMISSIONED CCG commission Adults biosimilar modulators (non- radiographic). NICE TA383 COMMISSIONED only, GP prescribing NOT expected. NHS England is Unlicensed indication. February 2016. responsible commissioner for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome.

Version 1 April 2021 Page 28 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Infliximab IV or 1.5.3 Cytokine Ulcerative Colitis (Sub-NICE TA329 Feb NOT NOT COMMISSIONED CCG commission Adults biosimilar modulators acute manifestations) 2015 Not COMMISSIONED only, GP prescribing NOT expected. NHS England is recommended responsible commissioner for paediatric use, uveitis,connective tissue, interstital lung disease, graft versus host, renal, sarcoidosis, hidadentis suppurativa and Bechets syndrome.

Ixekizumab 13.4.2 Humanized Plaque psoriasis NICE TA442 April In line with NICE Complete proforma Adults only, GP prescribing anti–interleukin-17 2017 TA329 (using agreed local NOT expected. monoclonal systems) antibody

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 systems) antibody Ixekizumab 10.1.3 Humanized Radiographic and non-NICE [ID1532] In NOT NOT COMMISSIONED anti–interleukin-17 radiographic axial development COMMISSIONED monoclonal spondyloarthritis, after [GID-TA10458] antibody NSAIDs Expected publication date: July 2021

Lanreotide 8.3.4.3 Somatostatin Non cancer No NICE Only in line with Local NOT COMMISSIONED NHS England is respnsible Analogues indications. guidance Policies commissioner for cancer indications and congenital anticipated. hyperinsulinism and for acromegaly but only when prescribed in a specialist centre.

Version 1 April 2021 Page 29 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Levofloxacin 5.1.2 Antibacterial drugs Chronic pulmonary No NICE NOT NOT COMMISSIONED Only excluded when given Solution for infections due to guidance COMMISSIONED by nebulisation/inhalation NHSE commissioning Inhalation Pseudomonas anticipated. responsibility. From aeruginosa in adults specialist centres only. NHS with CF England policy 170078P August 2018. No GP prescribing. Liothyronine Other endocrine Myxoedema coma No NICE In line with PAC NOT COMMISSIONED injection drugs guidance recommendations. anticipated

Liothyronine Other endocrine Thyroid replacement No NICE In line with PAC NOT COMMISSIONED Unlicensed indication. injection drugs in patients who are guidance recommendations. long term nil by anticipated mouth. Liothyronine Other endocrine Management of organ No NICE NOT NOT COMMISSIONED Unlicensed indication. injection drugs donor patients post guidance COMMISSIONED brain death. anticipated Lusutrombopag Platelet Disorder Thrombocytopenia in NICE TA 617, In line with NICE Complete proforma Drugs adults with chronic January 2020 TA617 (using agreed local liver disease prior to systems) elective procedures Macimorelin (oral) Growth Hormone Growth hormone No NICE NOT NOT COMMISSIONED UK launch plans unceratin deficiency in adults guidance COMMISSIONED anticipated

Version 1 April 2021 Page 30 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Mannitol 3.7 Mucolytics Cystic Fibrosis NICE TA266 NHSE Policy -Inhaled NHSE responsibility NHSE. Only excluded when November 2012 Therapy For Adults given by nebulisation / inhalation. And 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 NOT NOT COMMISSIONED cystic fibrosis. guidance COMMISSIONED anticipated. Masitinib Protein tyrosine Moderate Crohn’s No NICE NOT NOT COMMISSIONED Predicted UK launch not kinase inhibitor disease in patients guidance COMMISSIONED known. NHSE responsible commisisoner for cancer intolerant or with an anticipated. indications/GIST. NHSE unsatisfactory anticipated to be response to, responsible commissioner immunosuppressive for severe asthma and MS drugs and/or TNF- indications. inhibitors Masitinib Protein tyrosine Mild to moderate No NICE NOT NOT COMMISSIONED Predicted UK launch 2022. kinase inhibitor Alzheimer's disease - guidance COMMISSIONED NHSE responsible commisisoner for cancer adjunct anticipated. indications/GIST. NHSE anticipated to be responsible commissioner for severe asthma and MS indications.

Version 1 April 2021 Page 31 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Masitinib Protein tyrosine Amyotrophic Lateral NICE (ID967) NOT NOT COMMISSIONED Predicted UK launch 2022. kinase inhibitor Sclerosis (ALS) [GID-TA10157] COMMISSIONED NHSE responsible commisisoner for cancer Suspended indications/GIST. NHSE anticipated to be responsible commissioner for severe asthma and MS indications.

Mavrilimumab Rheumatoid arthritis No NICE NOT NOT COMMISSIONED guidance COMMISSIONED anticipated. Mepolizumab Fully humanised Chronic obstructive NICE (ID1237) NOT NOT COMMISSIONED Predicted UK launch date IgG monoclonal pulmonary disease Proposed [GID- COMMISSIONED 2022. NHS England responsible commissioner antibody specific TA10239] for asthma for interleukin 5 Expected indication.Eosinophilic publication date: Granulomatosis with TBC Polyangiitis (Churg Strauss syndrome) - NHSE likely to be responsible commissioners.

Mepolizumab Fully humanised Previously treated NICE (ID3817) NOT NOT COMMISSIONED Predicted UK launch date IgG monoclonal severe chronic Proposed [GID- COMMISSIONED 2022. NHS England responsible commissioner antibody specific rhinosinusitis with TA10701] for asthma for interleukin 5 nasal polyps Expected indication.Eosinophilic publication date: Granulomatosis with July 2022 Polyangiitis (Churg Strauss syndrome) - NHSE likely to be responsible commissioners.

Nemolizumab IL-31 RA moderate to severe No NICE NOT NOT COMMISSIONED Predicted UK launch date monoclonal atopic dermatitis guidance COMMISSIONED 2022. Not on excluded drugs list currently antibody anticipated

Version 1 April 2021 Page 32 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Nemolizumab IL-31 RA Moderate to severe No NICE NOT NOT COMMISSIONED Predicted UK launch date monoclonal prurigo nodularis guidance COMMISSIONED 2022. Not on excluded drugs list currently antibody anticipated.

Mirikizumab IgG4 humanised Moderate to severe No NICE NOT NOT COMMISSIONED Predicted UK launch date monocloncal plaque psoriasis guidance COMMISSIONED 2021. Not on excluded drugs list currently antibody anticipated Mirikizumab IgG4 humanised Moderately to No NICE NOT NOT COMMISSIONED Predicted UK launch date monocloncal severely active guidance COMMISSIONED 2023. Not on excluded drugs list currently antibody Crohn's disease anticipated Mirikizumab IgG4 humanised Moderate-to-severe No NICE NOT NOT COMMISSIONED Predicted UK launch date monocloncal active ulcerative guidance COMMISSIONED 2023. Not on excluded drugs list currently antibody colitis anticipated Nitazoxanide Thiazolide (first-in- Treatment of acute No NICE NOT NOT COMMISSIONED NHS England responsible class). uncomplicated guidance COMMISSIONED commissioner for Hepatitis C. influenza virus anticipated. infections. 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. Octreotide 8.3.4.3 Somatostatin Non cancer Only in line with Local Complete proforma NHS England responsible Analogues indications Policies (using agreed local commissioner for cancer, congenital systems) hyperinsulinaemia and acromegaly but only when prescribed in a specialist centre.

Version 1 April 2021 Page 33 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Olokizumab Cytokine modulator Moderate-to-severe No NICE NOT NOT COMMISSIONED Predicted UK launch date rheumatoid arthritis in guidance COMMISSIONED uncertain adults who previously anticipated. failed DMARD therapy Omalizumab 3.4.2 Allergen Previously treated NICE TA339 In line with NICE Complete proforma NHS England responsible Immunotherapy chronic spontaneous June 2015 TA339 (using agreed local for asthma & chronic sinusitis with nasal polyps urticaria systems) indication Omalizumab 3.4.3 Allergen Food allergy - in No NICE NOT NOT COMMISSIONED Predicted UK launch 2022 Immunotherapy patients with multiple guidance COMMISSIONED food allergies anticipated. Ozanimod 8.2 Selective moderate to severe NICE [ID3841] In NOT NOT COMMISSIONED Predicted UK launch 2021 sphingosine 1- ulcerative colitis development COMMISSIONED phosphate 1 [GID-TA10732] receptor (S1P1R) Date: TBC modulator Ozanimod 8.2 Selective Moderate-to-severe No NICE NOT NOT COMMISSIONED Predicted UK launch 2023 sphingosine 1- active Crohn's guidance COMMISSIONED phosphate 1 disease anticipated. receptor (S1P1R) modulator Pegaptanib 11.8.2 Subfoveal choroidal Neovascular (wet) NICE guideline NOT NOT COMMISSIONED neovascularisation age-related macular [NG82] not COMMISSIONED degeneration recommended Peginterferon alfa- 8.4.2 Other Myeoprolific No NICE Only in line with Local NOT COMMISSIONED NHS England responsible 2a immunomodulating disorders: guidance Policies commissioner for cancer, congenital drugs Polycythaemia Vera anticipated. hyperinsulinaemia and (PV) and Essential acromegaly but only when Thrombocythaemia prescribed in a specialist (ET) centre.NHS England is responsible commissioner for Hepatitis B and C.

Version 1 April 2021 Page 34 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Phenylephrine with 11.4.02 Retinal disorders / Intraocular lense No NICE NOT NOT COMMISSIONED Licensed but not launched. Ketorolac intraocular lens replacement surgery guidance COMMISSIONED replacement anticipated. surgery Piclidenoson Adenosine A3 Rheumatoid arthritis - No NICE NOT NOT COMMISSIONED Predicted UK launch 2021 receptor agonist first-line guidance COMMISSIONED anticipated. Piclidenoson Adenosine A3 Plaque psoriasis, No NICE NOT NOT COMMISSIONED Predicted UK launch 2022 receptor agonist moderate-to-severe. guidance COMMISSIONED anticipated. Pitolisant 4.1.1 Hypnotics and Excessive daytime NICE ID1065. NOT NOT COMMISSIONED anxiolytics sleepiness caused by Proposed [GID- COMMISSIONED obstructive sleep TA10385] apnoea Expected publication date: TBC

Pitolisant 4.1.1 Hypnotics and Narcolepsy with or No NICE NOT NOT COMMISSIONED anxiolytics without cataplexy guidance COMMISSIONED anticipated. Ranibizumab or 11.8.2 Neovascularisation Neovascular (wet) NICE TA155, In line with NICE Complete proforma GP prescribing NOT biosimilar age-related macular August 2008 TA155. (using agreed local expected. Biosimilar predicted UK launch 2022 degeneration systems) Ranibizumab or 11.8.2 Neovascularisation Diabetic Macular NICE TA274, Feb In line with TA274. Complete proforma GP prescribing NOT biosimilar Oedema 2013 (using agreed local expected. Biosimilar predicted UK launch 2022 systems) Ranibizumab or 11.8.2 Neovascularisation Macular oedema NICE TA283, In line with TA283. Complete proforma GP prescribing NOT biosimilar (retinal vein May 2013 (using agreed local expected. Biosimilar predicted UK launch 2022 occlusion) systems) Ranibizumab or 11.8.2 Neovascularisation CNV due to NICE TA298, In line with TA298. Complete proforma GP prescribing NOT biosimilar pathological myopia November 2013 (using agreed local expected. Biosimilar predicted UK launch 2022 systems)

Version 1 April 2021 Page 35 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Ranibizumab or 11.8.2 Neovascularisation Visual impairment No NICE NOT NOT COMMISSIONED Biosimilar predicted UK biosimilar due to choroidal guidance COMMISSIONED launch 2022 neovascularisation anticipated. (CNV) other than due to wet age-related macular degeneration, or pathologic myopia.

Ranibizumab or 11.8.3 Neovascularisation Moderately-severe to NICE TA637 NOT NOT COMMISSIONED Biosimilar predicted UK biosimilar severe non- June 2020 COMMISSIONED launch 2022 proliferative diabetic Terminated retinopathy (NPDR) appraisal and proliferative diabetic retinopathy (PDR) 2019

Reltecimod Immunomodulating necrotising soft tissue No NICE NOT NOT COMMISSIONED Predicted UK launch date drugs infection guidance COMMISSIONED uncertain anticipated Remestemcel-L Human Crohn’s disease, No NICE NOT NOT COMMISSIONED Predicted UK launch date mesenchymal stem moderate-to-severe, guidance COMMISSIONED uncertain cells given by i.v. in patients who have anticipated infusion in four previously failed at visits over two least one steroid, and weeks. This is an at least one ATMP. immunomodulator or biologic.

Version 1 April 2021 Page 36 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Rexmyelocel-T Autologous bone Critical limb No NICE NOT NOT COMMISSIONED Predicted UK launch date marrow-derived ischaemia. guidance COMMISSIONED uncertain mononuclear cells, anticipated which promote angiogenesis. ATMP. Rintatolimod 4 Immunomodulating Chronic fatigue No NICE NOT NOT COMMISSIONED Predicted UK launch date drugs syndrome guidance COMMISSIONED uncertain anticipated Risankizumab Humanised IgG1 Chronic plaque NICE TA 596 In line with NICE TA Complete proforma Adults only, GP prescribing Monoclonal psoriasis moderate- August 2019 596 (using agreed local NOT expected. antibody severe systems) Risankizumab Humanised IgG1 Psoriatic arthritis NICE ID1399. NOT NOT COMMISSIONED Predicted UK launch date Monoclonal Proposed [GID- COMMISSIONED 2021. It is anticipated that NHSE is responsible antibody TA10819] commissioner for paediatric Expected use. publication date: TBC . Risankizumab Humanised IgG1 Crohn's disease No NICE NOT NOT COMMISSIONED Predicted UK launch date Monoclonal guidance COMMISSIONED 2022. It is anticipated that NHSE is responsible antibody anticipated. commissioner for paediatric use. Risankizumab Humanised IgG1 Ulcerative colitis No NICE NOT NOT COMMISSIONED Predicted UK launch date Monoclonal guidance COMMISSIONED 2024. It is anticipated that NHSE is responsible antibody anticipated. commissioner for paediatric use.

Rituximab or 10.1.3 Cytokine Rheumatoid Arthritis NICE TA195, Aug In line with NICE Complete proforma NHS England are the biosimilar modulators after failure of TNF 2010 TA195. (using agreed local responsible responsible commissioner for inhibitor systems) indications listed on the Indications for NHS England drug list https://www.england.nhs.uk/ publication/nhs-england- drugs-list/

Version 1 April 2021 Page 37 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Rituximab or 10.1.3 Cytokine Rheumatoid arthritis No NICE Only in line with Local Complete proforma NHS England are the biosimilar modulators (first line) (unlicensed guidance Policies (using agreed local responsible responsible commissioner for indication) anticipated. systems) indications listed on the Indications for NHS England drug list https://www.england.nhs.uk/ publication/nhs-england- drugs-list/ Rituximab or 10.1.3 Cytokine ITP (unlicensed No NICE Only in line with Local Complete proforma NHS England are the biosimilar modulators indication) guidance Policies (using agreed local responsible responsible commissioner for anticipated. systems) indications listed on the Indications for NHS England drug list https://www.england.nhs.uk/ publication/nhs-england- drugs-list/ Rituximab or 10.1.3 Cytokine Refractory vasculitis Only in line with Local NOT COMMISSIONED NHS England are the biosimilar modulators (unlicensed Policies responsible responsible commissioner for indication) indications listed on the Indications for NHS England drug list https://www.england.nhs.uk/ publication/nhs-england- drugs-list/ Rituximab or 10.1.3 Cytokine JIA (unlicensed Patient currently Continuation and Complete proforma NHS England are the biosimilar modulators indication) responding to discontinuation in line (using agreed local responsible responsible commissioner for treatment,transiti with NHSE policy systems) indications listed on the oned from the E03/P/d (EO3X04). Indications for NHS England NHS England No initiation in adults drug list paediatric service https://www.england.nhs.uk/ publication/nhs-england- drugs-list/

Version 1 April 2021 Page 38 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

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. Local Commissioner. NHSE systems) responsible commissioner for paediatric ITP.

Romosozumab Humanised Osteoporosis in men Non- NOT NOT COMMISSIONED UK launch March 2020. It is monoclonal and postmenopausal bisphosphonates COMMISSIONED anticipated that NHSE is responsible commissioner antibody, sclerostin women for treating for use in men. inhibitor osteoporosis NICE [ID901] In development [GID-TA10072] Expected publication - TBC

Romosozumab Humanised Osteoporosis in men Severe NOT NOT COMMISSIONED monoclonal and postmenopausal osteoporosis COMMISSIONED antibody, sclerostin women NICE ID3936 inhibito Proposed [GID- TA10828]Expecte d publication date: TBC

Ruxolitinib JAK inhibitor Polycythaemia vera NICE TA356 NOT NOT COMMISSIONED UK availability 2021. NHSE September 2015 COMMISSIONED are responsible commissioners for cancer Terminated indication. appraisal

Version 1 April 2021 Page 39 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Ruxolitinib JAK inhibitor Chronic graft versus NICE [ID2716] In NOT NOT COMMISSIONED Predicted UK launch 2021. host disease (GvHD) development COMMISSIONED NHSE are responsible commissioners for cancer [GID-TA10761] indication and Acute graft Date: TBC- versus host disease (Currently (GvHD). suspended)

Ruxolitinib JAK inhibitor Alopecia areata, No NICE NOT NOT COMMISSIONED Predicted UK launch 2023. moderate-to-severe guidance COMMISSIONED NHSE are responsible commissioners for cancer anticipated. indication and Acute graft versus host disease (GvHD).

Ruxolitinib JAK inhibitor Atopic dermatitis No NICE NOT NOT COMMISSIONED Predicted UK launch date guidance COMMISSIONED 2021 or 2022 ( uncertain). NHSE are responsible anticipated. commissioners for cancer indication and Acute graft versus host disease (GvHD). Sarilumab No BNF Cytokine Moderately to NICE TA485 In line with NICE Complete proforma Adults only. GP prescribing category modulators severely active November 2017 TA485. (using agreed local NOT expected. NHS England responsible rheumatoid arthritis systems) commissioner for paediatric (RA) second line to use but do not commission DMARDs. as unlicensed indication.

Secukinumab 10.1.3 Cytokine Chronic plaque NICE TA350 July In line with NICE Complete proforma Adults only. GP prescribing modulators 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.

Version 1 April 2021 Page 40 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Secukinumab 10.1.3 Cytokine Ankylosing spondylitis NICE TA407 In line with NICE Complete proforma Adults only. GP prescribing modulators 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 Psoriatic arthritis, NICE TA455 May In line with NICE Complete proforma Adults only. GP prescribing modulators 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 Axial - NICE [ID1419] NOT NOT COMMISSIONED modulators spondyloarthritis (non- Proposed [GID- COMMISSIONED radiographical) TA10457] Publication date July 2021 Secukinumab 10.1.3 Cytokine Psoriatic arthritis, No NICE NOT NOT COMMISSIONED modulators axial manifestations guidance COMMISSIONED anticipated. Sirolimus chronic non- No NICE NOT NOT COMMISSIONED Predicted UK launch date (invitreal) infectious, posterior guidance COMMISSIONED 2022 segment uveitis anticipated. Sodium oxybate 4.1 Hypnotics and Narcolepsy with No NICE EoE PAC policy NOT COMMISSIONED NHS England is responsible anxiolytics cataplexy (adults) guidance commissioner for paediatric use. anticipated. Solriamfetol Hypnotics and Excessive daytime ID[1499] NOT NOT COMMISSIONED anxiolytics sleepiness caused by Proposed [GID- COMMISSIONED obstructive sleep TA10430] apnoea Publication date TBC

Version 1 April 2021 Page 41 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Solriamfetol 4.1 Hypnotics and Excessive waketime ID[1602] NOT NOT COMMISSIONED anxiolytics sleepiness caused by Proposed [GID- COMMISSIONED narcolepsy TA10524] Publication date TBC Somapacitan 6.5.1 Growth Hormone & Growth hormone No NICE NOT NOT COMMISSIONED Predicted UK launch date growth hormone deficiency in adults guidance COMMISSIONED 2021 for adults and 2022 fpr pre- pubertal children. NHS Receptor and pre-pubertal expected. England is responsible Antagonist. Long children commissioner for paediatric acting. use.

Somatrogon 6.5.3 Growth Hormone & Growth hormone No NICE NOT NOT COMMISSIONED Predicted UK launch date growth hormone deficiency in adults. guidance COMMISSIONED 2021. NHS England is responsible commissioner Receptor expected. for paediatric use. Antagonist. Long- acting formulation of somatotropin.

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

Somatropin 6.5.1 Growth Hormone Growth failure in NICE TA188, In line with NICE Complete proforma Local Commissioner and (children) or Growth children May 2010 TA188 and EoE PAC (using agreed local GOSH NB: Shared care arrangements with GPs in Hormone Receptor recommendations systems) place. Antagonist

Version 1 April 2021 Page 42 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Tanezumab 4.7 Nerve growth factor Osteoarthritis NICE [ID1603] NOT NOT COMMISSIONED Predicted UK launch 2021 inhibitor Proposed [GID- COMMISSIONED TA10711] Expected publication date September 2021

Tanezumab 4.7 Nerve growth factor Chronic low back pain No NICE NOT NOT COMMISSIONED Predicted UK launch inhibitor guidance COMMISSIONED uncertain expected. Tanezumab 4.7 Nerve growth factor Cancer pain due to No NICE NOT NOT COMMISSIONED Predicted UK launch 2022 inhibitor bone metastasis in guidance COMMISSIONED adults already taking expected. background opioid therapy

Teriparatide or 6.6.1 Drugs affecting Secondary prevention NICE TA161 Jan In line with NICE Complete proforma GP prescribing NOT biosimilar bone 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] May 2021 Teriparatide or 6.6.1 Drugs affecting Treatment of NICE review Non- NOT NOT COMMISSIONED biosimilar bone metabolism osteoporosis bisphosphonates COMMISSIONED associated with for treating glucocorticoids osteoporosis [ID901] In development [GID-TA10072] May 2021

Version 1 April 2021 Page 43 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Thrombomodulin 2 Fibrinolytic. Septic shock (Sepsis) No NICE NOT NOT COMMISSIONED NHSE responsible Recombinant Recombinant - with disseminated guidance COMMISSIONED commissioner for pseudoanerysm. Predicted Human human intravascular anticipated. UK launch uncertain thrombomodulin coagulation (DIC)

Tildrakizumab 13 Human interleukin- Plaque psoriasis in NICE TA575 April In line with NICE Complete proforma 23 antagonist adults, moderate-to- 2019 TA575 (using agreed local severe systems) Tobramycin 5.1.4 Antibacterial Drugs Cystic Fibrosis NHSE Policy -Inhaled NHSE responsibility. No Only excluded when given (Tobi®/Bramitob®) Therapy For Adults GP prescribing. by nebulisation / inhalation. nebuliser solution And Children With Cystic Fibrosis Policy Ref: A01/P/b Dec 2014

Tobramycin 5.1.5 Antibacterial Drugs Cystic Fibrosis NICE TA276 NHSE Policy -Inhaled No GP prescribing as Only excluded when given (Tobi® Podhaler) March 2013 Therapy For Adults Patient Access Scheme by nebulisation / inhalation. dry powder for And Children With not available in primary inhalation Cystic Fibrosis Policy care. Ref: A01/P/b Dec 2014

Tocilizumab 10.1.3 Cytokine modulator Rheumatoid Arthritis NICE TA247 Feb In line with NICE Complete proforma Adults only. GP prescribing 2012 or NICE TA247 or TA375 (using agreed local NOT expected. NHS England is responsible TA375 January systems) commissioner for paediatric 2016. (partial use, paediatric juvenile review of TA375, arthritis (NICE TA 373 and NICE ID2710. TA238) Takayasu arteritis In development and Giant cell arteritis (NICE TA518), systemic [GID-TA10586] sclerosis and COVID-19 Expected severe pneumonia.. publication date: TBC

Version 1 April 2021 Page 44 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Tocilizumab 10.1.3 Cytokine Polyarticular juvenile NICE TA373 Dec In line with NICE Complete proforma Adults only. GP prescribing modulators idiopathic arthritis 2015 TA373 criteria and (using agreed local NOT expected. NHS England is responsible continuation in young systems) commissioner for paediatric adults tranisitioning use, paediatric juvenile from NHS England arthritis (NICE TA 373 and paeds service TA238) Takayasu arteritis and Giant cell arteritis, systemic sclerosis and COVID-19 severe pneumonia. Tofacitinib 10.3.1 Cytokine modulator Rheumatoid arthritis, NICE TA480 In line with NICE Complete proforma It is anticipated that NHSE moderate-to-severe, October 2017 TA480 (using agreed local is responsible commissioner for paediatric use. 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 It is anticipated that NHSE second-line following October 2018 TA543 (using agreed local is responsible commissioner for paediatric use. failure of conventional systems) DMARDs, third-line following failure of biological DMARDs

Tofacitinib 10.3.1 Cytokine modulator Moderate-to-severe NICE TA547 In line with NICE Complete proforma It is anticipated that NHSE active ulcerative November 2018 TA547 (using agreed local is responsible commissioner for paediatric use. colitis in adults, systems) following failure of conventional therapy. Tofacitinib 10.3.1 Cytokine modulator Ankylosing spondylitis NICE ID[3865] NOT NOT COMMISSIONED Predicted UK launch date Proposed [GID- COMMISSIONED 2021 TA10771] Publication date TBC

Version 1 April 2021 Page 45 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Tofacitinib 10.3.1 Cytokine modulator JIA NICE ID[2718] NOT NOT COMMISSIONED Predicted UK launch date Proposed [GID- COMMISSIONED 2021. It is anticipated that NHSE is responsible TA10706] commissioner for paediatric Publication date use. October 2021 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 to No NICE In line with PAC NOT COMMISSIONED NHSE responsible for receptor antagonist syndrome of guidance recommendations. commissioning in hyponatraemia in cancer inappropriate anticipated. patients requiring antidiuretic hormone chemotherapy. secretion (SIADH) in patients who do not require chemotherapy. Tolvaptan 6.5.2 Vasopressin V2- Hyponatraemia from No NICE Only in line with Local NOT COMMISSIONED NHSE responsible for receptor antagonist other causes and guidance Policies commissioning in hyponatraemia in cancer other endocrine uses anticipated. patients requiring chemotherapy. Tralokinumab Monoclonal Moderate to severe NICE ID3734 NOT NOT COMMISSIONED Predicted UK launch date antibody atopic dermatitis Proposed [GID- COMMISSIONED 2021. It is anticipated that NHSE is responsible TA10596] commissioner for paediatric Expected use. publication December 2021

Version 1 April 2021 Page 46 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Upadacitinib 10 Janus kinase (JAK) Severe rheumatoid NICE TA665 In line with NICE Complete proforma It is anticipated that NHSE inhibitor arthritis December 2020 TA665 (using agreed local is responsible commissioner for paediatric use and Giant systems) cell (temporal) arteritis.

Upadacitinib 10 Janus kinase (JAK) Previously treated NICE ID3878 NOT NOT COMMISSIONED It is anticipated that NHSE inhibitor moderate active Proposed [GID- COMMISSIONED is responsible commissioner for paediatric use and Giant rheumatoid arthritis TA10759] cell (temporal) arteritis. Expected publication date: TBC

Upadacitinib 10 Janus kinase (JAK) Ulcerative colitis (UC) No NICE NOT NOT COMMISSIONED Predicted UK launch date inhibitor guidance COMMISSIONED 2023. It is anticipated that NHSE is responsible anticipated commissioner for paediatric use and Giant cell (temporal) arteritis. Upadacitinib 10 Janus kinase (JAK) Crohn's disease No NICE NOT NOT COMMISSIONED Predicted UK launch date inhibitor guidance COMMISSIONED 2023. It is anticipated that NHSE is responsible anticipated commissioner for paediatric use and Giant cell (temporal) arteritis. Upadacitinib 10 Janus kinase (JAK) Active psoriatic NICE ID2690 NOT NOT COMMISSIONED Predicted UK launch date inhibitor arthritis after Proposed [GID- COMMISSIONED 2021. It is anticipated that NHSE is responsible inadequate response TA10666] commissioner for paediatric to DMARDs Expected use and Giant cell publication date: (temporal) arteritis. Aug 2021

Upadacitinib 10 Janus kinase (JAK) active ankylosing NICE ID3848 NOT NOT COMMISSIONED Launch date 2021. It is inhibitor spondylitis Proposed [GID- COMMISSIONED anticipated that NHSE is responsible commissioner TA10735] for paediatric use and Giant Expected cell (temporal) arteritis. publication date: TBC

Version 1 April 2021 Page 47 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Upadacitinib 10 Janus kinase (JAK) Axial spondyloarthritis No NICE NOT NOT COMMISSIONED Launch date 2023. It is inhibitor guidance COMMISSIONED anticipated that NHSE is responsible commissioner anticipated for paediatric use and Giant cell (temporal) arteritis. Upadacitinib 10 Janus kinase (JAK) Moderate-to-severe NICE ID3733 NOT NOT COMMISSIONED UK launch 2021. It is inhibitor atopic dermatitis Proposed [GID- COMMISSIONED anticipated that NHSE is responsible commissioner TA10597] for paediatric use and Giant Expected cell (temporal) arteritis. publication date: October 2021 Ustekinumab 13.5.3 Drugs affecting the Psoriasis moderate to NICE TA180, In line with NICE Complete proforma Adults only. GP prescribing immune response severe Sept 2009 TA180. (using agreed local NOT expected. NHSE is responsible commissioner systems) for NICE TA455 for paediatric indications of adult TAs.

Ustekinumab 10.1.3 Drugs affecting the Psoriatic arthritis NICE TA340 In line with NICE Complete proforma Adults only. GP prescribing immune response June 2015 TA340 (using agreed local NOT expected. NHSE is responsible commissioner systems) for NICE TA455 for paediatric indications of adult TAs.

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. NHSE is responsible commissioner severely active systems) for NICE TA455 for Crohn’s disease after paediatric indications of previous treatment adult TAs.

Ustekinumab 13.5.3 Drugs affecting the Ulcerative colitis, NICE TA633 In line with NICE Complete proforma NHSE is responsible immune response moderate-to-severe June 2020 TA633 (using agreed local commissioner for paediatric indications. active disease, systems) second-line

Version 1 April 2021 Page 48 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Vadadustat 9 Hypoxia-inducible Anaemia in chronic No NICE NOT NOT COMMISSIONED Predicted UK launch date factor-prolyl kidney disease, guidance COMMISSIONED 2022. NHS England is responsible commissioner hydroxylase (HIF- dialysed and non- anticipated for dialysis induced PH) inhibitor dialysed patients - anaemia. first line Valbenazine 4 Vesicular Tardive dyskinesia in No NICE NOT NOT COMMISSIONED Launch date not known. monoamine adults guidance COMMISSIONED transporter-2 anticipated inhibitor Vedolizumab IV 1.5.3 Drugs affecting the Moderate to severe NICE TA342 In line with NICE Complete proforma NHS England is responsible immune response ulcerative colitis - June 2015 TA342 and locally (using agreed local commissioner for paediatric use. GP prescribing NOT second line after agreed patient systems) expected. conventional therapy pathway or TNF inhibitor Vedolizumab IV 1.5.3 Drugs affecting the Crohn's disease NICE TA352 Aug In line with NICE Complete proforma NHS England is responsible immune response second line after 2015 TA352 (using agreed local commissioner for paediatric use. GP prescribing NOT conventional therapy systems) expected. and TNF inhibitors

Vedolizumab Sub 13.5.3 Drugs affecting the Ulcerative colitis and No NICE Only in line with Local Complete proforma NHS England is responsible cut immune response Crohn’s disease. guidance Policies (using agreed local commissioner for paediatric use anticipated systems) Vericiguat (oral) Soluble guanylate Chronic heart failure NICE ID2731 NOT NOT COMMISSIONED UK availability 2021 cyclase stimulator with reduced ejection Proposed [GID- COMMISSIONED fraction TA10595] Expected publication date: TBC

Version 1 April 2021 Page 49 of 50 Appendix 1: Mid and South Essex CCGs Collaboration Commissioners' list of indications that may be commissioned for excluded drugs and devices 2021/2022 Drug name BNF Category Licensed Indication/ NICE Guidance Indications agreed Is this commissioned? Notes section Indication for funding across What is required for EoE funding approval?

Verteporfin 11.8.2 Subfoveal choroidal Photodynamic NICE guideline Only in line with Local NOT COMMISSIONED No GP prescribing. Local neovascularisation therapy for wet age- [NG82] Jan 2018 Policies Commissioner. related degeneration. (replaces NICE TA68, September 2003)

Verteporfin 11.8.2 Subfoveal choroidal Photodynamic No NICE NOT NOT COMMISSIONED neovascularisation therapy (PDT) with guidance COMMISSIONED verteporfin for anticipated Chronic Central Serous Retinopathy

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