CCG PbR Excluded Drugs List (Collaboration Commissioners' list of indications that may be commissioned for excluded drugs )

Transcription

1 Version CCG PbR Excluded Drugs List CCG PbR Excluded Drugs List Provisional list subject to publication of High Cost Drug exclusion list and and Indications for NHS England drugs list (Medicines not reimbursed through national prices and directly commissioned by NHS England) for High cost drugs excluded from the National Tariff are not commissioned by Clinical Commissioning Groups (CCGs) unless the drugs and indications have approval through local processes. Please note that the enclosed information reflects the current commissioning arrangements. These arrangements are subject to change in year if commissioning responsibility for particular drugs or services change between CCGs and the NHSE and / or new local drug policies are introduced or new NICE guidance is published. The pathways refered to in this document are avaialble on the JFC website accessible here: The tables in Appendix 1 summarise the policy on the commissioning of drugs. It is coded by a "traffic light" scheme as follows: Not commissioned. Where provider Trusts prescribe this treatment the funding responsibility lies with the provider and not the commissioner. No longer NTPS excluded, now included within tariff Approved for use in line with NICE Guidance or where NICE has been converted into a locally agreed protocol or EoE CCG policy. Notification or individual or group prior approval required using proforma or electronic Blueteq forms as per contract. Clinical evidence of outcomes may be requested by CCGs (in line with local contracts). Funding will not be authorised for patients who do not meet agreed criteria. Approved for use in line with locally agreed guidance only. Prior approval, notification proformas or electronic Blueteq forms should be completed. Indications with other minimum dataset information must be provided on back up data to invoices. NHSE commissioning responsibility. CCGs should not consider funding requests for these drugs in these indications / group of patients. For drugs or indications where the the current version of the NHS England drug list should be refered to for the commissioning position, this is located at :- Abaloparatide Analogue of human Osteoporosis- post-menopausal, with parathyroid hormone-higrelated risk of fracture protein Predicted UK launch is in Abatacept Cytokine modulators Rheumatoid arthritis after failure of anti-tnf Abatacept Cytokine modulators Rheumatoid Arthritis not previously treated with DMARDs or after conventional DMARDs only have failed NICE TA195, Aug 2010 NICE TA375, Jan criteria TA195 or RA pathway. TA375 criteria and RA pathway. expected. NHS use. expected. NHS use. Page 1 of 17

2 Abatacept Cytokine modulators Psoriatic arthritis Abatacept Cytokine modulators All other indications Adalimumab Cytokine modulators Rheumatoid arthritis NICE - TA375, Jan or TA195, Aug criteria TA375 or TA195 or RA pathway expected. NHS use. Predicted UK launch 2017 expected. NHS use, uveitis and Hidradenitis Suppurativa Adalimumab Cytokine modulators Psoriatic Arthritis NICE TA199, Aug 2010 criteria TA199or Psoriasis pathway (awaited as per JFC) expected. NHS use, uveitis and Hidradenitis Suppurativa Adalimumab Cytokine modulators Ankylosing spondylitis NICE TA143, May NICE review criteria TA143. ID694 in progress no due date expected. NHS use, uveitis and Hidradenitis Suppurativa Adalimumab Cytokine modulators Psoriasis NICE TA146, June 2008 criteria TA146 or Psoriasis pathway (awaited as per JFC) expected. NHS use, uveitis and Hidradenitis Suppurativa Adalimumab Cytokine modulators Crohn's Disease NICE TA187, May 2010 criteria TA187. expected. NHS use, uveitis and Hidradenitis Suppurativa Page 2 of 17

3 Adalimumab Cytokine modulators Axial spondylo-arthritis (nonradiographic) NICE TA383, Feb. Adalimumab Cytokine modulators Moderate to severe active ulcerative NICE TA329, Feb colitis after the failure of conventional 2015 therapy criteria TA383. criteria TA329. expected. NHS use, uveitis and Hidradenitis Suppurativa expected. NHS use, uveitis and Hidradenitis Suppurativa Adalimumab Cytokine modulators All other indications including Bechet's, Hidradenitis Suppurativa, Uveitis is NHS England. Afamelanotide Skin conditions Erythropoietic protoporphyria Added to NICE highly specialised technology guidance development list Aug No due date. Aflibercept Subfoveal choroidal neovascularisation Aflibercept Subfoveal choroidal neovascularisation Aflibercept Subfoveal choroidal neovascularisation Neovascular (wet) age-related macular degeneration. Macular oedema, secondary to CRVO Macular oedema, secondary to BRVO NICE TA294, July 2013 NICE TA305, February 2014 NICE TA409, Sept TA294 or /NEL wamd pathway. 5/0/ /ncl nel _wamd_pathway_ct_ new_format.pd f TA305 or /NEL CRVO pathway. 5/0/ /crvo_pa thway.pdf TA409 or /NEL BRVO pathway. 5/0/ /brvo_pa thway.pdf Predicted UK launch Page 3 of 17

4 Aflibercept Subfoveal choroidal Aflibercept Subfoveal choroidal neovascularisation Choroidal neovascularisation of the neovascularisation retina due to myopia Diabetic Macular Oedema NICE TA346, July 2015 TA346 July 2015 or /NEL DMO pathway. 5/0/ /dmo_pa thway_april_.pdf Predicted UK launch Q Aflibercept Subfoveal choroidal neovascularisation Diabetic retinopathy in patients with DMO Aflibercept Subfoveal choroidal All other indications neovascularisation Alirocumab 2.12 Lipid-regulating Hypercholesterolaemia, familial and drugs non-familial Alitretinoin Skin conditions Severe chronic hand eczema NICE Guidance, TA177, August 2009 Amikacin Liposomal inhalation Aminoglycosides Nontuberculous mycobacterial lung infection NICE TA 393, June TA393. TA177. UK launch expected. expected. use in CF Anakinra Cytokine modulators Rheumatoid arthritis NICE TA72, Nov 03 (replaced by NICE CG79, Feb 2010), not recommended Apremilast Cytokine modulators Psoriatic arthritis in DMARD naive patients Apremilast Cytokine modulators Active Psoriatic Arthritis TA433, Feb 2017 Apremilast Cytokine modulators Psoriasis (Psoriasis moderate to severe plaque psoriasis) Avatrombopag Platelet disorder drugs Avatrombopag Platelet disorder drugs NICE Guidance, TA419, November TA433, Feb 2017 TA419 or Psoriasis pathway (awaited as per JFC) ITP first line Thrombocytopenia associated with liver disease, pre-surgical procedure. expected.nhs England responsible adult specialised autoinflammatory disease and paediatric use use use use Launch due 2015 Predicted UK launch 2018 Page 4 of 17

5 CCG PbR Excluded Drugs List Aztreonam Lysine nebuliser solution Antibacterial drugs Cystic Fibrosis / bronchiectasis NHSE commissioning policy for CF. Bronchiectasis only in line with Local Policies Baricitinib Cytokine modulators Moderate to severe rheumatoid arthritis NHSE NHSE Only excluded when given by nebulisation / inhalation. use in CF Predicted UK launch 2017 Bortezomib Cold aggultimin disease IFR Botulinum Toxin A Prophylaxis of migraine Migraine prophylaxis NICE GUIDANCE TA260, June 2012 TA260. GP prescribing expected Botulinum Toxin A Essential tremor, chorea, tics and related disorders Chronic anal fissure, severe blepharospasm, hemifacial spasm, cervical dystonia (spasmodic torticollis), focal spasticity in upper and lower limb in adults (causes other than stroke), hyperhidrosis of the axillae, dysphagia caused by achalasia, overactive bladder, spasticity treatment in paediatric cerebral palsy, hypersalivation caused by disease and Hirschsprung's disease. NICE TA ID768 no due date For RF & UCLH, Brand and Indication must indications covered be provided in SLAM under voice are Spasmodic /spatic dysphonia, tourette's disorder affecting the larynx, laryngeal granuloma refractory to surgery. Also spasticity and dystonia associated with human prion disease, stroke, trauma /spinal injury. 0/9/ /jfc_jan_2 013_minutes_ag.pdf GP prescribing expected. for focal spasticity in children. Treatment of spasticity in paediatric cerebral palsy is commissioned by NHSE at specialist centres. For intravesical use in spinal cord injury not commissioned Botulinum Toxin A Essential tremor, chorea, tics and related disorders Laryngeal dystonia (spasmodic dystonia), hydradenitis suppurative, mechanical neck disorders, correction of strabismus (squint) in paediatrics, dysphagia (causes other than achalasia), Raynaud s Disease, Massateric Hypertrophy. anticipated..historical arrangement for BCF to reimburse for the following additional indication: achalasia, anal fissures, axillary hyperhidrosis, cerebral palsy, cervical dystonia, foream dystonia, hemifacial spasm, severe blepharospasm Page 5 of 17

6 Botulinum Toxin A Essential tremor, chorea, tics and related disorders Botulinum Toxin B Torsion, dystonias and other involuntary movements Brodalumab Drugs affecting the immune response Brodalumab Drugs affecting the immune response Canakinumab All other indications Spasmodic torticollis (Cervical dystonia) Psoriasis, chronic plaque Psoriatic arthritis Certolizumab Pegol Cytokine modulators Rheumatoid Arthritis not previously treated with DMARDs or after conventional DMARDs only have failed Certolizumab Pegol Cytokine modulators Early progressive rheumatoid arthritis, untreated by DMARDs Certolizumab Pegol Cytokine modulators Rheumatoid arthritis after TNF inhibitor Certolizumab Pegol Cytokine modulators Active psoriatic arthritis after DMARDs NICE TA375 Jan NICE ID537 no due date NICE TA415, Oct NICE TA445 of May 2017 TA375 Jan in line with NICE TA415, Oct TA445 of May 2017 Certolizumab Pegol Cytokine modulators Axial spondyloarthritis NICE TA 383, Feb NICE TA 383, Feb Certolizumab Pegol Cytokine modulators All other indications. Co- careldopa intestinal gel (Duodopa ) Parkinson's disease Management of advanced Parkinson s disease.historical arrangement for BCF to reimburse for the following additional indication: achalasia, anal fissures, axillary hyperhidrosis, cerebral palsy, cervical dystonia, foream dystonia, hemifacial spasm, severe blepharospasm use Adults only, GP prescribing expected. use Adults only, GP prescribing expected. commissioner - not commissioned commissioner - not commissioned Page 6 of 17

7 Colistimethate sodium powder (Promixin ) /injection for nebulisation Colistimethate sodium dry powder for inhalation (Colobreathe ) Antibacterial drugs Cystic Fibrosis NHSE Policy - Inhaled Therapy For Adults And Children With Cystic Fibrosis Policy Ref: A01/P/b Antibacterial drugs Cystic Fibrosis NICE TA276, March NHSE responsibility, but GPs may prescribe for new or existing patients. No GP prescribing of Colobreathe as Patient Access Scheme not available in primary care. Only excluded when given by nebulisation/inhalation. Only excluded when given by nebulisation/inhalation. Collagenase Enzymes Peyronie's disease (PsD) NICE ID849 in progress no due date Collagenase Enzymes Dupuytren's Contracture (ID621) NICE ID621 in progress no due date Deferasirox Iron overload Anaemia related to chronic iron overload for myelodysplastic syndrome only Deferiprone Iron overload Anaemia related to chronic iron overload for myelodysplastic syndrome only Desferrioxamine Iron overload Anaemia related to chronic iron overload for myelodysplastic syndrome only Dexamethasone intravitreal implant Macular oedema Macular oedema secondary to retinal vein occlusion. NICE TA suspended NICE TA229, July Dexamethasone intravitreal implant Macular oedema Diabetic Macular Oedema NICE TA349 July 2015 Only in line with Local Policies Only in line with Local Policies Only in line with Local Policies TA229, July 2011 TA349, July 2015 or DMO pathway. 5/0/ /dmo_pa thway_april_.pdf.. Complete proforma (using agreed local Complete proforma (using agreed local Complete proforma (using agreed local Only excluded from tariff when used in outpatients Only excluded from tariff when used in outpatients thalassemia and sickle cell disease thalassemia and sickle cell disease thalassemia and sickle cell disease PAC recommendations in development due June Dexamethasone intravitreal implant Macular oedema Inflammation of the posterior segment of the eye presenting as non-infectious uveitis NICE TA ID763 due May Page 7 of 17

8 Dibotermin alfa CCG PbR Excluded Drugs List Bone Morphogenetic Protein(BMP) Acute tibia fractures Digoxin immune fab Poisoning Life - threatening digoxin toxicity National Poisons Centre Guidelines Dimethyl fumarate Preparations for psoriasis Dimethyl fumarate Preparations for psoriasis Plaque psoriasis, moderate to severe anticipated Chronic plaque, moderate-to-severe, modified-release prep anticipated BY CCG FOR COMPLEX SPINAL SURGERY. BMP for secondary revision of spinal fusion surgery as per local commissioning policy letter dated Dec 2013 Only commissioned in line with National Poison Centres guidelines... Notification on SLAM... Dornase alpha 3.7 Mucolytics Cystic fibrosis NICE TA276 NHSE responsibility, but TA276 & NHS England GPs may prescribe for new Policy: A01/PS/a. or existing patients. complex spinal surgery - Available on named patient basis only in the hospital.. Predicted UK launch Also indicatied for multiple sclerosis. NHS England for Multiple Sclerosis. Predicted UK launch Also indicatied for multiple sclerosis. NHS England for Multiple Sclerosis. Erythropoietins Drugs used in renal anaemias Eculizumab Eltrombopag Platelet disorder drugs Eltrombopag Platelet disorder drugs Eptotermin alfa Bone morphogenic protein Pre-dialysis Paroxysmal nocturnal Haemoglobinuria Chronic idiopathic thrombocytopenic purpura (ITP) Thrombocytopenia in adult patients with chronic hepatitis C virus infection Acute tibia fracture (adults) NICE TA293, July 2013 TA293, July Notification via SLAM.. NHSE GP prescribing expected Erythropoeitin for non-dialysis renal patients Drugs used in renal anaemias Pre-dialysis.. Page 8 of 17

9 CCG PbR Excluded Drugs List Etanercept or licensed biosimilar Cytokine modulators Rheumatoid Arthritis NICE TA375 Jan or TA195 Aug Etanercept or licensed biosimilar Cytokine modulators Ankylosing spondylitis (adults) NICE TA383 Feb. Etanercept or licensed biosimilar Cytokine modulators Axial spondyloarthritis (nonradiographic) NICE TA383 Feb. Etanercept or licensed biosimilar Cytokine modulators Psoriatic Arthritis NICE TA199, August 2010 Etanercept or licensed biosimilar Cytokine modulators Psoriasis NICE TA103 July 2006 Etanercept or licensed biosimilar Cytokine modulators All other indications Evolocumab 2.12 PCSK9 Monoclonal Antibody Inhibitor Evolocumab 2.12 PCSK9 Monoclonal Antibody Inhibitor Fibrin sealants Blood-related products Homozygous familial hypercholesterolemia Hypercholesterolaemia, familial and non-familial Haemostatic / tissue glue. TA373 Jan or TA195 Aug 2010 or RA pathway TA383, Feb. TA383 Feb TA199, August 2010 TA199, August 2010 or Psoriasis pathway (awaited as per JFC). NICE TA date TBC (ID810). NICE TA 394 June TA394. Fluocinolone acetonide Macular oedema Chronic diabetic macular oedema NICE TA301, November 2013 Fomepizole Poisoning Poisoning National Poisons Centre Guidelines Golimumab Cytokine modulators Psoriatic Arthritis NICE TA220, April 2011 Golimumab Cytokine modulators Rheumatoid arthritis NICE TA375 Jan Golimumab Cytokine modulators Ankylosing spondylitis NICE TA383 Feb. Golimumab Cytokine modulators Moderate to severe ulcerative colitissecond line NICE TA329 Feb 2015 No longer NTPS excluded, now within tariff. in line with NICE TA301, November 2013 Only commissioned in line with National Poison Centres guidelines. TA220, April 2011 TA375 Jan or RA pathway In line NICE TA383, Feb TA329, Feb No longer NTPS excluded, now within tariff. Notification on SLAM. Check with CCGs NHS England Available on named patient basis only in the hospital. Page 9 of 17

10 Golimumab Cytokine modulators Axial spondyloarthritis (nonradiographic) Golimumab Iloprost Vasodilator antihypertensive drugs/pulmanory Arterial Hypertension Cytokine modulators All other indications Critical limb ischaemia NICE TA383 Feb. Infliximab or licensed biosimilar Cytokine modulators Crohn's Disease NICE TA187, May 2010 Infliximab or licensed biosimilar Cytokine modulators Rheumatoid Arthritis NICE TA375 Jan or TA195 Aug Infliximab or licensed biosimilar Cytokine modulators Psoriatic Arthritis NICE TA199, August 2010 Infliximab or licensed biosimilar Cytokine modulators Psoriasis (adults) NICE TA134, January 2008 Infliximab or licensed biosimilar Cytokine modulators Ulcerative Colitis (acute exacerbations) NICE TA163, December 2008 Infliximab or licensed biosimilar Cytokine modulators Ankylosing spondylitis NICE TA143, May not recommended. NICE review ID694 no due date Infliximab or licensed biosimilar Cytokine modulators Axial spondyloarthritis (nonradiographic) Infliximab or licensed biosimilar Cytokine modulators Ulcerative Colitis - 2nd line for moderate to severely active Infliximab or licensed biosimilar Cytokine modulators Ulcerative Colitis (Sub-acute manifestations) Infliximab or licensed biosimilar Cytokine modulators All other indications NICE TA383 Feb. NICE TA329 Feb 2015 NICE TA329 Feb 2015 Not recommended TA383 Feb. TA187, May 2010 TA375 Jan or TA195 Aug 2010 or RA pathway TA199, August 2010 TA134, January 2008 or Psoriasis pathway (awaited as per JFC) TA163, December 2008 TA383 Feb TA329 Feb Page 10 of 17

11 Ixekizumab Humanized Moderate to severe plaque psoriasis anti interleukin-17 monoclonal antibody TA442, April 2017 TA442, April 2017 Ixekizumab Humanized Ankylosing spondylitis anti interleukin-17 monoclonal antibody.. Ixekizumab Humanized Psoriatic arthritis anti interleukin-17 monoclonal antibody.. Lanreotide Somatostatin Analogues All indications except acromegaly, cancer and congenital hyperinsulinism Levofloxacin Solution for Inhalation Antibacterial drugs Chronic pulmonary infections due to Pseudomonas aeruginosa in adults with CF Lomitapide 2.12 Lipid-regulating drugs Hypercholesterolaemia, homozygous familial (HoFH)..... Acromegaly, Cancer and Congenital hyperinsulinism funded by NHSE Not routinely commissioned by NHS England Mannitol 3.7 Mucolytics Cystic Fibrosis NICE TA266 November 2012 TA266 and NHSE A01/P/bTA266. No GP prescribing for paediatric use. Mannitol 3.7 Mucolytics Indications other than cystic fibrosis. Ocriplasmin Retinal disorders Vitreomacular traction including NICE TA297 Oct those associated with macular holes TA297 Oct 2014 Complete proforma (using agreed local Octreotide Somatostatin Analogues All indications except acromegaly, cancer and congenital hyperinsulinism Postmenopausal osteoporosis Odanacatib Selective cathepsin- K inhibitor Odanacatib Selective cathepsin- Osteoporosis in men K inhibitor Omalizumab Allergen Previously treated chronic Immunotherapy spontaneous urticaria Only in line with Local Policies NICE TA339 June 2015 TA339 or JFC /NEL pathway Complete proforma (using agreed local Acromegaly, Cancer and Congenital hyperinsulinism funded by NHSE Discontinued Discontinued NHSE is responsible for Asthma Page 11 of 17

12 Parenteral Nutrition 9.3 Parenteral nutritionadults Intestinal Failure (after 14 days or where the patient is receiving TPN prior to admission) Pegaptanib Subfoveal choroidal neovascularisation Neovascular (wet) age-related macular degeneration Phenylephrine with Ketorolac Retinal disorders / Intraocular lense replacement intraocular lens surgery replacement surgery NICE CG32. Feb 2006 Only in line with Local Policies (using agreed NICE TA155, August 2008 Only in line with Local Policies (using agreed NHSE is responsible for: Children and Adult specialist intestinal failure services for patients with Intestinal Failure Type II and Type III (including the provision of home parenteral nutrition). Pasireotide Somatostatin Analogues Pasireotide Somatostatin Analogues Pegpleranib (E10030) Retinal disorders/intraocular lens replacement surgery Ranibizumab Neovascularisation Neovascular (wet) age-related macular degeneration Cushings Syndrome (3rd line adults) In line with NHS England: 16003/P Acromegaly Wet ARMD (age-related macular degeneration) NICE TA155, August 2008 Ranibizumab Neovascularisation Diabetic Macular Oedema NICE TA274, Feb 2013 Ranibizumab Neovascularisation Macular oedema (retinal vein occlusion) NICE TA283, May 2013 Ranibizumab Neovascularisation CNV due to pathological myopia NICE TA298, November 2013 Riluzole Torsion Dystonia and other involuntary movements ALS form of Motor Neurone Disease NICE Guidance TA20,Jan 2001 Rituximab Cytokine modulators Rheumatoid Arthritis after failure of TNF inhibitor NICE TA195, Aug 2009 crteria TA155 or /NEL wamd pathway crteria TA284 or /NEL wamd pathway crteria TA283 or /NEL wamd pathway crteria TA298 or /NEL wamd pathway crteria TA20 crteria TA194 not expected (launch plan: 2017) not expected not expected Page 12 of 17

13 CCG PbR Excluded Drugs List Rituximab or licensed biosimilar Cytokine modulators Rheumatoid arthritis (first line) Rituximab (Biosimilar) Cytokine modulators Rheumatoid Arthritis after failure of TNF inhibitor Rituximab or licensed biosimilar Cytokine modulators Auto Immune Haemolytic Anaemia (AIHA). NICE TA195, Aug 2010 Rituximab or licensed biosimilar Cytokine modulators ITP Rituximab or licensed biosimilar Cytokine modulators Refractory vasculitis NICE TA308 March 2014 Rituximab or licensed biosimilar Cytokine modulators Juvinile Arthritis NICE TA35 March See JFC pathway 5/0/ /ncl_ra_ protocol_july_2015..pd f In line with JFC: For AIHA. July 5/0/ /ncl_jfc_ minutes_july fin al2.pdf In line with JFC: For refractory or relapsed disease only (November 2012) In line with TA 308 and NHS England A13/P/a In line with NHS England E03X04 (Jul 2015): E03/P/d biologics for Juvenile Idiopathic Arthritis in Children and Adults Notification through SLAM Notification through SLAM NHSE responsibility; No GP prescribing. NHSE responsibility; No GP prescribing. Adults only. NHS England is responsible cancerous and specialist auto-inflammatotory conditions. Not licensed yet in UK. Adults only. NHS England is responsible cancerous and specialist auto-inflammatotory conditions. Adults only. NHS England is responsible cancerous and specialist auto-inflammatotory conditions. Adults only. NHS England is responsible cancerous and specialist auto-inflammatotory conditions. Adults only.no GP prescribing. NHS England is responsible cancerous and specialist auto-inflammatotory conditions. No GP prescribing. NHS cancerous and specialist auto-inflammatotory conditions. Page 13 of 17

14 CCG PbR Excluded Drugs List Rituximab or licensed biosimilar Cytokine modulators neuromyelitis optica N/A N/A N/A The first 2 courses of Rituximab, i.e. 1st month and 6th month (1 course=2 injections on day 1 and day 14) will be given and funded by NHS England commissioned centres. The central budget for Rituximab is held by The Walton Centre NHS Foundation Trust and that Oxford will cross charge Rituximab to the Walton Centre based on use. The centres will assess benefit after the second course of treatment and if ongoing care is needed Rituximab may be given locally as part of a shared care arrangement. On-going drug funding will be the responsibility of the patient s CCG. Rituximab or licensed biosimilar Cytokine modulators Other indications (adults) used in CCG commissioned service Romiplostim Platelet Disorder Drugs ITP NICE Guidance TA221, April 2011 Secukinumab Cytokine modulators Chronic plaque psoriasis moderatesevere after failed conventional therapies Secukinumab Cytokine modulators Active psoriatic arthritis after DMARDs Secukinumab Cytokine modulators Ankylosing spondylitis after DMARDs, anti TNF inhibitors NICE TA350 July NICE TA445, May 2017 NICE TA407, Sept crteria TA221 crteria TA350 or Psoriasis pathway (awaited as per JFC) TA445 of May 2017 criteria TA407 NHSE responsibility; No GP prescribing. Adults only.no GP prescribing. NHS England is responsible cancerous and specialist auto-inflammatotory conditions.ifr expected. NHS use. use Page 14 of 17

15 Secukinumab Cytokine modulators Rheumatoid arthritis Serelaxin Hypertension and Heart failure Heart failure NICE Guidance ID673 Siltuximab Cytokine modulators Castleman s disease Sirukumab Cytokine modulators Rheumatoid arthritis Sodium oxybate 4.1 Hypnotics and Narcolepsy with cataplexy (adults) NHSE is anxiolytics responsible for: -Narcolepsy - paediatric services Somatropin (adults) Growth Hormone or NICE approved uses only TA64, Aug 2003 Growth Hormone crteria TA42 or TA64 Receptor Antagonist Complete using agreed local systems (launch plan: 2018). NHSE responsible for paediatric indication (launch plan: 2018) (launch plan: 2018) (launch plan: 2017) Complete using agreed local systems Somatropin (children) Growth Hormone or NICE approved uses only Growth Hormone Receptor Antagonist NICE TA188, May 2010 crteria TA42 or TA65 NHSE is responsible for indications falling outside NICE guidance treated in specialist centres Tafamidis Teriflunomide Other immunomodulating drugs Teriparatide Drugs affecting bone metabolism Multiple Sclerosis Secondary prevention of osteoporotic fragility fractures Teriparatide Drugs affecting bone Treatment of osteoporosis metabolism associated with glucocorticoids Tesamorelin Growth Hormone & HIV associated lipodystrophy growth hormone Receptor Antagonist NICE TA 303 Jan 2014 and NHS ENGLAND POLICY: D04/P/b NICE TA161, Jan 2011 crteria TA246 As per Category C categorisation. Unlikely to be CCGS Thrombomodulin, Recombinant Human Fibrinolytics Septic shock (Sepsis) (adult, nonspecialist services) Tildrakizumab Skin conditions Psoriasis (adults) Page 15 of 17

16 Tobramycin (Tobi / Bramitob ) nebuliser solution Tobramycin (Tobi Podhaler) dry powder for inhalation CCG PbR Excluded Drugs List Antibacterial Drugs Cystic Fibrosis NICE TA276, March NHS ENGLAND CLINICAL COMMISSIONING POLICY: A01/P/bTA276 TA276 & NHS England Policy: A01/PS/a Antibacterial Drugs Cystic Fibrosis NICE TA276, March NHS ENGLAND CLINICAL COMMISSIONING POLICY: A01/P/bTA276 Tocilizumab Cytokine modulator Rheumatoid Arthritis NICE TA247 Feb 2012 or TA375 Jan crteria TA246 Tocilizumab Cytokine modulator Rheumatoid Arthritis NICE TA247 Feb 2012 or TA375 Jan crteria TA247 NHSE responsibility, but GPs may prescribe for new or existing patients.. expected. NHS use. expected. NHS use. Tocilizumab Cytokine modulator Juvenile Arthritis (adults) -Polyarticular -Systemic NHS England E03X04 (Jul 2015): E03/P/d biologics TA 373 for juvenile arthritis in paediatrics. Tocilizumab Cytokine modulator Other indications (adults) used in CCG commissioned service Tofacitinib Cytokine modulator Rheumatoid arthritis moderate-tosevere, methotrexate-naive ( - due Q delete) Tofacitinib Cytokine modulator Rheumatois arthritis moderate to severe in patients unresponsive to DMARDs or MTX Tofacitinib Cytokine modulator Psoriatic arthritis second-line following failure of conventional DMARDs, third-line following failure of biological DMARDs Tofacitinib Cytokine modulator Ulcerative colitis, Moderate-severe, acute treatment and maintenance NICE guidance ID526 anticipated January 2018 (launch plan: 2017) (launch plan: 2017) (launch plan 2018) (launch plan 2018) Page 16 of 17

17 CCG PbR Excluded Drugs List Tofacitinib Cytokine modulator Psoriasis (adults) Tofacitinib Cytokine modulator Juvenile Arthritis (adults) Tolvaptan Vasopressin V2- receptor antagonist Tolvaptan Vasopressin V2- receptor antagonist Vasopressin V2- receptor antagonist Ustekinumab Drugs affecting the immune response Ustekinumab Drugs affecting the immune response Ustekinumab Drugs affecting the immune response Ustekinumab Drugs affecting the immune response Vedolizumab Drugs affecting the immune response Vedolizumab Drugs affecting the immune response Verteporfin Subfoveal choroidal neovascularisation Autosomal dominant polycystic kidney disease, stage 2 or 3, rapidly progressing Hyponatraemia due to syndrome of inappropriate antidiuretic hormone secretion (SIADH). Hyponatraemia from other causes and other endocrine uses Psoriasis moderate to severe Crohn's disease Psoriasis, moderate to severe in adolescents (due Q4, delete) Psoriatic arthritis Crohn's disease second line after conventional therapy and TNF inhibitors Moderate to severe ulcerative colitis - second line after conventional therapy or TNF inhibitor Photodynamic therapy for wet agerelated macular degeneration. NICE TA358 October 2015 NICE TA180, Sept Updated March NICE ID843 due July 2017 NICE ID854 due July 2017 (age ranges covered TBC) NICE TA340 June Updated March NICE TA352 Aug 2015 NICE TA342 June 2015 NICE TA68, September 2003 TA358 crteria TA180 or Psoriasis pathway (awaited as per JFC) crteria TA340 crteria TA352 crteria TA342 TA68 or /NEL wamd pathway (launch plan unknown) (launch plan 2021) No GP prescribing for hyponatraemia in cancer. for hyponatraemia in cancer. expected. NHS use. expected. expected. NHS use. expected. NHS use. No GP prescribing Page 17 of 17