Northern, Eastern and Western Devon Clinical Commissioning Group South Devon and Torbay Clinical Commissioning Group

Northern, Eastern and Western Devon Clinical Commissioning Group South Devon and Torbay Clinical Commissioning Group

Northern, Eastern and Western Devon Clinical Commissioning Group South Devon and Torbay Clinical Commissioning Group Page 1 of 66 © October 2014. Not to be further copied without permission Risk Sharing Schemes (RSS) and Patient Access Schemes (PAS) Introduction Drugs which receive a positive NICE appraisal, that have a PAS scheme attached, are commissioned on the basis that any PAS is fully utilised and adhered to. When assessing new drugs and treatments - to decide whether they represent good value for the NHS - NICE looks at evidence on how well the treatment works compared with available alternatives, and the cost of treatment.

Drugs or treatments that are expensive and do not have a significant benefit over existing treatments are unlikely to be approved by NICE for use in the NHS. Patient access schemes are special ways Pharmaceutical companies can propose to enable patients to gain access to high costs drugs.

Where a patient access scheme exists it is vital that NHS bodies make full access to the scheme to secure maximum cost effectiveness of providing treatment. Each scheme is different and hence a good understanding of them will ensure they are used to their full potential. Document Index The schemes detailed in this document are listed alphabetically below. Click on the drug name below to be taken straight to the relevant section: Drug Indication NICE Abatacept (Orencia® ) rheumatoid arthritis after the failure of conventional disease- modifying anti-rheumatic drugs TA280 Abiraterone (Zytiga® ) castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen TA259 Afatinib (Giotrif® ) Epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small-cell lung cancer TA310 Aflibercept (Eylea® ) wet age-related macular degeneration TA294 Aflibercept (Eylea® ) visual impairment caused by macular oedema secondary to retinal vein occlusion TA305 Aflibercept (Zaltrap® ) Metastatic colorectal cancer that has progressed following prior oxaliplatin-based chemotherapy TA307 rejected Amifampridine (Firdapse® ) symptomatic treatment of Lambert Eaton Myasthenic Syndrome not NICE reviewed Azacitidine (Vidaza® ) myelodysplastic syndrome, chronic myelomonocytic leukaemia and acute myeloid leukaemia TA218 Bortezomib (Velcade® ) relapsed multiple myeloma TA129

Page 2 of 66 © October 2014. Not to be further copied without permission Drug Indication NICE Bosutinib (Bosulif® ) previously treated chronic myeloid leukaemia TA299 rejected Certolizumab pegol (Cimzia® ) rheumatoid arthritis TA186 Cetuximab (Erbitux® ) 1st line treatment of metastatic colorectal cancer TA176 Colistimethate sodium DPI (Colobreathe® ) Pseudomonas lung infection in cystic fibrosis TA276 Crizotinib (Xalkori® ) previously treated non-small-cell lung cancer associated with an anaplastic lymphoma kinase fusion gene TA296 rejected Degarelix (Firmagon® ) advanced hormone dependent prostate cancer not NICE reviewed Denosumab (Xgeva® ) prevention of skeletal-related events in adults with bone metastases from solid tumours TA265 Dimethyl fumarate (Tecfidera® ) relapsing-remitting multiple sclerosis TA320 Eltrombopag (Revolade® ) chronic immune (idiopathic) thrombocytopenic purpura TA293 Enzalutamide (Xtandi® ) metastatic hormone relapsed prostate cancer previously treated with a docetaxel containing regimen TA316 Erlotinib (Tarceva® ) 1st line treatment of locally advanced or metastatic EGFR- TK mutation-positive non-small-cell lung cancer TA258 Everolimus (Afinitor® ) advanced HER2-negative hormone-receptor-positive breast cancer after endocrine therapy TA295 rejected Fingolimod (Gilenya® ) highly active relapsing-remitting multiple sclerosis TA254 Fluocinolone acetonide intravitreal implant (Iluvien® ) chronic diabetic macular oedema after an inadequate response to prior therapy TA301 Gefitinib (Iressa® ) 1st line treatment of locally advanced or metastatic non small cell lung cancer TA192 Golimumab (Simponi® ) psoriatic arthritis TA220 Golimumab (Simponi® ) rheumatoid arthritis TA225 Golimumab (Simponi® ) ankylosing spondylitis TA233 Interferon beta 1a/ interferon beta 1b and Glatiramer Acetate multiple sclerosis TA32 Ipilimumab (Yervoy® ) previously treated advanced (unresectable or metastatic) melanoma TA268 Ipilimumab (Yervoy® ) previously untreated advanced (unresectable or metastatic) melanoma TA319 Lapatinib (Tyverb® ) advanced or metastatic breast cancer FAD rejected Lapatinib (Tyverb® ) advanced or metastatic breast cancer not NICE reviewed Lenalidomide (Revlimid® ) relapsed multiple myeloma TA171

Page 3 of 66 © October 2014. Not to be further copied without permission Drug Indication NICE Lenalidomide (Revlimid® ) myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality TA322 Mifamurtide (Mepact® ) osteosarcoma TA235 Nilotinib (Tasigna® ) chronic myeloid leukaemia (imatinib intolerant/ resistant) TA241 Nilotinib (Tasigna® ) 1st line treatment of chronic myeloid leukaemia TA251 Omalizumab (Xolair® ) severe persistent allergic asthma TA278 Pazopanib (Votrient® ) 1st line treatment of advanced renal cell carcinoma TA215 Pirfenidone (Esbriet® ) idiopathic pulmonary fibrosis TA282 Pixantrone (Pixuvri® ) multiply relapsed or refractory aggressive non-Hodgkin’s B- cell lymphoma TA306 Ranibizumab (Lucentis® ) wet age related macular degeneration TA155 Ranibizumab (Lucentis® ) diabetic macular oedema TA274 Ranibizumab (Lucentis® ) visual impairment caused by macular oedema secondary to retinal vein occlusion TA283 Ranibizumab (Lucentis® ) choroidal neovascularisation associated with pathological myopia TA298 Romiplostim (Nplate® ) chronic immune or idiopathic thrombocytopenic purpura TA221 Sodium Oxybate (Xyrem® ) narcolepsy with cataplexy in adult patients not NICE reviewed Sunitinib (Sutent® ) 1st line treatment of advanced and/or metastatic renal cell carcinoma TA169 Sunitinib (Sutent® ) 2nd line treatment of advanced and/or metastatic renal cell carcinoma TA178 rejected Sunitinib (Sutent® ) gastrointestinal stromal tumours TA179 Teriflunomide (Aubagio® ) relapsing-remitting multiple sclerosis TA303 Tobramycin DPI (TOBI Podhaler® ) pseudomonas lung infection in cystic fibrosis TA276 Tocilizumab (RoActemra® ) systemic juvenile idiopathic arthritis in children and young people aged 2 years and older TA238 Tocilizumab (RoActemra® ) rheumatoid arthritis in adults TA247 Trabectedin (Yondelis® ) advanced soft tissue sarcoma TA185 Ustekinumab (Stelara® ) moderate to severe psoriasis TA180 Vemurafenib (Zelboraf® ) locally advanced or metastatic BRAF V600 mutation- positive malignant melanoma TA269

Page 4 of 66 © October 2014. Not to be further copied without permission Abatacept (Orencia® ) for rheumatoid arthritis after the failure of conventional disease-modifying anti-rheumatic drugs (rapid review of TA234) TA280 1.1 Criteria NICE criteria: Abatacept in combination with methotrexate is recommended as an option for treating rheumatoid arthritis in adults whose disease has responded inadequately to 2 conventional disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, only if:  it is used in accordance with the recommendations for other biological DMARDs in Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis (NICE TA130) and  the manufacturer provides abatacept with the discount agreed in the patient access scheme 1.2 Scheme The Department of Health and the manufacturer (Bristol-Myers Squibb) have agreed that abatacept will be available to the NHS with a patient access scheme which makes abatacept available with a discount.

The size of the discount is commercial in confidence.

It is the responsibility of the manufacturer to communicate details of the discount to the relevant NHS organisations. Any enquiries from NHS organisations about the patient access scheme should be directed to BMS Customer Services (Chester), phone number 01244 586250, or to the following e-mail address: mg-ukpasadmin@bms.com 1.3 Summary of Scheme The manufacturer of abatacept has agreed a patient access scheme with the Department of Health in which abatacept will be available with a discount. The level of discount is commercial in confidence.

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Not to be further copied without permission Abiraterone (Zytiga® ) for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen TA259 1.1 Criteria NICE criteria: Abiraterone in combination with prednisone or prednisolone is recommended as an option for the treatment of castration-resistant metastatic prostate cancer in adults, only if:  their disease has progressed on or after one docetaxel-containing chemotherapy regimen, and  the manufacturer provides abiraterone with the discount agreed in the patient access scheme 1.2 Scheme The manufacturer has agreed a patient access scheme with the Department of Health which involves a single confidential discount being applied to the list price of abiraterone.

Contact details of drug company: 1.3 Summary of Scheme No action required The manufacturer has agreed a patient access scheme with the Department of Health which involves a single confidential discount being applied to the list price. Janssen-Cilag Ltd 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG Telephone: +44 (0)1494 567 567 Fax: +44 (0)1494 567 568 www: http://www.janssen.co.uk www: http://www.janssen-medinfo.co.uk Medical Information Direct Line: +44 (0)800 731 8450 Medical Information e-mail: medinfo@janssen-cilag.co.uk Customer Care direct line: +44 (0)800 731 5550

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Not to be further copied without permission Afatinib (Giotrif® ) for treating epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small-cell lung cancer TA310 1.1 Criteria NICE criteria: Afatinib is recommended as an option, within its marketing authorisation, for treating adults with locally advanced or metastatic non-small-cell lung cancer only if:  the tumour tests positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation, and  the persion has not previously had an EGFR-TK inhibitor, and  the manufacturer provides afatinib with the discount agreed in the patient access scheme 1.2 Scheme The manufacturer of afatinib has agreed a patient access scheme with the Department of Health in which a confidential discount is applied at the point of purchase or invoice.

Contact details of drug company: Boehringer Ingelheim Limited Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS Telephone: +44 (0)1344 424 600 Fax: +44 (0)1344 741 298 Medical Information Direct Line: +44 (0)1344 742579 Medical Information email: medinfo@bra.boehringer-ingelheim.com www: www.boehringer-ingelheim.co.uk 1.3 Summary of Scheme No action required The manufacturer (Boehringer Ingelheim) has agreed a patient access scheme with the Department of Health in which a confidential discount is applied at the point of purchase or invoice.

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Not to be further copied without permission Aflibercept solution for injection (Eylea® ) for treating wet age-related macular degeneration TA294 1.1 Criteria NICE criteria: Aflibercept solution for injection is recommended as an option for treating wet age-related macular degeneration only if:  it is used in accordance with the recommendations for ranibizumab in NICE technology appraisal guidance 155 (re-issued in May 2012, and  the manufacturer provides aflibercept solution for injection with the discount agreed in the patient access scheme.

1.2 Scheme The manufacturer has agreed a patient access scheme with the Department of Health which involves a confidential discount applied to the list price of aflibercept solution for injection. The level of the discount is commercial in confidence. Contact details of drug company: Bayer plc Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA Telephone: +44 (0)1635 563 000 Fax: +44 (0)1635 563 393 www: http://www.bayer.co.uk 1.3 Summary of Scheme No action required The manufacturer (Bayer) has agreed a patient access scheme with the Department of Health which involves a confidential discount applied to the list price of aflibercept solution for injection.

The level of the discount is commercial in confidence.

Page 8 of 66 © October 2014. Not to be further copied without permission Aflibercept solution for injection (Eylea® ) for treating visual impairment caused by macular oedema secondary to central retinal vein occlusion TA305 1.1 Criteria NICE criteria: Aflibercept solution for injection is recommended as an option for treating visual impairment caused by macular oedema secondary to retinal vein occlusion only if:  the manufacturer provides aflibercept solution for injection with the discount agreed in the patient access scheme.

1.2 Scheme The manufacturer of aflibercept solution for injection has agreed a patient access scheme with the Department of Health which makes aflibercept solution for injection available with a discount applied to the list price.

The level of discount is commercial in confidence. Contact details of drug company: Bayer plc Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA Telephone: +44 (0)1635 563 000 Fax: +44 (0)1635 563 393 www: http://www.bayer.co.uk 1.3 Summary of Scheme No action required The manufacturer (Bayer) has agreed a patient access scheme with the Department of Health which involves a confidential discount applied to the list price of aflibercept solution for injection. The level of the discount is commercial in confidence.

Page 9 of 66 © October 2014. Not to be further copied without permission Aflibercept (Zaltrap® ) in combination with irinotecan and fluorouracil-based therapy for treating metastatic colorectal cancer that has progressed following prior oxaliplatin-based chemotherapy TA307 rejected 1.1 Criteria  For treating, in combination with irinotecan and fluorouracil-based therapy, metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen.  Individual funding is required before prescribing, complete an NHS England Individual Funding Panel Request and await response 1.2 Scheme The manufacturer of aflibercept (Sanofi) has agreed a patient access scheme with the Department of Health that makes aflibercept available with a discount.

The size of the discount is commercial in confidence.

Contact details of drug company: Sanofi 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK Telephone: +44 (0)1483 505 515 Fax: +44 (0)1483 535 432 Medical Information Direct Line: +44 (0)845 372 7101 Medical Information e-mail: uk-medicalinformation@sanofi.com 1.3 Summary of Scheme No action required The manufacturer of aflibercept (Sanofi) has agreed a patient access scheme with the Department of Health that makes aflibercept available with a discount. The size of the discount is commercial in confidence.

Page 10 of 66 © October 2014. Not to be further copied without permission Amifampridine (Firdapse® ) for the symptomatic treatment of Lambert Eaton Myasthenic Syndrome (LEMS) 1.1 Criteria Individual funding is required before prescribing, complete an Individual Funding Panel Request and await response 1.2 Scheme The cost of treatment for an individual patient registered under the scheme will be capped at a maximum price in a 12 month period (equivalent to 14 packs).

Once the annual cap of 14 packs has been reached, subsequent packs will be supplied to each registered patient free of charge until the 12 month period is complete. Only patients registered with the scheme will benefit from the capped maximum price. Trusts wishing to participate in the scheme should register their patients with Healthcare at Home who will administer the scheme and track individual patients. Details and documentation can be requested by contacting BioMarin on 07795 117877 or Rkitson@bmrn.com Date scheme commenced: from November 11 Contact details of drug company: 1.3 Summary of Scheme The cost of treatment for an individual patient will be capped at a maximum price in a 12 month period (equivalent to 14 packs).

BioMarin Europe Ltd 164 Shaftesbury Avenue, London, WC2H 8HL Telephone: +44 (0)7795 117877

Page 11 of 66 © October 2014. Not to be further copied without permission Azacitidine (Vidaza® ) for the treatment of myelodysplastic syndrome, chronic myelomonocytic leukaemia and acute myeloid leukaemia TA218 1.1 Criteria Criteria: for the treatment of adults who are not eligible for haematopoietic stem cell transplantation and have:  intermediate-2 and high-risk myelodysplastic syndromes according to the International Prognostic Scoring System (IPSS) or  chronic myelomonocytic leukaemia with 10-29% marrow blasts without myeloproliferative disorder or  acute myeloid leukaemia with 20-30% blasts and multilineage dysplasia, according to the World Health Organization classification and  if the manufacturer provides azactidine with the discount agreed as part of the patient access scheme 1.2 Scheme The manufacturer (Celgene) has agreed a patient access scheme with the Department of Health in which azacitidine for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia will be available to the NHS with a discount, the level of which is commercial in confidence.

Commencement of scheme: January 2011 Contact details of drug company: 1.3 Summary of Scheme No action required Celgene Ltd Morgan House, Madeira Walk, Windsor, Berkshire, SL4 1PE, UK Telephone: +44 1753 498 600 Medical Information Direct Line: UK: 08448 010 045 Ireland: 1800 333 111 Medical Information e-mail: medinfo.uk.ire@celgene.com Medical Information Fax: UK: 08448 010 046 Ireland: 1800 333 112

Page 12 of 66 © October 2014. Not to be further copied without permission Bortezomib (Velcade® ) for relapsed multiple myeloma TA129 1.1 Criteria NICE criteria: Bortezomib monotherapy is recommended as possible treatment for progressive multiple myeloma for people:  whose multiple myeloma has relapsed for the first time after having one treatment, and  who have had a bone marrow transplant, unless it is not suitable for them.  After not more than four cycles of treatment, a blood or urine test should be done to check how well the cancer has responded to bortezomib.  Treatment should be continued only if there has been at least a partial response to the drug  For more extensive information please refer to www.nice.org.uk 1.2 Scheme The Velcade® Response Scheme (VRS) is for patients treated with bortezomib at first relapse only.

The Scheme allows for reimbursement of a maximum of 16 x 3.5mg vials if the patient does not show a “complete or partial response” after four cycles of treatment with bortezomib. Response is measured using serum-M protein (or Bence Jones urine protein). Before review of response for VRS purposes, all patients should receive 4 cycles of treatment unless toxicities prevent treating to 4 cycles. If, within the first 4 cycles, treatment has to be stopped because of tolerability reasons, the VRS only applies if the patient showed no response or a minor response to treatment. The manufacturer will reimburse the NHS with the full cost of treatment for those patients that have a less than 50% reduction in serum M-protein.

Those showing a complete or partial response (reduction of 50% or more) will have their treatment continued and the NHS will pay the cost of that treatment as it being seen as “an effective use of NHS resources” in this circumstance. All claims must be made within 60 days of the identified non response or minor response and on the appropriate VRS form. Reimbursements are in the form of replacement stock, credit note or full cash refund.

Date scheme commenced: 24 October 2007 Contact details of drug company: Janssen-Cilag Ltd 50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG Telephone: +44 (0)1494 567 567 Fax: +44 (0)1494 567 568 Medical Information Direct Line: +44 (0)800 731 8450 Medical Information e-mail: medinfo@janssen-cilag.co.uk Customer Care direct line: +44 (0)800 731 5550

Page 13 of 66 © October 2014. Not to be further copied without permission 1.3 Summary of Scheme If a patient is a non responder (as measure by serum M protein) after 4 cycles of bortezomib the Provider can claim back the full drug cost of the treatment in the form of replacement stock, credit note or full cash refund, which should be credited against the details of the patient for whom the claim has been made.

Page 14 of 66 © October 2014. Not to be further copied without permission Bosutinib (Bosulif® ) for previously treated chronic myeloid leukaemia – TA299 rejected 1.1 Criteria  For treating Philadelphia-chromosome-positive chronic myeloid leukaemia (CML)  Individual funding is required before prescribing, complete an NHS England Individual Funding Panel Request and await response 1.2 Scheme The manufacturer has agreed a patient access scheme with the Department of Health. The size of the discount is commercial in confidence. Contact details of drug company: Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ Telephone: +44 (0)1304 616 161 Fax: +44 (0)1304 656 221 1.3 Summary of Scheme The manufacturer of bosutinib (Pfizer) has agreed a patient access scheme with the Department of Health.

The size of the discount is commercial in confidence.

Page 15 of 66 © October 2014. Not to be further copied without permission Certolizumab pegol (Cimzia® ) for the treatment of rheumatoid arthritis TA186 1.1 Criteria NICE criteria: for the treatment of rheumatoid arthritis (RA)  have already tried methotrexate and another disease-modifying anti- rheumatic drug (DMARD), usually for at least 6 months, and  have severe 'active' rheumatoid arthritis, as assessed by a rheumatologist on two separate occasions  For more extensive information please refer to www.nice.org.uk 1.2 Scheme The scheme is known as the Cimzia® Patient Access Scheme. The manufacturer will not charge the NHS for the first 12 weeks of treatment for all patients who are using certolizumab in accordance with the terms of this programme.

This equates to 10 syringes of certolizumab. All patients who are prescribed certolizumab in line with the licensed indication and who receive homecare or hospital delivery from a provider contracted with the manufacturer (UCCB) to implement the Cimzia® Access Programme will be eligible. Syringes are administered through an agreed homecare company and invoiced free to the purchaser. If certolizumab is not judged effective after the free syringe period the patient can be removed from therapy at this stage with no further cost obligation to the manufacturer.

Date scheme commenced: 24 February 2010 Contact details of drug company: UCB Pharma Limited 208 Bath Road, Slough, Berkshire, SL1 3WE Telephone: +44 (0)1753 534 655 Fax: +44 (0) 1773 810644 Medical Information Direct Line: +44 (0)1753 447 690 Medical Information e-mail: Medicalinformationuk@ucb.com 1.3 Summary of Scheme The manufacturer will not charge the NHS for the first 12 weeks of treatment of certolizumab for all patients eligible for treatment. The drug will be delivered via a homecare company. Free stock should be recorded against the details of the patient receiving the stock.

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Not to be further copied without permission Cetuximab (Erbitux® ) for the first line treatment of metastatic colorectal cancer TA176 1.1 Criteria NICE criteria: Cetuximab given with 5-fluorouracil, folinic acid and oxaliplatin (FOLFOX) is recommended as a possible first treatment for people with metastatic colorectal cancer only when:  surgery to remove the cancer in the colon or rectum has been carried out or is possible  the metastases are only in the liver and cannot be removed surgically before treatment  the person is fit enough to have surgery to remove the cancer in the colon or rectum and to have liver surgery if it becomes possible to remove the metastases after cetuximab treatment  the manufacturer refunds 16% of the amount of cetuximab used on a per patient basis.

 For more extensive information please refer to www.nice.org.uk Cetuximab given with 5-fluorouracil, folinic acid and irinotecan (FOLFIRI) is recommended as a possible first treatment for people with metastatic colorectal cancer only when:  surgery to remove the cancer in the colon or rectum has been carried out or is possible  the metastases are only in the liver and cannot be removed surgically before treatment  the person is fit enough to have surgery to remove the cancer in the colon or rectum and to have liver surgery if it becomes possible to remove the metastases after cetuximab treatment  the person cannot take oxaliplatin because of its side effects or contraindications.

 NB No risk sharing scheme is attached to this regimen  For more extensive information please refer to www.nice.org.uk Treatment with cetuximab should stop after 16 weeks and the person should be assessed to see if they can have surgery to remove the metastases in their liver. People with metastases only in the liver who receive cetuximab should have their treatment managed only by multidisciplinary teams that involve highly specialised liver surgical services. 1.2 Scheme Patients receiving cetuximab in combination with FOLFOX (and in accordance with NICE guidance) are eligible for a rebate.

The Provider must register with the cetuximab rebate scheme and all stock must be supplied though AAH Hospital Service. Each patient must be registered via the Erbitux® patient registration form and posted or faxed to the Oncology Business Unit (OBU).

Page 17 of 66 © October 2014. Not to be further copied without permission The Provider will carry out monthly/quarterly review of usage and make a claim to the manufacturer (within the patient access scheme) for 16% of the vials which have been used during that period. The Erbitux® Pharmacy Claim Form is completed and returned to the OBU via post or fax. Cetuximab will be rebated in the form of free stock at a rate of 16% for all patients in the scheme on a per patient basis, with an option for rebate via credit note or cash. If the 16% rebate equates to a partial vial being claimed, the rebate will be rounded to the nearest vial.

At 16 weeks, treatment with cetuximab should stop and the patient should be assessed for resection of liver metastases.

Date scheme commenced: 26 August 2009 Contact details of drug company: Merck Serono Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK Telephone: +44 (0)208 818 7200 Fax: +44 (0)208 818 7267 Medical Information Direct Line: +44 (0)208 818 7373 Medical Information e-mail: medinfo.uk@merckserono.net Medical Information Fax: +44 (0)208 818 7274 1.3 Summary of Scheme This scheme allows the provider to reclaim 16% of the cost of cetuximab (when used in combination with FOLFOX) per patient, in the form of free stock, credit note or cash, which should be credited against the details of the patient.

Page 18 of 66 © October 2014. Not to be further copied without permission Colistimethate sodium (Colobreathe® ) and tobramycin (TOBI Podhaler® ) dry powders for inhalation for treating pseudomonas lung infection in cystic fibrosis TA276 1.1 Criteria NICE criteria: Tobramycin dry powder for inhalation (DPI) is recommended as an option for treating chronic pulmonary infection caused by Pseudomonas aeruginosa in people with cystic fibrosis only if:  Nebulised tobramycin is considered an appropriate treatment, that is, when colistimethate sodium is contraindicated, is not tolerated or has not produced an adequate clinical response and  The manufacturer provides tobramycin DPI with the discount agreed as part of the patient access scheme to primary, secondary and tertiary care in the NHS Colistimethate sodium DPI is recommended as an option for treating chronic pulmonary infection caused by Pseudomonas aeruginosa in people with cystic fibrosis only if:  They would clinically benefit from continued colistimethate sodium but do not tolerate it in its nebulised form and thus tobramycin therapy would otherwise be considered and  The manufacturer provides colistimethate sodium DPI with the discount agreed as part of the patient access scheme to primary, secondary and tertiary care in the NHS 1.2 Schemes The manufacturer of colistimethate sodium DPI (Forest Laboratories UK) has agreed a patient access scheme which makes colistimethate sodium DPI available with a discount applied to all invoices.

The size of the discount is commercial confidence. Contact details of drug company: Forest Laboratories UK Limited Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL Telephone: +44 (0)1322 421 800 Fax: +44 (0)1322 291 306 http://www.forestlabs.com Medical Information e-mail: medinfo@forest-labs.co.uk

Page 19 of 66 © October 2014. Not to be further copied without permission The manufacturer of tobramycin DPI (Novartis) has agreed a patient access scheme which makes tobramycin DPI available with a discount applied to all invoices. The size of the discount is commercial in confidence. Contact details of drug company: Novartis Pharmaceuticals UK Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR Telephone: +44 (0)1276 692 255 Fax: +44 (0)1276 698 449 Medical Information Direct Line: +44 (0)1276 698 370 Medical Information e-mail: medinfo.uk@novartis.com Customer Care direct line: +44 (0)845 741 9442 1.3 Summary of Schemes The manufacturer of colistimethate sodium DPI (Forest Laboratories UK) has agreed a patient access scheme which makes colistimethate sodium DPI available with a discount applied to all invoices.

The size of the discount is commercial confidence. The manufacturer of tobramycin DPI (Novartis) has agreed a patient access scheme which makes tobramycin DPI available with a discount applied to all invoices. The size of the discount is commercial in confidence.

Page 20 of 66 © October 2014. Not to be further copied without permission Crizotinib (Xalkori® ) for previously treated non-small-cell lung cancer associated with an anaplastic lymphoma kinase fusion gene – TA296 rejected 1.1 Criteria  For adults with previously treated anaplastic-lymphoma-kinase-positive advanced non-small-cell lung cancer  Individual funding is required before prescribing, complete an NHS England Individual Funding Panel Request and await response 1.2 Scheme The manufacturer has agreed a patient access scheme with the Department of Health which involves a confidential discount being applied to the list price of crizotinib.

Contact details of drug company: Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ Telephone: +44 (0)1304 616 161 Fax: +44 (0)1304 656 221 1.3 Summary of Scheme The manufacturer of crizotinib (Pfizer) has agreed a patient access scheme with the Department of Health This involves a discount applied to the list price of crizotinib. The level of the discount is commercial in confidence.

Page 21 of 66 © October 2014. Not to be further copied without permission Degarelix (Firmagon® ) for advanced hormone dependent prostate cancer 1.1 Criteria  Individual funding is required before prescribing, complete an Individual Funding Panel Request and await response  The Peninsula Health Technology Commissioning Group (PHTCG) decision – degarelix will not be routinely commissioned for this indication.

1.2 Scheme The Firmagon® (degarelix) PCO Rebate Scheme is a 5 year long scheme where a 30% rebate is paid to the PCT based on primary care spend. The idea is to remove the financial barrier to degarelix within primary care over the existing treatments. The PCT will sign an agreement with the manufacturer and complete a claim form every 3, 6 or 12 months for a cash refund.

Date scheme commenced: from November 09 (but an agreement must be signed with the manufacturer). Contact details of drug company: 1.3 Summary of Scheme The rebate scheme is a 5 year long 30% rebate paid to the PCT based on primary care spend. Ferring Pharmaceuticals Ltd The Courtyard, Waterside Drive, Langley, Berkshire, SL3 6EZ Telephone: +44 (0)1753 214 800 Fax: +44 (0)1753 214 802 WWW: http://www.ferring.co.uk Medical Information Direct Line: +44 (0)1753 214 845 Medical Information e-mail: medical@ferring.com Medical Information Fax: +44 (0)1753 214 801

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Not to be further copied without permission Denosumab (Xgeva® ) for the prevention of skeletal-related events in adults with bone metastases from solid tumours TA265 1.1 Criteria NICE criteria: Denosumab is recommended as an option for preventing skeletal- related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from breast cancer and from solid tumours other than prostate if:  bisphosphonates would otherwise be prescribed and  the manufacturer provides denosumab with the discount agreed in the patient access scheme It is not recommended:  For preventing skeletal-related events in adults with bone metastases from prostate cancer  For more extensive information please refer to www.nice.org.uk 1.2 Scheme No action required The manufacturer has agreed a Patient Access Scheme with the Department of Health in which a confidential discount on the list price of denosumab is offered.

Contact details of drug company: Amgen Ltd 240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD Telephone: +44 (0)1223 420 305 Fax: +44 (0)1223 426 314 Medical Information Direct Line: +44 (0)1223 436 441 Medical Information e-mail: gbinfoline@amgen.com Medical Information Fax: +44 (0)1223 426 314 Any enquiries from NHS organisations about the patient access scheme can be directed to the manufacturer at: xgeva-nicepas@amgen.com 1.3 Summary of Scheme No action required The manufacturer has agreed a patient access scheme with the Department of Health in which a confidential discount from the list price is applied to original invoices.

Page 23 of 66 © October 2014. Not to be further copied without permission Dimethyl fumarate (Tecfidera® ) for treating relapsing‑remitting multiple sclerosis TA320 1.1 Criteria NICE criteria: Dimethyl fumarate is recommended as an option for treating adults with active relapsing-remitting multiple sclerosis (normally defined as 2 clinically significant relapses in the previous 2 years), only if:  they do not have highly active or rapidly evolving severe relapsing-remitting multiple sclerosis and  the manufacturer provides dimethyl fumarate with the discount agreed in the patient access scheme 1.2 Scheme No action required The manufacturer has agreed a patient access scheme with the Department of Health in which a confidential discount is offered at the point of purchase or invoice.

Contact details of drug company: Biogen Idec Ltd Innovation House, 70 Norden Road, Maidenhead, Berkshire, SL6 4AY Telephone: +44 (0)1628 501 000 Fax: +44 (0)1628 501 010 Medical Information Direct Line: 0800 008 7401 Medical Information e-mail: biogenidec@professionalinformation.co.uk Medical Information Fax: +44(0)1748 828801 1.3 Summary of Scheme No action required The manufacturer of dimethyl fumarate (Biogen Idec) has agreed a patient access scheme with the Department of Health. This is a simple discount scheme, with the discount applied at the point of purchase or invoice. The level of discount is commercial in confidence.

Page 24 of 66 © October 2014. Not to be further copied without permission Eltrombopag (Revolade® ) for treating chronic immune (idiopathic) thrombocytopenic purpura (review of TA205) TA293 1.1 Criteria NICE criteria: Eltrombopag is recommended as an option for treating adults with chronic immune (idiopathic) thrombocytopenic purpura, within its marketing authorisation (that is, in adults who have had a splenectomy and whose condition is refractory to other treatments, or as a second-line treatment in adults who have not had a splenectomy because surgery is contraindicated), only if:  their condition is refractory to standard active treatments and rescue therapies, or  they have severe disease and a high risk of bleeding that needs frequent courses of rescue therapies and  the manufacturer provides eltrombopag with the discount agreed in the patient access scheme For more extensive information please refer to www.nice.org.uk 1.2 Scheme No action required The manufacturer has agreed a Patient Access Scheme with the Department of Health that makes eltrombopag available with a discount, the size of which is commercial in confidence.

Contact details of drug company: GlaxoSmithKline UK Stockley Park West, Uxbridge, Middlesex, UB11 1BT Telephone: +44 (0)800 221 441 Fax: +44 (0)208 990 4328 Medical Information e-mail: customercontactuk@gsk.com 1.3 Summary of Scheme No action required The manufacturer has agreed a patient access scheme with the Department of Health that makes eltrombopag available with a confidential discount.

Page 25 of 66 © October 2014. Not to be further copied without permission Enzalutamide (Xtandi® ) for metastatic hormone‑relapsed prostate cancer previously treated with a docetaxel‑containing regimen TA316 1.1 Criteria NICE criteria: Enzalutamide is recommended within its marketing authorisation as an option for treating metastatic hormone‑relapsed prostate cancer in adults whose disease has progressed during or after docetaxel-containing chemotherapy, only if the manufacturer provides enzalutamide with the discount agreed in the patient access scheme.

1.2 Scheme The manufacturer of enzalutamide has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the listed price, with the discount applied at the point of purchase or invoice. Contact details of drug company: Astellas Pharma Ltd 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, UK Telephone: +44 (0) 203 379 8700 Fax: +44 (0) 203 379 8820 Medical Information Direct Line: 0800 783 5018 Medical Information email: medinfo.gb@astellas.com 1.3 Summary of Scheme No action required The manufacturer (Astellas Pharma) has agreed a patient access scheme with the Department of Health in which a confidential discount is applied at the point of purchase or invoice.

Page 26 of 66 © October 2014. Not to be further copied without permission Erlotinib (Tarceva® ) for the first line treatment of locally advanced or metastatic EGFR-TK mutation positive non-small-cell lung cancer TA258 1.1 Criteria NICE criteria: erlotinib is recommended as an option for the first line treatment of people with locally advanced or metastatic non-small-cell lung cancer if:  they test positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation and  the manufacturer provides erlotinib at the discounted price agreed under the patient access scheme (revised in 2012) This NICE guidance supersedes the Peninsula Health Technology Commissioning Group (PHTCG) decision (Dec 2011).

1.2 Scheme The manufacturer has agreed a patient access scheme (revised in 2012) with the Department of Health in which a confidential discount from the list price is applied to original invoices. Contact details of drug company: Roche Products Limited Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW Telephone: +44 (0)1707 366 000 Fax: +44 (0)1707 338 297 www: http://www.rocheuk.com Medical Information Direct Line: +44 (0)800 328 1629 Medical Information e-mail: medinfo.uk@roche.com Customer Care direct line: +44 (0)800 731 5711 Medical Information Fax: +44 (0)1707 384555 1.3 Summary of Scheme No action required The manufacturer has agreed a patient access scheme (revised in 2012) with the Department of Health in which a confidential discount from the list price is applied to original invoices.

Page 27 of 66 © October 2014. Not to be further copied without permission Everolimus (Afinitor® ) in combination with exemestane for treating advanced HER2-negative hormone-receptor-positive breast cancer after endocrine therapy– TA295 rejected 1.1 Criteria  For treating postmenopausal women with advanced human epidermal growth factor receptor 2 (HER2) negative hormone-receptor-positive breast cancer that has recurred or progressed following treatment with a non-steroidal aromatase inhibitor  Individual funding is required before prescribing, complete a NHS England Individual Funding Panel Request and await response 1.2 Scheme The manufacturer of everolimus has agreed a patient access scheme with the Department of Health, in which the first month of treatment with everolimus is free.

Contact details of drug company: Novartis Pharmaceuticals UK Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR Telephone: +44 (0)1276 692 255 Fax: +44 (0)1276 698 449 Medical Information Direct Line: +44 (0)1276 698 370 Medical Information e-mail: medinfo.uk@novartis.com Customer Care direct line: +44 (0)845 741 9442 1.3 Summary of Scheme The manufacturer of everolimus (Novartis) has agreed a patient access scheme with the Department of Health, in which the first month of treatment with everolimus is free (including the option to offer the 5 mg tablet pack if there is a need to reduce the dose).

Page 28 of 66 © October 2014. Not to be further copied without permission Fingolimod (Gilenya® ) for highly active relapsing-remitting multiple sclerosis TA254 1.1 Criteria NICE criteria: fingolimod is recommended as an option for the treatment of highly active relapsing-remitting multiple sclerosis in adults, only if:  they have an unchanged or increased relapse rate or ongoing severe relapses compared with the previous year despite treatment with beta interferon, and  the manufacturer provides fingolimod with the discount agreed as part of the patient access scheme 1.2 Scheme The manufacturer has agreed a patient access scheme with the Department of Health in which a simple confidential discount is applied to the list price of fingolimod.

Contact details of drug company: Novartis Pharmaceuticals UK Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR Telephone: +44 (0)1276 692 255 Fax: +44 (0)1276 698 449 Medical Information Direct Line: +44 (0)1276 698 370 Medical Information e-mail: medinfo.uk@novartis.com Customer Care direct line: +44 (0)845 741 9442 Medical Information Fax: +44 (0)1707 384555 1.3 Summary of Scheme No action required The manufacturer will make fingolimod available with a discount applied to the list price. This size of the discount is commercial in confidence.

Page 29 of 66 © October 2014. Not to be further copied without permission Fluocinolone acetonide intravitreal implant (Iluvien® ) for treating chronic diabetic macular oedema after an inadequate response to prior therapy (rapid review of TA271) TA301 1.1 Criteria NICE criteria: Fluocinolone acetonide intravitreal implant is recommended as an option for treating chronic diabetic macular oedema that is insufficiently responsive to available therapies only if:  the implant is to be used in an eye with an intraocular (pseudophakic) lens and  the manufacturer provides fluocinolone acetonide intravitreal implant with the discount agreed in the patient access scheme revised.

1.2 Scheme The manufacturer has agreed a patient access scheme with the Department of Health which makes fluocinolone acetonide intravitreal implant available with a discount. The level of discount is commercial in confidence. Contact details of drug company: Alimera Sciences Limited Centaur House, Ancells Business Park, Fleet, Hampshire, GU15 2UL Telephone: +44 (0)1252 761 409 WWW: http://www.alimerasciences.com Medical Information Direct Line: 0800 019 1253 Medical Information e-mail: medicalinformation@alimerasciences.com Customer Care direct line: 0800 148 8274 1.3 Summary of Scheme The manufacturer (Alimera Sciences) has agreed a patient access scheme which makes fluocinolone acetonide intravitreal implant available with a discount.

The size of the discount is commercial in confidence.

Page 30 of 66 © October 2014. Not to be further copied without permission Gefitinib (Iressa® ) for first line treatment of locally advanced or metastatic non small cell lung cancer (NSCLC) TA192 1.1 Criteria NICE criteria: Gefitinib is recommended as an option for the first line treatment of people with locally advanced or metastatic non small cell lung cancer if:  They test positive for epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation  The manufacturer provides gefitinib at the fixed price agreed under the patient access scheme  For more extensive information please refer to www.nice.org.uk 1.2 Scheme Gefitinib will be available for a national single fixed payment of £12 200 per patient that covers the duration of the patient’s treatment, regardless of how long that may be.

This will be called the AstraZeneca Single Payment Access Scheme (SPAS). The manufacturer will not invoice the NHS until the third monthly pack of gefitinib is supplied. This means that patients who need less than 3 months of treatment will not incur a charge.

AstraZeneca is working with the NHS to ensure EGFR testing is available and the manufacturer will continue to pay for testing until the end of October 2010: http://www.nelm.nhs.uk/en/NeLM-Area/News/2009---September/16/Astra-Zeneca- offers-NHS-access-to-EGFR-mutation-testing-in-lung-cancer/). The patient is registered via the website, and medication is ordered as and when the patient requires it. A set fee of £12 200 per patient is invoiced to the Provider when the third monthly pack of gefitinib is supplied. Stock is sent to the pharmacy department with a patient identification number on the order.

The pharmacy department is charged one penny and then reimbursed by AstraZeneca, this is to simplify the booking in process. The patient can have the medication delivered in the community if the consultant believes the patient is stable and this would then avoid a tariff charge for an outpatient visit. The ‘once off payment’ invoice can be sent to the Commissioner directly or the Provider can pass it on.

A patient should stop treatment on progression of their disease, based on clinical judgment by radiological, CT and then RECIST criteria, although there is no set definition in the SPAS documentation. If the patient is intolerant of the treatment, therapy may be interrupted to manage the adverse effects or stopped. Date scheme commenced: 14 September 2009 (Single Payment Access Scheme).

Page 31 of 66 © October 2014. Not to be further copied without permission Contact details of drug company: AstraZeneca UK Limited Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU Telephone: +44 (0)1582 836 000 Fax: +44 (0)1582 838 000 Medical Information Direct Line: +44 (0)1582 836 836 Medical Information e-mail: medical.informationuk@astrazeneca.com Customer Care direct line: +44 (0)1582 837 837 Medical Information Fax: +44 (0)1582 838 003 1.3 Summary of Scheme Gefitinib will be purchased as a single payment (£12 200) via the AstraZeneca Single Payment Access Scheme (SPAS), regardless of duration of treatment.

The manufacturer will not invoice the NHS until the third monthly pack of gefitinib is supplied. This means that patients who need less than 3 months of treatment will not incur a charge.

Page 32 of 66 © October 2014. Not to be further copied without permission Golimumab (Simponi® ) for the treatment of psoriatic arthritis TA220 1.1 Criteria NICE criteria: for the treatment of active and progressive psoriatic arthritis in adults:  if used as described for other tumour necrosis factor (TNF) inhibitor treatments in NICE technology appraisal 199 and  the manufacturer provides the 100mg dose of golimumab at the same cost as the 50mg dose 1.2 Scheme A patient access scheme has been agreed whereby Schering-Plough will supply the 100mg dose of golimumab to the NHS at the same cost as the 50mg dose.

Contact details of drug company: Schering-Plough Ltd (Merck Sharp & Dohme Limited), Hertford Road, Hoddesdon, Herts, EN11 9BU, UK Telephone: +44 (0)1992 467272 Medical Information e-mail: medicalinformationuk@merck.com Medical Information Fax: +44 (0)1992 479 292 1.3 Summary of Scheme No action required The manufacturer will supply the 100mg dose of golimumab to the NHS at the same cost as the 50mg dose.

Page 33 of 66 © October 2014. Not to be further copied without permission Golimumab (Simponi® ) for the treatment of rheumatoid arthritis (after the failure of previous anti-rheumatic drugs) TA225 1.1 Criteria NICE criteria: in combination with methotrexate for the treatment of rheumatoid arthritis in adults whose rheumatoid arthritis has responded inadequately to conventional disease-modifying anti-rheumatic drugs (DMARDs) only, including methotrexate, if:  it is used as described for other tumour necrosis factor (TNF) inhibitor treatments in NICE technology appraisal 130, and  the manufacturer provides the 100mg dose of golimumab at the same cost as the 50mg dose 1.2 Scheme A patient access scheme has been agreed whereby Schering-Plough will supply the 100mg dose of golimumab to the NHS at the same cost as the 50mg dose.

Contact details of drug company: Schering-Plough Ltd (Merck Sharp & Dohme Limited), Hertford Road, Hoddesdon, Herts, EN11 9BU, UK Telephone: +44 (0)1992 467272 Medical Information e-mail: medicalinformationuk@merck.com Medical Information Fax: +44 (0)1992 479 292 1.3 Summary of Scheme No action required The manufacturer will supply the 100mg dose of golimumab to the NHS at the same cost as the 50mg dose.

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