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

   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
                                   rheumatoid arthritis after the failure of conventional disease-
Abatacept (Orencia®)                                                                                 TA280
                                   modifying anti-rheumatic drugs
                                   castration-resistant metastatic prostate cancer previously
Abiraterone (Zytiga®)                                                                                TA259
                                   treated with a docetaxel-containing regimen
                                   Epidermal growth factor receptor mutation-positive locally
Afatinib (Giotrif®)                                                                                  TA310
                                   advanced or metastatic non-small-cell lung cancer
Aflibercept (Eylea®)               wet age-related macular degeneration                              TA294
                                   visual impairment caused by macular oedema secondary to
Aflibercept (Eylea®)                                                                                 TA305
                                   retinal vein occlusion
                                   Metastatic colorectal cancer that has progressed following        TA307
Aflibercept (Zaltrap®)
                                   prior oxaliplatin-based chemotherapy                              rejected
                                   symptomatic treatment of Lambert Eaton Myasthenic                 not NICE
Amifampridine (Firdapse®)
                                   Syndrome                                                          reviewed
                                   myelodysplastic syndrome, chronic myelomonocytic
Azacitidine (Vidaza®)                                                                                TA218
                                   leukaemia and acute myeloid leukaemia
Bortezomib (Velcade®)              relapsed multiple myeloma                                         TA129



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Drug                               Indication                                                   NICE
                                                                                                TA299
Bosutinib (Bosulif®)               previously treated chronic myeloid leukaemia
                                                                                                rejected
Certolizumab pegol
                                   rheumatoid arthritis                                         TA186
(Cimzia®)
Cetuximab (Erbitux®)               1st line treatment of metastatic colorectal cancer           TA176
Colistimethate sodium DPI
                                   Pseudomonas lung infection in cystic fibrosis                TA276
(Colobreathe®)
                                   previously treated non-small-cell lung cancer associated     TA296
Crizotinib (Xalkori®)
                                   with an anaplastic lymphoma kinase fusion gene               rejected
                                                                                                not NICE
Degarelix (Firmagon®)              advanced hormone dependent prostate cancer
                                                                                                reviewed
                                   prevention of skeletal-related events in adults with bone
Denosumab (Xgeva®)                                                                              TA265
                                   metastases from solid tumours
Dimethyl fumarate
                                   relapsing-remitting multiple sclerosis                       TA320
(Tecfidera®)
Eltrombopag (Revolade®)            chronic immune (idiopathic) thrombocytopenic purpura         TA293
                                   metastatic hormone relapsed prostate cancer previously
Enzalutamide (Xtandi®)                                                                          TA316
                                   treated with a docetaxel containing regimen
                                   1st line treatment of locally advanced or metastatic EGFR-
Erlotinib (Tarceva®)                                                                            TA258
                                   TK mutation-positive non-small-cell lung cancer
                                   advanced HER2-negative hormone-receptor-positive breast      TA295
Everolimus (Afinitor®)
                                   cancer after endocrine therapy                               rejected
Fingolimod (Gilenya®)              highly active relapsing-remitting multiple sclerosis         TA254
Fluocinolone acetonide
                                   chronic diabetic macular oedema after an inadequate
intravitreal implant                                                                            TA301
                                   response to prior therapy
(Iluvien®)
                                   1st line treatment of locally advanced or metastatic non
Gefitinib (Iressa®)                                                                             TA192
                                   small cell lung cancer
Golimumab (Simponi®)               psoriatic arthritis                                          TA220
                         ®
Golimumab (Simponi )               rheumatoid arthritis                                         TA225
                         ®
Golimumab (Simponi )               ankylosing spondylitis                                       TA233
Interferon beta 1a/
interferon beta 1b and             multiple sclerosis                                           TA32
Glatiramer Acetate
                                   previously treated advanced (unresectable or metastatic)
Ipilimumab (Yervoy®)                                                                            TA268
                                   melanoma
                                   previously untreated advanced (unresectable or metastatic)
Ipilimumab (Yervoy®)                                                                            TA319
                                   melanoma
                                                                                                FAD
Lapatinib (Tyverb®)                advanced or metastatic breast cancer
                                                                                                rejected
                                                                                                not NICE
Lapatinib (Tyverb®)                advanced or metastatic breast cancer
                                                                                                reviewed
Lenalidomide (Revlimid®)           relapsed multiple myeloma                                    TA171

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Drug                                 Indication                                                     NICE
                                     myelodysplastic syndromes associated with an isolated
Lenalidomide (Revlimid®)                                                                            TA322
                                     deletion 5q cytogenetic abnormality
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
                         ®            st
Pazopanib (Votrient )                1 line treatment of advanced renal cell carcinoma              TA215
Pirfenidone (Esbriet®)               idiopathic pulmonary fibrosis                                  TA282
                                     multiply relapsed or refractory aggressive non-Hodgkin’s B-
Pixantrone (Pixuvri®)                                                                               TA306
                                     cell lymphoma
Ranibizumab (Lucentis®)              wet age related macular degeneration                           TA155
Ranibizumab (Lucentis®)              diabetic macular oedema                                        TA274
                                     visual impairment caused by macular oedema secondary to
Ranibizumab (Lucentis®)                                                                             TA283
                                     retinal vein occlusion
                                     choroidal neovascularisation associated with pathological
Ranibizumab (Lucentis®)                                                                             TA298
                                     myopia
Romiplostim (Nplate®)                chronic immune or idiopathic thrombocytopenic purpura          TA221
                                                                                                    not NICE
Sodium Oxybate (Xyrem®)              narcolepsy with cataplexy in adult patients
                                                                                                    reviewed
                                     1st line treatment of advanced and/or metastatic renal cell
Sunitinib (Sutent®)                                                                                 TA169
                                     carcinoma
                                     2nd line treatment of advanced and/or metastatic renal cell    TA178
Sunitinib (Sutent®)
                                     carcinoma                                                      rejected
Sunitinib (Sutent®)                  gastrointestinal stromal tumours                               TA179
                                 ®
Teriflunomide (Aubagio )             relapsing-remitting multiple sclerosis                         TA303
Tobramycin DPI
                                     pseudomonas lung infection in cystic fibrosis                  TA276
(TOBI Podhaler®)
                                     systemic juvenile idiopathic arthritis in children and young
Tocilizumab (RoActemra®)                                                                            TA238
                                     people aged 2 years and older
Tocilizumab (RoActemra®)             rheumatoid arthritis in adults                                 TA247
Trabectedin (Yondelis®)              advanced soft tissue sarcoma                                   TA185
                             ®
Ustekinumab (Stelara )               moderate to severe psoriasis                                   TA180
                                     locally advanced or metastatic BRAF V600 mutation-
Vemurafenib (Zelboraf®)                                                                             TA269
                                     positive malignant melanoma




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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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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:

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

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.




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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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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.




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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.




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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.




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

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).




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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:

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

1.3 Summary of Scheme

No action required




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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




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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.




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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.




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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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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).



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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.




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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 18 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 19 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 20 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:
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

1.3 Summary of Scheme

The rebate scheme is a 5 year long 30% rebate paid to the PCT based on primary
care spend.




                                                Page 21 of 66
© October 2014. 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 22 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 23 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 24 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 25 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 26 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 27 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 28 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 29 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 30 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 31 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 32 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.




                                                Page 33 of 66
© October 2014. Not to be further copied without permission
Golimumab (Simponi®) for the treatment of ankylosing spondylitis
TA233


1.1 Criteria

NICE criteria: for the treatment of severe, active ankylosing spondylitis in adults only
if:

             it is used as described for adalimumab and etanercept in NICE technology
              appraisal 143, and
             the manufacturer provides the 100mg dose of golimumab at the same
              cost as the 50mg dose in accordance with the patient access scheme

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 34 of 66
© October 2014. Not to be further copied without permission
Interferon beta 1a/interferon beta 1b and Glatiramer Acetate for
Multiple Sclerosis TA32



1.1 Criteria

The eligibility criteria for the scheme is stated below:
The ABN (Association of British Neurologists) recommends beta interferons or
glatiramer acetate for all patients with relapsing remitting MS who:
         1. Can walk independently (beta interferons) or at least 100 metres without
            assistance (glatiramer acetate)
         2. Have had at least two clinically significant relapses in the last two years.
         3. Are over 18 years old

The ABN recommends beta interferons (not glatiramer acetate) for patients with
secondary progressive MS who:
         1. Can walk at least ten metres with or without stairs
         2. Have had two or more disabling relapses in the past two years
         3. Have had a minimal increase in disability due to gradual progression in
            the last two years
         4. Are over 18 years old

1.2 Scheme

A price per patient per year has been agreed between drug companies and the
Department of Health. The discounted price is received directly by the Provider and
the Commissioner will fund accordingly. Patients are monitored using Expanded
Disability Status Score (EDSS), a method of quantifying disability in MS. This is
assessed at their initiation into the scheme and re-evaluated and recorded annually.
The price the NHS pays for each drug may be adjusted at the two-yearly analysis
points to ensure it is kept at an agreed threshold, thus guaranteeing the NHS
continues to acquire the drugs cost-effectively.
Interferon beta brands: Rebif® (beta 1a), Betaferon® (beta 1b), Avonex® (beta 1a)
and other drug included in this list: glatiramer (Copaxone®)
The expected drug costs per patient per year being supplied to the NHS for the
purposes of the scheme are:
- Rebif (£7,513 lower dose & £8,942 higher dose)
- Betaferon (£7,259)
- Avonex (£8,502)
- Copaxone (£5,823)

Date Scheme Commenced: February 2002

1.3 Summary of Scheme

A price per patient per year has been agreed between manufacturers and
Department of Health. The discounted price is received directly by the Provider.
There is no reimbursement to claim.


                                                Page 35 of 66
© October 2014. Not to be further copied without permission
Ipilimumab (Yervoy®) for previously treated advanced (unresectable
or metastatic) melanoma TA268


1.1 Criteria

NICE criteria: for the treatment of advanced (unresectable or metastatic melanoma in
people, only if:

             they have received prior therapy, and
             the manufacturer provides ipilimumab with the discount agreed in the
              patient access scheme

1.2 Scheme

The manufacturer of ipilimumab has agreed a patient access scheme with the
Department of Health, in which a discount on the list price of ipilimumab is offered.
The size of the discount is commercial in confidence.

Contact details of drug company:

Bristol-Myers Squibb Pharmaceutical Limited
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge,
Middlesex, UB8 1DH
Telephone: +44(0)1895 523 000
Fax: +44(0)1895 523 010
Medical Information Direct Line: +44(0)1895 523 740
Medical Information e-mail: medical.information@bms.com
Medical Information Fax: +44(0)1895 523 677

1.3 Summary of Scheme

No action required

The manufacturer will offer a discount on the list price of ipilimumab.




                                                Page 36 of 66
© October 2014. Not to be further copied without permission
Ipilimumab    (Yervoy®)   for   previously untreated                      advanced
(unresectable or metastatic) melanoma TA319


1.1 Criteria

NICE criteria: Ipilimumab is recommended, within its marketing authorisation, as an
option for treating adults with previously untreated advanced (unresectable or
metastatic) melanoma, only if the manufacturer provides ipilimumab with the discount
agreed in the patient access scheme.

1.2 Scheme

The manufacturer provided the same patient access scheme as agreed with the
Department of Health for TA268 (above). This offers a discount on the list price of
ipilimumab, the size of which is commercial in confidence.

Contact details of drug company:

Bristol-Myers Squibb Pharmaceutical Limited
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge,
Middlesex, UB8 1DH
Telephone: +44(0)1895 523 000
Fax: +44(0)1895 523 010
Medical Information Direct Line: +44(0)1895 523 740
Medical Information e-mail: medical.information@bms.com
Medical Information Fax: +44(0)1895 523 677

1.3 Summary of Scheme

No action required

The manufacturer will offer a discount on the list price of ipilimumab.




                                                Page 37 of 66
© October 2014. Not to be further copied without permission
Lapatinib (Tyverb®) for advanced or metastatic breast cancer – FAD
rejected


1.1 Criteria

                  For tumours which overexpress ErbB2 (HER2)
                  Used in combination with capecitabine
                  Progressive disease following prior therapy, which must include
                   anthracyclines and taxanes and therapy with trastuzumab in the
                   metastatic setting
                  Individual funding is required before prescribing, complete an
                   Individual Funding Panel Request and await response

1.2 Scheme

There are two alternative patient access schemes for lapatinib. The first is lapatinib
for advanced or metastatic breast cancer used in combination with capecitabine
(NICE rejected) - the 12 Week Scheme and the second is lapatinib for advanced or
metastatic breast cancer used in combination with capecitabine or with an aromatase
inhibitor (currently not reviewed by NICE) - the Discount Scheme.

Scheme 1: The 12 Week Scheme. The manufacturer will reimburse the cost of up to
a maximum of the first 12 weeks of treatment regardless of the patient being a
responder/non responder. Initial supplies will be made through GSK normal
distribution channels to the Provider treating each patient. Providers will then apply
for a retrospective rebate, in the form of a cash reimbursement at one of the following
points:
    1. At point of discontinuation, for patients stopping treatment before 12 weeks.
    2. Following clinical review at week 12, for patients continuing to receive
        treatment at this point.
The maximum rebate that GSK will provide per patient is equivalent to 12 weeks
treatment with lapatinib. Providers must complete a standard agreement outlining
the terms and conditions of supply. A Rebate Application Form for the Tyverb®
Patient Access Programme (TPAP) must be completed per patient.

Date scheme commenced: 2 February 2009.

This scheme was included in the submission to NICE, which received a negative
FAD (final appraisal decision). Lapatinib is not recommended by NICE for women
with previously treated metastatic or advanced breast cancer whose tumours
overexpress HER2. Although this received a negative FAD in October 2010, NICE
have stated that they are not issuing guidance at this stage as they believe that a
better way of assessing the value of lapatinib is to consider it alongside the use of
trastuzumab beyond progression. Applications for individual patient funding would be
required until a positive NICE guidance.




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