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Attn: Newsdesks
 Health Correspondents

SMC ISSUES ADVICE ON NEW DRUGS

The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:

• sunitinib (Sutent) for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST)

Further Details:

SUNITINIB (SUTENT)

• Sunitinib (Sutent) is accepted for use within NHSScotland for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance.
• Sunitinib compared with placebo delayed tumour progression by approximately five months.
• Treatment with sunitinib should not be continued if there is evidence of unacceptable toxicity or progression of disease.
• This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of sunitinib. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.
• The manufacturer provided budget impact estimates that included the PAS. Under the scheme, 4 new patients were assumed to be treated with sunitinib in year one, and then 14 patients in each year thereafter, representing 24% and 80% of eligible patients respectively. The manufacturer estimated the gross budget impact at £55k in year one and £239k in year five.

Notes for editors – Glossary:

• Patient Access Scheme – In March 2009, it was announced that an agreed national framework would be introduced to allow the operation of PAS in NHSScotland. A patient access scheme assessment group (PASAG) will be established to review and advise NHSScotland on the feasibility of proposed schemes for implementation. PASAG will operate separately from SMC in order to maintain the integrity and independence of the assessment process of SMC. At present, a transitional PASAG has been established.
• Gastrointestinal stromal tumour (GIST) – A GIST is a rare type of sarcoma found in the digestive system. Sarcomas are cancers that develop in connective tissues (such as muscle, fat, nerves, blood vessels and bone). Many GISTs occur in the stomach, but they can develop anywhere along the length of the digestive system.

Notes for editors – About SMC:

1. The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) in Scotland about the use of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. It does this after new medicines have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) / European Medicines Evaluation Agency (EMEA).

2. The SMC process encourages pharmaceutical manufacturers to make a submission before a product is launched. The aim is to issue advice as soon as possible after the launch of a product.

3. Membership of the SMC has been derived from NHS Boards across Scotland. Membership is wide ranging across multi-disciplines of NHS Scotland and also includes members of the Association of British Pharmaceutical Industry (ABPI), and patient and voluntary group representatives.

4. This advice represents the views of the Scottish Medicines Consortium and was arrived at after careful consideration of the available evidence. Health professionals are expected to take due account of this recommendation when exercising their clinical judgement. This recommendation does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

For further information, contact Stephen Ferguson on 07779 329 689.