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SMC ISSUES ADVICE ON NEW DRUGS

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

• Vildagliptin (Galvus) for the treatment of type 2 diabetes mellitus (restricted)

Further Details:

VILDAGLIPTIN (GALVUS)

• Vildagliptin (Galvus) is accepted for restricted use for the treatment of type 2 diabetes mellitus as dual oral therapy in combination with metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin.
• It is restricted to use in patients only when the addition of sulphonylureas is not appropriate, and represents an alternative to other agents such as thiazolidinediones. Efficacy is similar to thiazolidinedione drugs added at this stage in therapy. It appears to have minimal effect on body weight.
• Vildagliptin is also licensed for use in combination with sulphonylureas or thiazolidinedione drugs for the treatment of type 2 diabetes. The manufacturer’s submission related only to the use of vildagliptin in combination with metformin. SMC cannot recommend the use of vildagliptin in combination with these agents.
• The manufacturer estimated that the gross drug budget cost of vildagliptin, used as dual oral therapy in combination with metformin, would be £110k (2659 patients) in year one rising to £432k in year five (31482 patients). Some savings may be made due to the displacement of other drugs.

Notes for editors – Glossary:

1. Type 2 diabetes mellitus - Most people who have diabetes have type 2 diabetes. People with type 2 diabetes produce insulin, but either do not make enough insulin or their bodies do not use the insulin they make.

2. Sulphonylureas – A class of drugs used as therapy for diabetes mellitus that acts by increasing insulin release from the beta cells in the pancreas.

3. Thiazolidinedione – A class of drugs used as therapy for diabetes mellitus. Commonly referred to as glitazones.

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 or Colin McAllister on 07813 095930