603 10 saxagliptin (Onglyza)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:
- saxagliptin (Onglyza) for use within NHSScotland in adult patients with type 2 diabetes mellitus as add-on combination therapy with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control (restricted).
Further Details:
- Saxagliptin (Onglyza) is accepted for restricted use within NHSScotland in adult patients with type 2 diabetes mellitus as add-on combination therapy with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control.
- 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, as assessed by measurement of HbA1c, is comparable to another dipeptidyl peptidase-4 inhibitor. It appears to have minimal effect on body weight.
- Saxagliptin 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 saxagliptin in combination with metformin.
- SMC cannot recommend the use of saxagliptin in combination with sulphonylureas or thiazolidinediones.
- The manufacturer estimated that 4,576 patients would be eligible for add-on treatment with a thiazolidinedione or DPP-IV inhibitor. The share of the market for saxagliptin as add-on therapy was estimated at 5% (229 patients) in year 1, rising to 25% (1,277 patients) by year 5. On this basis the gross drug cost was estimated at £99k in year 1, rising to £554k by year 5. Given cost offsets the net drug budget impact of saxagliptin was estimated at £11k in year 1, rising to £63k by year 5.
Notes for editors – Glossary:
Type 2 diabetes mellitus – Diabetes mellitus is a condition in which there is too much sugar present in the blood. Type 2 diabetes develops when the body does not make enough insulin (a hormone which helps sugar to be used by the body) or the insulin that is produced does not work properly. Keeping blood sugar levels as near to normal as possible reduces the risk of long-term diabetes complications such as heart disease, blindness, stroke and kidney failure.
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.