408/07 SMC issue advice on new drug Sitagliptin (Januvia)
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:
Sitagliptin (Januvia) for treatment of patients with type 2 diabetes mellitus (restricted)
Further Details:
SITAGLIPTIN (JANUVIA)
- Sitagliptin (Januvia) is accepted for restricted use for treatment of patients with type 2 diabetes mellitus, to improve glycaemic control in combination with metformin when diet and exercise, plus metformin, do not provide adequate glycaemic control.
- It should be 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 sulphonylurea and thiazolidinedione drugs added at this stage in therapy. It appears to have minimal effects on body weight.
- The manufacturer estimated the net budget impact at £150k in year one based on approximately 600 patients treated and £533k in year five based on approximately 1800 patients treated. These figures may be an underestimate.
Notes for editors – Glossary:
- Diabetes mellitus – This condition occurs when the level of glucose (sugar) in the blood becomes higher than normal. In type 2 diabetes, the illness and symptoms tend to develop gradually (over weeks or months), because the body still makes insulin
- Metformin – An anti-diabetic drug commonly used in type 2 diabetes that allows the body to make better use of insulin
- Sulphonylureas - A class of anti-diabetic drug commonly used used in type 2 diabetes. These drugs act by increasing insulin release from the pancreas.
- Thiazolidinediones – A class of anti-diabetic drug that acts by making the body more sensitive to insulin
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