466 08 dabigatran etexilate (Pradaxa)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drugs for use within NHSScotland:
- dabigatran etexilate (Pradaxa) for the primary prevention of venous thromboembolic events (VTE)
DABIGATRAN ETEXILATE (PRADAXA)
- dabigatran etexilate (Pradaxa) is accepted for the primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
- In two large studies in patients undergoing either total knee or total hip replacement surgery, dabigatran was non-inferior to low molecular weight heparin in the incidence of VTE and all cause mortality with patients having a similar incidence of major bleeding events. The two drugs have similar costs per dose but dabigatran has lower administration costs and is an oral therapy. This may facilitate longer duration of thromboprophylaxis, however the risks and benefits of this longer treatment duration need to be considered on a case-by-case basis.
- The manufacturer estimates that the expenditure on drug therapies to trea this indication will be increase by £14,000 in year 1 and 190,000 in year 5 with the addition of dabigatran. However, resource savings from avoiding the administration costs of LMWH reduce the cost increase to about £8,000 in year 1, and £100,000 in year 5.
Notes for editors – Glossary:
1. Venous thromboembolic events (VTE) - blood clots in the veins or lungs.
2. Low molecular weight heparin – A blood-thinning drug.
3. Thromboprophylaxis – Treatment whereby small doses of a blood-thinning drug are given to those with a risk of blood clots.
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