597 10 epoetin alfa (Binocrit)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:
- epoetin alfa (Binocrit) for treatment of symptomatic anaemia associated with chronic renal failure
Further Details:
EPOETIN ALFA (BINOCRIT)
- epoetin alfa (Binocrit) is accepted for use within NHS Scotland for treatment of symptomatic anaemia associated with chronic renal failure in adult and paediatric patients:
- treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;
- treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. - Binocrit can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia, if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more for males).
- Epoetin alfa (Binocrit) is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference product (epoetin alfa (Eprex)).
- Unlike some other erythropoiesis stimulating agents, Binocrit is only licensed for administration by the intravenous route in the indications under review.
- The manufacturer estimated Binocrit would be associated with savings of £10k in year 1 rising to £33k in year 5 within the CRF and autologous predonation indications. It was estimated that 94 CRF patients would be treated with Binocrit in year 1 based on a market share of 4%, rising to 328 patients in year 5 based on a market share of 14%.
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.