Epoetin delta (Dynepo) 41807

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

• Epoetin delta (Dynepo) for the treatment of anaemia in patients with chronic renal failure.

Further Details:

EPOETIN DELTA (DYNEPO)

• Epoetin delta (Dynepo) is accepted for use for the treatment of anaemia in patients with chronic renal failure. It may be used in patients on dialysis and in patients not on dialysis.
• Clinical studies have demonstrated epoetin delta’s efficacy and safety profile in correcting and maintaining haemoglobin levels for up to a year in predialysis, haemodialysis and peritoneal dialysis patients, when administered via both the subcutaneous and intravenous routes.
• The manufacturer suggested that use of epoetin delta would be cost saving, with predicted savings of £52k in year one rising to £543k in year five. These figures were based on 2,816 patients treated in year one and 3,426 in year five and a predicted 100% market share each year for epoetin delta. The manufacturer’s predictions may overestimate the potential cost savings.

Notes for editors – Glossary:

• Haemodialysis – This is a form of renal dialysis i.e. a method for removing waste products such as potassium and urea, as well as free water from the blood when the kidneys are incapable of it due to renal failure. It is typically carried out in a dedicated facility in a hospital or a clinic.
• Peritoneal dialysis – This is a form of renal dialysis where dialysis fluid is instilled via a peritoneal dialysis catheter.

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