Following a full submission, the SMC has accepted epoetin alfa (Binocrit®) for use within NHS Scotland for the treatment of symptomatic anaemia associated with chronic renal failure in adult and paediatric patients.

Binocrit® can additionally be used to increase the yield of autologous blood from patients in a predonation programme; however 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 (haemoglobin 10 to 13g/dL [6.2 to 8.1 mmol/L], no iron deficiency), 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).

Binocrit® is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference product (epoetin alfa (Eprex®)). Binocrit® is only licensed for administration by the intravenous route in the indications under review.