epoetin alfa (Binocrit)

Following a full submission

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 hromboembolic 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).

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 British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name.