2 The technology

2.1 Bendamustine (Levact, Napp Pharmaceuticals) is an alkylating anti-tumour agent. It has a UK marketing authorisation for the 'first-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate'.

2.2 The most common adverse reactions with bendamustine hydrochloride are haematological adverse reactions (leukopenia, thrombocytopenia), dermatological toxicities (allergic reactions), constitutional symptoms (fever) and gastrointestinal symptoms (nausea, vomiting). For full details of side effects and contraindications, see the summary of product characteristics.

2.3 Bendamustine is administered by intravenous infusion, over
30–60 minutes on days 1 and 2, every 4 weeks. Dose depends on body surface area (100 mg/m²). Bendamustine is available as 25-mg vials in packs of 5 and 20 for £347.26 and £1379.04 respectively, and 100-mg vials in packs of 5 for £1379.04 (excluding VAT; 'Monthly index of medical specialities' [MIMS], November 2010). The mean cost of bendamustine per person taken from the manufacturer's submission is £4741.54, assuming a body surface area of 1.72 m2 and an average treatment course of 4.9 cycles (including product wastage). Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)