2 The technology
2.1 Rituximab (MabThera, Roche) is a chimeric monoclonal antibody that binds selectively to the CD20 antigen expressed on the surface of mature B lymphocytes and tumour cells that express CD20. Rituximab is licensed for the first-line treatment of people with chronic lymphocytic leukaemia in combination with chemotherapy. Rituximab is administered intravenously, once every 4 weeks for a total of six cycles; a complete course of treatment with rituximab lasts 24 weeks. Dosing is calculated according to body surface area, with an initial dose of 375 mg/m² followed by 500 mg/m² for all subsequent doses. Six cycles of rituximab equate to a total dose of 2875 mg/m². The summary of product characteristics states that rituximab should be administered under the close supervision of an experienced physician, and in an environment where full resuscitation facilities are immediately available.
2.2 The most frequently observed adverse events in people receiving rituximab are infusion-related reactions, including cytokine release syndrome. The majority of these reactions occur during the first infusion. Serious but rare adverse events associated with rituximab include neutropenia and leucopenia (including febrile neutropenia), infections (predominantly bacterial and viral) and cardiovascular events (hypotension, hypertension, arrhythmias and angina). Very rare serious adverse events include hepatitis B reactivation and progressive multifocal leucoencephalopathy. For full details of side effects and contraindications, see the summary of product characteristics.
2.3 Rituximab is available in 100 mg (10 ml) and 500 mg (50 ml) vials. The cost of a 100 mg vial is £174.63, and of a 500 mg vial is £873.15 (excluding VAT; 'British national formulary' [BNF] edition 57). For a person with a body surface area of 1.93 m², the cost of rituximab for the first dose is £1397 and for subsequent doses £1746 including wastage of excess rituximab. The total cost of rituximab is £10,128 per course. Costs may vary in different settings because of negotiated procurement discounts.