3 The technology
3.1 Rituximab (MabThera, Roche Products) is a genetically engineered chimeric (mouse/human) monoclonal antibody that depletes B cells by targeting cells bearing the CD20 surface marker. Rituximab as a first-line treatment for follicular lymphoma was originally licensed in combination with CVP. The marketing authorisation was subsequently revised (January 2008) to allow the use of a wider range of chemotherapy regimens. The subject of this review of 'Rituximab for the treatment of follicular lymphoma' (NICE technology appraisal guidance 110) is the wider indication: rituximab for the treatment of previously untreated stage III−IV follicular lymphoma in combination with chemotherapy (not just CVP).
3.2 Rituximab has been associated with infusion-related reactions and infections, sometimes severe or life-threatening. Severe reactions are more common in people with high tumour burden, and the incidence and severity of infusion reactions decreases with successive infusions. It is contraindicated in people with active severe infections, and in people with severe heart failure or severe uncontrolled cardiac disease. For full details of side effects and contraindications, see the summary of product characteristics.
3.3 The recommended dose of rituximab in combination with chemotherapy for induction treatment of previously untreated patients with follicular lymphoma is 375 mg/m2 body surface area, per cycle, for up to eight cycles, administered on day 1 of the chemotherapy cycle. The cost of one 10-ml (100-mg) vial is £174.63 and one 50-ml (500-mg) vial is £873.15 (excluding VAT; British national formulary [BNF] edition 61). For a person with a body surface area of 1.85 m2 and assuming vial wastage, the cost per infusion of rituximab induction treatment is £1222.41 (excluding VAT). Costs may vary in different settings because of negotiated procurement discounts.