2 The technology
2.1 Bevacizumab (Avastin, Roche Products) is a recombinant humanised monoclonal IgG1 antibody that inhibits the formation of blood vessels (angiogenesis inhibitor). It targets the biological activity of human vascular endothelial growth factor (VEGF), which stimulates new blood vessel formation in the tumour. Bevacizumab in combination with fluoropyrimidine-based chemotherapy has a UK marketing authorisation for the treatment of patients with metastatic carcinoma of the colon or the rectum.
2.2 The summary of product characteristics (SPC) lists the following conditions that may be associated with bevacizumab treatment: gastrointestinal perforations, fistulae, wound healing complications, hypertension, proteinuria, arterial and venous thromboembolism, haemorrhage, pulmonary haemorrhage/haemoptysis, congestive heart failure, reversible posterior leucoencephalopathy and neutropenia. For full details of side effects and contraindications, see the SPC.
2.3 Bevacizumab is administered as an intravenous infusion. Bevacizumab treatment is given in combination with chemotherapy and is licensed for use until progression of the underlying disease. The recommended dosage for metastatic carcinoma of the colon or rectum is 5 mg/kg or 10 mg/kg of body weight once every 2 weeks when given with oxaliplatin and fluorouracil plus folinic acid (FOLFOX) or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks when given with oxaliplatin and capecitabine (XELOX). Bevacizumab is available in 100-mg and 400-mg vials at net prices of £242.66 and £924.40 respectively (excluding VAT; 'British national formulary' [BNF] edition 58). For first-line treatment with bevacizumab, the manufacturer's economic model assumed a dosage of 5 mg/kg of body weight once every 2 weeks when given with FOLFOX and 7.5 mg/kg of body weight given once every 3 weeks XELOX, in line with the NO16966 trial. The acquisition cost of bevacizumab (excluding VAT and assuming wastage) for a patient weighing 70 kg is £924.40 at a dosage of 5 mg/kg every 2 weeks and £1409.72 at a dosage of 7.5 mg/kg every 3 weeks. The manufacturer of bevacizumab (Roche Products) proposed a patient access scheme to the Department of Health for the use of bevacizumab in metastatic colorectal cancer. The Department of Health was content for NICE to consider the patient access scheme proposed by Roche. However, it had concerns about the scheme's complexity and believed that the administrative burden of the scheme was greater than that originally set out by the manufacturer.