2 The technology
2.1 Ipilimumab (Yervoy, Bristol-Myers Squibb Pharmaceuticals) is a fully human antibody that binds to cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), a molecule expressed on T-cells that plays a critical role in regulating natural immune responses. Ipilimumab has a UK marketing authorisation for 'the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy'. For further information, see the summary of product characteristics.
2.2 Ipilimumab is most commonly associated with adverse reactions resulting from increased or excessive immune activity including diarrhoea, rash, pruritus, fatigue, nausea, vomiting, decreased appetite and abdominal pain. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.3 The recommended dose of ipilimumab is 3 mg per kilogram of body weight (mg/kg) administered intravenously over a 90-minute period every 3 weeks, with a total of 4 doses for the full treatment course. The summary of product characteristics states that all 4 doses should be administered 'as tolerated, regardless of the appearance of new lesions or growth of existing lesions'. Ipilimumab costs £3750 for 50 mg and £15,000 for 200 mg (excluding VAT, British national formulary, September 2012). Assuming an average body weight of 70 kg, each dose of ipilimumab would need a 200 mg vial and a 50 mg vial costing £18,750. A 4-dose course would therefore cost £75,000, not including administration costs. Costs may vary in different settings because of negotiated procurement discounts. The manufacturer of ipilimumab has agreed a patient access scheme with the Department of Health, in which a discount on the list price of ipilimumab is offered. The size of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.