2 The technology

2.1 Ipilimumab (YERVOY, Bristol-Myers Squibb) 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 is designed to block the activity of CTLA‑4 resulting in augmentation and prolongation of the T‑cell immune response, thereby sustaining the immune attack on cancer cells. It has a UK marketing authorisation 'for the treatment of advanced (unresectable or metastatic) melanoma in adults'. 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 for a total of 4 doses.

2.2 The summary of product characteristics lists the following very common adverse reactions for ipilimumab: 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 Ipilimumab is priced at £3750 per 10‑ml vial (5 mg/ml) or £15,000 per 40‑ml vial (5 mg/ml) (excluding VAT; 'British national formulary' [BNF] edition 67). The manufacturer of ipilimumab has agreed a patient access scheme with the Department of Health, in which a confidential discount on the list price of ipilimumab is offered. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.