2 The technology

2 The technology

2.1 Belimumab (Benlysta, GlaxoSmithKline) is a human monoclonal antibody that inhibits the activity of B‑lymphocyte stimulator (BLyS). Belimumab has a marketing authorisation 'as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity (for example, positive anti-double-stranded DNA and low complement) despite standard therapy'.

2.2 According to the summary of product characteristics, adverse reactions with belimumab include bronchitis, viral gastroenteritis, cystitis, pharyngitis, nasopharyngitis, leukopenia, hypersensitivity reactions, depression, insomnia, migraine, diarrhoea, nausea, pain in extremity, infusion-related reactions and pyrexia. For full details of adverse reactions and contraindications, see the summary of product characteristics.

2.3 Belimumab is available as a 120‑mg or 400‑mg powder for intravenous infusion in solution. The recommended dose regimen is 10 mg/kg belimumab on days 0, 14 and 28, and at 4‑week intervals thereafter. The summary of product characteristics states that discontinuation of treatment with belimumab should be considered if there is no improvement in disease control after 6 months of treatment. The list price of belimumab is £121.50 for a 120‑mg vial and £405 for a 400‑mg vial (excluding VAT; British national formulary [accessed June 2015]). Assuming vial wastage, the drug cost per administration for a person weighing 65–76 kg is £769.50. The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of belimumab. The level 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.

  • National Institute for Health and Care Excellence (NICE)