2 Information about belimumab
Marketing authorisation indication
2.1 The intravenous formulation of belimumab (Benlysta, GlaxoSmithKline) 'is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti‑dsDNA and low complement) despite standard therapy'. The subcutaneous formulation 'is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti‑dsDNA and low complement) despite standard therapy'.
Dosage in the marketing authorisation
2.2 The dosage schedules are available in the summary of product characteristics for the intravenous formulation of belimumab and the summary of product characteristics for the subcutaneous formulation of belimumab.
Price
2.3 The list price of belimumab for the intravenous infusion is £121.50 for a 120‑mg vial and £405.00 for a 400‑mg vial (excluding VAT; BNF online accessed November 2021). The list price for the subcutaneous injection is £222.75 for a 200‑mg pre-filled pen (excluding VAT; company submission).
2.4 The company has a commercial arrangement for both formulations. This makes belimumab available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.