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Belimumab for treating active autoantibody-positive systemic lupus erythematosus

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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 schedule for the intravenous formulation of belimumab is available in this summary of product characteristics and for the subcutaneous formulation in this summary of product characteristics.

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 May 2021). The list price for the subcutaneous injection is confidential. The company has a commercial arrangement for both formulations, which would have applied if the technology had been recommended.