belimumab (Benlysta)

following an abbreviated submission:

belimumab (Benlysta®) is accepted for restricted use within NHSScotland.

Indication under review: 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.

SMC restriction: in adults with evidence for at least one marker of serological disease activity (low complement, positive anti-dsDNA) and a Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score ≥10.

SMC has previously accepted belimumab powder for concentrate for infusion for restricted use (SMC2477).

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of belimumab. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.