belimumab (Benlysta)

following a second resubmission:

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

Indication under review: 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.

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.

Belimumab, in addition to standard therapy, modestly improved disease control in patients with SLE in two phase III studies.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.