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belimumab (Benlysta)

Advice

following a resubmission:

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

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: patients with evidence of serological disease activity (i.e. positive anti-dsDNA and low complement) 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 of care, modestly improved disease control in patients with SLE in two phase III studies. 

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.

Drug Details

Drug Name: belimumab (Benlysta)
SMC Drug ID: 775/12
Manufacturer: GlaxoSmithKline UK Ltd
Indication: 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.
BNF Category:
Sub Category: 10.1 Drugs used in rheumatic diseases and gout
Submission Type: Resubmission
Status: Restricted
Date Advice Published: 8 May 2017

Archived Advice

Full submission 9 April 2012

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