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belimumab (Benlysta®)


Following a limited submission

AWMSG advice

Status: Recommended with restrictions

Belimumab (Benlysta®) is recommended as an option for restricted use within NHS Wales.

Belimumab (Benlysta®) is licensed as add-on therapy in patients aged 5 years to < 18 years old with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy.

Belimumab (Benlysta®) is restricted for the treatment of patients who have serological disease activity (defined as positive anti-double-stranded DNA and low complement) and a Safety of Estrogen in Lupus National Assessment – Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score greater than or equal to 10 despite standard treatment. Belimumab (Benlysta®) treatment should be continued beyond 24 weeks only if the SELENA-SLEDAI score has improved by 4 points or more.

Belimumab (Benlysta® ) is not recommended for use within NHS Wales outside of this subpopulation.

This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS/WPAS price.

 Final Recommendation: belimumab (Benlysta®) 3778 (PDF, 491Kb)
 Appraisal Report: belimumab (Benlysta) 3778 (PDF, 134Kb)

Medicine details

Medicine name belimumab (Benlysta®)
Formulation 120 mg powder for concentrate for solution for infusion, 400 mg powder for concentrate for solution for infusion
Reference number 3778

Treatment of systemic lupus erythematosus in children

Company GlaxoSmithKline
BNF chapter Immunological products & vaccines
Submission type Limited
Status Recommended with restrictions
Advice number 0720
NMG meeting date 25/06/2020
AWMSG meeting date 15/07/2020
Date of issue 04/08/2020
Commercial arrangement PAS