Following a limited submission
|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.
|Medicine name||belimumab (Benlysta®)|
|Formulation||120 mg powder for concentrate for solution for infusion, 400 mg powder for concentrate for solution for infusion|
Treatment of systemic lupus erythematosus in children
|BNF chapter||Immunological products & vaccines|
|Status||Recommended with restrictions|
|NMG meeting date||25/06/2020|
|AWMSG meeting date||15/07/2020|
|Date of issue||04/08/2020|