Belimumab for the treatment of active autoantibody-positive systemic lupus erythematosus: updated NICE draft guidance

SPS commentary:

Current guidance from NICE (TA397) recommends belimumab as an option as add-on treatment for active autoantibody-positive systemic lupus erythematosus in adults only if all of the following apply:

 

• There is evidence for 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 of greater than or equal to 10 despite standard treatment.

 

• Treatment with belimumab is continued beyond 24 weeks only if the SELENA-SLEDAI score has improved by 4 points or more.

 

• The company provides belimumab with the discount agreed in the patient access scheme.

 

• Under the conditions for data collection, monitoring, patient eligibility and consent, ongoing treatment, cost to the NHS, and review by NICE as laid out in the managed access agreement.

 

The current appraisal document reviews the additional evidence collected as part of the managed access agreement, including data collected using the British Isles Lupus Assessment Group-Biologics Registry (BILAG-BR). Additional clinical trial evidence presented in the company’s updated submission to address uncertainties identified during the original appraisal is also reviewed.

 

The DRAFT guidance update concludes that the cost-effectiveness estimates are uncertain, and the most likely estimates are higher than what NICE normally considers an acceptable use of NHS resources. Belimumab is therefore not recommended for use in the NHS.