high disease activity is defined as at least 1 serological biomarker (positive anti-double-stranded DNA or low complement) and a SELENA‑SLEDAI score of greater than or equal to 10
treatment is continued beyond 24 weeks only if the SELENA‑SLEDAI score has improved by 4 points or more
the company provides belimumab according to the commercial arrangement.
Why the committee made these recommendations
This appraisal reviews the additional evidence collected as part of the managed access agreement for belimumab for systemic lupus erythematosus (NICE technology appraisal guidance 397).
Standard therapies include non-steroidal anti-inflammatory drugs, corticosteroids, antimalarials and immunosuppressants. Other treatments include biological disease-modifying antirheumatic drugs such as rituximab.
Clinical trial evidence suggests that, after a year of treatment, belimumab plus standard therapy reduces disease activity more than standard therapy alone. However, the results are uncertain because the trials were short, so the long-term benefit is unknown. Also, the effect of belimumab compared with rituximab is unknown.
The cost-effectiveness estimates are also uncertain. But there is an unmet need for effective treatments in people with systemic lupus erythematosus, and some benefits of belimumab may not be taken into account in the cost-effectiveness results. For people with high disease activity despite standard treatment, the most likely cost-effectiveness estimates are within what NICE normally considers an acceptable use of NHS resources. So, belimumab is recommended for these people.