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Belimumab for treating active autoantibody-positive systemic lupus erythematosus

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1 Recommendations

1.1 Belimumab is not recommended, within its marketing authorisation, as an add-on therapy for active autoantibody-positive systemic lupus erythematosus in people 5 years and older when there is a high degree of disease activity (for example, positive anti-double-stranded DNA, low complement) and despite standard therapy.

1.2 People who started belimumab as part of the managed access agreement can continue until NICE publishes its final guidance. If the final guidance does not recommend belimumab for use in the NHS, they and their clinician will need to decide on an NHS-funded treatment and change to this within 1 year.

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. Also, the long-term benefit of belimumab compared with standard therapy or rituximab is unknown.

The cost-effectiveness estimates are also uncertain, and the most likely estimates are higher than what NICE normally considers an acceptable use of NHS resources. So, belimumab is not recommended for use in the NHS.