Belimumab (Benlysta®) for the treatment of adult patients with auto-antibody-positive systemic lupus erythematosus (SLE)

Zorginstituut Nederland has carried out an assessment of the medicinal product subcutaneous belimumab (Benlysta®) and a re-assessment of intravenous belimumab, the latter of which is subject to Conditional Inclusion in the insured standard package.

Outcome of assessment of belimumab

The Zorginstituut establishes that the addition of both the subcutaneous and the intravenous delivery formulations of belimumab to the usual treatment of adult patients with auto-antibody-positive SLE with a high level of disease activity (e.g. positive anti-dsDNA and low complement), despite standard care, complies with ‘established medical science and medical practice’. In combination with exemption from supplying cost-effectiveness data, this leads to the conclusion that both delivery formulations of belimumab fall within the basic package of the Health Insurance Act (Zvw).

This report is a summary of recommendations by Zorginstituut Nederland. The original text of this excerpt is in Dutch. The full report describes the considerations that resulted in this outcome of assessment of the Zorginstituut. The Zorginstituut was advised by the Scientific Advisory Board (WAR).