On March 9, 2011, the US Food and Drug Administration (FDA) approved belimumab (Benlysta®) for intravenous use, an intravenously delivered agent, for use in individuals with active, autoantibody-positive lupus (systemic lupus erythematosus [SLE]) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs (NSAIDs). It is the first inhibitor intended to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells. BLyS is overexpressed in patients with systemic lupus erythematosus (SLE) and other autoimmune diseases. After subsequent studies using the intravenous formulation, the FDA granted approval in pediatric individuals age five years and older. Additionally, a subcutaneous formulation of belimumab (Benlysta®) for use in adults was also FDA approved.
Two clinical studies involving 1,684 individuals with lupus demonstrated the safety and effectiveness of belimumab (Benlysta®) for intravenous use. The studies diagnosed individuals with active lupus and randomized them to receive belimumab (Benlysta®) for intravenous use plus standard therapy, or an inactive infused solution (placebo) plus standard therapy. The studies excluded anyone who had received prior B-cell targeted therapy or intravenous cyclophosphamide, and those who had active lupus involving the kidneys or central nervous system.
The individuals treated with belimumab (Benlysta®) for intravenous use and standard therapies experienced less disease activity than those who received a placebo and standard-of-care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses.
Subsequent safety and efficacy results for subjects treated up to seven years continue to support disease control and safety profile in individuals with active SLE taking belimumab plus standard therapy.
There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company's off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
M32.0 Drug-induced systemic lupus erythematosus
M32.10 Systemic lupus erythematosus, organ or system involvement unspecified
M32.11 Endocarditis in systemic lupus erythematosus
M32.12 Pericarditis in systemic lupus erythematosus
M32.13 Lung involvement in systemic lupus erythematosus
M32.14 Glomerular disease in systemic lupus erythematosus
M32.15 Tubulo-interstitial nephropathy in systemic lupus erythematosus
M32.19 Other organ or system involvement in systemic lupus erythematosus
M32.8 Other forms of systemic lupus erythematosus
M32.9 Systemic lupus erythematosus, unspecified
THE FOLLOWING MODIFIER IS USED WHEN REPORTING
Belimumab (Benlysta®) for Intravenous Use
JA Intravenous administration
Policy: MA08.007s:Medicare Part B vs. Part D Crossover Drugs
Policy: MA08.012c:Off-label Coverage for Prescription Drugs and/or Biologics