Belimumab (Benlysta®) is a human monoclonal antibody that specifically recognizes and blocks the biological activity of B-lymphocyte stimulator. Elevated levels of BLyS prolong the survival of B lymphocytes (B cells) which can contribute to the production of autoantibodies – antibodies that target the body’s own tissues. Studies have shown that belimumab can reduce autoantibody levels and help control autoimmune disease activity.
Belimumab (Benlysta) is administered either intravenously or subcutaneously, in the treatment of adult individuals with active, auto-antibody positive systemic lupus erythematosus who are receiving standard therapy.
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Belimumab (Benlysta) may be considered medically necessary when ALL of the following criteria are met:
The use of belimumab (Benlysta) for all other indications is considered experimental/investigational due to lack of scientific evidence, and therefore, not covered including but not limited to ANY of the following:
NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.