Description

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.

Criteria

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:

• Individual is 5 years of age or older; and
• Diagnosis of active systemic lupus erythematosus; and
• Positive anti-nuclear antibody (ANA) titer (greater than or equal to 1:80) or anti-double-stranded DNA antibody (anti-dsDNA) greater than or equal to 30 IU/ml; and
• Will continue to receive concomitant standard of care for treatment of systemic lupus which includes ANY of the following (alone or in combination):
  • Corticosteroids (e.g. prednisone); or
  • Antimalarials (i.e. hydroxychloroquine ); or
  • Immunosuppressives (e.g. azathioprine, mycophenolate mofetil, or methotrexate).

Procedure Codes

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:

• Individual with active central nervous system lupus; or
• Individuals with severe lupus nephritis, active nephritis, or requiring hemodialysis; or
• Individuals currently being treated with biologics or intravenous cyclophosphamide.

Procedure Codes

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.

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

NA

Links

References (PDF)