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) may be considered medically necessary when ALL of the following criteria are met:

Systemic Lupus Erythematosus

• Individual is five (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
• Insufficient response to TWO standard of care drug classes:
  • Corticosteroids (e.g. prednisone); or
  • Antimalarials (i.e. hydroxychloroquine); or
  • Immunosupressives (e.g. azathioprine, mycophenolate mofetil, or methotrexate); 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).

Lupus Nephritis

• Individual is 18 years of age or older, and
• Diagnosis of active lupus nephritis; and
• Individual is receiving standard therapy (e.g. corticosteroids, immunosuppressive drugs, medications to control blood pressure or prevent blood clots if indicated)

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 requiring hemodialysis; or
• Individuals currently being treated with biologics.    

Belimumab (Benlysta) may be considered medically necessary for individuals 18 years of age and older when applicable clinical criteria for individual medication policies are met and when administered in a physician’s office not affiliated with a hospital, specialized infusion centers not affiliated with a hospital or in the home.

Outpatient facility (Outpatient Hospital IV Infusion Department or Hospital-based Outpatient Clinical Level of Care) administration may be considered medically necessary if ANY of the following criteria are present to indicate the member is medically unstable for infusions in other than an outpatient facility setting:

• Member’s home is considered unsuitable for care by the home infusion provider; or
• Individual’s medical status requires enhanced monitoring beyond that which would routinely be needed for infusion therapy; or
• Previous severe adverse reaction (including but not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure) during or following administration of prescribed medication despite standard pre-medication; or
• Individual is receiving other medications that require close monitoring with a higher level of care (e.g., cytotoxic chemotherapy or blood products); or
• Individual is at high risk for complications due to medication administration (e.g., at risk for post-transplant complications, increased risk of infusion reactions due to presence of circulating antibodies, unstable vascular access, cardiopulmonary condition at risk for severe adverse reactions, unstable renal function with inability to safely tolerate IV volume loads, etc.); or 
• Individual is initiating therapy or re-initiating therapy after a period of at least 6 months with no therapy; or
• Physically and/or cognitively impaired AND a home caregiver is not available to comply with the required treatment regimen and schedule.

Home health services may be considered medically necessary when utilized for the administration of home infusion therapy and when provided by licensed eligible provider. Each case will be addressed on an individual basis.

The medications identified in this policy will be considered not medically necessary if administered in an unapproved hospital outpatient setting when an approved site of care is a viable option for treatment.

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. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits. 

Evidence-based guidelines support the administration of injectable medications in alternative sites of care such as the non-hospital physician’s office, non-hospital infusion center or in the home.  Administration of the injectable medications subject to this policy at alternate sites of care is based upon the professional judgment of the provider, and takes into account the clinical appropriateness for each individual member. Requests for administration of any dose of the drugs listed in this policy received from a hospital-based facility, physician’s office or specialized infusion center will be assessed for meeting the policy exception criteria based on the clinical documentation provided by the requesting practitioner.