BENLYSTA (belimumab)

BENLYSTA (belimumab)

Self-Administration – injectable 
Medical Administration – intravenous

Diagnosis considered for coverage: 

• Indicated for the treatment of:
  • Patients aged 5 years and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy
  • Patients aged 5 years and older with active lupus nephritis who are receiving standard therapy
• Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active central nervous system lupus. Use of Benlysta is not recommended in this situation

Coverage Criteria:

For diagnosis of SLE:

• Dose does not exceed one of the following:
  • SC: 200 mg once weekly 
  • IV: 10 mg/kg at 2?week intervals for the first 3 doses and at 4?week intervals thereafter; AND
• Patient meets one of the following:
  • Request is for Benlysta vials: Patient is 5 years of age or older
  • Request is for Benlysta autoinjectors and prefilled syringes: Patient is 18 years of age or older; AND
• Diagnosis of active systemic lupus erythematosus (SLE); AND
• Prescribed by or in consultation with a rheumatologist; AND
• Autoantibody positive (i.e., anti-nuclear antibody [ANA] titer greater than or equal to 1:80 or anti-dsDNA level greater than or equal to 30 IU/mL); AND
• Trial and failure, contraindication, or intolerance to two standard of care treatments for active SLE (e.g., antimalarials [e.g., Plaquenil (hydroxychloroquine)], corticosteroids [e.g., prednisone], or immunosuppressants [e.g., methotrexate, Imuran (azathioprine)]); AND
• Currently receiving at least one standard of care treatment for active SLE (e.g., antimalarials [e.g., Plaquenil (hydroxychloroquine)], corticosteroids [e.g., prednisone], or immunosuppressants [e.g., methotrexate, Imuran (azathioprine)])

For diagnosis of active lupus nephritis:

• Dose does not exceed one of the following:
  • SC: 400-mg dose (two 200-mg injections) once weekly for 4 doses, then 200 mg once weekly thereafter
  • IV: 10 mg/kg at 2?week intervals for the first 3 doses and at 4?week intervals thereafter; AND
• Patient meets one of the following:
  • Request is for Benlysta vials: Patient is 5 years of age or older
  • Request is for Benlysta autoinjectors and prefilled syringes: Patient is 18 years of age or older; AND
• Diagnosis of active lupus nephritis; AND
• Prescribed by or in consultation with a nephrologist or rheumatologist; AND
• Currently receiving standard of care treatment for active lupus nephritis (e.g., corticosteroids [e.g., prednisone] with mycophenolate or cyclophosphamide)

Reauthorization Criteria:

For diagnosis of SLE and active lupus nephritis:

• Dose does not exceed the FDA label maximum dose; AND
• Documentation of positive clinical response to therapy (e.g., decrease or stabilization of symptoms, improvement in functional impairment, decrease of corticosteroid dose, decrease in pain medications)

Coverage Duration:

• Initial: 6 months
• Reauthorization: 6 months

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Recommended SC dose:
  • Adult Patients with SLE: 200 mg once weekly
  • Adult Patients with Lupus Nephritis: 400-mg dose (two 200-mg injections) once weekly for 4 doses, then 200 mg once weekly thereafter
• Recommended IV dose:
  • Adult and Pediatric Patients with SLE or Lupus Nephritis: 10 mg/kg at 2?week intervals for the first 3 doses and at 4?week intervals thereafter
• For SLE, if transitioning from intravenous therapy with Benlysta to subcutaneous administration, administer the first subcutaneous dose 1 to 4 weeks after the last intravenous dose
• A patient with lupus nephritis may transition from intravenous therapy with Benlysta to subcutaneous therapy any time after the patient completes the first 2 intravenous doses. If  transitioning, administer the first subcutaneous dose of 200 mg 1 to 2 weeks after the last intravenous dose.

Policy Updates:

• 9/4/2018 – New policy approved by P&T.
• 6/1/2023 – Updated format and criteria for SLE. Addition of criteria for active lupus nephritis

References:

• Benlysta Prescribing Information. GlaxoSmithKline LLC. Philadelphia, PA. February 2023. 
• Per clinical consult with rheumatologist, October 4, 2017. 
• American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Guidelines. Guidelines for referral and management of systemic lupus erythematosus. Arthritis Rheum. 1999 Sep;42(9):1785-96. 
• American College of Rheumatology Guidelines for Screening, Case Definition, Treatment and Management of Lupus Nephritis. Arthritis Care Res (Hoboken). 2012 Jun; 64(6): 797-808. 
• Fanouriakis A, Kostopoulou M, Alunno A, et al. Ann Rheum Dis 2019;78:736–745.