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Benlysta (belimumab subcutaneous injection)Cigna

Systemic lupus erythematosus (SLE)

Initial criteria

  • Patient age ≥ 5 years; AND
  • Patient has autoantibody-positive SLE defined as positive for ANA and/or anti-dsDNA antibody; AND
  • Patient meets ONE of the following: (a) Medication used concurrently with at least one other standard therapy (e.g., antimalarial such as hydroxychloroquine, systemic corticosteroid such as prednisone, or immunosuppressant such as azathioprine, mycophenolate mofetil, methotrexate); OR (b) Patient intolerant to standard therapy due to significant toxicity, as determined by prescriber; AND
  • Medication prescribed by or in consultation with a rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist

Reauthorization criteria

  • Patient meets ONE of the following: (a) Medication used concurrently with at least one other standard therapy (e.g., antimalarial such as hydroxychloroquine, systemic corticosteroid such as prednisone, or immunosuppressant such as azathioprine, mycophenolate mofetil, methotrexate); OR (b) Patient intolerant to standard therapy due to significant toxicity, as determined by prescriber; AND
  • Medication prescribed by or in consultation with a rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist; AND
  • Patient has responded to Benlysta subcutaneous or intravenous, as determined by prescriber (e.g., reduction in flares, reduction in corticosteroid dose, decrease of anti-dsDNA titer, improvement in complement levels C3, C4, or improvement in specific organ dysfunction)

Approval duration

initial 4 months; continuation 1 year