Benlysta (belimumab subcutaneous injection) — Medica

Initial criteria

• age ≥ 5 years
• Patient has autoantibody-positive systemic lupus erythematosus (positive for ANA and/or anti-dsDNA antibody)
• ONE of the following: concurrent use with at least one standard therapy (e.g., antimalarial, systemic corticosteroid, immunosuppressant such as azathioprine, mycophenolate mofetil, methotrexate) OR intolerance to standard therapy due to significant toxicity determined by the prescriber
• Medication is prescribed by or in consultation with a rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist

Reauthorization criteria

• ONE of the following: concurrent use with at least one standard therapy (e.g., antimalarial, systemic corticosteroid, immunosuppressant such as azathioprine, mycophenolate mofetil, methotrexate) OR intolerance to standard therapy due to significant toxicity determined by the prescriber
• Medication is prescribed by or in consultation with a rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist
• Patient has responded to Benlysta (subcutaneous or intravenous) as determined by the 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; Reauthorization: 1 year