Benlysta subcutaneous — Medica

Initial criteria

• age ≥ 5 years
• Diagnosis of lupus nephritis has been confirmed on biopsy (e.g., WHO class III, IV, or V lupus nephritis)
• Medication is being used concurrently with an immunosuppressive regimen (e.g., azathioprine, cyclophosphamide, leflunomide, methotrexate, mycophenolate mofetil, and/or systemic corticosteroid)
• Medication is prescribed by or in consultation with a nephrologist or rheumatologist

Reauthorization criteria

• Medication is being used concurrently with an immunosuppressive regimen (e.g., azathioprine, cyclophosphamide, leflunomide, methotrexate, mycophenolate mofetil, and/or systemic corticosteroid)
• Medication is prescribed by or in consultation with a nephrologist or rheumatologist
• Patient has responded to Benlysta (subcutaneous or intravenous) as determined by the prescriber (e.g., improvement in organ dysfunction, reduction in flares, reduction in corticosteroid dose, decrease of anti-dsDNA titer, and improvement in complement levels [C3, C4])

Approval duration

Initial: 6 months; Reauthorization: 1 year