Benlysta — Blue Cross Blue Shield of Texas

Initial criteria

• 1. The patient has not been previously approved for the requested agent and requires initial evaluation review
• 2. The patient has a diagnosis of active systemic lupus erythematosus (SLE) WITHOUT active lupus nephritis AND BOTH of the following: (a) The patient is currently treated with standard SLE therapy (corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide) AND (b) The patient will continue standard SLE therapy in combination with the requested agent OR
• 3. The patient has a diagnosis of active lupus nephritis (LN) AND BOTH of the following: (a) The patient is currently treated with background immunosuppressive LN therapy (for Lupkynis: corticosteroids plus mycophenolate; for Benlysta: corticosteroids plus mycophenolate, azathioprine, or cyclophosphamide) AND (b) The patient will continue such background therapy in combination with the requested agent
• 4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist, nephrologist), or has consulted with one
• 5. If the requested agent is Benlysta, then ALL of the following: (a) The patient does NOT have severe active CNS lupus AND (b) ONE of the following: (1) The patient will NOT be using the requested agent in combination with Lupkynis OR (2) BOTH of the following: (A) The patient has a diagnosis of active LN AND (B) The patient has tried and had an inadequate response to TWO standard therapy courses (e.g., corticosteroids and Benlysta plus mycophenolate/azathioprine/cyclophosphamide; corticosteroids and Lupkynis plus mycophenolate) and will use Benlysta in combination with Lupkynis plus mycophenolate (medical records required)
• 6. If the requested agent is Lupkynis, then BOTH of the following: (a) The patient will NOT be using the requested agent in combination with cyclophosphamide OR Saphnelo AND (b) ONE of the following: (1) The patient will NOT be using the requested agent in combination with Benlysta OR (2) BOTH of the following: (A) The patient has a diagnosis of active LN AND (B) The patient has tried and had an inadequate response to TWO standard therapy courses (e.g., corticosteroids and Benlysta plus mycophenolate/azathioprine/cyclophosphamide; corticosteroids and Lupkynis plus mycophenolate) and will use Lupkynis in combination with Benlysta plus mycophenolate (medical records required)
• 7. The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• 2. The patient has had clinical benefit with the requested agent
• 3. Clinical use continues to satisfy diagnosis-specific conditions under the initial criteria

Approval duration

12 months