Benlysta — Blue Cross Blue Shield of Illinois

Initial criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
• 2. The patient has had clinical benefit with the requested agent AND
• 3. ONE of the following:
• A. The patient has a diagnosis of active systemic lupus erythematosus (SLE) WITHOUT active lupus nephritis (LN) AND BOTH of the following:
• 1. The patient is currently treated with standard SLE therapy (i.e., corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide) AND
• 2. The patient will continue standard SLE therapy in combination with the requested agent OR
• B. The patient has a diagnosis of active lupus nephritis (LN) AND BOTH of the following:
• 1. The patient is currently treated with background immunosuppressive LN therapy (e.g., Lupkynis requests: corticosteroids plus mycophenolate; Benlysta requests: corticosteroids plus mycophenolate, azathioprine, or cyclophosphamide) AND
• 2. The patient will continue background immunosuppressive LN therapy in combination with the requested agent OR
• C. The patient has a diagnosis other than active SLE OR active LN AND
• 4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist, nephrologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
• 5. If the requested agent is Benlysta, then ALL of the following:
• A. The patient does NOT have severe active central nervous system (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, or cyclophosphamide; corticosteroids and Lupkynis plus mycophenolate) and will be using Benlysta in combination with Lupkynis plus mycophenolate (medical records required) AND
• C. ONE of the following (Refer to “Agents NOT to be used Concomitantly” table):
• 1. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL4 inhibitors) OR
• 2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
• A. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND
• B. There is support for the use of combination therapy (submitted copy of clinical trials, phase III studies, or guidelines required) AND
• 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, or cyclophosphamide; corticosteroids and Lupkynis plus mycophenolate) and will be using Lupkynis in combination with Benlysta plus mycophenolate (medical records required) AND
• 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 AND
• 2. The patient has had clinical benefit with the requested agent AND
• 3. Ongoing criteria for indication (SLE without active LN or active LN) continue to be met AND
• 4. No new contraindications or disallowed concomitant therapies have developed

Approval duration

12 months