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Benlysta Prior Authorization Criteria - Medicare Part D
Medicare Utilization Management Policy
Version Date: 01/01/2025

Prior Authorization Criteria for Approval

Initial Evaluation

Benlysta will be approved when ALL of the following are met:

  1. ONE of the following: 
    1. The patient has a diagnosis of active systemic lupus erythematosus (SLE) disease AND BOTH of the following: 
      1. The patient is at least 5 years of age AND 
      2. The patient will continue standard SLE therapy [corticosteroids (e.g., methylprednisolone, prednisone), hydroxychloroquine, immunosuppressives (e.g., azathioprine, methotrexate, oral cyclophosphamide)] in combination with the requested medication OR 
    2. The patient has a diagnosis of active lupus nephritis (LN) AND BOTH of the following: 
      1. The patient is at least 18 years of age AND 
      2. The patient will continue standard LN therapy [corticosteroids (e.g., methylprednisolone, prednisone), immunosuppressives (e.g., azathioprine, mycophenolate)] in combination with the requested medication AND 
  2. The patient will NOT be using the requested medication in combination with another biologic medication AND 
  3. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval: 12 months

Renewal Evaluation

Benlysta will be approved when ALL of the following are met:

  1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria AND 
  2. ONE of the following: 
    1. The patient has diagnosis of active systemic lupus erythematosus (SLE) disease AND BOTH of the following: 
      1. The patient is at least 5 years of age AND 
      2. The patient will continue standard SLE therapy [corticosteroids (e.g., methylprednisolone, prednisone), hydroxychloroquine, immunosuppressives (e.g., azathioprine, methotrexate, oral cyclophosphamide)] in combination with the requested medication OR
    2. The patient has a diagnosis of active lupus nephritis (LN) AND BOTH of the following:
      1. The patient is at least 18 years of age AND
      2. The patient will continue standard LN therapy [corticosteroids (e.g., methylprednisolone, prednisone), immunosuppressives (e.g., azathioprine, mycophenolate)] in combination with the requested medication AND 
  3. The patient has had clinical benefit with the requested medication AND 
  4. The patient will NOT be using the requested medication in combination with another biologic medication AND 
  5. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval: 12 months
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