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Lupkynis — Blue Cross Blue Shield of New Mexico

active lupus nephritis (LN)

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 SLE WITHOUT active LN AND BOTH of the following:
  • 1. The patient is currently treated with standard SLE therapy (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 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 has consulted with a specialist AND
  • 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, 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:
  • 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

  • Continuation of therapy may be approved when the patient meets all initial criteria, has been previously approved for the requested agent through the plan’s Prior Authorization process, and has demonstrated clinical benefit with the requested agent.

Approval duration

12 months