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Lupkynis — Blue Cross Blue Shield of Alabama

active systemic lupus erythematosus (SLE) without active lupus nephritis (LN)

Initial criteria

  • ONE of the following:
  • - The patient has been treated with the requested agent (not starting on samples) within the past 90 days OR the prescriber states the patient has been treated with the requested agent within the past 90 days and is at risk if therapy is changed
  • - BOTH of the following:
  • • ONE of the following:
  • - The patient has a diagnosis of active systemic lupus erythematosus (SLE) without active lupus nephritis (LN) AND BOTH of the following:
  • • The requested agent is FDA labeled or compendia supported for SLE AND
  • • ONE of the following:
  • - Has tried and had an inadequate response to hydroxychloroquine OR
  • - Has an intolerance or hypersensitivity to hydroxychloroquine OR
  • - Has an FDA labeled contraindication to hydroxychloroquine AND
  • • ONE of the following:
  • - Has tried and had an inadequate response to ONE corticosteroid OR immunosuppressive agent (azathioprine, methotrexate, mycophenolate, cyclophosphamide) OR
  • - Has an intolerance or hypersensitivity to ONE corticosteroid OR immunosuppressive agent OR
  • - Has an FDA labeled contraindication to ALL corticosteroids and immunosuppressive agents
  • - OR the patient has a diagnosis of active lupus nephritis (LN) AND BOTH of the following:
  • • The requested agent is FDA labeled or compendia supported for LN AND
  • • The patient has Class III, IV, or V lupus nephritis confirmed via kidney biopsy
  • - OR the patient has another FDA labeled indication for the requested agent and route of administration
  • • AND if the patient has an FDA labeled indication, then ONE of the following:
  • - The patient’s age is within FDA labeling for the requested indication OR
  • - There is support for using the requested agent for the patient’s age for the requested indication
  • • AND if the patient has a compendia-supported indication, then the indication is supported in compendia for the requested agent and route of administration
  • • AND if diagnosis is active SLE without LN, BOTH of the following:
  • - The patient is currently treated with standard SLE therapy (corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide) AND
  • - The patient will continue standard SLE therapy in combination with the requested agent
  • • AND if diagnosis is active LN, the patient will be using background immunosuppressive LN therapy in combination with the requested agent (Lupkynis: corticosteroids plus mycophenolate; Benlysta: corticosteroids plus mycophenolate, azathioprine, or cyclophosphamide)
  • • AND the prescriber is a specialist (rheumatologist, nephrologist) or has consulted with one
  • • AND if the requested agent is Benlysta, then ALL of the following:
  • - The patient does NOT have severe active CNS lupus AND
  • - ONE of the following:
  • • The patient will NOT be using the requested agent in combination with Lupkynis OR
  • • BOTH of the following:
  • - The patient has active LN AND
  • - 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 with Lupkynis plus mycophenolate (medical records required)
  • - AND ONE of the following:
  • • The patient will NOT be using the requested agent in combination with another immunomodulatory agent (TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
  • • The prescribing information does not limit such combination and there is support for use of combination therapy (clinical trial or guideline documentation required)
  • • AND if the requested agent is Lupkynis, then BOTH of the following:
  • - The patient will NOT use Lupkynis in combination with cyclophosphamide OR Saphnelo AND
  • - ONE of the following:
  • • The patient will NOT use Lupkynis in combination with Benlysta OR
  • • BOTH of the following:
  • - The patient has active LN AND
  • - Has tried and had an inadequate response to TWO standard therapy courses and will use Lupkynis with Benlysta plus mycophenolate (medical records required)
  • • AND the patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s PA process AND has clinical benefit with the requested agent AND ONE of the following:
  • - The patient has active SLE without active LN AND BOTH of the following:
  • • Currently treated with standard SLE therapy (corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide)
  • • Will continue standard SLE therapy in combination with the requested agent
  • - OR the patient has active lupus nephritis (LN) AND BOTH of the following:
  • • Currently treated with background immunosuppressive LN therapy (Lupkynis: corticosteroids plus mycophenolate; Benlysta: corticosteroids plus mycophenolate, azathioprine, or cyclophosphamide)
  • • Will continue background therapy in combination with the requested agent
  • - OR the patient has another indication other than active SLE or LN
  • AND the prescriber is a specialist (rheumatologist, nephrologist) or has consulted one
  • AND if the requested agent is Benlysta, the same restrictions as initial (no severe CNS lupus; combination restrictions; documentation required if used with Lupkynis)
  • AND if the requested agent is Lupkynis, the same restrictions as initial (no combination with cyclophosphamide or Saphnelo; combination with Benlysta only under defined conditions)

Approval duration

12 months