Lupkynis — Blue Cross Blue Shield of Illinois

Initial criteria

• ONE of the following: the requested agent is eligible for continuation of therapy AND 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 OR the patient meets clinical criteria for new start
• For new start: ONE of the following: patient has diagnosis of active SLE without active LN AND the requested agent is FDA labeled or compendia supported for SLE AND has tried and had inadequate response, intolerance, hypersensitivity, or contraindication to hydroxychloroquine AND has tried and had inadequate response, intolerance, hypersensitivity, or contraindication to one corticosteroid or immunosuppressive agent (azathioprine, methotrexate, mycophenolate, cyclophosphamide) OR patient has diagnosis of active LN AND the requested agent is FDA labeled or compendia supported for LN AND has Class III, IV, or V lupus nephritis confirmed via kidney biopsy OR patient has another FDA labeled indication
• If patient has FDA labeled indication, age must be within FDA labeling or have support in compendia for that age
• If patient has active SLE without LN, patient is currently treated with standard SLE therapy (corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide) AND will continue standard therapy in combination with requested agent
• If patient has active LN, patient will use background immunosuppressive LN therapy (for Lupkynis: corticosteroids plus mycophenolate; for Benlysta: corticosteroids plus mycophenolate, azathioprine, or cyclophosphamide)
• Prescriber is a specialist in the area (e.g., rheumatologist, nephrologist) or has consulted with one
• If requested agent is Benlysta, patient does NOT have severe active CNS lupus AND will not use Benlysta with Lupkynis unless patient has active LN and has tried and had inadequate response to two standard therapy courses (e.g., corticosteroids and Benlysta plus mycophenolate, azathioprine, or cyclophosphamide; corticosteroids and Lupkynis plus mycophenolate) AND will use Benlysta in combination with Lupkynis plus mycophenolate (medical records required)
• Requested agent will NOT be used concomitantly with another immunomodulatory agent unless label does not limit such use and there is support for combination therapy provided (clinical trial or guideline references)
• If requested agent is Lupkynis, patient will NOT use Lupkynis with cyclophosphamide or Saphnelo AND will not use with Benlysta unless patient has active LN and has tried and had inadequate response to two standard therapy courses and will use Lupkynis with Benlysta plus mycophenolate (medical records required)
• Patient does NOT have any FDA labeled contraindications to requested agent
• Compendia sources allowed: AHFS or DrugDex 1, 2a, or 2b level of evidence

Reauthorization criteria

• Patient continues to meet initial criteria and is responding to therapy or continues to derive benefit based on prescriber assessment (implied by renewal evaluation section requiring criteria met for approval)

Approval duration

12 months