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Lupkynis (voclosporin) — Blue Cross Blue Shield of New Mexico

other FDA labeled indications

Initial criteria

  • Requested agent is eligible for continuation of therapy and patient has been treated with the requested agent within the past 90 days and is at risk if therapy is changed OR meets all new-start requirements below:
  • Diagnosis of active systemic lupus erythematosus (SLE) without active lupus nephritis (LN) AND requested agent is FDA labeled or compendia supported for SLE AND BOTH of the following:
  • • Patient has tried and had an inadequate response to, intolerance, hypersensitivity, or FDA labeled contraindication to hydroxychloroquine
  • • Patient has tried and had an inadequate response to, intolerance, hypersensitivity, or FDA labeled contraindication to ONE corticosteroid or immunosuppressive agent (azathioprine, methotrexate, mycophenolate, or cyclophosphamide)
  • OR Diagnosis of active lupus nephritis (LN) AND requested agent is FDA labeled or compendia supported for LN AND Class III, IV, or V lupus nephritis confirmed by kidney biopsy
  • OR Patient has another FDA labeled or compendia supported indication for the requested agent and route of administration
  • If the patient has an FDA labeled indication, then patient's age is within labeled age range OR there is support for use in patient's age for the indication and route
  • If patient has SLE without LN, BOTH of the following:
  • • Patient is currently treated with standard SLE therapy (corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide)
  • • Patient will continue standard SLE therapy in combination with requested agent
  • If patient has LN, patient will use background immunosuppressive LN therapy in combination with requested agent (Lupkynis: corticosteroids plus mycophenolate; Benlysta: corticosteroids plus mycophenolate, azathioprine, or cyclophosphamide)
  • Prescriber is a specialist in the area (e.g., rheumatologist, nephrologist), or has consulted with a specialist
  • If requested agent is Benlysta, ALL of the following:
  • • Patient does NOT have severe active CNS lupus
  • • NOT used in combination with Lupkynis unless BOTH of the following: patient has active LN AND has tried and had inadequate response to TWO standard therapy courses and will use Benlysta with Lupkynis plus mycophenolate (medical records required)
  • • NOT used in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL4 inhibitors) unless labeling does not limit combination and literature supports combination (documentation required)
  • If requested agent is Lupkynis, BOTH of the following:
  • • NOT used with cyclophosphamide or Saphnelo
  • • NOT used with Benlysta unless BOTH: patient has active LN AND 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 the requested agent

Reauthorization criteria

  • Criteria for renewal not fully stated in this section (see next section of policy). Typically requires documentation of continued clinical benefit and absence of contraindications.

Approval duration

12 months