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Benlysta — Blue Cross Blue Shield of Oklahoma

other FDA labeled or compendia supported indications

Initial criteria

  • ALL of the following:
  • 1. ONE of the following:
  • A. Continuation of therapy: patient treated with requested agent (not samples) within past 90 days and at risk if changed OR
  • B. Newly starting therapy and meets ALL of the following diagnostic and treatment conditions:
  • • ONE of the following:
  • – Diagnosis of active systemic lupus erythematosus (SLE) without active LN AND BOTH:
  • 1. Agent is FDA labeled or compendia supported for SLE
  • 2. BOTH:
  • A. ONE of the following regarding hydroxychloroquine:
  • • Tried and had inadequate response OR intolerance/hypersensitivity OR contraindication to hydroxychloroquine
  • B. ONE of the following regarding corticosteroid or immunosuppressive agent (azathioprine, methotrexate, mycophenolate, cyclophosphamide):
  • • Tried and had inadequate response OR intolerance/hypersensitivity to ONE corticosteroid or immunosuppressive agent OR
  • • Contraindication to ALL corticosteroids and immunosuppressive agents
  • – OR Diagnosis of active lupus nephritis (LN) AND BOTH:
  • 1. Agent is FDA labeled or compendia supported for LN
  • 2. Patient has Class III, IV, or V LN confirmed via kidney biopsy
  • – OR Patient has another FDA labeled indication for the agent and route
  • 2. Patient’s age within FDA labeling or supported in compendia for requested indication and route
  • 3. If SLE without LN: BOTH currently treated with and will continue standard SLE therapy (corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide) in combination with requested agent
  • 4. If active LN: patient will use background immunosuppressive LN therapy (e.g., Lupkynis requests: corticosteroids plus mycophenolate; Benlysta requests: corticosteroids plus mycophenolate, azathioprine, or cyclophosphamide) in combination with requested agent
  • 5. Prescriber is a specialist (rheumatologist, nephrologist) or has consulted with such a specialist
  • 6. If requested agent is Benlysta, then ALL:
  • A. Patient does NOT have severe active CNS lupus
  • B. ONE of the following:
  • • Will NOT use with Lupkynis OR
  • • If will use with Lupkynis, BOTH: diagnosis of active LN AND tried inadequate response to TWO standard therapy courses and will use Benlysta + Lupkynis + mycophenolate (medical records required)
  • C. ONE of the following:
  • • Will NOT use with another immunomodulatory agent (TNF, JAK, IL4 inhibitors) OR
  • • If used with such an agent, prescribing info does not prohibit combination AND supporting clinical evidence provided
  • 7. If requested agent is Lupkynis, then BOTH:
  • A. Will NOT use with cyclophosphamide OR Saphnelo
  • B. ONE of the following:
  • • Will NOT use with Benlysta OR
  • • If will use with Benlysta, BOTH: diagnosis of active LN AND tried inadequate response to TWO standard therapy courses and will use Lupkynis + Benlysta + mycophenolate (medical records required)
  • 8. Patient does NOT have any FDA labeled contraindications
  • Compendia allowed: AHFS, or DrugDex level 1, 2a, or 2b

Reauthorization criteria

  • ALL of the following:
  • 1. Continuation of therapy criteria: patient previously approved and continues to meet criteria
  • 2. Patient continues to benefit from therapy per prescriber documentation
  • 3. No new contraindications to therapy

Approval duration

12 months