Lupkynis — Blue Cross Blue Shield of Montana

Initial criteria

• ONE of the following:
• A. Continuation of therapy: The prescriber states the patient has been treated with the requested agent (not samples) within the past 90 days and is at risk if therapy is changed OR
• B. NEW Therapy: BOTH of the following:
• 1. ONE of the following:
• A. The patient has a diagnosis of active SLE without active LN AND BOTH of the following:
• • Requested agent is FDA labeled or compendia supported for SLE AND
• • BOTH of the following:
• ◦ ONE of the following: tried and inadequate response to, intolerance, hypersensitivity, or FDA labeled contraindication to hydroxychloroquine
• ◦ ONE of the following: tried and inadequate response to, intolerance, hypersensitivity, or FDA labeled contraindication to ONE corticosteroid OR immunosuppressive agent (azathioprine, methotrexate, mycophenolate, cyclophosphamide)
• B. The patient has a diagnosis of active LN AND BOTH of the following:
• • Requested agent is FDA labeled or compendia supported for LN AND
• • Class III, IV, or V lupus nephritis confirmed by kidney biopsy
• C. The patient has another FDA labeled indication or a compendia supported indication for the requested agent and route
• 2. If FDA labeled indication, then ONE of the following:
• • Age is within FDA labeling for indication and route OR
• • Use is supported for age for indication and route OR
• • Patient has another compendia supported indication for requested route
• 3. If active 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
• 4. If active LN: patient will use background immunosuppressive LN therapy in combination with requested agent
• - Lupkynis requests: corticosteroids plus mycophenolate
• - Benlysta requests: corticosteroids plus mycophenolate, azathioprine, or cyclophosphamide
• 5. Prescriber is a rheumatologist, nephrologist, or has consulted one
• 6. If requested agent is Benlysta, ALL of the following:
• • No severe active CNS lupus
• • ONE of the following:
• – Will NOT be used with Lupkynis OR
• – Patient has active LN AND has tried and had 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 in combination with Lupkynis plus mycophenolate (medical records required)
• • ONE of the following:
• – Will NOT be used with another immunomodulatory agent (TNF inhibitors, JAK inhibitors, IL4 inhibitors) OR
• – Will be used with another immunomodulatory agent AND BOTH:
• A. Prescribing information does not limit such use
• B. Support for combination therapy provided (clinical trials, phase III studies, or guidelines)
• 7. If requested agent is Lupkynis, BOTH of the following:
• A. Will NOT be used with cyclophosphamide OR Saphnelo AND
• B. ONE of the following:
• – Will NOT be used with Benlysta OR
• – Patient has active LN AND has tried and inadequate response to TWO standard therapy courses and will use Lupkynis with Benlysta plus mycophenolate (medical records required)
• 8. Patient does NOT have any FDA labeled contraindications to the requested agent
• Compendia allowed: AHFS, DrugDex 1, 2a, or 2b

Reauthorization criteria

• ALL of the following:
• • previously approved agent; prescriber attests benefit and continued need (implied from standard renewal structure, though details not explicitly stated in this chunk)

Approval duration

12 months