Lupkynis — Blue Cross Blue Shield of Texas

Initial criteria

• ONE of the following: (A) The requested agent is eligible for continuation of therapy AND prescriber states patient has been treated with requested agent (not samples) within past 90 days and is at risk if therapy is changed OR (B) 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: (1) The requested agent is FDA labeled or compendia supported for SLE AND (2) BOTH of the following: (A) ONE of the following: (1) Patient has tried and had an inadequate response to hydroxychloroquine OR (2) intolerance or hypersensitivity to hydroxychloroquine OR (3) FDA labeled contraindication to hydroxychloroquine AND (B) ONE of the following: (1) Patient has tried and had an inadequate response to ONE corticosteroid OR immunosuppressive agent (azathioprine, methotrexate, mycophenolate, cyclophosphamide) OR (2) intolerance or hypersensitivity to ONE corticosteroid OR immunosuppressive agent OR (3) FDA labeled contraindication to ALL corticosteroids AND immunosuppressive agents
• OR (B) The patient has a diagnosis of active LN AND BOTH of the following: (1) The requested agent is FDA labeled or compendia supported for LN AND (2) The patient has Class III, IV, or V lupus nephritis confirmed via kidney biopsy
• OR (C) The patient has another FDA labeled indication for the requested agent and route of administration
• If the patient has an FDA labeled indication, ONE of the following must apply: (A) age within FDA labeling for indication and route of administration OR (B) support for use in current age OR (C) indication supported in compendia
• If active SLE without active LN: BOTH of following: (A) currently treated with standard SLE therapy (corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide) AND (B) will continue standard SLE therapy in combination with requested agent
• If active LN: patient will use background immunosuppressive LN therapy (Lupkynis requests: corticosteroids plus mycophenolate; Benlysta requests: corticosteroids plus mycophenolate, azathioprine, or cyclophosphamide) in combination with requested agent
• Prescriber is a specialist in patient's diagnosis (rheumatologist, nephrologist) or has consulted with one
• If requested agent is Benlysta: (A) patient does NOT have severe active CNS lupus AND (B) ONE of the following: (1) NOT using in combination with Lupkynis OR (2) BOTH of the following: (A) diagnosis of active LN AND (B) 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 not to be used with another immunomodulatory agent unless labeling permits combination and supportive clinical evidence submitted
• If requested agent is Lupkynis: BOTH of following: (A) patient will NOT use in combination with cyclophosphamide OR Saphnelo AND (B) ONE of the following: (1) will NOT use with Benlysta OR (2) BOTH (A) diagnosis of active LN AND (B) tried and had inadequate response to TWO standard therapy courses as above and will use Lupkynis with Benlysta plus mycophenolate (medical records required)
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Compendia allowed: AHFS or DrugDex level 1, 2a, or 2b
• Alternate pathway (member resides in Ohio; Fully Insured or HIM Shop plan) requires no contraindication AND one of the following: another FDA labeled indication OR compendia supported indication OR two peer-reviewed journal articles supporting proposed use

Reauthorization criteria

• All of the following must be met (details follow on next page; policy states prerequisite of continuation and clinical benefit expected)

Approval duration

12 months