Benlysta — Blue Cross Blue Shield of Kansas

Initial criteria

• ONE of the following: (A) The requested agent is eligible for continuation of therapy AND ONE of the following: (1) The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR (2) The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the 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 systemic lupus erythematosus (SLE) WITHOUT active lupus nephritis (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) The patient has ONE of the following: (A) Has tried and had an inadequate response to hydroxychloroquine OR (B) Has an intolerance or hypersensitivity to hydroxychloroquine OR (2) The patient has an FDA labeled contraindication to hydroxychloroquine AND (B) ONE of the following: (1) The patient has ONE of the following: (A) Has tried and had an inadequate response to ONE corticosteroid OR immunosuppressive agent (i.e., azathioprine, methotrexate, mycophenolate, cyclophosphamide) OR (B) Has an intolerance or hypersensitivity to ONE corticosteroid OR immunosuppressive agent (i.e., azathioprine, methotrexate, mycophenolate, cyclophosphamide) OR (2) The patient has an FDA labeled contraindication to ALL corticosteroids AND immunosuppressive agents (i.e., azathioprine, methotrexate, mycophenolate, cyclophosphamide) OR (B) The patient has a diagnosis of active lupus nephritis (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: (A) The patient's age is within FDA labeling for the requested indication and agent OR (B) There is support for use at the patient's age for the requested indication OR (C) The patient has another compendia-supported indication
• If the patient has diagnosis of active SLE WITHOUT active LN, BOTH of the following: (A) The patient is currently treated with standard SLE therapy (corticosteroids, hydroxychloroquine, azathioprine, methotrexate, mycophenolate, cyclophosphamide) AND (B) The patient will continue standard SLE therapy in combination with the requested agent
• If the patient has a diagnosis of active LN, the patient will be using background immunosuppressive LN therapy (Lupkynis requests: corticosteroids plus mycophenolate; Benlysta requests: corticosteroids plus mycophenolate, azathioprine, or cyclophosphamide) in combination with the requested agent
• The prescriber is a specialist in rheumatology or nephrology, or has consulted with a specialist
• If the requested agent is Benlysta, ALL of the following: (A) The patient does NOT have severe active CNS lupus AND (B) ONE of the following: (1) The patient will NOT be using Benlysta in combination with Lupkynis OR (2) BOTH of the following: (A) The patient has active LN AND (B) 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 be using Benlysta in combination with Lupkynis plus mycophenolate (medical records required)
• If the requested agent is Benlysta, ONE of the following: (A) The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL4 inhibitors) OR (B) The patient will be using with another immunomodulatory agent AND BOTH of the following: (1) The prescribing information does NOT limit combination use AND (2) There is support for combination therapy (clinical trial or guideline evidence required)