Kineret — Blue Cross Blue Shield of Kansas

Initial criteria

• A. The patient has a diagnosis of CAPS with symptoms of arthralgia/arthritis/myalgia, chronic aseptic meningitis, skeletal abnormalities of epiphyseal overgrowth/frontal bossing OR
• B. The patient has a diagnosis of DIRA AND BOTH of the following: 1. Diagnosis confirmed via genetic testing for mutations in the IL1RN gene AND 2. Agent used for maintenance of remission OR
• C. The patient has a diagnosis of RP AND BOTH of the following: 1. Pericarditis recurs after a symptom-free interval of ≥4 weeks after acute episode AND 2. ONE of the following: (A) ALL of the following: (1) Tried and inadequate response to colchicine after ≥6 months therapy AND (2) ONE of: (A) Colchicine + NSAID ≥1 week OR (B) Colchicine + aspirin ≥1 week OR (C) Intolerance/hypersensitivity to ONE NSAID or aspirin OR (D) FDA-labeled contraindication to ALL NSAIDs and aspirin AND (3) ONE of: (A) Colchicine + corticosteroid ≥1 week OR (B) Intolerance/hypersensitivity to ONE corticosteroid OR (C) FDA-labeled contraindication to ALL corticosteroids OR (B) Intolerance/hypersensitivity to colchicine OR (C) FDA-labeled contraindication to colchicine OR (D) Patient has another FDA-labeled indication for requested agent and route of administration
• 2. If FDA-labeled indication, ONE of the following: (A) Patient’s age within FDA labeling OR (B) Support for use in patient’s age for the indication
• 3. Or patient has another indication supported in compendia for requested agent and route
• 4. If requested agent is Arcalyst for DIRA, patient weight ≥10 kg
• 5. Prescriber is a specialist (allergist, cardiologist, immunologist, pediatrician, rheumatologist) or has consulted with one
• 6. ONE of the following regarding immunomodulatory use: (A) Will NOT use in combination with another immunomodulatory agent (TNF, JAK, IL-4 inhibitors) OR (B) Will use in combination AND BOTH of following: (1) Prescribing info does NOT limit such use AND (2) Support for combination therapy (clinical trials, phase III studies, or guidelines submitted)
• 7. Patient does NOT have any FDA-labeled contraindications
• Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence

Reauthorization criteria

• 1. Patient previously approved through plan’s prior authorization process
• 2. Patient has had clinical benefit with requested agent
• 3. Prescriber is a specialist or has consulted with specialist
• 4. ONE of the following regarding immunomodulatory use: (A) Will NOT use in combination with another immunomodulatory agent (TNF, JAK, IL-4, etc.) OR (B) Will use in combination AND BOTH: (1) Prescribing information does NOT limit combination AND (2) Support for combination use provided
• 5. Patient does NOT have any FDA-labeled contraindications

Approval duration

12 months