Arcalyst (rilonacept) — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ONE of the following:
• A. BOTH of the following:
• 1. ONE of the following:
• A. Diagnosis of CAPS AND BOTH:
• - Diagnosis of FCAS OR MWS
• - BOTH: elevated pretreatment serum inflammatory markers (CRP or serum amyloid A) AND ≥2 symptoms typical for CAPS (urticarial-like rash, cold/stress triggered episodes, sensorineural hearing loss, musculoskeletal symptoms such as arthralgia/arthritis/myalgia, chronic aseptic meningitis, skeletal abnormalities of epiphyseal overgrowth/frontal bossing)
• OR
• B. Diagnosis of DIRA AND BOTH:
• - Diagnosis confirmed via genetic testing for IL1RN mutation
• - Agent used for maintenance of remission
• OR
• C. Diagnosis of recurrent pericarditis (RP) AND BOTH:
• 1. Pericarditis recurs ≥4 weeks after prior episode
• 2. ONE of the following:
• A. ALL of the following:
• - Tried colchicine ≥6 months AND inadequate response, AND
• - Colchicine used with NSAID or aspirin ≥1 week OR intolerance/contraindication to all NSAIDs/aspirin, AND
• - Colchicine used with corticosteroid ≥1 week OR intolerance/contraindication to corticosteroids
• OR
• B. Intolerance or hypersensitivity to colchicine
• OR
• C. FDA-labeled contraindication to colchicine
• OR
• D. Other FDA-labeled indication for agent and route of administration AND patient’s age within or supported by FDA labeling for indication
• OR
• E. Other indication supported in compendia for requested agent and route of administration
• ADDITIONAL REQUIREMENTS:
• - If indication is DIRA, patient weight ≥10 kg
• - Prescriber is or has consulted with specialist (allergist, cardiologist, immunologist, pediatrician, rheumatologist)
• - ONE of the following:
• A. NOT using in combination with another immunomodulatory agent (e.g., TNF inhibitor, JAK inhibitor, IL-4 inhibitor)
• OR
• B. Combination use allowed when prescribing information does not limit and support is provided (clinical trials/guidelines)
• - No FDA labeled contraindications
• ADDITIONAL ALTERNATIVE CRITERIA:
• 1. BCBS MT Fully Insured or MT HIM member <18 years, with indication supported by ≥2 peer-reviewed journal articles as generally safe/effective for condition and age group, and no contraindications
• OR
• 2. Ohio residents with Fully Insured or HIM Shop plan, no contraindications, AND one of:
• - Other FDA-labeled indication
• - Other compendia-supported indication
• - ≥2 peer-reviewed articles supporting safe/effective use (excluding case studies)

Reauthorization criteria

• 1. Previously approved for agent through plan prior authorization
• 2. Clinical benefit with treatment documented
• 3. Prescriber is or has consulted with a specialist (allergist, cardiologist, immunologist, pediatrician, rheumatologist)
• 4. ONE of the following:
• A. NOT using with another immunomodulatory agent (TNF inhibitor, JAK inhibitor, IL-4 inhibitor)
• OR
• B. Combination use supported by prescribing info and clinical evidence (trials, phase III studies, or guidelines)
• 5. No FDA labeled contraindications

Approval duration

12 months