Arcalyst — Blue Cross Blue Shield of New Mexico

Initial criteria

• ONE of the following:
• A. BOTH of the following:
• 1. ONE of the following: CAPS diagnosis AND BOTH of the following:
• a. Patient has ONE of: Familial Cold Autoinflammatory Syndrome (FCAS) OR Muckle-Wells Syndrome (MWS)
• b. BOTH of the following:
• i. Patient has history of elevated pretreatment serum inflammatory markers (C-reactive protein/serum amyloid A)
• ii. Patient has history of at least TWO symptoms typical for CAPS (urticarialike rash, cold/stress triggered episodes, sensorineural hearing loss, musculoskeletal symptoms of arthralgia/arthritis/myalgia, chronic aseptic meningitis, skeletal abnormalities of epiphyseal overgrowth/frontal bossing)
• OR B. Diagnosis of deficiency of interleukin-1 receptor antagonist (DIRA) AND BOTH of the following:
• 1. Diagnosis confirmed via genetic testing for IL1RN mutations
• 2. Requested agent used for maintenance of remission
• OR C. Diagnosis of recurrent pericarditis (RP) AND BOTH of the following:
• 1. Pericarditis recurs after a symptom-free interval of 4 weeks or longer after acute episode
• 2. ONE of the following:
• A. ALL of the following:
• 1. Tried and had inadequate response to colchicine after at least 6-month therapy
• 2. ONE of the following:
• a. Colchicine used with NSAID ≥ 1 week OR
• b. Colchicine used with aspirin ≥ 1 week OR
• c. Intolerance or hypersensitivity to ONE NSAID or aspirin OR
• d. FDA labeled contraindication to ALL NSAIDs and aspirin
• 3. ONE of the following:
• a. Colchicine used with corticosteroid ≥ 1 week OR
• b. Intolerance or hypersensitivity to ONE corticosteroid OR
• c. FDA labeled contraindication to ALL corticosteroids
• B. Intolerance or hypersensitivity to colchicine OR
• C. FDA labeled contraindication to colchicine
• OR D. Patient has another FDA labeled indication for the requested agent and route of administration
• If patient has FDA labeled indication, then ONE of: patient age within FDA labeling OR evidence supports use in patient age
• OR B. Patient has another indication that is supported in compendia for requested agent and route of administration
• For Arcalyst in DIRA, patient weight ≥ 10 kg
• Prescriber is specialist (allergist, cardiologist, immunologist, pediatrician, rheumatologist) or has consulted such specialist
• ONE of the following regarding concomitant therapy:
• A. Patient will NOT use concurrently with another immunomodulatory agent (TNF, JAK, IL-4 inhibitors)
• B. If used in combination, BOTH:
• 1. Prescribing information does NOT limit such use
• 2. There is support for combination therapy (clinical trials, phase III studies, or guidelines)
• Patient does NOT have any FDA labeled contraindications to requested agent
• Special cases:
• For BCBS MT Fully Insured or MT HIM members under age 18 years:
• - No FDA contraindications
• - Indication supported in TWO peer-reviewed medical journal articles as generally safe and effective
• - Support for use in age bracket (infancy, childhood, adolescence) from TWO such articles
• For Ohio Fully Insured or HIM Shop (SG) members:
• - Member resides in Ohio
• - Plan is Fully Insured or HIM Shop (SG)
• - No FDA labeled contraindications
• - ONE of the following:
• 1. Another FDA labeled indication OR
• 2. Compendia-supported indication OR
• 3. TWO peer-reviewed journal articles supporting use as safe and effective

Reauthorization criteria

• Patient previously approved through plan Prior Authorization process
• Patient has had clinical benefit with requested agent
• Prescriber is a specialist in the area of diagnosis or has consulted one
• ONE of the following regarding concomitant therapy:
• A. Patient will NOT use concurrently with another immunomodulatory agent (TNF, JAK, IL-4 inhibitors)
• B. If used in combination, BOTH:
• 1. Prescribing information does NOT limit such use
• 2. Support for combination therapy (clinical trials or guidelines) submitted
• Patient does NOT have FDA labeled contraindications

Approval duration

12 months