Arcalyst — Blue Cross Blue Shield of Montana

Initial criteria

• ONE of the following:
• A. BOTH of the following:
• 1. ONE of the following: A. The patient has a diagnosis of Cryopyrin-Associated Periodic Syndrome (CAPS) AND BOTH of the following: (1) The patient has ONE of the following disorders (phenotypes): Familial Cold Autoinflammatory Syndrome (FCAS) OR Muckle-Wells Syndrome (MWS); (2) BOTH of the following: A. The patient has a history of elevated pretreatment serum inflammatory markers (C-reactive protein/serum amyloid A); AND B. The patient has a history of at least two symptoms typical for CAPS (urticarialike rash, cold/stress triggered episodes, sensorineural hearing loss, musculoskeletal symptoms, chronic aseptic meningitis, skeletal abnormalities).
• B. The patient has a diagnosis of deficiency of interleukin-1 receptor antagonist (DIRA) AND BOTH of the following: (1) The patient's diagnosis confirmed via genetic testing for IL1RN mutation; AND (2) The requested agent is used for maintenance of remission.
• C. The patient has a diagnosis of recurrent pericarditis (RP) AND BOTH of the following: (1) The patient has pericarditis that recurs after a symptom-free interval ≥ 4 weeks after an acute episode; AND (2) ONE of the following: A. ALL of the following: patient tried colchicine for ≥ 6 months; colchicine used concomitantly with NSAID or aspirin ≥ 1 week OR intolerance or contraindication to these; and colchicine used concomitantly with corticosteroid ≥ 1 week or intolerance/contraindication to corticosteroids; OR B. intolerance or hypersensitivity to colchicine; OR C. FDA labeled contraindication to colchicine.
• D. The patient has another FDA labeled indication for the requested agent and route of administration AND ONE of the following: age within FDA labeling or supported by clinical evidence for age.
• B. The patient has another indication supported in compendia for the requested agent and route of administration.
• Additional requirements: If the requested agent is Arcalyst for DIRA, patient weight ≥ 10 kg.
• Prescriber specialist or has consulted a specialist (allergist, cardiologist, immunologist, pediatrician, rheumatologist).
• The patient not using or appropriately combined with another immunomodulatory agent consistent with labeling and supported by evidence.
• The patient has no FDA labeled contraindications.
• Alternative approval pathways: For BCBS MT Fully Insured or MT HIM members age < 18 years, must meet published evidence criteria with two supporting peer-reviewed studies on indication and age appropriateness. OR For Ohio Fully Insured or HIM Shop (SG) members, clinical use may be justified by FDA label, compendia support, or two peer-reviewed journal articles as generally safe and effective.
• Compendia allowed: AHFS or DrugDex levels 1, 2a, 2b; Oncology compendia: NCCN 1 or 2A, AHFS-DI, DrugDex 1,2A,2B, or Clinical Pharmacology, Lexi-Drugs A, or peer-reviewed medical literature.

Reauthorization criteria

• The patient previously approved for requested agent through plan’s process.
• The patient has had clinical benefit with the requested agent.
• The prescriber is a specialist or has consulted a specialist (allergist, cardiologist, immunologist, pediatrician, rheumatologist).
• The patient not using or appropriately combined with another immunomodulatory agent consistent with labeling and supported by evidence.
• The patient has no FDA labeled contraindications.

Approval duration

12 months