Arcalyst (rilonacept) — Blue Cross Blue Shield of Illinois

Initial criteria

• ONE of the following:
• A. BOTH of the following: 1. ONE of the following A. Diagnosis of CAPS AND BOTH of the following: (1) Patient has ONE of the following phenotypes: FCAS OR MWS AND (2) BOTH of the following: (A) History of elevated pretreatment serum inflammatory markers (C-reactive protein/serum amyloid A) AND (B) History of ≥2 symptoms typical for CAPS (e.g., urticarialike 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 of the following: (1) Diagnosis confirmed via genetic testing for mutations in IL1RN gene AND (2) Requested agent used for maintenance of remission OR C. Diagnosis of recurrent pericarditis (RP) AND BOTH of the following: (1) Pericarditis that recurs after symptom-free interval ≥4 weeks after initial acute episode AND (2) ONE of the following: (A) ALL of the following: (1) Tried and had inadequate response to colchicine after ≥6-month therapy AND (2) ONE of the following: (A) Colchicine used concomitantly with NSAID ≥1 week OR (B) Colchicine used concomitantly with aspirin ≥1 week OR (C) Intolerance or hypersensitivity to ONE NSAID or aspirin OR (D) FDA labeled contraindication to ALL NSAIDs and aspirin AND (3) ONE of the following: (A) Colchicine used concomitantly with corticosteroid ≥1 week OR (B) Intolerance or hypersensitivity to ONE corticosteroid OR (C) FDA labeled contraindication to ALL corticosteroids OR (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 AND 2. If FDA labeled indication, THEN ONE of the following: (A) Patient’s age within FDA labeling OR (B) There is support for use for that age
• B. Patient has another indication supported in compendia for requested agent and route of administration
• AND if requested agent is Arcalyst for DIRA, patient weight ≥10 kg
• AND Prescriber is a specialist in area of diagnosis (e.g., allergist, cardiologist, immunologist, pediatrician, rheumatologist) or has consulted one
• AND ONE of the following: (A) Patient will NOT use requested agent in combination with another immunomodulatory agent (TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) If used in combination, BOTH of the following: (1) Use not limited per prescribing information AND (2) There is supporting evidence (clinical trials, phase III studies or guidelines provided)
• AND Patient has no FDA labeled contraindications to requested agent
• Compendia allowed: AHFS or DrugDex level 1, 2a, 2b
• Length of Approval: 12 months
• Alternate approvals:
• 1. For BCBS MT Fully Insured or MT HIM members: age <18 years, no contraindication, and indication supported in ≥2 peer-reviewed journals as safe/effective and age group supported in ≥2 such studies.
• 2. For Ohio Fully Insured or HIM Shop members: resides in Ohio, plan is Fully Insured or HIM Shop, no contraindication, and one of: another FDA labeled indication OR supported compendia indication OR ≥2 peer-reviewed journal articles as safe and effective.

Reauthorization criteria

• Patient previously approved for requested agent through plan’s prior authorization process
• Patient has experienced clinical benefit with requested agent
• Prescriber is a specialist in area of diagnosis or has consulted one
• ONE of the following: (A) Patient will NOT use agent in combination with another immunomodulatory agent OR (B) if used in combination BOTH: (1) use not limited per prescribing info AND (2) there is support for combination therapy (submitted studies/guidelines)
• Patient has no FDA labeled contraindications to requested agent

Approval duration

12 months