WHA
 

Arcalyst (rilonacept)

Indications for Prior Authorization

Arcalyst (rilonacept) injection
  • For diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS)
    Indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and pediatric patients 12 years and older.

  • For diagnosis of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
    Indicated for the maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing at least 10 kg.

  • For diagnosis of Recurrent Pericarditis
    Indicated for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and pediatric patients 12 years and older.

Criteria

Arcalyst

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS)

  • Diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and/or Muckle-Wells Syndrome (MWS) [A]
    • AND
  • Prescribed by or in consultation with one of the following:
    • Immunologist
    • Allergist
    • Dermatologist
    • Rheumatologist
    • Neurologist
    • Specialist with expertise in the management of CAPS
Arcalyst

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS)

  • Patient has experienced disease stability or improvement in clinical symptoms while on therapy as evidenced by one of the following:
    • Improvement in rash, fever, joint pain, headache, or conjunctivitis
    • Decreased number of disease flare days
    • Normalization of inflammatory markers (C-reactive protein [CRP], erythrocyte sedimentation rate [ESR], serum amyloid A [SAA])
    • Corticosteroid dose reduction
    • Improvement in MD global score or active joint count
Arcalyst

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

  • Diagnosis of deficiency of interleukin-1 receptor antagonist (DIRA)
    • AND
  • Patient weighs at least 10 kg
    • AND
  • Patient is currently in remission (e.g., no fever, skin rash, and bone pain; no radiological evidence of active bone lesions; C-reactive protein [CRP] less than 5 mg/L)
Arcalyst

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Recurrent Pericarditis

  • Diagnosis of recurrent pericarditis as evidenced by at least 2 episodes that occur a minimum of 4 to 6 weeks apart [1,2]
    • AND
  • Prescribed by or in consultation with a cardiologist
    • AND
  • Trial and failure, contraindication, or intolerance to at least one of the following [2]:
    • nonsteroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen, naproxen)
    • colchicine
    • corticosteroids (e.g., prednisone)
Arcalyst

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Recurrent Pericarditis

  • Patient demonstrates positive clinical response to therapy

  • Guideline ID
    GL-661188

  • Formulary
    Premium

  • Effective date
    Oct 1, 2026

  • P&T approval date
    Aug 19, 2008

P & T Revisions

2026-07-30, 2025-12-18, 2025-08-06, 2024-08-06, 2023-08-22, 2023-08-07, 2022-08-03, 2022-04-05, 2021-08-02, 2021-05-07, 2021-02-03, 2020-07-14

  1. Arcalyst Prescribing Information. Regeneron Pharmaceuticals. Zug, Switzerland. May 2021.
  2. Wang, T, Klein, A, Cremer, P. et al. 2025 Concise Clinical Guidance: An ACC Expert Consensus Statement on the Diagnosis and Management of Pericarditis: A Report of the American College of Cardiology Solution Set Oversight Committee. JACC. 2025 Dec, 86 (25) 2691–2719. https://doi.org/10.1016/j.jacc.2025.05.023. Accessed July 2026.
  3. Klein AL, Imazio M, Cremer P, et al. Phase 3 trial of interleukin-1 trap rilonacept in recurrent pericarditis. N Engl J Med 2021;384:31-41.
  1. CAPS refer to rare genetic syndromes generally caused by mutations in the NLRP-3 [Nucleotide-binding domain, leucine rich family (NLR), pyrin domain containing 3] gene (also known as Cold-Induced Auto-inflammatory Syndrome-1 [CIAS1]). CAPS disorders are inherited in an autosomal dominant pattern with male and female offspring equally affected. Features common to all disorders include fever, urticaria-like rash, arthralgia, myalgia, fatigue, and conjunctivitis. In most cases, inflammation in CAPS is associated with mutations in the NLRP-3 gene which encodes the protein cryopyrin, an important component of the inflammasome. Mutations in NLRP-3 result in an overactive inflammasome resulting in excessive release of activated IL-1β that drives inflammation. [1]
  • 2026-07-30: 2026 Annual Review. Update to CAPS criteria to remove requirement that it will not be used in combination with another biologic agent. Added aspirin as an example of NSAID for recurrent pericarditis.
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2025-08-06: 2025 Annual Review - no changes
  • 2024-08-06: 2024 Annual Review - updated references
  • 2023-08-22: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-08-07: Annual review - no criteria changes
  • 2022-08-03: Annual review - no criteria changes
  • 2022-04-05: Updated prescriber requirement for CAPS
  • 2021-08-02: Annual review - removed CAPS age criterion
  • 2021-05-07: Addition of criteria for the new recurrent pericarditis indication
  • 2021-02-03: Addition of criteria for new DIRA indication.
  • 2020-07-14: Annual review