Arcalyst (rilonacept) prior authorization and coverage
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Defines prior authorization, initial and reauthorization criteria for Arcalyst (rilonacept) for Colorado Rocky Mountain Health Plans members; applies to providers requesting coverage under the plan's clinical pharmacy program.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy - CAPS
Covered when ALL of the following are met for CAPS initial therapy:
Authorization will be issued for 12 months
Reauthorization - CAPS
Covered when ALL of the following are met for CAPS reauthorization:
Authorization will be issued for 12 months
Initial Therapy - DIRA
Covered when ALL of the following are met for DIRA initial therapy:
Authorization will be issued for 12 months
Initial and Reauthorization - Recurrent Pericarditis
Covered when ALL of the following are met for recurrent pericarditis:
Authorization will be issued for 12 months
Authorization will be issued for 12 months
Coverage for Arcalyst (rilonacept) is subject to the member’s benefit plan and applicable law. State mandates and federal regulatory requirements may modify or supersede the clinical criteria in this policy. In addition, member-specific benefit plan coverage (including plan exclusions, prior authorization rules, and utilization management programs) can affect whether a service is covered and the conditions under which it is reimbursed.
Providers should verify eligibility and benefits prior to initiating therapy and follow any additional policies or utilization management programs referenced by the member’s plan. Authorization decisions documented under this policy do not override separate program rules or legal requirements that may apply.
Initial Authorization Rules
Initial Authorization Rules
Initial authorization requirements by indication
Authorization for 12 months
Authorization for 12 months
Authorization for 12 months
Reauthorization / Continuation Criteria
Reauthorization
Reauthorization requirements across indications
Authorization issued for 12 months
Provider Actions and Requirements
Prior authorization required for Arcalyst (rilonacept)
Prior authorization is required for Arcalyst (rilonacept). Initial authorization is granted when the diagnosis criteria for the specific covered indication (CAPS, DIRA, or recurrent pericarditis) are met. Authorizations are issued for 12 months.
No step therapy requirement specified
No specific step therapy requirements are listed in this policy.
Documentation and claims may be used to support authorization
Prior authorization decisions may be based on prior claim or medication history, diagnosis codes (ICD‑10), and/or claim logic; documentation of diagnosis and treatment response is used for reauthorization.
- Document diagnosis consistent with the covered indication (CAPS, DIRA, or recurrent pericarditis).
- For reauthorization, provide evidence of positive clinical response to Arcalyst therapy.
Automated approvals and potential supply limits
Automated approval and re-approval processes may be used depending on program or therapeutic class, and supply limits may be enforced which could result in denial or quantity limitation.
- Be aware that prior approvals may be issued automatically based on claims/diagnosis logic in some programs.
- Supply limits may apply and could limit the quantity authorized.
Definitions
Background
Arcalyst (rilonacept) is an interleukin‑1 (IL‑1) blocker used for specific inflammatory conditions. This policy defines prior authorization and coverage criteria for Arcalyst across its covered indications and notes that approvals are generally issued for 12 months. The FDA‑labeled indications addressed in the policy include treatment of Cryopyrin‑Associated Periodic Syndromes (CAPS), maintenance of remission in Deficiency of Interleukin‑1 Receptor Antagonist (DIRA) for qualifying pediatric patients, and treatment and reduction in recurrence risk of recurrent pericarditis in patients aged 12 years and older.
When requesting prior authorization, providers must document the diagnosis and clinical information that meet the indication‑specific criteria in this policy. Because plan rules and regulatory requirements can vary, providers should confirm any additional documentation or program requirements with the payer prior to submission.
Step Therapy
| Step | Requirement |
|---|---|
| 1 | No specific step therapy requirements are listed in this policy. |
Quantity Limits
Site of Care
Infusion center site-of-care
The policy does not specify any site-of-care restrictions for infusion centers.
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