CurrentUnitedHealthcarePolicy 2025 P 1009-13

Arcalyst (rilonacept) prior authorization

UnitedHealthcare prior authorization policy for Arcalyst (rilonacept) covering indications, initial authorization and reauthorization criteria for members; affects providers requesting coverage for Arcalyst.

Policy Summary

PayerUnitedHealthcare

PolicyArcalyst (rilonacept) prior authorization

Policy CodePolicy 2025 P 1009-13

Change TypeNo material change

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals are issued for 12 months when the member has a covered diagnosis (CAPS, DIRA in remission, or recurrent pericarditis).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period routinely issued

2011-2025policy review history span

3indications listed

Coverage Criteria for Arcalyst (rilonacept)

Initial Authorization — CAPS

Covered when ALL of the following are met:

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Initial Authorization — DIRA

Covered when ALL of the following are met:

DIRA initial authorization: (1) Diagnosis of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

AND (2) Disease is in remission (e.g., diary score < 0.5; CRP < 0.5 mg/dL; absence of objective skin rash; no radiological evidence of active bone lesions)

Initial Authorization Requirements by Indication

Initial Authorization — grouped by indication

Initial authorization requirements by indication

CAPS initial: Diagnosis of CAPS (FCAS or MWS)

Authorization issued for 12 months

DIRA initial: Diagnosis of DIRA AND disease is in remission as defined (diary score < 0.5; CRP < 0.5 mg/dL; absence of objective skin rash; no radiological evidence of active bone lesions)

RP initial: Diagnosis of recurrent pericarditis (RP)

Authorization issued for 12 months

Reauthorization / Continuation Requirements

Reauthorization — grouped continuation requirements

Reauthorization (continuation) requirements

Continuation: Documentation of positive clinical response to Arcalyst therapy is required for reauthorization

Authorization issued for 12 months

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Arcalyst (rilonacept). Providers must obtain approval before initiating therapy. Covered diagnoses include Cryopyrin-Associated Periodic Syndromes (CAPS) — including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS); Deficiency of Interleukin-1 Receptor Antagonist (DIRA); and recurrent pericarditis (RP). Initial authorizations are typically issued for 12 months.

Covered diagnoses: CAPS (FCAS, MWS)
DIRA
Recurrent pericarditis (RP)

Step Therapy

Step Therapy / Trial Requirements

There are no explicit step-therapy or trial-of-failure requirements specified in the coverage criteria. Authorization decisions are based on meeting the listed diagnostic criteria and required documentation.

Documentation Required

Reauthorization Documentation Required

For reauthorization, documentation of a positive clinical response to Arcalyst therapy is required. Reauthorizations are generally issued for 12 months; providers should supply clinical evidence of benefit at the time of renewal.

Documentation of positive clinical response to therapy
Reauthorization period: 12 months

Denial Risk

Coverage Limitations and Program Rules

Coverage may be limited by state mandates, federal requirements, the member's benefit plan, or other programs (for example, site-of-care or specialty pharmacy program rules). UnitedHealthcare may also approve initial and reauthorizations based on prior claim/medication history, diagnosis codes (ICD‑10), and automated claim logic; supply limits may apply.

Subject to member benefit plan and applicable state or federal mandates
Approvals may be based on claim/medication history, ICD‑10 codes, and program-specific automated processes
Supply limits may be in place

Definitions

CAPS (Cryopyrin-Associated Periodic Syndromes)

DefinitionCryopyrin-Associated Periodic Syndromes (CAPS)

Included subtypesFamilial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS)

Age indication (labeling)Adults and children 12 years and older for CAPS indications

DIRA (Deficiency of Interleukin-1 Receptor Antagonist)

DefinitionDeficiency of Interleukin-1 Receptor Antagonist (DIRA)

Indication scopeMaintenance of remission indication applies to adults and pediatric patients weighing at least 10 kg

Remission example criteriaDiary score < 0.5; CRP < 0.5 mg/dL; absence of objective skin rash; no radiological evidence of active bone lesions

Background

Arcalyst (rilonacept) is an interleukin-1 blocker used for specific inflammatory conditions. Per the policy, Arcalyst is indicated for treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in appropriate patients, for maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and children weighing at least 10 kg, and for treatment and reduction in risk of recurrence of recurrent pericarditis (RP) in patients aged 12 years and older. Prior authorization is required and when approved, an authorization is typically issued for 12 months.

Step	Requirement
1	No explicit step therapy or trial‑of‑failure requirements are specified in this policy.

Site of Care

Note

No specific infusion center requirement stated

No specific site-of-care requirement is stated for Arcalyst; supply limits and program variations (including site or program-specific rules) may apply.

Supply limits may be in place.
Program variations may affect automated approvals or site-of-care processes.

Policy Summary

PayerUnitedHealthcare

PolicyArcalyst (rilonacept) prior authorization

Policy CodePolicy 2025 P 1009-13

Change TypeNo material change

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals are issued for 12 months when the member has a covered diagnosis (CAPS, DIRA in remission, or recurrent pericarditis).

SourceLink

On This Page

OpenPayer

Arcalyst (rilonacept) prior authorization

Coverage Criteria for Arcalyst (rilonacept)

Initial Authorization Requirements by Indication

Reauthorization / Continuation Requirements

Provider Actions and Authorization Requirements

Coding and Clinical Threshold Examples

Definitions

Background

Step Therapy

Quantity Limits and Supply

Site of Care