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Arcalyst (rilonacept) prior authorization policy - OpenPayer

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OpenPayerPolicy UpdatesPharmacy & Specialty DrugsArcalyst (rilonacept) prior authorization policy

CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1009-13

Arcalyst (rilonacept) prior authorization policy

Defines prior authorization/notification coverage criteria, initial and reauthorization rules, and program controls for Arcalyst (rilonacept) including indications CAPS, DIRA (maintenance of remission), and recurrent pericarditis for applicable members. Also notes automated approval based on claim history and potential supply limits or state mandates.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyArcalyst (rilonacept) prior authorization policy

Policy CodePolicy 2025 P 1009-13

Change TypeAnnual review / criteria updates

Effective DateAug 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Arcalyst; approvals are issued for 12 months when criteria are met.

POLICY UPDATE CHANGES

Added coverage criteria for deficiency of IL-1 receptor antagonist (DIRA) and recurrent pericarditis in 5/2021.

Annual review with no change to coverage criteria in 5/2023, 5/2024, and 5/2025.

Change control history documents prior adjustments to criteria (e.g., removal/addition of IL-1 agents requirement, age changes) in years 2013-2016.

3Covered Indications

12 moAuthorization duration

May 2025Last annual review

Coverage Summary

Scope: Defines prior authorization/notification coverage criteria, initial and reauthorization rules, and program controls for Arcalyst (rilonacept) for the indications CAPS (including FCAS and MWS), maintenance of remission for DIRA, and recurrent pericarditis for applicable members. Policy implements prior authorization and reauthorization requirements tied to diagnosis and documented clinical response/remission criteria where specified. Approvals are issued for 12 months for initial and reauthorization when criteria are met.

Program identifiers: Program Number 2025 P 1009-13; Policy number: 2025 P 1009-13.

Policy metadata

Covered Indications3

Authorization duration12 months

Last annual reviewMay 2025

Effective date2025-08-01

Policy number2025 P 1009-13

Initial Authorization Criteria

Initial Authorization - CAPS

Arcalyst will be approved based on the following criterion:

ALL of the following

Diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS)

Authorization will be issued for 12 months.

Initial Authorization - DIRA (maintenance of remission)

Arcalyst will be approved based on the following criteria:

ALL of the following

Diagnosis of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
Disease is in remission
- Diary score for DIRA remission: Diary score of < 0.5 (reflecting no fever, skin rash and bone pain)< 0.5
- C-reactive protein (CRP) for DIRA remission: Acute phase reactants < 0.5 mg/dL CRP< 0.5 mg/dL
- Absence of objective skin rash
- No radiological evidence of active bone lesions

Authorization will be issued for 12 months.

Initial Authorization - Recurrent Pericarditis (RP)

Arcalyst will be approved based on the following criterion:

ALL of the following

Diagnosis of recurrent pericarditis (RP)

Authorization will be issued for 12 months.

Reauthorization / Continuation Criteria

Reauthorization - CAPS

Arcalyst will be approved based on the following criterion:

Documentation of positive clinical response to Arcalyst therapy

Authorization will be issued for 12 months.

Reauthorization - DIRA

Arcalyst will be approved based on the following criterion:

Documentation of positive clinical response to Arcalyst therapy

Authorization will be issued for 12 months.

Reauthorization - Recurrent Pericarditis

Arcalyst will be approved based on the following criterion:

Documentation of positive clinical response to Arcalyst therapy

Authorization will be issued for 12 months.

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization/notification is required for Arcalyst. Approvals (initial and reauthorization where criteria are met) are issued for 12 months.

Program Number 2025 P 1009-13
Automated approval may be possible per program rules

Documentation Required

Document clinical response for reauthorization

For reauthorization, providers must document a positive clinical response to Arcalyst therapy to support continued approval.

Documentation Required

Document DIRA remission criteria

For DIRA initial authorization, providers must document that the disease is in remission and supply objective remission data.

Diary score < 0.5 (reflecting no fever, skin rash and bone pain)
Acute phase reactants: CRP < 0.5 mg/dL
Absence of objective skin rash
No radiological evidence of active bone lesions

Billing Rule

Supply limits and automated approvals

Supply limits may apply. UnitedHealthcare may approve initial and re-authorization based solely on prior claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated approval and re-approval processes varies by program or therapeutic class.

Documentation Required

State mandates and benefit plan limits

State mandates, federal regulatory requirements, and the member-specific benefit plan coverage may impact coverage criteria and should be considered when determining coverage.

Applicable Codes & Identifiers

Diagnosis codes referenced (ICD-10)ICD-10

No codes listed

Program/Coverage administrative identifiersmixed

Program Number 2025 P 1009-13

UnitedHealthcare Pharmacy Clinical Pharmacy Programs identifier for Arcalyst prior authorization

Clinical Evidence & References

Primary reference: Arcalyst [package insert], Regeneron Pharmaceuticals, Inc.; May 2021.

Background summary: Arcalyst (rilonacept) is an interleukin-1 blocker indicated for CAPS (including FCAS and MWS) in adults and children ≥12 years, for maintenance of remission of DIRA in patients weighing at least 10 kg, and for treatment and reduction in recurrence risk of recurrent pericarditis in patients ≥12 years.

Background

Arcalyst (rilonacept) is an interleukin-1 (IL-1) blocker indicated for Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children aged 12 years and older; for maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing at least 10 kg; and for treatment and reduction in risk of recurrence of recurrent pericarditis in adults and children 12 years and older.

This policy implements prior authorization and reauthorization rules tied to the diagnosis and requires documentation of positive clinical response for reauthorization. For DIRA initial authorization, the policy requires documentation of disease remission, including a diary score of < 0.5, CRP < 0.5 mg/dL, absence of objective skin rash, and no radiological evidence of active bone lesions. Supply limits and automated approvals based on prior claims or diagnosis codes may apply.

DIRA remission thresholds

Diary score for DIRA remission< 0.5

C-reactive protein (CRP) for DIRA remission< 0.5 mg/dL

Revision History

5/2021material_change

Annual review added coverage criteria for Deficiency of Interleukin-1 Receptor Antagonist (DIRA) and recurrent pericarditis; updated background and references.

5/2023annual_review

Annual review with no change to coverage criteria; added state mandate footnote and updated reference format.

5/2024annual_review

Annual review with no change to coverage criteria.

5/2025annual_reviewLatest

Annual review with no change to coverage criteria.

2013-2016 (historical)historical_edits

Change control history documents prior adjustments including formatting updates, adding IL‑1 agents requirement, removal/addition of clinical symptom and acute phase reactant requirements, and in 4/2016 simplification of criteria to require diagnosis only.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyArcalyst (rilonacept) prior authorization policy

Policy CodePolicy 2025 P 1009-13

Change TypeAnnual review / criteria updates

Effective DateAug 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Arcalyst; approvals are issued for 12 months when criteria are met.

On This Page

Coverage Summary Initial Authorization Criteria Reauthorization / Continuation Criteria Provider Actions Applicable Codes & Identifiers Clinical Evidence & References Background Revision History