CurrentNeighborhood Health Plan of Rhode IslandPolicy 1800-A

Arcalyst (rilonacept) — Coverage Criteria

This policy governs prior authorization and coverage criteria for Arcalyst (rilonacept) for Neighborhood Health Plan of Rhode Island members, describing covered indications, required documentation, prescriber specialties, and duration of authorization.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyArcalyst (rilonacept) — Coverage Criteria

Policy CodePolicy 1800-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization with required documentation; approvals are generally granted for up to 12 months when indication-specific criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA-approved indications covered

12 moTypical authorization duration

>=12Min age for CAPS & RP

>=10 kgMin weight for DIRA

Coverage Criteria for Arcalyst (rilonacept)

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Cryopyrin-associated periodic syndromes (CAPS) — Initial therapy

Authorization of 12 months may be granted when ALL of the following are met:

CAPS initial: Member has a diagnosis of familial cold autoinflammatory syndrome (FCAS) or Muckle-Wells syndrome (MWS) with classic signs and symptoms

examples: recurrent, intermittent fever and rash; symptoms often exacerbated by exposure to generalized cool ambient temperature

Functional impairment: Member has functional impairment limiting activities of daily living

Cryopyrin-associated periodic syndromes (CAPS) — Continuation therapy

Authorization of 12 months may be granted for members using rilonacept for CAPS who achieve or maintain a positive clinical response when ALL of the following are met:

Age: Member is 12 years of age or older>= 12 years

includes new members

Clinical response: Member achieves or maintains a positive clinical response evidenced by low disease activity or improvement in signs and symptoms

Deficiency of interleukin-1 receptor antagonist (DIRA) — Initial therapy

Authorization of 12 months may be granted when ALL of the following are met:

Genetic confirmation: Member has IL1RN gene variants

IL1RN gene variant status required for initial requests

Use case: Rilonacept (Arcalyst) will be used for maintenance of remission following treatment with Kineret (anakinra)

Weight: Member weighs at least 10 kg>= 10 kg

DIRA — Continuation therapy

Authorization of 12 months may be granted for members using rilonacept for DIRA who achieve or maintain a positive clinical response when ALL of the following are met:

Weight: Member weighs at least 10 kg>= 10 kg

includes new members

Clinical response: Member achieves or maintains a positive clinical response evidenced by low disease activity or improvement in signs and symptoms

Recurrent pericarditis (RP) — Initial and continuation therapy

Authorization of 12 months may be granted when ALL of the following are met:

Episodes: Member has had at least two episodes of pericarditis>= 2 episodes

Prior therapy failure: Member has failed at least 2 agents of standard therapy (e.g., colchicine, NSAIDs, corticosteroids)

Age: Member is 12 years of age or older>= 12 years

TB screening and concomitant therapy restrictions (applies to all indications)

Coverage requires the following safety prerequisites:

TB screening: Documented negative TB test (TST or IGRA) within 12 months for persons naïve to biologic or targeted synthetic drugs; positive tests require further testing to exclude active diseasewithin 12 months

Do not administer if active TB; latent TB must be treated prior to initiation

Concomitant therapy: Member cannot use rilonacept concomitantly with any other biologic drug or targeted synthetic drug

Requests for rilonacept that are for indications other than the FDA-approved indications listed in this policy (Cryopyrin‑Associated Periodic Syndromes, maintenance of remission for Deficiency of Interleukin‑1 Receptor Antagonist, and recurrent pericarditis) are considered experimental/investigational and may be denied. For all indications, safety prerequisites apply, including documented TB screening and restrictions on concomitant biologic or targeted synthetic therapies.

Use of rilonacept (Arcalyst) for any indication not listed among the FDA‑approved indications in this policy is considered not medically necessary and will not be approved.

Referenced Drug Coding and Eligibility

Referenced Drugmixed

Arcalyst (rilonacept)

Drug listed; includes brand and generic and all dosage forms and strengths unless otherwise stated

Minimum weight for DIRA

Minimum weight for DIRAMember must weigh at least 10 kg

Applies to initial and continuation therapyThreshold applies to both initial authorization and continuation (includes new members)

Documentation requirementWeight must be documented in medical record or chart notes submitted with request

Minimum age for CAPS and RP

Minimum age for CAPS and RPMember must be 12 years of age or older

Applies to initial and continuation therapyThreshold applies to both initial authorization and continuation (includes new members)

Indication-specific requirementAge requirement is specified for CAPS (12+ years) and recurrent pericarditis (12+ years)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required for coverage. Initial authorizations may be granted for up to 12 months when criteria for the specific FDA‑approved indication are met. Continuation/renewal requests must document ongoing clinical benefit.

Authorization duration: up to 12 months for eligible indications
Continuation requests: require documentation of maintained or improved clinical response

Step Therapy

Recurrent Pericarditis Step Requirement

For recurrent pericarditis, initial authorization may be granted when diagnostic and treatment-step criteria are satisfied. Renewal requires documentation of clinical benefit (reduced recurrence or improvement in signs/symptoms).

Initial request criteria: at least two prior episodes of pericarditis; failure of at least two standard therapies (e.g., colchicine, NSAIDs, corticosteroids).
Authorization duration: up to 12 months for members ≥12 years of age.
Continuation criteria: evidence of decreased recurrence or improvement in at least one clinical measure (pericarditic/pleuritic chest pain, pericardial/pleural rubs, ECG changes, pericardial effusion, or inflammatory marker such as CRP).

Documentation Required

Required Documentation

Submit documentation to support the clinical indication and prior treatment history. Specific documentation differs by indication and by whether the request is for initial or continuation therapy.

Initial requests: chart notes, medical records, or claims history showing prior medications tried and response to therapy.
DIRA initial requests: IL1RN gene variant status must be provided.
Continuation requests: chart notes or medical record documentation supporting positive clinical response (e.g., reduced symptoms, objective measures).
For all indications: documented negative TB test (TST or IGRA) within 12 months for biologic/targeted‑synthetic‑naïve patients; if TB screening is positive, provide further evaluation to exclude active disease before treatment.
Do not administer concomitant biologic or targeted synthetic immunomodulatory drugs; documentation should confirm no concurrent use.

Denial Risk

Non‑approved Indications

Requests for indications other than the FDA‑approved uses listed (e.g., any uses beyond CAPS, DIRA maintenance, and recurrent pericarditis in specified age/weight groups) are considered experimental/investigational and not medically necessary.

Non‑approved indications: any condition not among the FDA‑approved indications (CAPS, maintenance of remission of DIRA, treatment/reduction in recurrence of recurrent pericarditis for specified ages/weights).

Background

Rilonacept (Arcalyst) is an interleukin‑1 (IL‑1) inhibitor approved to treat autoinflammatory conditions driven by IL‑1 signaling. The FDA‑approved uses covered by this policy include treatment of Cryopyrin‑Associated Periodic Syndromes (CAPS) — including Familial Cold Autoinflammatory Syndrome and Muckle‑Wells Syndrome — in patients aged >= 12 years; maintenance of remission for Deficiency of Interleukin‑1 Receptor Antagonist (DIRA) in patients weighing >= 10 kg; and treatment of recurrent pericarditis in patients aged >= 12 years. Prior to initiation, members must have documented TB screening (negative TST or IGRA within 12 months for biologic/targeted‑synthetic–naïve persons) and rilonacept must not be used concomitantly with any other biologic or targeted synthetic agent.

Key Definitions

CAPS (Cryopyrin-associated periodic syndromes)

Covered diagnosesFamilial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS)

Age thresholdPatients must be 12 years of age or older

Clinical criteria for initial approvalDiagnosis with classic signs/symptoms (e.g., recurrent/intermittent fever and rash; symptoms may be exacerbated by cool ambient temperature) and functional impairment limiting activities of daily living

Authorization durationApprovals are generally granted for up to 12 months when criteria are met

DIRA (Deficiency of interleukin-1 receptor antagonist)

Covered indicationMaintenance of remission for Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

Genetic confirmationMember must have IL1RN gene variants (genetic confirmation required for initial requests)

Minimum weightMember must weigh at least 10 kg

Use case and sequencingArcalyst (rilonacept) will be used for maintenance of remission following treatment with Kineret (anakinra)

Authorization durationApprovals are generally granted for up to 12 months when criteria are met

Recurrent pericarditis (RP)

Covered conditionRecurrent pericarditis (RP) with at least two prior episodes

Prior therapy requirementMember must have failed at least 2 agents of standard therapy (e.g., colchicine, NSAIDs, corticosteroids)

Age thresholdPatients must be 12 years of age or older

Authorization durationApprovals are generally granted for up to 12 months when criteria are met

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyArcalyst (rilonacept) — Coverage Criteria

Policy CodePolicy 1800-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization with required documentation; approvals are generally granted for up to 12 months when indication-specific criteria are met.

SourceLink

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