Rilonacept (Arcalyst) — CPB 0770 | AETNA Coverage Update

Aetna modified CPB 0770 covering rilonacept (Arcalyst) billing, effective December 9, 2025. Here's what billing teams need to know.

Aetna, a CVS Health company, updated Clinical Policy Bulletin CPB 0770 governing rilonacept (Arcalyst) coverage for commercial medical plans. The policy covers three indications — cryopyrin-associated periodic syndromes (CAPS), deficiency of interleukin-1 receptor antagonist (DIRA), and recurrent pericarditis (RP) — billed under HCPCS J2793 and administered via CPT 96372. If your practice bills J2793 for any of these diagnoses, the updated criteria in this coverage policy are what Aetna's reviewers will use to approve or deny your claims starting December 9, 2025.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Rilonacept (Arcalyst) — CPB 0770
Policy Code	CPB 0770
Change Type	Modified
Effective Date	December 9, 2025
Impact Level	Medium
Specialties Affected	Rheumatology, Immunology, Cardiology
Key Action	Audit prior authorization submissions for J2793 to confirm all three indication-specific criteria are documented before billing

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Aetna Rilonacept Coverage Criteria and Medical Necessity Requirements 2025

The real issue with this coverage policy is how tightly Aetna stacks the criteria. Every indication requires multiple conditions to be met simultaneously — and missing even one kills the prior authorization.

CAPS (Cryopyrin-Associated Periodic Syndromes)

Members must be 12 or older. The diagnosis must be either familial cold autoinflammatory syndrome (FCAS) with classic signs — recurrent, intermittent fever and rash worsened by cool ambient temperatures — or Muckle-Wells syndrome (MWS), with chronic fever and rash of waxing and waning intensity. Both conditions are coded under ICD-10 M04.1 and M04.2 in the broader code set.

Medical necessity requires two things: a confirmed FCAS or MWS diagnosis with classic presentation, and functional impairment that limits activities of daily living. Document both explicitly in the chart before submitting for prior auth. "Diagnosis confirmed" alone won't cut it.

DIRA (Deficiency of Interleukin-1 Receptor Antagonist)

This is the narrowest indication. Members must weigh at least 10 kg, carry confirmed IL1RN mutations, and have already received anakinra (Kineret) — rilonacept here is specifically a maintenance therapy following anakinra treatment. If your patient hasn't gone through anakinra first, Aetna won't cover the switch to rilonacept under this indication.

This step-therapy requirement is worth flagging to your prescribing immunologist or rheumatologist before submitting. A prior authorization that skips the anakinra history will deny.

Recurrent Pericarditis (RP)

For RP, members must be 12 or older, have at least two documented episodes of pericarditis, and have failed at least two standard therapy agents. Those agents include colchicine, NSAIDs, and corticosteroids — many of which appear in the related HCPCS codes for this policy (J1741 for injectable ibuprofen, J1100 for dexamethasone sodium phosphate, J7509–J7512 for oral steroids).

Document the failed therapies with specificity: agent name, dose, duration, and reason for discontinuation or failure. Aetna's reviewers will look for this, and vague chart notes create denial risk.

TB Screening Requirement — All Indications

Every indication has a shared prerequisite: a documented negative TB test within 12 months of initiating therapy for patients who are biologic-naïve. Acceptable tests are the tuberculosis skin test (TST, billed as CPT 86580) or an interferon-release assay (IGRA, billed as CPT 86480 or 86481). A positive TB screening triggers additional requirements before rilonacept can be initiated. Make sure the TB test date appears in the prior auth submission — this is a common omission that delays approvals.

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Aetna Rilonacept Exclusions and Non-Covered Indications

Aetna's position is clear: all indications not listed in CPB 0770 are considered experimental, investigational, or unproven. There is no coverage pathway for off-label rilonacept use under commercial plans governed by this policy.

The real financial exposure here is reimbursement risk on off-label claims. Rilonacept is an expensive biologic. A claim denial on J2793 for an unlisted indication means your practice absorbs the cost unless you secured an advance beneficiary notice equivalent or documented the patient's financial responsibility upfront. If you're seeing rilonacept used outside CAPS, DIRA, or RP, loop in your compliance officer before billing J2793.

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Coverage Indications at a Glance

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Aetna Rilonacept Billing Guidelines and Action Items 2025

This is where rilonacept billing gets operationally demanding. The policy is clean in structure, but the documentation requirements are specific enough that gaps in the chart will translate directly into claim denials.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Rilonacept Under CPB 0770

Covered HCPCS Code (When Selection Criteria Are Met)

Code	Type	Description Copy
J2793	HCPCS	Injection, rilonacept, 1 mg

Administration Code

Code	Type	Description Copy
96372	CPT	Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular

TB Screening Codes (Required — All Indications, Biologic-Naïve Patients)

Code	Type	Description Copy
86480	CPT	Tuberculosis test, cell mediated immunity antigen response measurement; gamma interferon
86481	CPT	Tuberculosis test; enumeration of gamma interferon-producing T-cells in cell suspension
86580	CPT	Skin test; tuberculosis, intradermal

Related Imaging Codes

Standard Therapy and Comparator HCPCS Codes (Related to CPB 0770)

Key ICD-10-CM Diagnosis Codes

Note: The full ICD-10 code set under CPB 0770 contains 279 codes. The table above reflects selected key diagnosis codes relevant to the covered indications. Review the full code list at the Aetna CPB 0770 source to confirm applicable codes for your patient mix.

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