CurrentCignaPolicy N/A

Inflammatory Conditions - Arcalyst Prior Authorization Policy

Defines Cigna's prior authorization criteria for coverage of Arcalyst (rilonacept) for FDA‑approved indications (CAPS, DIRA, recurrent pericarditis) and lists not medically necessary uses and prescribing/monitoring expectations; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Arcalyst Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateFeb 18, 2026

Key ActionPrior authorization required; ensure specialist prescribing or consultation and documentation that the patient meets indication-specific criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA-approved indications covered

6 moInitial approval CAPS/DIRA

3 moInitial approval pericarditis

1 yrRenewal approval duration

RequiredSpecialist requirement

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Coverage Criteria for Arcalyst (rilonacept)

Cryopyrin-Associated Periodic Syndromes (CAPS)

Covered for CAPS when ONE of the following is met:

A) Initial Therapy. Approve for 6 months if ALL of the following are met: (i) Patient is 6gt;= 12 years of age; AND (ii) The medication is prescribed by or in consultation with a rheumatologist, geneticist, allergist/immunologist, or dermatologist.

B) Patient is Currently Receiving Arcalyst. Approve for 1 year if ALL of the following are met: (i) Patient has been established on this medication for at least 6 months (patients with < 6 months or restarting are reviewed under Initial Therapy); AND (ii) Patient meets at least ONE of the following: (a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: resolution of fever, improvement in rash/skin manifestations, normalization or clinically significant improvement in serum markers such as C-reactive protein or amyloid A, reduction in proteinuria, stabilization of serum creatinine); OR (b) Compared with baseline, patient experienced improvement in at least one symptom (examples: fewer cold-induced attacks; less joint pain/tenderness, stiffness, or swelling; decreased fatigue; improved function or activities of daily living).

Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

Covered for DIRA when ONE of the following is met:

A) Initial Therapy. Approve for 6 months if ALL of the following are met: (i) Patient is 6gt;= 10 kg (22 pounds); AND (ii) Genetic testing has confirmed bi-allelic pathogenic variants in the IL1RN gene; AND (iii) According to the prescriber, patient has demonstrated a clinical benefit with Kineret (anakinra subcutaneous injection) (examples: normalized acute phase reactants; resolution of fever, skin rash, and bone pain; reduced corticosteroid dose); AND (iv) The medication is prescribed by or in consultation with a rheumatologist, geneticist, dermatologist, or a physician specializing in the treatment of autoinflammatory disorders.

B) Patient is Currently Receiving Arcalyst. Approve for 1 year if ALL of the following are met: (i) Patient has been established on this medication for at least 6 months (patients with < 6 months or restarting are reviewed under Initial Therapy); AND (ii) Patient meets at least ONE of the following: (a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: improvement in rash/skin manifestations, normalization or clinically significant improvement in serum markers such as C-reactive protein or erythrocyte sedimentation rate, reduction in proteinuria, stabilization of serum creatinine); OR (b) Compared with baseline, patient experienced an improvement in at least one symptom.

Pericarditis

Covered for Pericarditis when ONE of the following is met:

A) Initial Therapy. Approve for 3 months if ALL of the following are met: (i) Patient is 6gt;= 12 years of age; AND (ii) Patient has recurrent pericarditis; AND (iii) Prior to starting Arcalyst, the patient had a history of at least three episodes of pericarditis; AND (iv) Patient meets ONE of the following: (a) For the current episode, the patient is receiving standard treatment (NSAIDs, colchicine, and/or systemic corticosteroids); OR (b) Standard treatment is contraindicated; AND (v) The medication is prescribed by or in consultation with a cardiologist or rheumatologist.

B) Patient is Currently Receiving Arcalyst. Approve for 1 year if ALL of the following are met: (i) Patient has been established on this medication for at least 3 months (patients with < 3 months or restarting are reviewed under Initial Therapy); AND (ii) Patient meets at least ONE of the following: (a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: normalization of inflammatory biomarkers such as erythrocyte sedimentation rate and/or C-reactive protein, continued resolution of fever); OR (b) Compared with baseline, patient experienced an improvement in at least one symptom.

Arcalyst should not be administered in combination with another biologic agent for an inflammatory condition (concurrent biologic therapy). Arcalyst has not been used in combination with tumor necrosis factor inhibitors (TNFis). An increased incidence of serious infections has been associated with another interleukin-1 blocker (Kineret [anakinra]) when given in combination with TNFis.

Any other uses not specified as covered above are considered not medically necessary.

The appendix provides examples of biologic agents, mechanisms of action, and example indications for reference; it does not itself establish additional covered indications or explicit exclusions beyond the conditions noted above.

Coding and Measured Criteria

No billing codes listedmixed

No codes listed

CRP threshold (inv-09)

C-reactive protein (CRP) threshold> 1 mg/dL

ContextACC uses CRP > 1 mg/dL as a marker of inflammatory phenotype in pericarditis

Use in trials/guidanceElevated CRP used to identify patients for IL-1 inhibitor therapy in recurrent/refractory pericarditis

Weight requirement (inv-10)

Minimum weight for DIRA maintenance≥ 10 kg

Relation to indicationDIRA indication specifies maintenance of remission in patients weighing ≥ 10 kg

Trial/prescribing note

Provider Requirements, Documentation, and Authorization

Prior Authorization

Prior authorization required

Prior Authorization Required — approvals are provided for specified durations (initial and continuation) and initial approvals must be prescribed by or in consultation with a specialist who manages the treated condition.

Initial and continuation approval durations are specified per indication (e.g., 6 months initial for CAPS and DIRA; 3 months initial for pericarditis; continuation approvals commonly 1 year when established on therapy).
Initial approval requires the medication to be prescribed by or in consultation with a specialist (rheumatologist, cardiologist, geneticist, allergist/immunologist, dermatologist, or other specialty appropriate to the indication).

Note

Reference list only

Reference list only — Appendix lists biologic agents, mechanisms of action, and example indications for clinician reference. The appendix does not itself establish prior authorization rules or coverage criteria.

Definitions and Abbreviations

CAPS (inv-20)

DefinitionCryopyrin-associated periodic syndromes (CAPS) are a spectrum of rare genetic syndromes including familial cold autoinflammatory syndrome (FCAS), Muckle‑Wells syndrome (MWS), and neonatal onset multisystem inflammatory disease (NOMID/CINCA).

Pathophysiology/treatmentCAPS are IL‑1 mediated; IL‑1 blockers are recommended as standard of care across the spectrum to control symptoms and inflammation.

Age for ArcalystArcalyst indicated for CAPS in patients ≥ 12 years of age.

DIRA (inv-21)

DefinitionDeficiency of interleukin‑1 receptor antagonist (DIRA) is caused by bi‑allelic loss‑of‑function variants in the IL1RN gene and presents as an IL‑1 mediated autoinflammatory disorder.

Recommended therapy

Background on Arcalyst (rilonacept)

Arcalyst (rilonacept) is an interleukin-1 (IL-1) blocker indicated for treatment of IL-1–mediated autoinflammatory conditions. FDA‑approved indications include cryopyrin-associated periodic syndromes (CAPS) — including familial cold autoinflammatory syndrome (FCAS) and Muckle‑Wells syndrome (MWS) — for patients aged ≥12 years, maintenance treatment for deficiency of interleukin-1 receptor antagonist (DIRA) in appropriately selected patients, and reduction in recurrence risk for recurrent pericarditis in patients aged ≥12 years. Clinical trial and guideline evidence support symptomatic and biomarker improvement with IL‑1 blockade in these conditions; prior authorization is required with specified initial and renewal approval durations per indication.

Appendix: Biologic Agents, Mechanisms, and Examples

The appendix lists approximately 30 biologic products grouped by agent and formulation and summarizes their mechanisms of action (for example, inhibition of IL‑6, IL‑17/IL‑17A, IL‑23, integrin antagonism, CD20-directed cytolytic antibodies, and T‑cell costimulation modulation). For each agent the appendix provides example FDA‑approved indications (not a comprehensive list) for clinician reference; it does not replace product prescribing information and is intended as a reference only.