CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Arcalyst (rilonacept) — Coverage Criteria

Defines prior authorization, clinical criteria, documentation, prescriber specialty, and renewal requirements for coverage of rilonacept (Arcalyst) for specified indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyArcalyst (rilonacept) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation (diagnosis, prior therapies, IL1RN status for DIRA, and TB screening) to request a 12-month approval when clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

>=12 yrsmin age CAPS & RP

>=10 kgmin weight DIRA

≥2 agentsRP prior therapy failures

test within 12 moTB screening

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Coverage Criteria for Rilonacept (Arcalyst)

Cryopyrin-associated periodic syndromes (CAPS) — Initial authorization

Authorization of 12 months may be granted for members 12 years of age or older for treatment of CAPS when ALL of the following are met:

CAPS initial criteria: Member has a diagnosis of familial cold autoinflammatory syndrome (FCAS) with classic signs and symptoms (recurrent, intermittent fever and rash often exacerbated by exposure to generalized cool ambient temperature) or Muckle-Wells syndrome (MWS) with classic signs and symptoms (chronic waxing and waning fever and rash, sometimes exacerbated by exposure to generalized cool ambient temperature).age >=12 years

12-month authorization

CAPS functional impairment: Member has functional impairment limiting activities of daily living.

CAPS — Renewal/Continuation

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:

CAPS continuation criteria: Member shows a positive clinical response evidenced by low disease activity or improvement in signs and symptoms of CAPS.age >=12 years

12-month renewal

DIRA — Initial authorization

Authorization of 12 months may be granted for members weighing at least 10 kg for treatment of DIRA when ALL of the following are met:

DIRA initial criteria: Member has documented IL1RN gene variants.weight >=10 kg

DIRA treatment context: Rilonacept (Arcalyst) will be used for maintenance of remission following treatment with Kineret (anakinra).

12-month authorization

DIRA — Renewal/Continuation

Authorization of 12 months may be granted for members weighing at least 10 kg (including new members) who are using rilonacept for DIRA and who achieve or maintain a positive clinical response when ALL of the following are met:

DIRA continuation criteria: Member shows a positive clinical response evidenced by low disease activity or improvement in signs and symptoms of DIRA.weight >=10 kg

12-month renewal

Recurrent pericarditis (RP) — Initial authorization

Authorization of 12 months may be granted for members 12 years of age or older for treatment of recurrent pericarditis when ALL of the following are met:

RP initial criteria — episodes: Member has had at least two episodes of pericarditis.age >=12 years

RP initial criteria — prior therapy: Member has failed at least 2 agents of standard therapy (e.g., colchicine, non-steroidal antiinflammatory drugs [NSAIDs], corticosteroids).

12-month authorization

Recurrent pericarditis (RP) — Renewal/Continuation

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

RP continuation criteria: Member demonstrates decreased recurrence of pericarditis or improvement in signs and symptoms as evidenced by improvement in pericarditic/pleuritic chest pain, pericardial or pleural rubs, electrocardiogram (ECG) findings, pericardial effusion, or C-reactive protein (CRP).age >=12 years

12-month renewal

All indications for rilonacept (Arcalyst) other than the FDA‑approved uses listed in this policy — treatment of Cryopyrin‑Associated Periodic Syndromes (CAPS) in patients ≥12 years, maintenance of remission for Deficiency of Interleukin‑1 Receptor Antagonist (DIRA) in patients weighing ≥10 kg, and treatment/reduction in recurrence risk for recurrent pericarditis (RP) in patients ≥12 years — are considered experimental/investigational and not medically necessary.

Rilonacept may not be used concomitantly with any other biologic drug or targeted synthetic drug. Requests for concurrent therapy with another biologic or targeted synthetic agent are not allowed and may be denied.

Use of rilonacept for indications other than the FDA‑approved indications listed in this policy is not medically necessary and is considered experimental/investigational.

Authorization Eligibility & Coding Thresholds

Authorization eligibility thresholds

Minimum age for CAPS and RPMembers must be at least 12 years of age for CAPS and recurrent pericarditis (RP)

Minimum weight for DIRAMembers must weigh at least 10 kg for DIRA

Recurrent pericarditis episode requirementMember must have had at least two episodes of pericarditis

Recurrent pericarditis prior therapy failureMember must have failed at least 2 agents of standard therapy (e.g., colchicine, NSAIDs, corticosteroids)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for rilonacept. Approvals may be granted for up to 12 months when specified clinical criteria are met for each FDA-approved indication.

Authorization duration: up to 12 months when criteria met

Step Therapy

Recurrent Pericarditis Step Therapy

For recurrent pericarditis, step therapy requires failure of at least two agents of standard therapy (for example, colchicine, NSAIDs, corticosteroids) prior to approval of rilonacept.

Recurrent pericarditis: documented failure of ≥2 standard agents (e.g., colchicine, NSAIDs, corticosteroids)

Documentation Required

Required Documentation

Initial request documentation must include IL1RN gene variant status for DIRA and chart notes, medical records, or claims history documenting previous medications tried and clinical response. Continuation requests must include chart notes or medical record documentation supporting positive clinical response.

DIRA initial requests: IL1RN gene variant status
Initial requests: chart notes/medical record documentation or claims history of prior medications tried and response
Continuation requests: chart notes/medical record documentation of positive clinical response

Documentation Required

TB Screening and Active TB

Documentation of a negative TB test (TST or IGRA) within 12 months is required for persons naïve to biologic or targeted synthetic drugs. If TB screening is positive, further evaluation (e.g., chest x-ray) must confirm no active disease. Do not administer rilonacept to members with active TB. If latent TB is identified, TB treatment must be initiated prior to starting therapy.

Negative TB test (TST or IGRA) within 12 months for biologic‑naïve persons
If TB screen positive: further testing to exclude active TB (e.g., chest x-ray)
Do not administer if active TB is present; treat latent TB prior to initiating therapy

Denial Risk

Indications Not Covered

Use of rilonacept for any indication other than the listed FDA‑approved indications is considered experimental/investigational and not medically necessary.

Non‑FDA indications considered experimental/investigational

Background

Rilonacept (Arcalyst) is an interleukin‑1 inhibitor with FDA‑approved indications for: treatment of Cryopyrin‑Associated Periodic Syndromes (CAPS) — including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle‑Wells Syndrome (MWS) — in adults and pediatric patients aged ≥12 years; maintenance of remission of Deficiency of Interleukin‑1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing ≥10 kg; and treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients aged ≥12 years.

Definitions

DIRA — definition and thresholds

DefinitionDeficiency of interleukin-1 receptor antagonist (DIRA)

Genetic requirement for maintenance useMaintenance use of rilonacept requires presence of IL1RN gene variants

Treatment contextRilonacept (Arcalyst) is used for maintenance of remission following initial treatment with Kineret (anakinra)

Weight thresholdMember must weigh at least 10 kg to qualify for DIRA treatment

CAPS — definition

DefinitionCryopyrin-associated periodic syndromes (CAPS) — includes familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS)

Clinical featuresFCAS: recurrent, intermittent fever and rash often exacerbated by exposure to cool ambient temperature; MWS: chronic waxing and waning fever and rash, sometimes cold-exacerbated

Age threshold (clinical eligibility)Indicated for adults and pediatric patients 12 years of age and older

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyArcalyst (rilonacept) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation (diagnosis, prior therapies, IL1RN status for DIRA, and TB screening) to request a 12-month approval when clinical criteria are met.

SourceLink

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