CurrentMass General Brigham Health PlanPolicy N/A

Arcalyst (rilonacept) prior authorization and coverage

Defines prior authorization, specialty pharmacy designation, coverage criteria, and continuation requirements for Arcalyst (rilonacept) for Mass General Brigham Health Plan members across clinical indications (CAPS, DIRA, recurrent pericarditis). Affects prescribers, pharmacies, and plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyArcalyst (rilonacept) prior authorization and coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionPrior authorization is required and the medication must be filled at a contracted specialty pharmacy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical approval duration

>=10 kgmin weight (DIRA)

>=12 yrsmin age (CAPS, RP)

Specialtyfill

Coverage Criteria for Arcalyst (rilonacept)

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Initial Therapy

Authorization may be granted when the following diagnosis-specific criteria are met:

CAPS initial: Member is >=12 years of age AND has a diagnosis of familial cold autoinflammatory syndrome (FCAS) with classic signs/symptoms (recurrent, intermittent fever and rash often exacerbated by exposure to generalized cool ambient temperature) or Muckle-Wells syndrome (MWS) with classic signs/symptoms (chronic fever and rash of waxing and waning intensity) AND member has functional impairment limiting activities of daily living AND medication is prescribed by or in consultation with a rheumatologist or immunologist.age >=12 years

From chunks 3-4

DIRA initial: Member weighs at least 10 kg AND has IL1RN mutation confirmed by documentation AND Arcalyst will be used for maintenance of remission following treatment with anakinra AND medication is prescribed by or in consultation with a rheumatologist or immunologist.weight >=10 kg

From chunk 5

Recurrent pericarditis initial: Member is >=12 years of age AND has had at least two episodes of pericarditis AND member has failed at least two agents of standard therapy (e.g., colchicine, NSAIDs, corticosteroids) with failure confirmed by chart notes, medical record documentation, or claims history (including response to therapy) AND medication is prescribed by or in consultation with a cardiologist, rheumatologist, or immunologist.>=2 prior episodes; failure of >=2 agents

From chunk 6

Continuation Therapy

Authorization for continuation may be granted for members already using Arcalyst who demonstrate clinical benefit:

CAPS continuation: Member is >=12 years of age and is using the requested medication for CAPS and achieves or maintains a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition.clinical improvement

From chunk 7

DIRA continuation: Member weighs at least 10 kg and is using the requested medication for DIRA and achieves or maintains a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition.clinical improvement

From chunk 8

Recurrent pericarditis continuation: Member is >=12 years of age and is using the requested medication for recurrent pericarditis and achieves or maintains a positive clinical response evidenced by decreased recurrence of pericarditis or improvement in signs and symptoms, demonstrated by improvement in any of: pericarditic chest pain, pericardial rubs, electrocardiogram (ECG), pericardial effusion, or C-reactive protein (CRP).improvement in any listed clinical/diagnostic measures

From chunk 9; approvals granted for 12 months

Provider Requirements and Actions

Prior Authorization

Prior Authorization and Specialty Fill

Prior authorization is required; medication is designated specialty and must be filled at a contracted specialty pharmacy.

Prior authorization required
Specialty medication — must be filled at contracted specialty pharmacy
Medical benefit and specialty limitations apply
Contact (All Plans, Specialty Medications): Phone: 877-519-1908; Fax: 855-540-3693

Step Therapy

Step Therapy for Recurrent Pericarditis

Member must have failed at least two agents of standard therapy (for example: colchicine, NSAIDs, corticosteroids) before authorization for recurrent pericarditis will be considered.

At least two distinct standard therapy agents must have been tried and documented
Applies to members 12 years of age or older for recurrent pericarditis

Documentation Required

Therapy Failure Documentation

Failure of at least two standard therapy agents for recurrent pericarditis must be documented in the medical record. Acceptable documentation includes chart notes, medical record documentation, or claims history showing previous medications tried and the member's response to therapy.

Include dates of trials, medication names, doses, duration, and reasons for discontinuation or inadequate response
Chart notes or specialist consultation (cardiologist, rheumatologist, or immunologist) supporting clinical failure are required

Note

New Member Continuation Requirement

Authorization may be granted for new members who are currently receiving treatment with the requested medication (excluding products obtained as samples or via manufacturer patient assistance programs).

New member continuation available when prior therapy is documented and not obtained via samples or manufacturer assistance

Documentation Required

Genetic Confirmation for DIRA

For deficiency of interleukin-1 receptor antagonist (DIRA), genetic confirmation of IL1RN mutation status is required. Treatment must be prescribed by or in consultation with a rheumatologist or immunologist and used for maintenance of remission following treatment with anakinra (Kineret).

Documented IL1RN mutation status required
Member must weigh at least 10 kg
Prescriber requirement: rheumatologist or immunologist

Definitions

CAPS — definition and presentation

DefinitionCryopyrin-associated periodic syndromes (CAPS) — includes Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

Typical presentationRecurrent, intermittent fever and rash; symptoms often exacerbated by exposure to generalized cool ambient temperature (FCAS) or chronic waxing-and-waning fever and rash (MWS).

Functional impactMay cause functional impairment limiting activities of daily living—documented impairment is required for coverage consideration.

Prescribing requirementMedication must be prescribed by or in consultation with a rheumatologist or immunologist.

Age thresholdIndication approved for adults and children 12 years of age and older.

DIRA — definition and treatment context

DefinitionDeficiency of interleukin-1 receptor antagonist (DIRA) caused by IL1RN mutations confirmed by documentation.

Treatment contextArcalyst (rilonacept) is used for maintenance of remission following treatment with Kineret (anakinra).

Weight thresholdAuthorized for patients weighing at least 10 kg.

Prescribing requirementMedication must be prescribed by or in consultation with a rheumatologist or immunologist.

Recurrent pericarditis — definition and treatment criteria

DefinitionRecurrent pericarditis — history of at least two episodes of pericarditis.

Step-therapy requirementMember must have failed at least two agents of standard therapy (e.g., colchicine, NSAIDs, corticosteroids) with failure confirmed by chart notes, medical records, or claims history.

Age thresholdIndication approved for adults and pediatric patients 12 years of age and older.

Prescribing requirementMedication must be prescribed by or in consultation with a cardiologist, rheumatologist, or immunologist.

Background

Rilonacept (Arcalyst) is indicated for three FDA-approved uses: treatment of cryopyrin-associated periodic syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle‑Wells Syndrome (MWS) in patients aged 12 years and older; maintenance of remission for deficiency of interleukin-1 receptor antagonist (DIRA) in adults and pediatric patients weighing at least 10 kg; and treatment of recurrent pericarditis and reduction in risk of recurrence in patients aged 12 years and older. Use outside these indications is considered experimental/investigational and not medically necessary.