CurrentMass General Brigham Health PlanPolicy N/A

Elfabrio (pegunigalsidase alfa-iWxj) prior authorization and coverage criteria

Defines prior authorization, eligibility, and reauthorization criteria for Elfabrio for adults with confirmed Fabry disease under Mass General Brigham Health Plan pharmacy/medical benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyElfabrio (pegunigalsidase alfa-iWxj) coverage criteria

Policy CodePolicy N/A

Change TypeMaterial revision — prescriber specialty required

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit two medical charts confirming diagnosis plus prescriber specialty and attestation that medication will not be used with Galafold or Fabrazyme.

SourceLink

POLICY UPDATE CHANGES

Updated initial criteria to require specialist prescriber.

Authorization may be granted for members new to the plan within the past 90 days who are currently receiving the medication.

12 monthsApproval duration

2Medical records required

90 daysNew-member grace period

adultsIndication population

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Coverage Criteria for Elfabrio

Initial Therapy

Authorization may be granted when ALL of the following are met, or for new-to-plan members currently receiving treatment within the past 90 days (excludes samples/PAP).

Entry paths: Path A: Member new to the plan within the past 90 days and currently receiving the requested medication (excludes products obtained only as samples or via manufacturer patient assistance programs). Path B: Member meets ALL clinical criteria listed under 'Clinical requirements (Path B)'.

See Clinical requirements (Path B) for the alternative authorization path; see Continuation Therapy for reauthorization requirements.

Clinical requirements (Path B)

When seeking authorization via clinical criteria, ALL of the following must be met.

Diagnostic confirmation: Two medical charts showing diagnosis was confirmed by enzyme assay demonstrating a deficiency in alpha-galactosidase enzyme activity or by genetic testing, or documentation the member is a symptomatic obligate carrier.

Two separate medical records required to confirm diagnostic testing.

Diagnosis: Member has a diagnosis of Fabry disease.

Combination therapy attestation: Provider attestation that the requested medication will not be used in combination with Galafold or Fabrazyme.

Provider must affirm no concurrent use with listed therapies.

Prescriber specialty: Prescriber is a nephrologist, cardiologist, or a specialist in metabolic disorders or genetics.

Specialist prescriber requirement operationalized per policy change.

Continuation Therapy

Reauthorization will be approved when documentation demonstrates response to therapy and within standard approval duration:

Response documentation: Documentation (medical charts or laboratory results) demonstrating the member is responding to therapy (for example: reduction in plasma GL-3 or GL-3 inclusions, improvement and/or stabilization in renal function, or pain reduction).

Submit supporting clinical data with reauthorization request.

Approval duration: Initial approvals and reauthorizations are granted for 12 months.12 months

Products obtained only as samples or provided through a manufacturer's patient assistance program are not eligible for the new-to-plan 'currently receiving treatment' 90-day grace. If the member's only source of the medication is through samples or a manufacturer assistance program, the exception for members new to the plan within the past 90 days does not apply and prior authorization must follow the standard clinical criteria.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required; may be granted for members new to the plan within the past 90 days who are currently receiving the medication (excludes products obtained as samples or via manufacturer patient assistance programs).

Documentation Required

Combination Therapy Restriction

Provider must attest medication will not be used in combination with Galafold or Fabrazyme.

Documentation Required

Required Documentation

Required documentation — Submit two medical charts showing diagnosis confirmation by enzyme assay demonstrating a deficiency in alpha‑galactosidase enzyme activity or by genetic testing, or documentation that the member is a symptomatic obligate carrier; documentation of a diagnosis of Fabry disease; provider attestation (including that the medication will not be used with Galafold or Fabrazyme); and that the prescriber is a nephrologist, cardiologist, or a specialist in metabolic disorders or genetics. For continuation requests, submit clinical documentation (e.g., medical charts, laboratory results) demonstrating response to therapy such as reduction in plasma globotriaosylceramide (GL-3) or GL-3 inclusions, improvement or stabilization in renal function, or pain reduction.

Key Definitions

Diagnosis confirmation criteria

Diagnostic methodsEnzyme assay demonstrating deficiency in alpha-galactosidase A activity, genetic testing confirming pathogenic variant, or documentation that the member is a symptomatic obligate carrier

Number of confirming records requiredTwo (2) medical charts documenting the diagnostic confirmation

Diagnosis requiredMember must have a clinical diagnosis of Fabry disease

Prescriber specialtyPrescriber must be a nephrologist, cardiologist, or a specialist in metabolic disorders or genetics

Combination therapy prohibitionProvider must attest the medication will not be used in combination with Galafold or Fabrazyme

Background

Elfabrio (pegunigalsidase alfa-iWxj) is indicated for the treatment of adults with confirmed Fabry disease. Diagnosis may be confirmed by an enzyme assay demonstrating deficiency of alpha-galactosidase A activity or by genetic testing; symptomatic obligate carriers are included. The prescriber should be a nephrologist, cardiologist, or a specialist in metabolic disorders or genetics when requesting authorization.

Revision History

2025-03-01policy_effective_dateLatest

Policy changes requiring specialist prescriber for initial authorization became effective; initial criteria updated to require prescriber be a nephrologist, cardiologist, or specialist in metabolic disorders or genetics.

2024-12-11policy_revision

Reviewed and updated at December P&T to operationalize initial criteria by specifying specialist prescriber; effective date set for 2025-03-01.

2023-09-13