CurrentCommunity-CarePolicy N/A

Coverage criteria for pegunigalsidase alfa (Elfabrio) for Fabry disease

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Criteria for medical benefit coverage and authorization of pegunigalsidase alfa (Elfabrio) for treatment of Fabry disease for affected members and prescribing providers.

Policy Summary

PayerCommunity-Care

PolicyCoverage criteria for pegunigalsidase alfa (Elfabrio) for Fabry disease

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Last ReviewSep 1, 2023

Next Review DateSep 1, 2024

Key ActionObtain prior authorization with documentation of GLA gene mutation/deletion or low/absent alpha-galactosidase A activity and prescriber specialty or consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum age

1 yrAuth period

NoneQuantity limits

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CurrentCommunity-CarePolicy N/A

Coverage criteria for pegunigalsidase alfa (Elfabrio) for Fabry disease

Customize your policy alerts

Sign up for all Community-Care policy alerts

Know when Community-Care releases new policies or updates existing guidance.

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Criteria for medical benefit coverage and authorization of pegunigalsidase alfa (Elfabrio) for treatment of Fabry disease for affected members and prescribing providers.

Policy Summary

PayerCommunity-Care

PolicyCoverage criteria for pegunigalsidase alfa (Elfabrio) for Fabry disease

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Last ReviewSep 1, 2023

Next Review DateSep 1, 2024

Key ActionObtain prior authorization with documentation of GLA gene mutation/deletion or low/absent alpha-galactosidase A activity and prescriber specialty or consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum age

1 yrAuth period

NoneQuantity limits

Coverage Criteria for Pegunigalsidase Alfa (Elfabrio)

Initial Therapy

Covered when ALL of the following are met for initial approval:

Initial Approval Criteria: 1) Prescribed by, or in consultation with, a medical geneticist or other prescriber specialized in the treatment of Fabry disease; 2) Diagnosis of Fabry disease confirmed by documentation of a galactosidase alpha (GLA) gene mutation or deletion OR documentation of low or absent alpha-galactosidase A (alphaGal A) enzyme activity; 3) Patient aged >= 18 years; 4) Will not be used in combination with agalsidase beta (Fabrazyme) or migalastat (Galafold).

Continuation Therapy

Continuation of therapy covered when ALL of the following are met:

Continuation Criteria: 1) Diagnosis of Fabry disease; 2) Member is being monitored, has benefited from therapy, and is appropriate to continue therapy with pegunigalsidase alfa (Elfabrio).

Use of pegunigalsidase alfa (Elfabrio) in combination with other specific Fabry therapies is not permitted. Combination therapy with agalsidase beta (Fabrazyme) or migalastat (Galafold) is prohibited and such use does not meet the coverage criteria for initial approval.

These coverage criteria apply only to adults. Therapy for patients younger than 18 years is not covered under these criteria and requests for members under 18 do not meet the policy's criteria for approval.

Confirmation of Fabry disease accepted for coverage

Accepted documentation to confirm Fabry disease for coverage:

Accepted diagnostic confirmation: Documentation of a galactosidase alpha (GLA) gene mutation or deletion

Genetic testing showing a pathogenic or likely pathogenic GLA variant or documented gene deletion.

Accepted diagnostic confirmation: Documentation of low or absent alpha-galactosidase A (alphaGal A) enzyme activity

Biochemical enzyme assay results demonstrating low or absent alpha-galactosidase A activity.

Coding and Age Requirements

Applicable HCPCS CodesHCPCS

J2508

HCPCS code listed

Minimum age

Minimum patient age>= 18 years

Applies toInitial approval and continuation criteria require patient to be aged >= 18 years

Not covered under criteriaTherapy for patients younger than 18 years is not covered

Prescriber Requirements and Documentation

Prior Authorization

Prior authorization required for Elfabrio (pegunigalsidase alfa)

Prior authorization is required for pegunigalsidase alfa (Elfabrio) and approval is contingent on meeting the coverage criteria: the drug must be prescribed by, or in consultation with, a medical geneticist or other prescriber specialized in the treatment of Fabry disease; diagnosis confirmed by GLA gene mutation/deletion or low/absent alpha-galactosidase A enzyme activity; patient aged ≥ 18 years; and not used in combination with specified excluded therapies.

HCPCS: J2508

Note

Documentation Required

Required diagnostic and prescriber documentation

Required documentation to support approval: either documentation of a galactosidase alpha (GLA) gene mutation or deletion OR documentation of low or absent alpha-galactosidase A (alphaGal A) enzyme activity; also document that the prescriber is a medical geneticist or that treatment was in consultation with a prescriber specialized in Fabry disease.

Definitions and Diagnostic Criteria

Confirmed Fabry disease

Acceptable diagnostic evidence (Genetic)Documentation of a galactosidase alpha (GLA) gene mutation or deletion

Acceptable diagnostic evidence (Enzyme)Documentation of low or absent alpha-galactosidase A (alphaGal A) enzyme activity

PurposeRequired to confirm diagnosis of Fabry disease to support use of pegunigalsidase alfa (Elfabrio)

Use in authorizationDocumentation of either GLA mutation/deletion OR low/absent enzyme activity is required for prior authorization

Indications Supported for Coverage

Confirmation of Fabry disease to support therapy with pegunigalsidase alfa (Elfabrio).

Confirmation of Fabry disease to support therapy with pegunigalsidase alfa (Elfabrio):

Diagnostic evidence accepted: GLA gene mutation or deletion documented

Used to support initiation or continuation of pegunigalsidase alfa (Elfabrio).

Diagnostic evidence accepted: Low or absent alpha-galactosidase A (alphaGal A) enzyme activity documented

Used to support initiation or continuation of pegunigalsidase alfa (Elfabrio).

Eligibility Requirements

The policy does not require a particular family history to establish eligibility for pegunigalsidase alfa (Elfabrio). No specific family history requirement is stated as a condition for coverage.

Confirmation of Fabry disease is required prior to approval. Coverage requires either documentation of a GLA (galactosidase alpha) gene mutation or deletion or documentation of low or absent alpha-galactosidase A (alphaGal A) enzyme activity.

Background on Fabry Disease

Fabry disease is an inherited lysosomal storage disorder caused by deficiency of the enzyme alpha-galactosidase A. Diagnosis is commonly confirmed by identification of a pathogenic variant (mutation or deletion) in the GLA gene or by demonstration of low or absent alpha-galactosidase A enzyme activity.

Not Covered

Beyond the explicitly listed exclusions for combination use with agalsidase beta (Fabrazyme) or migalastat (Galafold), the policy does not enumerate additional genetic tests or indications as excluded. No other genetic tests or indications are specifically listed as not covered under this policy.