CurrentCignaPolicy IP0400

Migalastat (Galafold) for Fabry disease — Coverage Criteria

Cigna coverage policy governing medical necessity, authorization, reauthorization, and excluded uses for migalastat (Galafold) in adults with Fabry disease; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyMigalastat (Galafold) for Fabry disease — Coverage Criteria

Policy CodePolicy IP0400

Change TypeNo material changes

Effective DateFeb 1, 2025

Next Review Date

Key ActionObtain prior authorization; initial approval up to 12 months and reauthorization requires documentation of beneficial response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age ≥18minimum patient age for coverage

12 monthsauthorization duration

Documented benefitcontinuation requirement

Concurrent ERTnot covered example

Coverage Criteria for Migalastat (Galafold)

Initial therapy (Medical Necessity)

Migalastat (Galafold) is considered medically necessary when ALL of the following are met:

Age 18 years or older>=18 years

supported by chunk 5

Diagnosis confirmation for males: Male individual with a pathogenic or likely pathogenic amenable galactosidase alpha gene (GLA) variant based on in vitro assay data

chunk 5

Diagnosis confirmation for females or VUS

Signs or symptoms (at least one): 1. Crises of severe pain in the extremities (acroparesthesia); 2. Appearance of vascular cutaneous lesions (angiokeratomas); 3. Sweating abnormalities (anhidrosis, hypohidrosis or hyperhidrosis); 4. Albuminuria/proteinuria; 5. Renal failure; 6. Cardiomyopathy

Policy Summary

PayerCigna

PolicyMigalastat (Galafold) for Fabry disease — Coverage Criteria

Policy CodePolicy IP0400

Change TypeNo material changes

Effective DateFeb 1, 2025

Next Review Date

Key ActionObtain prior authorization; initial approval up to 12 months and reauthorization requires documentation of beneficial response.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Concurrent administration of migalastat (Galafold) with enzyme replacement therapy is considered experimental/investigational and is not covered. Specifically, concurrent use with Fabrazyme (agalsidase beta) has been studied only in a limited setting (one small study, n=23) assessing single-dose coadministration; while a single dose of Galafold increased α‑Gal activity, the long-term safety and efficacy of combining Galafold with Fabrazyme have not been established and Galafold is not FDA‑approved for concurrent use with Fabrazyme. Similarly, concurrent use with Elfabrio (pegunigalsidase alfa) has not been evaluated and is not FDA‑approved. Requests for coverage for these concurrent regimens may be denied.

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation of migalastat (Galafold). Initial authorization may be approved for up to 12 months. Reauthorization requests may be approved for up to 12 months (same duration as initial approval).

Initial approval duration: up to 12 months
Reauthorization approval duration: up to 12 months

Note

No Step Therapy Specified

No step therapy requirements are specified for migalastat (Galafold) in this policy.

Documentation Required

Documentation Requirements

Documentation must include evidence supporting the diagnosis of Fabry disease and genetic variant data: a pathogenic or likely pathogenic amenable GLA variant based on in vitro assay data for males; for females (or when a variant of uncertain significance is reported), documentation must include a pathogenic or likely pathogenic amenable GLA variant or an amenable VUS by in vitro assay data AND clinical evidence of at least one sign or symptom of Fabry disease (e.g., acroparesthesia, angiokeratomas, sweating abnormalities, albuminuria/proteinuria, renal failure, or cardiomyopathy). Medication should be prescribed by or in consultation with a medical geneticist, nephrologist, or a physician who specializes in Fabry disease.

Evidence of diagnosis: genetic testing showing an amenable GLA variant based on in vitro assay data.
For females or when GLA variant is VUS: additional documentation of ≥1 Fabry sign/symptom (acroparesthesia, angiokeratomas, sweating abnormalities, albuminuria/proteinuria, renal failure, cardiomyopathy).
Prescribing clinician: medical geneticist, nephrologist, or Fabry disease specialist (or consultation documented).

Denial Risk

Concurrent Use with Enzyme Replacement Therapy — Denial Risk

Requests for concurrent use of migalastat (Galafold) with enzyme replacement therapies such as Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa) are considered experimental/undefined and are not FDA‑approved. Such concurrent-use requests are subject to denial.

Concurrent use with Fabrazyme (agalsidase beta) — not FDA approved; long-term safety and efficacy not established.
Concurrent use with Elfabrio (pegunigalsidase alfa) — not evaluated; not FDA approved for concurrent use.

Key Definitions

Amenable GLA variant

DefinitionAn amenable GLA (galactosidase alpha) variant is a GLA gene variant shown to be amenable to treatment with migalastat (Galafold) based on in vitro assay data (per product labeling).

Assay basisAmenability is determined by in vitro assay data demonstrating that the variant-encoded α‑Gal enzyme can be stabilized and has sufficient activity with migalastat (per product labeling and indication).

Population scopeIndication and amenability assessment apply to adults (age ≥18 years) with an amenable GLA variant as determined by in vitro assay data.

Clinical note for females or VUSFor females or individuals with a variant of uncertain significance (VUS), an amenable GLA variant per in vitro assay data must be present and, for coverage, at least one listed sign or symptom of Fabry disease is required (see coverage criteria).

Most actionable itemAmenability must be demonstrated by in vitro assay data as specified in product labeling; documentation of an amenable GLA variant is required for medical necessity and prior authorization of migalastat (Galafold).

OpenPayer

Migalastat (Galafold) for Fabry disease — Coverage Criteria

Coverage Criteria for Migalastat (Galafold)

Provider Actions, Prior Authorization, and Documentation Requirements

Key Definitions

Background