CurrentCignaPolicy N/A

Fabry Disease - Galafold Prior Authorization Policy

Prior authorization policy for Galafold (migalastat capsules) prescribing, coverage criteria, and exclusions for Cigna-administered health benefit plans. Defines required patient characteristics, prescriber specialty, approval duration, and disallowed concurrent uses.

Policy Summary

PayerCigna

PolicyFabry Disease - Galafold Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAdded restriction (Elfabrio concurrent use)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended for Galafold; ensure the medication is prescribed by or in consultation with a geneticist, nephrologist, or a physician who specializes in Fabry disease and request approvals for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added concurrent use with Elfabrio as a condition not recommended for approval.

No criteria changes noted in prior annual revision.

1Covered Indication (FDA-approved)

2Explicit Non-covered Concurrent Uses Listed

Coverage Summary

Coverage summary: Galafold (migalastat) is indicated for treatment of Fabry disease in adults with an amenable GLA variant determined by in vitro assay. This policy applies to Cigna-administered health benefit plans and requires prior authorization. Approvals are provided for 1 year for the FDA-approved indication. (Policy review date: 11/06/2024; last annual revision noted 11/15/2023 and 11/06/2024.)

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FDA-Approved Indication - Approval Criteria

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

Patient is ≥ 18 years of age
Patient has an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data
The medication is prescribed by or in consultation with a geneticist, nephrologist, or a physician who specializes in the treatment of Fabry disease
Documentation of prescriber specialty or consultation should be provided with the prior authorization request

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Not Covered / Experimental Uses

Not Covered / Considered Experimental or Investigational

Galafold is considered experimental, investigational or unproven for ANY other use(s) including (but not limited to):

Concurrent use with Fabrazyme (agalsidase beta intravenous infusion) — long-term safety and efficacy of concurrent use not established; Galafold is not FDA approved for concurrent use with Fabrazyme
One small study assessed single-dose coadministration; long-term safety/efficacy not established
Concurrent use with Elfabrio (pegunigalsidase alfa intravenous infusion) — Galafold has not been evaluated for use in combination with Elfabrio and is not FDA approved for concurrent use with enzyme replacement therapy
Added as a condition not recommended for approval in the annual revision

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Rationale: Long-term safety and efficacy of concurrent use of Galafold with enzyme replacement therapies has not been established; Galafold is not FDA approved for concurrent use with Fabrazyme, and Galafold has not been evaluated in combination with Elfabrio. A material policy change added concurrent use with Elfabrio as a condition not recommended for approval.

Provider Actions & Authorization

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Galafold. Approvals are provided for the duration noted: 1 year for the FDA-approved indication.

Approval duration: 1 year

Documentation Required

Prescriber specialty or consultation required

The medication must be prescribed by or in consultation with a geneticist, nephrologist, or a physician who specializes in the treatment of Fabry disease. Documentation of prescriber specialty or consultation should be provided with the prior authorization request.

Provide documentation of prescriber specialty or consultation with the PA request

Denial Risk

Not covered uses - concurrent enzyme replacement therapy

Requests for concurrent use of Galafold with enzyme replacement therapies such as Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa) are considered experimental, investigational, or unproven and are not eligible for approval.

Background & Definitions

Galafold is an oral α‑galactosidase A pharmacological chaperone indicated for treatment of Fabry disease in adults with an amenable GLA variant based on in vitro assay data. Fabry disease is an X‑linked lysosomal storage disorder in which deficient α‑Gal activity leads to accumulation of globotriaosylceramide (GL‑3) and progressive multisystem disease affecting the kidneys, heart, and nervous system.

Amenable GLA variant: A galactosidase alpha gene (GLA) mutation shown to be amenable to migalastat treatment based on in vitro assay data.

Policy Summary

PayerCigna

PolicyFabry Disease - Galafold Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAdded restriction (Elfabrio concurrent use)

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Fabry Disease - Galafold Prior Authorization Policy

Coverage Summary

Not Covered / Experimental Uses

Applicable Codes

Provider Actions & Authorization

Clinical Evidence & References

Background & Definitions

Revision History