CurrentColorado Rocky Mountain Health Plans | UnitedHealthcare Pharmacy Clinical Pharmacy ProgramsPolicy 2025 P 1258-8

Galafold® (migalastat) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Defines UnitedHealthcare prior authorization/notification criteria for Galafold (migalastat) for treatment of adults with Fabry disease with an amenable GLA variant, including initial and reauthorization criteria and authorization duration. Applies to UnitedHealthcare commercial plans; notes state mandates and plan benefit variations.

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare Pharmacy Clinical Pharmacy Programs

PolicyGalafold® (migalastat) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1258-8

Change TypeClarified / Revised (annual reviews)

Effective DateDec 1, 2025

Next Review Date

Key ActionPrior authorization/notification required; document amenable GLA variant for initial approval and positive clinical response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Added Elfabrio (pegunigalsidase alfa-iwxj) as a drug to not be used in combination with Galafold.

Reauthorization duration set to 12 months.

Annual reviews with updates to references; no changes to clinical coverage criteria in multiple years.

2Decision nodes (Initial, Reauthorization)

12Authorization duration (months)

Coverage Summary

Defines UnitedHealthcare prior authorization/notification criteria for Galafold (migalastat) for treatment of adults with Fabry disease who have an amenable GLA variant. Applies to UnitedHealthcare commercial plans and program number 2025 P 1258-8; state mandates and member-specific benefit plan coverage may affect criteria. Authorization decisions include initial and reauthorization nodes, and authorizations are issued for 12 months. Galafold is approved under accelerated approval based on reduction in KIC GL-3 substrate.

Initial Therapy Criteria

Initial Authorization

Galafold will be approved based on all of the following criteria:

Diagnosis of Fabry disease
Genetic variant: Patient has an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data
See definition for 'Amenable GLA variant'
Concomitant therapy exclusion: Patient is not receiving Galafold in combination with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj)

Continuation / Reauthorization Criteria

Reauthorization

Galafold will be approved based on both of the following criteria:

Clinical response: Documentation of positive clinical response to Galafold therapy
Provider must document positive clinical response for reauthorization.
Concomitant therapy exclusion: Patient is not receiving Galafold in combination with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj)
Claims may be denied if used in combination with excluded enzyme therapies.

Authorization and Dates

Authorization duration12 months

Effective date2025-12-01

Last review2025-10

Policy number2025 P 1258-8

Unapproved / Concomitant Therapy Exclusions

Galafold must not be used in combination with enzyme replacement therapies — specifically Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj). Change history notes that Elfabrio was added as a drug to not be used in combination with Galafold in the 10/2023 review.

Provider Actions & Authorization Workflow

Prior Authorization

Prior authorization required

Prior authorization/notification required per UnitedHealthcare Pharmacy Clinical Pharmacy Programs; approvals granted when initial or reauthorization criteria are met.

Documentation Required

Genetic variant documentation

Provider must document that the patient has an amenable GLA variant based on in vitro assay data for initial approval.

Documentation Required

Clinical response documentation for reauthorization

Provider must document positive clinical response to Galafold therapy for reauthorization.

Billing Rule

Authorization duration

Authorizations will be issued for 12 months.

Denial Risk

Concomitant enzyme therapy exclusion

Claims may be denied or approval withheld if Galafold is used in combination with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj).

Prior Authorization

Automated approval allowance

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic as part of automated processes.

Definitions & Clinical Evidence

Galafold (migalastat) is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data. This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate, and continued approval may require verification of clinical benefit in confirmatory trials.

Amenable GLA variant: a galactosidase alpha gene (GLA) variant shown to be responsive to migalastat based on in vitro assay data.

Reference: Galafold [package insert], Amicus Therapeutics US, LLC; March 2025.

Revision History

10/2023clarified