CurrentColorado Rocky Mountain Health PlansPolicy N/A

Galafold (migalastat) prior authorization

Criteria and authorization rules for coverage of Galafold (migalastat) for adults with Fabry disease; applies to UnitedHealthcare Pharmacy Clinical Pharmacy Programs as listed for Colorado Rocky Mountain Health Plans members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGalafold (migalastat) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting Fabry disease diagnosis and an amenable GLA variant by in vitro assay.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Adultsindicated population

12 moauthorization period

Excludedcombination therapy

P&T reviewsprogram review history

Coverage Criteria

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Initial Authorization: a) Diagnosis of Fabry disease;

Item a must be met

Initial Authorization: b) Patient has an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data;

Item b must be met

Initial Authorization: c) Patient is not receiving Galafold in combination with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj).

Item c must be met

Reauthorization

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

Reauthorization: a) Documentation of positive clinical response to Galafold therapy;

Item a must be met

Reauthorization: b) Patient is not receiving Galafold in combination with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj).

Item b must be met; authorization will be issued for 12 months

Initial Therapy

Initial therapy criteria

Initial Therapy: Confirmed diagnosis of Fabry disease; amenable GLA variant demonstrated by in vitro assay; not used in combination with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj)

Reauthorization / Continuation

Reauthorization

Reauthorization/continuation criteria

Continuation: Documentation of positive clinical response to Galafold therapy; patient must not be receiving Galafold in combination with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj)

Authorization renewed for 12 months

Provider Actions & Operational Notes

Prior Authorization

Prior Authorization Required — Initial Authorization

Initial authorization is required. Submit documentation showing the diagnosis of Fabry disease and evidence the patient has an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data. Include supporting clinical records and genetic test results with the initial prior authorization request. Operational steps: verify member eligibility, attach genetic assay report demonstrating an amenable GLA variant, and indicate the requested dose and anticipated duration.

Diagnosis: Fabry disease
Documentation: genetic testing report showing amenable GLA variant (in vitro assay)
Operational: verify eligibility and include dose/duration in request

Denial Risk

Combination Therapy Exclusion

Galafold must not be used in combination with enzyme replacement therapies Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj). Requests indicating combination therapy are exclusionary and may be denied. If a patient previously received or is receiving Fabrazyme or Elfabrio, document clinical rationale and contact the plan before submitting a PA.

Combination therapy with Fabrazyme (agalsidase beta) — excluded
Combination therapy with Elfabrio (pegunigalsidase alfa-iwxj) — excluded
Requests implying combination therapy may be denied

Documentation Required

Reauthorization Documentation Required

For reauthorization, provide documentation of a positive clinical response to Galafold therapy. Acceptable evidence includes improvement or stabilization of disease markers, symptom reduction, clinician assessment notes, and relevant laboratory or functional test results. Clearly state duration of prior benefit and attach follow-up evaluations demonstrating continued clinical benefit.

Required: documentation of positive clinical response to Galafold
Examples: symptom improvement, clinician assessment, labs/functional tests
Include duration of benefit and follow-up evaluations

Note

Automated Approval Note

Automated approval and re-approval processes may be used where available. The plan may approve initial or continued therapy based on prior claim/medication history, submitted diagnosis codes (ICD-10), and claim logic without additional clinical documentation. Availability of automated workflows and any supply limits vary by program and therapeutic class; confirm whether the member’s program supports automated PA.

Automated approvals may rely on prior claims/medication history and ICD-10 diagnosis codes
Processes and supply limits vary by program/therapeutic class
Confirm program-specific automated PA availability before submission

Definitions

Amenable GLA variant — definition

DefinitionA galactosidase alpha gene (GLA) variant shown to be amenable based on in vitro assay data.

Clinical implicationOnly patients with an amenable GLA variant demonstrated by in vitro assay are indicated for Galafold (migalastat).

Evidence basisAmenability is determined using in vitro assay data; the drug’s indication requires this demonstration.

Regulatory noteThe Galafold indication for adults with an amenable GLA variant was approved under accelerated approval linked to surrogate endpoint data.

Background

Galafold (migalastat) is a pharmacological chaperone that binds to and stabilizes certain mutant forms of alpha-galactosidase A, facilitating proper folding and trafficking of the enzyme to lysosomes. It is indicated for the treatment of adults with confirmed Fabry disease who have an amenable GLA variant demonstrated by in vitro assay. Approval was granted based on surrogate biomarker effects (reduction in kidney interstitial capillary cell GL-3), and continued benefit may depend on confirmatory clinical trial results.