CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Galafold (migalastat) — Coverage Criteria for Fabry Disease

Covers authorization criteria, quantity limits, and duration for Galafold (migalastat) to treat Fabry disease in members with an amenable GLA variant; applies to Medicaid population served by the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGalafold (migalastat) — Coverage Criteria for Fabry Disease

Policy CodePolicy N/A

Change TypeNo material change

Effective Date3/1/2021

Next Review DateN/A

Key ActionObtain prior authorization and document confirmed Fabry disease and an amenable GLA variant; initial and continuation approvals may be granted for 6 months each.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsApproval duration

14/28dQuantity limit

18+Minimum age

No enzyme comboProhibited combo

Coverage Criteria for Galafold (migalastat)

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.

ALL of the following

Age: Patient is 18 years old or older>=18 years
Diagnosis confirmation: Diagnosis of Fabry disease confirmed by enzyme assay demonstrating deficient alpha-galactosidase A activity, or by genetic testing, or the member is a symptomatic obligate carrier
Documentation required
Amenable variant: Documentation that the patient has an amenable GLA variant based on validated in vitro assay data
No combination therapy: Galafold will not be used in combination with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj)
Prohibited concomitant use
Renal function: Patient does not have severe renal impairment or end-stage renal disease requiring dialysis

Continuation Therapy

Covered for continued treatment when ALL of the following are met:

ALL of the following

Prior authorization period: Patient has prior authorization and is requesting reauthorization for continued treatment
Authorization of 6 months may be granted
Clinical response: Patient is responding to therapy (for example, reduction in plasma globotriaosylceramide [GL-3] or GL-3 inclusions)
Documentation of response required

Initial Authorization Criteria

Initial Therapy

Initial authorization may be granted for 6 months when criteria are met.

ALL of the following

Age: Patient is 18 years or older>=18 years
Confirmed diagnosis: Diagnosis confirmed by enzyme assay demonstrating deficient alpha-galactosidase activity or by genetic testing (or symptomatic obligate carrier)
Documentation required
Amenable variant: Documentation of an amenable GLA variant based on in vitro assay data
No combination therapy: Not to be used in combination with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj)
Prohibited concomitant use
Renal function: No severe renal impairment or end-stage renal disease requiring dialysis

Reauthorization / Continuation Criteria

Continuation Therapy

Reauthorization may be granted for 6 months when patient is responding to therapy.

ALL of the following

Response to treatment: Clinical response such as reduction in plasma GL-3 or GL-3 inclusions is documented
Documentation required
Authorization period: Previous authorization in place; continuation authorization granted for 6 months

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Initial and continuation authorizations may be granted for 6 months each for patients meeting criteria.

Initial approval: 6 months
Continuation approval: 6 months

Step Therapy

No step therapy specified for this policy.

Documentation Required

Documentation Requirement

Provide documentation of confirmed Fabry disease via enzyme assay demonstrating alpha-galactosidase deficiency or by genetic testing. Also provide documentation that the patient has an amenable GLA variant based on in vitro assay data.

Denial Risk

Denial may be triggered if the patient lacks documentation of confirmed Fabry disease, documentation of an amenable GLA variant, evidence the drug will not be used in combination with excluded therapies, or other required information such as renal status.

Background

Fabry disease is an X-linked lysosomal storage disorder caused by deficient alpha-galactosidase A activity leading to accumulation of glycosphingolipids. Migalastat (Galafold) is an oral pharmacologic chaperone indicated for patients with an amenable GLA (galactosidase alpha) gene variant. Treatment eligibility requires confirmation of Fabry disease by enzyme assay demonstrating deficient alpha-galactosidase activity or by genetic testing (or symptomatic obligate carrier status), documentation that the patient has an amenable GLA variant based on validated in vitro assay data, and that the patient meets renal function and other coverage criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGalafold (migalastat) — Coverage Criteria for Fabry Disease

Policy CodePolicy N/A

Change TypeNo material change

Effective Date3/1/2021

Next Review DateN/A

Key ActionObtain prior authorization and document confirmed Fabry disease and an amenable GLA variant; initial and continuation approvals may be granted for 6 months each.

SourceLink

On This Page

OpenPayer

Galafold (migalastat) — Coverage Criteria for Fabry Disease

Coverage Criteria for Galafold (migalastat)

Initial Authorization Criteria

Reauthorization / Continuation Criteria

Provider Actions and Documentation Requirements

Quantity Limits for Galafold (migalastat)

Definitions

Background