CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Galafold (migalastat) — Coverage Criteria for Fabry Disease

This policy governs authorization and coverage criteria for Galafold (migalastat) to treat adults with Fabry disease who have an amenable GLA variant; it applies to Medicaid members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGalafold (migalastat) — Coverage Criteria for Fabry Disease

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2021

Next Review Date

Key ActionObtain prior authorization and provide documentation of confirmed Fabry disease and an amenable GLA variant; approvals are granted for 6 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauth duration

18+min age

14 caps/28dquantity limit

Fabrazyme/Elfabrioincompatible therapies

Coverage and Medical Necessity Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial therapy criteria: A. Patient is 18 years old or older; AND B. The diagnosis of Fabry disease was confirmed by enzyme assay demonstrating a deficiency of alpha-galactosidase enzyme activity or by genetic testing, or the member is a symptomatic obligate carrier; AND C. Documentation that the patient has an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data; AND D. Galafold will not be used in combination with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj); AND E. Documentation that the patient does not have severe renal impairment or end-stage renal disease requiring dialysis.

Initial authorization duration: 6 months.

inv-02: Continuation Therapy

Continuation criteria for reauthorization:

Continuation therapy criteria: Authorization of 6 months may be granted for continued treatment in patients requesting reauthorization with documentation of an amenable galactosidase alpha gene (GLA) variant who are responding to therapy (e.g., reduction in plasma globotriaosylceramide [GL-3] or GL-3 inclusions).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGalafold (migalastat) — Coverage Criteria for Fabry Disease

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2021

Next Review Date

Key ActionObtain prior authorization and provide documentation of confirmed Fabry disease and an amenable GLA variant; approvals are granted for 6 months when criteria are met.

SourceLink

On This Page

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Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Authorization of 6 months may be granted for treatment of Fabry disease when criteria are met. Providers must submit diagnostic and genetic documentation confirming Fabry disease and an amenable GLA variant. Initial and continuation approvals are each for 6 months when requirements are satisfied.

Affected therapy: Galafold (migalastat)
Do not combine with Fabrazyme (agalsidase beta) or Elfabrio (pegunigalsidase alfa-iwxj)

Step Therapy

No step therapy prerequisites specified for this therapy.

Documentation Required

Provide documentation confirming the diagnosis of Fabry disease and that the patient has an amenable galactosidase alpha (GLA) variant. Acceptable documentation includes enzyme assay demonstrating deficient alpha-galactosidase activity or genetic testing results, and in vitro assay data showing the GLA variant is amenable. Also include evidence of lack of severe renal impairment or dialysis dependence when applicable.

Enzyme assay results showing deficient alpha-galactosidase activity
Genetic testing report identifying GLA variant
In vitro assay data demonstrating variant is amenable
Clinical documentation of treatment response for reauthorization (e.g., reduction in plasma GL-3)

Denial Risk

Denial Risk Conditions

Authorization may be denied if the member is under 18 years of age or if diagnostic/genetic documentation confirming Fabry disease and an amenable GLA variant is insufficient. Denials may also occur if Galafold is requested in combination with Fabrazyme or Elfabrio, or if the patient has severe renal impairment or is dialysis-dependent without appropriate justification.

Age < 18 years
Missing or insufficient enzyme assay or genetic testing documentation
Request to use Galafold with Fabrazyme or Elfabrio
Severe renal impairment or end-stage renal disease requiring dialysis

Key Definitions

Amenable GLA variant — definition

DefinitionAmenable galactosidase alpha gene (GLA) variant: a GLA gene variant demonstrated by in vitro assay data to be responsive to migalastat.

Evidence requirementDocumentation that the patient has an amenable GLA variant based on in vitro assay data is required for authorization.

Authorization implicationPresence of an amenable GLA variant is required for initial and continuation approvals of Galafold (migalastat).

Exclusion notePatients without an amenable GLA variant are not authorized for treatment with Galafold under this policy.

Responding to therapy — reauthorization examples

Example biomarker responseReduction in plasma globotriaosylceramide (GL-3).

Example histologic responseReduction in GL-3 inclusions.

Use for reauthorizationDocumentation of response to therapy (e.g., reduced plasma GL-3 or GL-3 inclusions) is required when requesting continuation authorization.

Authorization duration on reauthorizationContinuation approvals are granted for 6 months when response is documented.

OpenPayer

Galafold (migalastat) — Coverage Criteria for Fabry Disease

Coverage and Medical Necessity Criteria

Prior Authorization, Documentation, and Prescriber Requirements

Key Definitions

Clinical Background