CurrentAvMedPolicy N/A

Galafold

Prior authorization and step-edit form and clinical criteria for coverage of Galafold (migalastat) through AvMed specialty pharmacy (PropriumRx). Defines initial and reauthorization clinical requirements, exclusions, documentation requirements, and treatment duration.

Policy Summary

PayerAvMed

PolicyGalafold

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review Date

Key ActionPrescribing physician must sign and print name on the request form and submit all required documentation (lab results, HEK assay, genetic testing, chart notes) or authorization may be denied.

SourceLink

POLICY UPDATE CHANGES

Form includes clinical criteria for initial (6 months) and reauthorization (12 months) requirements and lists prior review dates.

18+Minimum Age (years)

6/12Authorization Durations (initial/reauth months)

>=4x ULNUrinary GL3 threshold

eGFR <30Renal impairment exclusion (mL/min)

Coverage Summary

Galafold (migalastat) is covered with criteria restricting use to adults with amenable GLA variants and requiring biochemical or genetic confirmation plus clinical manifestations or elevated biomarkers. Coverage requires age ≥ 18 years, submission of current eGFR, specialist prescriber, and diagnostic confirmation by enzyme activity testing, GLA gene sequencing, or a GLP-validated HEK assay. Initial approval is limited to 6 months with reauthorization criteria including reduced/stabilized urinary GL3. Exclusions: severe renal impairment (eGFR < 30 mL/min), dialysis/ESRD, prior or scheduled kidney transplant, and concurrent use of enzyme replacement therapy (ERT) such as Fabrazyme.

Key thresholds

Minimum age>= 18 years

Urinary GL3>= 4x ULN

Renal impairment exclusioneGFR < 30 mL/min

Authorization durationsInitial 6 months; Reauthorization 12 months