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