Fabrazyme IV (Medical)
Defines medical prior authorization clinical criteria, documentation requirements, exclusions, initial and reauthorization approval durations and dosing limits for Fabrazyme (agalsidase beta) IV infusion (J0180) for members of AvMed. Applies to outpatient IV administration via medical benefit and outlines provider, lab, and specialty pharmacy requirements.
No material clinical/coverage changes.
Coverage Summary
Scope: This policy defines medical prior authorization clinical criteria, documentation requirements, exclusions, initial and reauthorization approval durations, and dosing limits for Fabrazyme (agalsidase beta) IV infusion (HCPCS code J0180) for AvMed members; it applies to outpatient IV administration via the medical benefit and outlines provider, lab, and specialty pharmacy requirements.
Background: Fabrazyme is an IV enzyme replacement therapy for Fabry disease and the policy requires confirmation of diagnosis, submission of baseline and follow-up biomarker monitoring, specialist prescribing, and documentation of appropriate prophylaxis/treatment for affected organ systems.
Coverage stance: covered_with_criteria — all listed clinical criteria and documentation must be met for approval.
Initial Approval Duration: 6 months.
Reauthorization Duration: 6 months.
Maximum Dose: 1 mg/kg every 2 weeks.
Minimum Age: ≥ 2 years.
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