CurrentmhnPolicy CP.PHAR.158

Clinical Policy: Agalsidase Beta (Fabrazyme)

Defines medical necessity criteria, dosing limits, approval durations, continued therapy requirements, and coding implications for Fabrazyme (agalsidase beta) for commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Agalsidase Beta (Fabrazyme)

Policy CodePolicy CP.PHAR.158

Change TypeAdded exclusions and documentation requirements

Effective Date02.16

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

Added exclusion for concomitant use with Elfabrio to align with Elfabrio criteria.

Added requirement for documentation of member's weight for dose calculation purposes.

Updated age limit to ≥ 2 years per FDA pediatric extension.

Added requirement that therapy be prescribed by or in consultation with specified specialists (clinical geneticist and others).

1FDA-approved Indications

≥2Minimum age (years)

1 mg/kg/2wMax dosing regimen

J0180Primary HCPCS code

Coverage Summary

covered_with_criteria — Defines medical necessity criteria, dosing limits, approval durations, continued therapy requirements, and coding implications for Fabrazyme (agalsidase beta) for commercial, HIM, and Medicaid lines of business.

Scope: Fabrazyme (agalsidase beta) for treatment of confirmed Fabry disease in patients aged ≥ 2 years, with requirements for specialist prescriber/consultation, weight documentation for dosing, prohibition on concurrent use with Galafold or Elfabrio, and a dosing limit of 1 mg/kg every 2 weeks.

Fabrazyme: recombinant human alpha-galactosidase A enzyme indicated for treatment of Fabry disease in patients aged ≥ 2 years.

Age≥ 2 years

Maximum dose1 mg/kg every 2 weeks

Primary HCPCS codeJ0180