CurrentMass General Brigham Health PlanPolicy N/A

Fabrazyme (agalsidase beta) — Prior Authorization (Pharmacy Benefit)

Defines prior authorization requirements for Fabrazyme (agalsidase beta) under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members, including initial and continuation criteria and specialty dispensing rules.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFabrazyme (agalsidase beta) — Prior Authorization (Pharmacy Benefit)

Policy CodePolicy N/A

Change TypeMaterial revisions and clarifications

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization for Fabrazyme under the pharmacy benefit with documentation confirming diagnosis (enzyme assay or genetic testing) and, for reauthorization, medical charts or lab results demonstrating clinical benefit.

SourceLink

POLICY UPDATE CHANGES

Updated initial criteria to require that member will not use Fabrazyme in combination with Elfabrio (and clarified combination prohibition).

Reauthorization criteria updated to include additional examples of positive response and documentation must be medical charts or lab results.

Policy updated to indicate it no longer applies to the medical benefit and applies under the pharmacy benefit only.

12 moInitial and reauthorization approval duration

>=2 yrsMinimum patient age for indication

Commercial/ExchangePlan applicability

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Coverage Criteria for Fabrazyme (agalsidase beta)

Initial Therapy

Authorization may be granted when ALL of the following are met:

Initial Authorization

Diagnostic requirement: Member meets ONE of: (a) diagnosed with Fabry disease confirmed by enzyme assay demonstrating a deficiency of alpha-galactosidase enzyme activity (documentation required); OR (b) symptomatic obligate carrier (documentation required)
Combination therapy prohibition: Member will not use Fabrazyme in combination with Galafold or Elfabrio
Prescriber specialty: Prescriber must be a nephrologist, cardiologist, or specialist in metabolic disorders or genetics

New-to-plan allowance: Prior authorization may be granted for members new to the plan within the past 90 days who are currently receiving the medication (excludes samples or manufacturer patient assistance program supplies)

Continuation of Therapy

Reauthorization will be approved when ALL of the following are met:

Reauthorization

Clinical response documentation: Submission of documentation (e.g., medical charts or lab results) demonstrating response to therapy (examples: reduction in plasma globotriaosylceramide [GL-3] or GL-3 inclusions, improvement and/or stabilization in renal function, pain reduction)
Approval duration: Reauthorization granted for up to 12 months

Use of Fabrazyme in combination with Galafold or Elfabrio is prohibited. Authorization for Fabrazyme will not be granted when the member is expected to receive concomitant therapy with either of these agents.

Initial Therapy — Detailed Criteria

Initial Therapy

Initial authorization criteria

Initial Authorization: Diagnosis confirmation or symptomatic obligate carrier; no concomitant use with Galafold/Elfabrio; prescriber specialty requirement

Documentation of diagnosis or symptomatic obligate carrier is required

Continuation / Reauthorization Criteria

Continuation of Therapy

Reauthorization criteria

Reauthorization: Member must show clinical benefit documented by medical charts or lab results (examples include reduction in plasma GL-3 or GL-3 inclusions, improvement/stabilization of renal function, pain reduction)

Reauthorization duration: up to 12 months

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required under the pharmacy benefit for Commercial/Exchange members.

Applies to pharmacy benefit for Commercial/Exchange members
Specialty medication must be filled at a contracted specialty pharmacy

Documentation Required

Required Documentation

Provide documentation confirming diagnosis and supporting clinical information. Include copies of enzyme assay results demonstrating deficient alpha-galactosidase activity or genetic testing confirming a pathogenic GLA variant, or documentation that the patient is a symptomatic obligate carrier. For continuation requests, submit clinical evidence of response to therapy (for example, reduction in plasma GL-3 or GL-3 inclusions, improvement or stabilization of renal function, or pain reduction).

Required: enzyme assay results OR genetic testing confirming Fabry disease

Site of Care and Dispensing Requirements

Billing Rule

Specialty pharmacy dispensing required

Fabrazyme is designated a specialty medication and must be dispensed through a contracted specialty pharmacy.

This medication must be filled at a contracted specialty pharmacy per the plan's specialty limitations.

Key Definitions

inv-09: Confirmed Fabry disease — definition and diagnostic methods

DefinitionConfirmed Fabry disease: diagnosis demonstrated by enzyme assay showing deficiency of alpha-galactosidase activity or by genetic testing.

Accepted diagnostic methodsEnzyme assay demonstrating deficient alpha-galactosidase enzyme activity (documentation required).

Alternative diagnostic methodGenetic testing confirming a pathogenic GLA variant (documentation required).

Documentation requirementMedical record documentation must be submitted to confirm assay or genetic test results.

inv-10: Symptomatic obligate carrier — definition and documentation requirement

DefinitionSymptomatic obligate carrier: a carrier of Fabry disease who is exhibiting symptoms.

Background

Fabrazyme (agalsidase beta) is an enzyme replacement therapy indicated for treatment of confirmed Fabry disease in adults and pediatric patients aged >= 2 years. Diagnosis must be confirmed by either an enzyme assay showing deficiency of alpha-galactosidase activity or by genetic testing; documentation is required. Symptomatic obligate carriers may also meet diagnostic criteria when appropriate documentation is provided. Prescriptions should be managed under the pharmacy benefit with prior authorization and specialty pharmacy dispensing as specified in the policy.