CurrentAetnaPolicy N/A

Fabrazyme (agalsidase beta) Medication Precertification Request

Aetna outpatient precertification/authorization request form to obtain prior approval for Fabrazyme (agalsidase beta) infusions (start or continuation), collecting patient, prescriber, administration, product, diagnosis, and required clinical information to support medical necessity review.

Policy Summary

PayerAetna

PolicyFabrazyme (agalsidase beta) Medication Precertification Request

Policy CodePolicy N/A

Change TypeAdministrative form (no material changes)

Effective Date

Next Review Date

Key ActionProviders must submit this completed precertification form with all required clinical information to Aetna via phone or fax prior to initiation or continuation of Fabrazyme therapy for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

2Form pages

RequiredMandatory signature

YesMedicare Part B contacts included

Policy overview

This Aetna outpatient precertification/authorization request form is used to obtain prior approval for Fabrazyme (agalsidase beta) infusions for initiation or continuation of therapy. The form collects patient, prescriber, place of administration and administration code(s), product (Fabrazyme) and dosing details, diagnosis (ICD codes), and the required clinical information to support medical necessity review.

Required clinical information includes whether the infusion is in an outpatient hospital setting; any infusion-related adverse events or severe reactions; laboratory-confirmed Fabrazyme-IgE antibodies; severe venous access issues; significant behavioral, physical, or cognitive impairments and caregiver availability; medical instability (respiratory, cardiovascular, renal) that may limit tolerance of infusion; and confirmation of a Fabry disease diagnosis. Initiation-specific fields ask for enzyme assay or genetic testing confirmation, symptomatic obligate carrier status, and concomitant use with Galafold (migalastat). Continuation-specific fields ask whether the patient is responding to therapy and the date of last treatment.

Required clinical information (precertification form fields)

Required clinical information for all precertification requests

All required clinical information must be completed for all precertification requests

Infusion setting: Indicate if infusion is in an outpatient hospital setting (Yes/No)
Adverse event history: Document if patient experienced an adverse event with the product not responding to conventional interventions or a severe adverse event (anaphylaxis, anaphylactoid reactions, myocardial infarction, thromboembolism, seizures) during or immediately after an infusion (Yes/No)
IgE antibody status: Document laboratory confirmed Fabrazyme-IgE antibodies (Yes/No)
Venous access issues: Document severe venous access issues requiring special interventions only available in outpatient hospital setting (Yes/No)
Behavioral or caregiver limitations: Document significant behavioral issues and/or physical or cognitive impairment impacting safety of infusion therapy AND lack of access to a caregiver (Yes/No)
Form asks for description when applicable
Medical instability: Document if patient is medically unstable (respiratory, cardiovascular, renal conditions) limiting ability to tolerate large volume/load or predispose to severe adverse event that cannot be managed in alternate setting (Yes/No)
Form asks for description and to specify cardiopulmonary/respiratory/renal/other when applicable
Diagnosis confirmation: Confirm diagnosis of Fabry disease (Yes/No)

Initiation requests

Clinical documentation required for initiation requests

Diagnostic confirmation: Diagnosis confirmed by enzyme assay demonstrating deficiency of alpha-galactosidase enzyme activity OR by genetic testing (Yes/No)
Symptomatic obligate carrier: Is the patient a symptomatic obligate carrier? (Yes/No)
Concomitant Galafold use: Will Fabrazyme be used concomitantly with Galafold (migalastat)? (Yes/No)

Continuation requests

Clinical documentation required for continuation requests

Response to therapy: Is the patient responding to therapy (e.g., reduction in plasma GL-3/Gb3 or inclusions, improvement/stabilization in renal function, pain reduction)? (Yes/No)
Date of last treatment: Provide date of last treatment for continuation requestsdate

What providers must do

Prior Authorization

Precertification required

Providers must submit this completed precertification form with all required clinical information to Aetna via phone or fax prior to initiation or continuation of Fabrazyme therapy for review.

Documentation Required

Clinical documentation requirements

For all requests provide answers to all listed clinical questions. Required items include infusion setting, adverse events during/after infusion, Fabrazyme‑IgE antibody status, severe venous access issues, behavioral or physical/cognitive impairments and caregiver access, medical instability (cardiopulmonary, respiratory, renal, other), and confirmation of Fabry disease. For initiation requests, document enzyme assay or genetic testing confirmation, symptomatic obligate carrier status, and whether used with Galafold (migalastat). For continuation requests, document clinical response to therapy and date of last treatment.

Is infusion in an outpatient hospital setting?
Has the patient experienced an adverse event during or immediately after an infusion (including severe events) or one not responding to conventional interventions?
Does the patient have laboratory‑confirmed Fabrazyme‑IgE antibodies?
Does the patient have severe venous access issues requiring outpatient hospital‑only interventions?
Does the patient have significant behavioral/physical/cognitive impairment impacting infusion safety and lack a caregiver? (provide description if yes)
Is the patient medically unstable (cardiopulmonary, respiratory, renal, other) that limits tolerance of large volume/load or predisposes to severe adverse events? (specify and describe)
Confirm diagnosis of Fabry disease
Initiation: confirm by enzyme assay or genetic testing; indicate symptomatic obligate carrier status; report concomitant use with Galafold
Continuation: document response to therapy (e.g., GL‑3/Gb3 reduction, renal improvement/stabilization, pain reduction) and date of last treatment

Documentation Required

Signature and attestation

The request must be signed and dated by the person completing the form; the form warns that knowingly providing false information is a fraudulent insurance act subject to criminal and civil penalties.

Billing Rule

Administrative contact for Medicare Part B

Medicare Advantage Part B precertification phone and fax numbers are provided on the form and must be used when applicable.

Medicare Advantage Part B Phone: 1-866-503-0857
Medicare Advantage Part B Fax: 1-844-268-7263

Background and definitions

This precertification/notification form is used by Aetna to collect administrative and clinical information necessary to evaluate medical necessity for Fabrazyme infusions in outpatient settings, for both initiation and continuation of therapy. The form includes contact information for Aetna precertification phone and fax (including Medicare Advantage Part B numbers), fields to indicate start or continuation of treatment, and sections to capture patient, insurance, prescriber, administration/place of service, product, diagnosis, and comprehensive clinical details required for review.

Fabrazyme is the brand name for agalsidase beta, an enzyme replacement therapy for Fabry disease.