Subject: Fabrazyme 2054-A SGM P2023
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FABRAZYME
(agalsidase beta)
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Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
FDA-Approved Indication
Fabrazyme is indicated for the treatment of adult and pediatric
patients 2 years of age and older with confirmed Fabry disease.
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review:
A. Initial requests: alpha-galactosidase enzyme assay or genetic
testing results supporting diagnosis. In the case of obligate
carriers, the documentation must be submitted for the
parent.
B. Continuation requests: lab results or chart notes
documenting a positive response to therapy (e.g., reduction
in plasma globotriaosylceramide [GL-3, Gb3] or GL-3/Gb3
inclusions, improvement and/or stabilization in renal
function, pain reduction).
III. CRITERIA FOR INITIAL APPROVAL
Fabry disease
Authorization of 12 months may be granted for treatment of
Fabry disease when both of the following criteria are met:
A. The diagnosis of Fabry disease was confirmed by enzyme
assay demonstrating a deficiency of alpha-galactosidase
enzyme activity or by genetic testing, or the member is a
symptomatic obligate carrier; and
B. Fabrazyme will not be used in combination with Galafold.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section III who are responding to therapy
(e.g., reduction in plasma globotriaosylceramide [GL-3, Gb3] or
GL-3/Gb3 inclusions, improvement and/or stabilization in renal
function, pain reduction).
Place of Service:
Outpatient
The above policy is based on the following references:
- Fabrazyme [package insert]. Cambridge, MA: Genzyme Corporation; March 2021.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
August 18, 2023
