Subject: Cerdelga 2050-A SGM P2024
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 Indications
Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1
who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor
metabolizers (PMs) as detected by an FDA-cleared test.
Limitations of use:
Patients who are CYP2D6 ultra-rapid metabolizers (URMs) may not achieve adequate
concentrations of Cerdelga to achieve a therapeutic effect. A specific dosage cannot be
recommended for those patients whose CYP2D6 genotype cannot be determined
(indeterminate metabolizers).
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. Beta-glucocerebrosidase enzyme assay or genetic testing results supporting diagnosis, and
B. The results of the CYP2D6 test.
III. CRITERIA FOR INITIAL APPROVAL
Gaucher disease type 1
Authorization of 12 months may be granted for treatment of Gaucher disease type 1 when all of
the following criteria are met:
A. Diagnosis of Gaucher disease was confirmed by enzyme assay demonstrating a deficiency
of beta-glucocerebrosidase (glucosidase) enzyme activity or by genetic testing.
B. Member is a CYP2D6 extensive metabolizer, an intermediate metabolizer, or a poor
metabolizer as detected by an FDA-cleared test.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment of an indication listed in
Section III when all of the following criteria are met:
A. Member meets the criteria for initial approval.
B. Member is not experiencing an inadequate response or any intolerable adverse events from
therapy.
Place of Service:
Outpatient
The above policy is based on the following references:
- Cerdelga [package insert]. Cambridge, MA: Genzyme Corporation; December 2022.
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.
June 16, 2024
