Subject: Cerdelga 2050-A SGM P2023
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:
1. Diagnosis of Gaucher disease was confirmed by enzyme
assay demonstrating a deficiency of beta-glucocerebrosidase
(glucosidase) enzyme activity or by genetic testing
2. 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; July 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.
June 18, 2023
