Subject: Cerdelga 2050-A SGM P2022

Drug

CERDELGA  (eliglustat)

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 the
            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 26, 2022