Subject: Fintepla 3982-A SGM 2022

Drug

FINTEPLA  (fenfluramine)

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 Indications¹
            Fintepla is indicted for the treatment of seizures associated
            with Dravet syndrome and Lennox-Gastaut syndrome in
            patients 2 years of age and older.

            All other indications are considered
            experimental/investigational and not medically necessary.

 

     II.  CRITERIA FOR INITIAL APPROVAL

           A.  Seizures associated with Dravet syndrome¹
                Authorization of 12 months may be granted for treatment of
                seizures associated with Dravet syndrome in members 2
                years of age and older.

 
           B.  Seizures associated with Lennox-Gastaut syndrome¹
                Authorization of 12 months may be granted for treatment of
                seizures associated with Lennox-Gastaut syndrome in
                members 2 years of age and older.

 
    III.  CONTINUATION OF THERAPY

            Authorization of 12 months may be granted for all members
            (including new members) who meet all of the following:
            1.  The member meets one of the following:
                 a.  The member has seizures associated with Lennox-
                      Gastaut syndrome
                 b.  The member has seizures associated with Dravet
                      syndrome
            2.  The member is at least 2 years of age
            3.  The member has achieved and maintained positive clinical
                  response as evidenced by reduction in frequency or
                  duration of seizures compared with seizure activity prior to
                  starting Fintepla

     IV.  OTHER

            Due to well documented potential for serious adverse effects,
            phentermine and fenfluramine are not recommended to be
            used concurrently. Member cannot use the requested
            medication concomitantly with phentermine.

                                              

Place of Service:

Outpatient

The above policy is based on the following references:

1. Fintepla [package insert]. Emeryville, CA: Zogenix, Inc.; March 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.

November 21, 2022