Subject: Idhifa 2238-A SGM P2022

Drug

IDHIFA  (enasidenib)

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.

           A.  FDA-Approved Indication
                Idhifa is indicated for the treatment of adult patients with
                relapsed or refractory acute myeloid leukemia (AML) with an
                isocitrate dehydrogenase-2 (IDH-2) mutation as detected by
                an FDA-approved test.

           B.  Compendial Uses
                As a single agent in patients 60 years of age or older with
                IDH2-mutated AML in the following settings:
                1.  Treatment induction when not a candidate for intensive
                     remission induction therapy or declines intensive therapy
                2.  Post-induction therapy following response to previous
                     lower intensity therapy with the same regimen

                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: medical record documentation of
           isocitrate dehydrogenase-2 (IDH2) mutation

 
   III.  CRITERIA FOR INITIAL APPROVAL 

           Acute Myeloid Leukemia (AML)  
           A.  Authorization of 12 months may be granted for treatment
                induction of newly diagnosed AML with a susceptible IDH2
                mutation when all of the following criteria is met:
                1.  The requested medication will be used as a single-agent
                2.  Member is age 60 years or older
                3.  Member has comorbidities that preclude the use of
                     intensive induction chemotherapy or declines intensive
                     induction chemotherapy

           B.  Authorization of 12 months may be granted for post-
                induction therapy for AML with a susceptible IDH2 mutation
                when all of the following criteria is met:
                1.  The requested medication will be used as a single-agent
                2.  Member is age 60 years or older
                3.  Member has experienced response to Idhifa therapy.

           C.  Authorization of 12 months may be granted for treatment of
                relapsed or refractory AML with a susceptible IDH2
                mutation.

 
    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 when there is no evidence of
           unacceptable toxicity or disease progression while on the
           current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Idhifa [package insert]. Summit, NJ: Celgene Corporation; November 2020.
2. The NCCN Drugs & Biologics Compendium^® © 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed January 7, 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 26, 2022