Subject: Idhifa 2238-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.
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:
- Idhifa [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; August 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed January 7, 2023.
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
