Subject: Vanflyta 6096-A SGM P2023a
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
Acute Myeloid Leukemia
Vanflyta in combination with standard cytarabine and
anthracycline induction and cytarabine consolidation, and as
maintenance monotherapy following consolidation
chemotherapy, for the treatment of adult patients with newly
diagnosed acute myeloid leukemia (AML) that is FLT3 internal
tandem duplication (ITD)-positive as detected by an FDA-
approved test.
Limitations of Use:
Vanflyta is not indicated as maintenance monotherapy
following allogeneic hematopoietic stem cell transplantation
(HSCT); improvement in overall survival with Vanflyta in this
setting has not been demonstrated.
All other indications are considered
experimental/investigational and not medically necessary.
B. Compendial Use
Relapsed/ Refractory AML
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review: medical record documentation of
FLT3 internal tandem duplication (ITD) mutation.
III. CRITERIA FOR INITIAL APPROVAL
Acute Myeloid Leukemia (AML)
Authorization of 12 months may be granted for treatment of AML
that is FLT3 internal tandem duplication (ITD)-positive when the
requested medication is not being used as single agent
maintenance therapy following hematopoietic stem cell
transplantation (HSCT) in either of the following clinical settings:
A. The requested medication will be used for treatment of newly
diagnosed disease.
B. The requested medication is being used for treatment of
relapsed or refractory disease in combination with standard
cytarabine and anthracycline induction if the member has
previously experienced response to therapy with the
requested medication.
IV. CONTINUATION OF THERAPY
Authorization of 12 months (for up to 36 months maintenance
therapy) 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:
- Vanflyta [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; July 2023.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 11, 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.
December 31, 2023
