Subject: Vanflyta SGM 6096-A P2026

Drug

VANFLYTA  (quizartinib)

Policy:

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

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.

Compendial Uses²

·        AML – as maintenance therapy post-allogeneic HSCT, in remission with history of FLT3-ITD

      ·        Myeloid/lymphoid neoplasms with eosinophilia and FLT3 rearrangement in chronic phase or blast phase

      ·        Myeloid, lymphoid, or mixed lineage neoplasms with eosinophilia and FLT3 rearrangement in blast phase

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

Documentation

Submission of the following information is necessary to initiate the prior authorization review: medical record documentation of FLT3 internal tandem duplication (ITD) mutation.

Coverage Criteria

Acute Myeloid Leukemia (AML)^1-2

Authorization of 12 months may be granted for the treatment of AML that is FLT3 internal tandem duplication (ITD)-positive in any of the following clinical settings:

·        Induction therapy or re-induction in combination with cytarabine and daunorubicin or idarubicin

·        Consolidation therapy in combination with cytarabine

·        Maintenance therapy as a single agent

Myeloid/Lymphoid Neoplasms with Eosinophilia²

Authorization of 12 months may be granted for the treatment of myeloid and/or lymphoid neoplasms with eosinophilia with a FLT3 rearrangement in the chronic or blast phase.

Continuation of Therapy

Authorization of 12 months (for up to 36 months maintenance therapy for AML or treatment of myeloid/lymphoid neoplasms with eosinophilia) may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section 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.      Vanflyta [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; June 2024.

2.     The NCCN Drugs & Biologics Compendium® © 2026 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed January 8, 2026.

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 14, 2026