Subject: Xospata SGM 2807-A P2026

Drug

XOSPATA  (gilteritinib)

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

Xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.

Compendial Uses²

·        Acute Myeloid Leukemia (AML)

·        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 and isocitrate dehydrogenase 1 (IDH1) mutation status, where applicable.

Coverage Criteria

Acute Myeloid Leukemia (AML)^1,2

Authorization of 12 months may be granted for the treatment of FLT3 mutation-positive AML without IDH1 mutation as a single agent or in combination with azacitidine in any of the following clinical settings:

·        Induction therapy if not a candidate for or declines intensive induction therapy

·        Post-induction therapy when the member has experienced response to Xospata therapy

Authoriation of 12 months may be granted for the treatment of FLT3 mutation-positive AML as a single agent in any of the following clinical settings:

·        Maintenance therapy post-allogeneic hematopoietic cell transplantation

·        Relapsed or refractory disease

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 phase or blast phase.

Continuation of Therapy

Authorization of 12 months (for up to 26 months maintenance therapy for AML) 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.      Xospata [package insert]. Northbrook, IL: Astellas Pharma US, Inc.; January 2022.

2.     The NCCN Drugs & Biologics Compendium® © 2026 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed January 9, 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.

July 14, 2026