Subject: Xospata 2807-A SGM P2023

Drug

XOSPATA  (gilteritinib)

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
               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.

          B.  Compendial Uses
               1.  Myeloid/lymphoid neoplasms with eosinophilia and FLT3
                    rearrangement in chronic phase or blast phase
               2.  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.

    II.  DOCUMENTATION

          Submission of the following information is necessary to initiate
          the prior authorization review: medical record documentation
          of FLT3 mutation

  III.  CRITERIA FOR INITIAL APPROVAL

          A.  Acute Myeloid Leukemia (AML)
               Authorization of 12 months may be granted for the treatment
               of FLT3 mutation-positive relapsed or refractory AML when
               the requested medication is used as a single-agent.

          B.  Myeloid/Lymphoid Neoplasms with eosinophilia
               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.

   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. Xospata [package insert]. Northbrook, IL: Astellas Pharma US, Inc.; January 2022.
2. The NCCN Drugs & Biologics Compendium^® 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed January 09, 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