Subject: Xospata 2807-A SGM P2022
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 Indications
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
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:
- Xospata [package insert]. Northbrook, IL: Astellas Pharma US, Inc.; January 2022.
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 26, 2022
