CurrentCentenePolicy CP PHAR.412

Gilteritinib (Xospata)

Policy governs medical necessity criteria, prior authorization requirements, dosing limits, and approval durations for gilteritinib (Xospata) for commercial, HIM and Medicaid lines of business, including FDA-approved use in relapsed/refractory FLT3-mutated AML and a specified off-label use (myeloid/lymphoid neoplasm with eosinophilia).

Policy Summary

PayerCentene

PolicyGilteritinib (Xospata)

Policy CodePolicy CP PHAR.412

Change TypeCoverage criteria and administrative updates

Effective DateJan 15, 2019

Next Review Date

Key ActionProvider must submit chart notes, lab results or other clinical information supporting diagnosis, FLT3 mutation status, prior therapy and response to meet approval criteria.

POLICY UPDATE CHANGES

Oral oncology generic redirection language clarified to 'must use' generic when available.

Approval duration for Commercial line of business revised to 12 months or duration of request, whichever is less.

MLNE (myeloid/lymphoid neoplasm with eosinophilia) NCCN recommended off-label use added.

References and template changes updated across annual reviews with no significant policy changes in recent reviews.

1FDA-approved Indications (AML)

1NCCN-recommended Off-label Indication (MLNE)

120 mg/dayMaximum Daily Dose

Coverage Summary

Scope: This policy governs medical necessity criteria, prior authorization requirements, dosing limits, and approval durations for gilteritinib (Xospata) across Commercial, HIM and Medicaid lines of business, including the FDA-approved use in adult patients with relapsed or refractory FLT3‑mutated acute myeloid leukemia (AML) and a specified NCCN‑recommended off‑label use for myeloid/lymphoid neoplasm with eosinophilia (MLNE).

Coverage stance: covered_with_criteria — Xospata is authorized when the policy's clinical criteria are met (diagnosis, age, FLT3 mutation, prescriber specialty, dosing limits, documentation). For MLNE the policy follows NCCN‑recommended off‑label guidance and requires MLNE be in chronic or blast phase per NCCN-aligned requirements.

FDA indication: Aligned to the Xospata label — indicated for treatment of adult patients with relapsed or refractory AML with a FLT3 mutation (as detected by an FDA‑approved test).

Policy principle: The policy aligns coverage to the FDA indication and NCCN recommendations and enforces an oral oncology generic‑use redirection principle — members must use generic gilteritinib when available unless a contraindication or clinically significant adverse effects are documented by the prescriber.

Quick decision aid — key thresholds & facts

Maximum daily dose<= 120 mg/day (120 mg PO QD; 3 x 40 mg tablets)

Minimum prior exposure for continuation>= 30 days (must have received Xospata for at least 30 days)

Age requirement> 18 years (adult patients)

FDA‑approved indications (count)1 (relapsed/refractory FLT3‑mutated AML)

NCCN‑recommended off‑label indication1 (MLNE — myeloid/lymphoid neoplasm with eosinophilia; chronic or blast phase)

Initial Therapy Criteria — AML (FDA‑approved)

Initial Therapy Criteria — MLNE (Off‑label)

Continuation Therapy Criteria

Other Indications & Exclusions

IV. Diagnoses/Indications Not Authorized

Non-FDA approved indications which are not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided per off-label use policies

See off-label use policies CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid

ref':

title": "IV. Diagnoses/Indications Not Authorized"

Prior Authorization & Provider Requirements

Prior Authorization

Prior authorization required

Requests must meet policy criteria and are subject to Centene prior authorization; prescriber must document consultation with or prescription by an oncologist/hematologist.

Documentation Required

Submit supporting documentation

Provider must submit chart notes, lab results or other clinical information supporting diagnosis, FLT3 mutation status, prior therapy and response to meet approval criteria.

Applicable Codes

Product Strengths/Availabilitymixed

40 mg tablet

Tablets: 40 mg

Clinical Evidence & References

Primary references: Xospata Prescribing Information (January 2022) and National Comprehensive Cancer Network (NCCN) guidance for Acute Myeloid Leukemia and Myeloid/Lymphoid Neoplasms with Eosinophilia (2024).

Policy alignment: This policy follows the FDA prescribing information for the approved relapsed/refractory FLT3‑mutated AML indication and incorporates NCCN recommendations for both AML and the NCCN‑recommended off‑label MLNE use.

MLNE note: MLNE use is included as a NCCN‑recommended off‑label indication in the policy and requires documentation (chronic or blast phase) per NCCN-aligned criteria.

Do not duplicate metrics: (Statistics and approval durations are detailed in policy sections and not restated here.)

Background

Drug description: Gilteritinib (Xospata) is an oral tyrosine kinase inhibitor indicated for adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring a FLT3 mutation.

Policy alignment: Coverage and clinical criteria are aligned to the FDA‑approved indication and to NCCN recommendations; applicable approval durations and clinical requirements are specified by line of business in the policy.

Generic redirection: The policy enforces oral oncology generic redirection — members must use generic gilteritinib when a generic is available unless the prescriber documents a contraindication or clinically significant adverse effects that justify brand use.

Product availability and dosing: Available as 40 mg tablets; the policy incorporates the FDA‑listed maximum dosing of 120 mg/day (3 tablets/day) and requires dosing justification when doses exceed the FDA maximum or are used off‑label.

Policy metadata (compact)

Policy numberCP PHAR.412

Effective date01.15.19

Last review date02.25

Definitions

Definitions:

AML — acute myeloid leukemia.

MLNE — myeloid/lymphoid neoplasm with eosinophilia.

FLT3 — FMS‑like tyrosine kinase 3 (gene/protein associated with certain AML cases).

NCCN — National Comprehensive Cancer Network.

Revision History

01.20.22approval_duration_change

Commercial approval duration revised to 12 months or duration of request, whichever is less (Medicaid/HIM retained at 6 months).

11.09.21generic_redirection_clarified

Oral oncology generic redirection language clarified to 'must use' generic gilteritinib when available unless contraindicated or clinically significant adverse effects are experienced.

10.12.20added_off_label_mlne

MLNE (myeloid/lymphoid neoplasm with eosinophilia) NCCN-recommended off-label use added; continued therapy duration for AML increased to 12 months during this review.