ModifiedmhnPolicy CP.PHAR.412

Gilteritinib (Xospata) coverage

Defines medical necessity and prior authorization requirements for gilteritinib (Xospata) for adults with FLT3‑mutated relapsed or refractory AML and certain off‑label MLNE uses across commercial, HIM and Medicaid lines of business.

Policy Summary

Payermhn

PolicyGilteritinib (Xospata) coverage

Policy CodePolicy CP.PHAR.412

Change TypeAuthorization duration and generic redirection updates

Effective DateJan 15, 2019

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, FLT3 mutation, specialist involvement, age ≥18, and use generic gilteritinib if available unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

Updated initial authorization durations from 6 months to 12 months for applicable lines of business.

Clarified requirement that members must use generic gilteritinib, if available, unless contraindicated or adverse effects are experienced.

Commercial approval duration revised to 12 months or duration of request, whichever is less.

Updated initial authorization durations from 6 months to 12 months.

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

Clarified oral oncology generic redirection language to 'must use'.

120 mg/daymaximum daily dose for AML

Age ≥ 18minimum age for coverage

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Coverage Criteria

inv-01: Initial Therapy - AML

Covered when ALL of the following are met

AML initial criteria: 1. Diagnosis of relapsed or refractory AML; 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age >= 18 years; 4. Documentation of a FLT3 mutation; 5. Member must use generic gilteritinib, if available, unless contraindicated or clinically significant adverse effects are experienced; 6. Request meets one of the following: (a) Dose does not exceed 120 mg (3 tablets) per day; or (b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

inv-02: Initial Therapy - MLNE (off‑label)

Covered when ALL of the following are met

MLNE initial criteria: 1. Diagnosis of a myeloid/lymphoid neoplasm with eosinophilia (MLNE) in chronic phase or blast phase; 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age >= 18 years; 4. Documentation of a FLT3 mutation; 5. Member must use generic gilteritinib, if available, unless contraindicated or clinically significant adverse effects are experienced; 6. Dose is within the FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

inv-03: Continuation Therapy

Covered when ALL of the following are met

Continuation criteria: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Xospata for a covered indication and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. Member must use generic gilteritinib, if available, unless contraindicated or clinically significant adverse effects are experienced; 4. If request is for a dose increase, request meets one of the following: (a) New dose does not exceed 120 mg (3 tablets) per day; or (b) New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the prescriber provides sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or per the member's evidence of coverage documents.

Coverage under this clinical policy is subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance). State Medicaid provisions take precedence where they conflict with this policy, and applicable federal or state laws and Health Plan administrative policies also apply.

Uses that are non‑FDA approved and not supported by adequate off‑label evidence as required by the referenced off‑label policies are considered not authorized and will be denied unless the prescriber submits the required supporting documentation demonstrating efficacy and safety.

This clinical policy is intended as a guide to medical necessity and to assist in making coverage determinations; it does not constitute medical advice, a treatment recommendation, or a guarantee of payment. Coverage decisions remain subject to the policy terms, applicable laws and regulations, and the member's coverage documents, and providers must apply professional medical judgment when treating members.

Coding and Dosing

No procedure or billing codes listedmixed

No codes listed

Maximum daily dose — 120 mg/day

Maximum daily dose (AML)120 mg/day (does not exceed 120 mg; 3 tablets)

Dosing regimen (AML)120 mg PO once daily

Dose exceptionDose >120 mg/day allowed only if supported by practice guidelines or peer-reviewed literature with prescriber evidence

Initial authorization duration — 12 months

Initial authorization duration (Medicaid/HIM)12 months

Initial authorization duration (Commercial)12 months or duration of request, whichever is less

Recent update

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must confirm diagnosis and meet all approval criteria before requesting Xospata (gilteritinib). Requests must document member age (≥18), specialist involvement (prescribed by or in consultation with an oncologist or hematologist), and presence of an FLT3 mutation. For Xospata brand requests, providers must use generic gilteritinib when available unless contraindicated or clinically significant adverse effects occur.

Applicable to all indications in Section I
Must be prescribed by or in consultation with an oncologist or hematologist
Age ≥ 18 years and documentation of FLT3 mutation required
Generic gilteritinib must be used if available unless contraindicated

Note

Authorization Duration Updated

Initial authorization durations were updated to 12 months for applicable lines of business. Commercial authorizations are for 12 months or the duration of the request, whichever is less. Medicaid/HIM authorizations are 12 months.

Background

Gilteritinib (Xospata) is an oral tyrosine kinase inhibitor indicated for adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring a FLT3 mutation. The policy also includes an off‑label pathway for myeloid/lymphoid neoplasm with eosinophilia (MLNE) in chronic or blast phase with documented FLT3 mutation. For AML the dosing limit is a maximum of 120 mg/day, and coverage requires documentation of diagnosis, specialist involvement, age ≥ 18, and FLT3 mutation status; generic gilteritinib must be used if available unless contraindicated or clinically significant adverse effects occur.

Definitions

AML — acute myeloid leukemia

AcronymAML

Definitionacute myeloid leukemia

Context in policyUsed as the primary indication for gilteritinib coverage when relapsed or refractory with FLT3 mutation

FLT3 — FMS‑like tyrosine kinase 3

AcronymFLT3

DefinitionFMS-like tyrosine kinase 3

RelevanceDocumentation of a FLT3 mutation is required for coverage

Initial Therapy Criteria

inv-25: Initial — Initial authorization conditions

Initial authorization conditions

Initial authorization conditions: 1. Diagnosis consistent with covered indications (see Initial Therapy - AML or MLNE); 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age >= 18 years; 4. Documentation of FLT3 mutation provided; 5. Member must use generic gilteritinib if available unless contraindicated or clinically significant adverse effects; 6. Dosing does not exceed 120 mg/day unless supported by practice guidelines or peer-reviewed literature with prescriber evidence; 7. Prescribed regimen must be FDA-approved or recommended by NCCN.

inv-26: INITIAL THERAPY CRITERIA — Initial authorization duration update reflected in 1Q 2026 review

Initial authorization duration update reflected in 1Q 2026 review

Initial authorization duration updated to 12 months for applicable lines of business (per 1Q 2026 annual review). Commercial approvals: 12 months or duration of request, whichever is less; Medicaid/HIM: 12 months.

Continuation Therapy Criteria

inv-27: Continuation — Continuation approvals require confirmation of response and prior use

Continuation approvals require confirmation of response and prior use

Continuation verification: 1. Member has been receiving Xospata via the health plan benefit or has documentation of use for at least 30 days; 2. Clinical documentation demonstrates the member is responding positively to therapy; 3. Member must use generic gilteritinib if available unless contraindicated or clinically significant adverse effects; 4. Dose increases must meet the same limits as initial therapy (not exceed 120 mg/day) or be supported by practice guidelines or peer-reviewed literature with prescriber evidence; 5. Prescribed regimen must be FDA-approved or recommended by NCCN.

inv-28: CONTINUATION CRITERIA — Continuation and renewal authorization durations referenced in document history

Continuation and renewal authorization durations referenced in document history

Continuation/renewal durations: Approval durations for continuation and renewals follow documented policy durations: Medicaid/HIM — 12 months; Commercial — 12 months or duration of request, whichever is less. These duration updates are reflected in the policy revision history (1Q 2026).

Step Therapy

Step	Requirement
1	Member must use generic gilteritinib if available prior to brand unless contraindicated or clinically significant adverse effects occur.

Quantity Limits

Gilteritinib (Xospata) — 120 mg

ProductGilteritinib (Xospata)

Standard daily quantity120 mg per day (maximum)

Tablet strength noted in policy40 mg tablets (implied by 3 tablets = 120 mg)

Revision History

2022-01-20revised

Commercial approval duration revised from length of benefit to 12 months or duration of request, whichever is less.

2021-11-09clarified

Oral oncology generic redirection language clarified to require use of generic gilteritinib ('must use').

2022-11-22updated

MLNE off‑label usage criteria updated to require documentation of chronic phase or blast phase to align with NCCN recommendations; legacy Wellcare approval duration consolidated with Medicaid/HIM to 6 months.