CurrentHealth NetPolicy CP PHAR.412

Gilteritinib (Xospata) coverage

Defines medical necessity and prior authorization criteria for gilteritinib (Xospata) for members of Health Net lines of business including Commercial, HIM, and Medicaid; applies to prescribing clinicians and pharmacies seeking coverage.

Policy Summary

PayerHealth Net

PolicyGilteritinib (Xospata) coverage

Policy CodePolicy CP PHAR.412

Change TypeNo material change

Effective DateJan 15, 2019

Next Review Date

Key ActionSubmit documentation (chart notes, lab results, or other clinical information) showing the member meets all approval criteria, including FLT3 mutation and at least 30 days of treatment for continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

120 mg/daymaximum dose referenced

40 mgtablet strength available

12 moapproval duration (commercial)

6 moapproval duration (Medicaid/HIM)

NCCN 1NCCN rating impact

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inv-01: Initial Approval — Relapsed or Refractory AML

Covered when ALL of the following are met

Initial AML criteria: Diagnosis of relapsed or refractory acute myeloid leukemia (AML);

Initial AML criteria: Age > 18 years;

Initial AML criteria: Prescribed by or in consultation with an oncologist or hematologist;

Initial AML criteria: Documentation of an FLT3 mutation;

Initial AML criteria: For Xospata requests, member must use generic gilteritinib, if available, unless contraindicated or clinically significant adverse effects are experienced;

Initial AML criteria: Dose does not exceed 120 mg (3 tablets) per day, or a dose above this is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence);dose <= 120 mg/day

Initial AML criteria: Prescribed regimen must be FDA‑approved or recommended by NCCN.

inv-02: Initial Approval — Myeloid/Lymphoid Neoplasm with Eosinophilia (MLNE) (off-label)

Covered when ALL of the following are met (NCCN‑recommended off‑label use)

MLNE off-label criteria: Diagnosis of a myeloid/lymphoid neoplasm with eosinophilia (MLNE) in chronic phase or blast phase;

MLNE off-label criteria: Prescribed by or in consultation with an oncologist or hematologist;

MLNE off-label criteria: Documentation of an FLT3 mutation;

MLNE off-label criteria: For Xospata requests, member must use generic gilteritinib, if available, unless contraindicated or clinically significant adverse effects are experienced;

inv-18: Initial Therapy — Initial therapy criteria

Initial therapy criteria

Initial therapy nodes: Diagnosis appropriate for the requested indication;

Initial therapy nodes: Age > 18 years;

Initial therapy nodes: Prescribed by or in consultation with an oncologist or hematologist;

Initial therapy nodes: Documentation of an FLT3 mutation when required for the indication;

Initial therapy nodes: For Xospata requests, member must use generic gilteritinib if available unless contraindicated or clinically significant adverse effects are experienced;

Requests for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (for example, CP.CPA.09 for Commercial and HIM.PA.154 for Health Insurance Marketplace/HIM).

Following the NCCN rating increase for Xospata (gilteritinib) from 2A to 1, the prior requirement for a trial of other tyrosine kinase inhibitors (TKIs) as a step prior to approval for AML has been removed. The policy reflects this change by eliminating TKI trial requirements from the AML indications and aligning prior‑authorization and step‑therapy language with current NCCN guidance.

inv-03: Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Continued therapy criteria: Member is currently receiving medication via the Centene benefit with documentation supporting current use for a covered indication and has received Xospata for at least 30 days;

Continued therapy criteria: Member is responding positively to therapy;

Continued therapy criteria: For Xospata dose increase requests, the new dose does not exceed 120 mg (3 tablets) per day or the increased dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence);dose <= 120 mg/day for increases

Continued therapy criteria: For Xospata requests, member must use generic gilteritinib if available unless contraindicated or clinically significant adverse effects are experienced;

inv-19: Continuation Therapy — Continuation therapy requirements

Continuation therapy requirements

Continuation nodes: Member has received Xospata for at least 30 days and is currently receiving the medication for a covered indication;

Continuation nodes: Member is responding positively to therapy;

Continuation nodes: Generic gilteritinib must be used if available unless contraindicated or clinically significant adverse effects are experienced;

Continuation nodes: If request is for a dose increase, the new dose must not exceed 120 mg (3 tablets) per day unless supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).dose <= 120 mg/day for increases

inv-20: AML Continuing Therapy — Continuation therapy duration for AML

AML continuation duration: AML continuing therapy duration increased to 12 months.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required. Provider must submit documentation (such as chart notes, laboratory results, pathology or molecular testing reports, and other clinical information) that supports the member meets all approval criteria for relapsed or refractory acute myeloid leukemia (AML) with a documented FLT3 mutation. Requests must document member age (>18 years) and that the drug is prescribed by or in consultation with an oncologist or hematologist.

Affected drug: gilteritinib (Xospata)
Required documentation: chart notes, lab results, molecular testing confirming FLT3 mutation, treatment history
Prescriber: oncologist or hematologist

Documentation Required

Off‑Label (MLNE) Documentation Required

Documentation Requirement (MLNE off‑label use): For requests of gilteritinib for myeloid/lymphoid neoplasms with eosinophilia (MLNE) or other NCCN‑recommended off‑label indications, the provider must submit supporting evidence and specify disease phase (chronic phase or blast phase) to align with NCCN recommendations. Off‑label uses must be supported by practice guidelines or peer‑reviewed literature when not FDA‑approved.

Prescriber must submit supporting literature or guideline citations when indication is off‑label
Specify disease phase (chronic phase or blast phase) for MLNE requests

Note

Operational Requirements & Authorization Duration

Provider Action — Generic First Requirement and Other Operational Notes: Members must use generic gilteritinib when available unless contraindicated or the member experiences clinically significant adverse effects. Dose must not exceed 120 mg per day unless a higher dose is supported by FDA labeling or by practice guidelines/peer‑reviewed literature (prescriber must submit supporting evidence). Authorization durations: Commercial — up to 12 months or duration requested (whichever is less); Medicaid/Legacy Wellcare — 6 months. Non‑FDA indications not addressed by this policy may be denied unless sufficient documentation of efficacy and safety is provided per off‑label use policies.

Generic redirection: must use generic gilteritinib unless contraindicated
Maximum standard dose: 120 mg/day (3 tablets) unless supported by evidence
Authorization duration: Commercial = up to 12 months or duration requested; Medicaid/Legacy Wellcare = 6 months
Non‑FDA indications require additional documentation per off‑label policies (CP.CPA.09, HIM.PA.154)

Step Therapy & Prior Steps

Step	Requirement	Notes
1	Member must use generic gilteritinib if available unless contraindicated or clinically significant adverse effects are experienced.	Oral oncology generic redirection / 'must use' language; applies to Xospata requests.

Step	Requirement	Notes
1	TKI trial requirements removed as a prior step for AML.	Change implemented after Xospata NCCN rating increased from 2A to 1 (1Q 2021 annual review).

Definitions

FLT3 — Definition

TermFLT3

DefinitionFMS-like tyrosine kinase 3

ContextReferenced in policy as the mutation required for gilteritinib (Xospata) use in AML and MLNE indications

AML — Definition

TermAML

DefinitionAcute myeloid leukemia

ContextPrimary FDA‑approved indication for gilteritinib when FLT3 mutation is present

MLNE — Definition

TermMLNE

DefinitionMyeloid/lymphoid neoplasm with eosinophilia

ContextIncluded in policy as an NCCN‑recommended off‑label indication (chronic or blast phase documentation required)

Background

Gilteritinib (Xospata) is an oral tyrosine kinase inhibitor indicated for adult patients with relapsed or refractory acute myeloid leukemia (AML) who have an FLT3 mutation detected by an FDA‑approved test. The policy also includes an NCCN‑recommended off‑label indication for myeloid/lymphoid neoplasm with eosinophilia (MLNE) when specified criteria are met. Authorization criteria require documentation of diagnosis, oncologist/hematologist involvement, FLT3 mutation status, adherence to dosing thresholds (for example, dose ≤ 120 mg/day unless supported by guidelines), and use of generic gilteritinib when available unless contraindicated.

Policy Summary

PayerHealth Net

PolicyGilteritinib (Xospata) coverage

Policy CodePolicy CP PHAR.412

Change TypeNo material change

Effective DateJan 15, 2019

Next Review Date

SourceLink

On This Page

MLNE off-label criteria:

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).

MLNE off-label criteria: Prescribed regimen must be FDA‑approved or recommended by NCCN.

Initial therapy nodes: Dose is within FDA maximum limits (not to exceed 120 mg/day for AML) or is supported by practice guidelines/peer‑reviewed literature for off‑label use (prescriber must submit supporting evidence);dose <= 120 mg/day

Initial therapy nodes: Prescribed regimen must be FDA‑approved or recommended by NCCN.

Continued therapy criteria: Prescribed regimen must be FDA‑approved or recommended by NCCN.

Continuation nodes: Prescribed regimen must be FDA‑approved or recommended by NCCN.

OpenPayer

Gilteritinib (Xospata) coverage

Coverage Criteria

Provider Actions & Requirements

Step Therapy & Prior Steps

Definitions

Background