CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Xospata (gilteritinib) — Coverage Criteria

Defines clinical and administrative criteria for authorization of Xospata (gilteritinib) for members, including accepted indications, documentation standards, and exclusion criteria; applies to utilization management staff and network ordering providers processing medication requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXospata (gilteritinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 26, 2024

Next Review DateN/A

Key ActionObtain prior authorization with documentation of FLT3-ITD or FLT3-TKD mutation and supporting evidence per FDA labeling, CMS compendia, or NCCN/ASCO guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

120 mgsingle dose limit

90 tabletsmonthly limit

FLT3‑mut AMLprimary covered indication

ADMIRALkey evidence

FDA/NCCN/CMSaccepted sources

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Coverage Criteria for Xospata (gilteritinib)

inv-01: Initial therapy / covered indication

Covered when ALL of the following are met:

Primary indication: Member has relapsed or refractory acute myeloid leukemia (AML) with FLT3-ITD or FLT3-TKD mutation.

Supportive evidence: Use is supported by FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

inv-02: Continuation Therapy

Continuation therapy covered when ALL of the following are met:

Recent prior use: Requested medication was used within the last year.

No progression or intolerance: Member has not experienced disease progression and/or intolerance to the requested medication.

No additional agents: Additional medication(s) are not being added to the continuation request.

Exclusion and limit triggers: Coverage is not provided for treatment when there is disease progression while taking Xospata (gilteritinib), for requests that exceed the single-dose limit of 120 mg, or when treatment would exceed the maximum supply of 90 tablets per month (40 mg tablet units referenced).

Investigational or off‑label uses: Requests for Xospata for indications that are off‑label and not generally accepted by the medical community may be denied if the supporting evidence is insufficient. Insufficiency is assessed against criteria such as whether the patient and disease are represented in the evidence, whether the treatment regimen studied matches the requested regimen, whether reported outcomes are clinically meaningful (for example ASCO‑recommended thresholds such as hazard ratio < 0.80 or at least a 3‑month survival benefit for OS/PFS), the appropriateness of study design, and the quality of evidence (with nonrandomized trials sometimes acceptable but case reports and meeting abstracts without full peer‑reviewed publications generally inadequate).

Use of Xospata for off‑label indications that are not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature is considered investigational and may be denied. The policy evaluates sufficiency of evidence by considering representation of the patient population and cancer, adequacy of the regimen studied, clinical meaningfulness of outcomes, appropriateness of study design, and the overall quality of published evidence — with case reports and meeting abstracts without full articles generally not providing adequate support.

Initial Therapy

inv-14: Initial therapy

Diagnosis: Relapsed or refractory AML with FLT3 ITD or TKD mutation.

Supporting evidence: Use supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

Continuation Therapy Criteria

inv-15: Continuation therapy

Used within last year: Requested medication was used within the last year.

No progression/intolerance: Member has not experienced disease progression and/or intolerance to the requested medication.

No new medications: Additional medication(s) are not being added to the continuation request.

Coding and Quantity Limits

Drug codes referencedNDC

NDC	Drug product coding referenced as applicable for medication requests

inv-06: Single dose limit — 120 mg

Single dose limit120 mg per single dose

Source policy textDosing exceeds single dose limit of Xospata (Gilteritinib) 120 mg

EnforcementRequests exceeding this single-dose limit may be excluded per exclusion criteria

inv-07: Maximum monthly tablet limit — 90 tablets/month (40 mg tablet units referenced)

Maximum monthly tablet limit90 tablets per month (40 mg tablet units referenced)

Source policy textTreatment exceeds the maximum limit of 90 (40mg) tablets/month

Quantity and Dose Limits

inv-17: Xospata (gilteritinib) — quantity limit (90)

DrugXospata (gilteritinib)

Quantity limit (per policy)90 tablets per month

Unit referenceLimit expressed using 40 mg tablet units as referenced in policy

inv-18: Xospata (gilteritinib) — single dose (120 mg)

DrugXospata (gilteritinib)

Single dose limit120 mg per single dose

Policy citationDosing exceeds single dose limit of Xospata (Gilteritinib) 120 mg

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation of the FDA-approved indication or supporting evidence (CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature) and demonstrate adherence to labeling and dosing limits.

Prior authorization required for initial and continuation therapy
Include documentation of indication and adherence to dosing limits

Note

Provider Action – Submission Details

Providers should ensure timely submission of prior authorization requests and include clinical documentation showing mutation status (FLT3‑ITD or FLT3‑TKD for AML), prior response history, and any concomitant therapies when applicable.

Specify FLT3 mutation status when applicable
Document prior treatment history and lack of progression for continuation requests

Definitions

inv-13: FLT3-mutated relapsed/refractory AML — documented molecular diagnostic requirement for curation

Required documentationMember has relapsed or refractory AML with FLT3-ITD or FLT3-TKD mutation (documented molecular diagnostic)

Evidence basisUse must be supported by FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature

Supporting referenceADMIRAL trial cited as key supporting evidence in policy references

Background

Xospata (gilteritinib) is a targeted tyrosine kinase inhibitor approved for treatment of relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutations. Clinical trial evidence (for example the ADMIRAL trial cited in the source) supports its use in FLT3‑mutated relapsed/refractory AML; refer to the FDA label and peer‑reviewed literature for administration, monitoring, and detailed clinical data.

Step Therapy

Step therapy requirement	Details
No specific step therapy sequence described	Coverage is determined based on meeting the clinical indication (relapsed or refractory AML with FLT3-ITD or FLT3-TKD mutation) and required supporting evidence (FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15).
Prior authorization	Prior authorization is required with documentation of the indication and supporting evidence; continuation requests allowed if prior use within the last year without disease progression or intolerance and no additional agents are being added.

Site of Care / Administration

Note

Hospital outpatient: follow FDA label for administration and monitoring

For hospital outpatient administration and monitoring details, refer to the FDA product labeling/Prescribing Information.

Follow the FDA label for administration instructions, monitoring requirements, and safety precautions when administering in the hospital outpatient setting.