CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Xospata (Gilteritinib) — Coverage Criteria

Defines accepted indications, inclusion and exclusion criteria, and utilization management for Xospata (gilteritinib) for treatment of cancer—primarily relapsed or refractory FLT3‑mutated acute myeloid leukemia—and describes UM review and approval processes for Neighborhood Health Plan of Rhode Island (Evolent-managed).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXospata (Gilteritinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJuly 26, 2024

Next Review DateN/A

Key ActionSubmit medication requests to Evolent Utilization Management for review; final approval rests with the Utilization Management Committee.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

07/26/2024effective date

Relapsed/RR AML w/ FLT3primary covered indication

120 mgsingle dose max

90 tabsmonthly limit

Coverage Criteria for Xospata (gilteritinib)

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Inclusion / Continuation Criteria

Covered when ALL of the following are met

Initial or continuation coverage for Xospata: Member has relapsed or refractory acute myeloid leukemia (AML) with FLT3 ITD or FLT3 TKD mutation.

Continuation request exemption conditions: For continuation requests to be exempt from this policy: (1) the requested medication was used within the last year, AND (2) the member has not experienced disease progression and/or intolerance to the requested medication, AND (3) additional medication(s) are not being added to the continuation request.

Continuation exemption per policy II.A.

Coverage excludes requests when any of the following apply: (1) disease progression occurred while the member was receiving Xospata (gilteritinib); (2) the prescribed dosing exceeds the single dose maximum of 120 mg; or (3) the requested supply exceeds the maximum monthly quantity of 90 (40 mg) tablets. Additionally, use is excluded when Xospata is requested for an investigational or off‑label indication that lacks sufficient supporting evidence as defined in policy (e.g., not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature and guideline standards).

Use of Xospata (gilteritinib) is considered not medically necessary when requested for investigational or off‑label indications that do not have adequate supporting evidence. Adequate evidence is defined by the policy as support from FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature and professional guidelines; studies must meaningfully represent the patient population, regimen, and clinically meaningful outcomes (per ASCO thresholds), and rely on appropriate study designs. Case reports or meeting abstracts without full peer‑reviewed publication generally do not meet the evidentiary standard.

Regimen	Indication (per policy/source)	Notes / Supporting evidence	Coverage status
Gilteritinib monotherapy (Xospata)	Relapsed or refractory acute myeloid leukemia (AML) with FLT3 ITD or TKD mutation	Modeled on the ADMIRAL trial and consistent with FDA prescribing information for Xospata; references include the ADMIRAL clinical trial publication and Xospata prescribing information.	Covered with criteria

Provider Actions, Review, and Authorization Rules

Prior Authorization

UM Review and Final Approval

Medication requests for Xospata (Gilteritinib) are processed by Evolent Utilization Management. Final approval authority rests with the Utilization Management Committee. Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

All prior authorization and medication requests must be submitted to Evolent Utilization Management for review.
Final authorization decisions are made by the Utilization Management Committee.
Requests not authorized by Evolent/UM may be considered not approvable and not reimbursable.

Note

Continuation Request Exemption

Continuation (renewal) requests are exempt from additional policy requirements when all conditions are met: the medication was used within the last year, the member has not experienced disease progression or intolerance to the medication, and no additional medications are being added to the continuation request.

Used within the last year
No disease progression and no intolerance to the requested medication
No additional medications added to the continuation request

Documentation Required

Supporting Evidence Required

Use of Xospata (Gilteritinib) must be supported by one of the following sources: FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) clinical guidelines, or acceptable peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards.

FDA-approved product labeling
CMS-recognized compendia
NCCN or ASCO clinical guidelines
Acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15

Denial Risk

Exclusion Triggers

Requests will be denied when any exclusion criteria are met, including disease progression while on Xospata, dosing or quantity limits exceeded, investigational or insufficient evidence for off-label use, or other conditions listed below.

Disease progression while taking Xospata (Gilteritinib)
Single dose exceeds 120 mg
Monthly quantity exceeds 90 (40 mg) tablets
Investigational use or off-label indications lacking sufficient evidence as defined by CMS compendia or acceptable peer-reviewed literature
Insufficient supporting evidence includes inadequate patient representation, regimen mismatch, lack of clinically meaningful outcomes, poor experimental design, reliance on isolated case reports or abstracts without full peer-reviewed articles

Biomarker Requirements (FLT3 Testing)

FLT3 (ITD or TKD) — Biomarker requirement for coverage

Required biomarkerFLT3 mutation (either internal tandem duplication [ITD] or tyrosine kinase domain [TKD])

PurposeRequired to establish eligibility for coverage of gilteritinib (Xospata) in relapsed or refractory AML

Testing requirementDocumented FLT3‑ITD or FLT3‑TKD mutation in the member's medical record or molecular testing report

FLT3‑mutated AML — Definition: relapsed or refractory AML with FLT3 ITD or TKD mutation

DefinitionRelapsed or refractory acute myeloid leukemia (AML) with FLT‑3 ITD or FLT‑3 TKD mutation

Clinical contextSpecifies the disease state for which gilteritinib (Xospata) coverage is provided — AML that has relapsed or is refractory and harbors an FLT3 mutation

Implication for coverageMember must have relapsed or refractory AML and a confirmed FLT3 (ITD or TKD) mutation to meet the primary inclusion criterion for treatment with Xospata