CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vanflyta (quizartinib) coverage criteria for FLT3-ITD positive AML

Defines indications, contraindications, exclusions, coding, and prior authorization expectations for use of Vanflyta (quizartinib) in adult patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia and related utilization management rules for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVanflyta (quizartinib) coverage criteria for FLT3-ITD positive AML

Policy CodePolicy N/A

Change TypeUpdated indications and added dosage quantity limits

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of FLT3-ITD positive status by an FDA-approved test and evidence of use with standard induction/consolidation (maintenance permitted) to support coverage.

SourceLink

POLICY UPDATE CHANGES

Updated indication section to specify use with standard induction/consolidation and maintenance for newly diagnosed FLT3-ITD positive AML.

Added maximum dosage form quantities to exclusion criteria (monthly tablet limits and single-dose limit).

Converted to new Evolent guideline template and replaced prior UM ONC_1484 Vanflyta guideline.

FLT3-ITDrequired biomarker for indicated patients

J8999billing code listed for quizartinib

53 mgsingle dose maximum excluded if exceeded

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Coverage Criteria for Vanflyta (quizartinib)

Initial therapy coverage criteria

Covered when ALL of the following are met

Indication and biomarker: Adult member with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test

Use in context of standard induction and consolidation; maintenance monotherapy allowed following consolidation

Treatment context: Use with standard cytarabine and anthracycline induction and cytarabine consolidation, or as maintenance monotherapy following consolidation chemotherapy

Safety program: Patient enrolled in Vanflyta REMS and baseline and periodic ECG and electrolyte (potassium and magnesium) monitoring performed per prescribing information

Do not initiate or escalate dose if QTcF >450 msec; correct hypokalemia or hypomagnesemia prior to dosing

Requests will be excluded or denied when any of the following apply: documented disease progression while taking Vanflyta (quizartinib); dosing that exceeds the single dose limit of 53 mg; or treatment that exceeds the maximum monthly tablet limits of 28 (17.7 mg) or 56 (26.5 mg) tablets per month. These limits are enforced for utilization management and billing control and will result in denial if not met.

Use of Vanflyta (quizartinib) for investigational indications or off-label uses that are not supported by sufficient evidence or not generally accepted by the medical community is considered not medically necessary. Sufficient evidence must be supported by CMS-recognized compendia or acceptable peer‑reviewed literature and should address patient/cancer characteristics, the administered regimen, and clinically meaningful outcomes (for example, ASCO-recommended benchmarks such as hazard ratio <0.80 and survival benefit thresholds). Case reports and meeting abstracts without full peer‑reviewed articles generally do not provide adequate support.

Regimen	Indication / Line of therapy	Coverage status
Quizartinib (Vanflyta) administered in combination with standard cytarabine and anthracycline induction and cytarabine consolidation; maintenance monotherapy with quizartinib following consolidation	Newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive in adults (used as first-line induction/consolidation; maintenance after consolidation permitted)	Covered

Billing and Coding

Drug HCPCS codesHCPCSCovered

J8999

quizartinib

Single dose limit

Single dose maximum (exclude if exceeded)53 mg

Source policy noteExclusion criterion: Dosing exceeds single dose limit of Vanflyta (quizartinib) 53 mg.

Related actionRequests exceeding this single dose will be denied per exclusion criteria.

Monthly tablet limits

Monthly tablet limit option A28 tablets per month (17.7 mg strength)

Monthly tablet limit option B56 tablets per month (26.5 mg strength)

Policy application

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vanflyta (quizartinib). Continuation requests may be approved without full re-review when ALL continuation conditions are met.

Continuation permitted if member has not experienced disease progression on Vanflyta
Continuation permitted if medication was used within the last year with no lapse >30 days of active authorization
Continuation permitted if no additional medications are being added to the continuation request

Note

Therapy Context

Vanflyta (quizartinib) is indicated for use in adults with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive when given with standard cytarabine and anthracycline induction and cytarabine consolidation, and may be used as maintenance monotherapy following consolidation.

Use in combination with standard cytarabine and anthracycline induction

Biomarker Requirements

FLT3-ITD testing requirement

Required FLT3-ITD detectionFLT3 internal tandem duplication (ITD) must be detected by an FDA-approved test to meet indication.

Indication contextDetection required for newly diagnosed adult AML patients considered for Vanflyta in combination with induction/consolidation or maintenance.

Documentation implicationClinical documentation must support FLT3-ITD–positive status as detected by an FDA-approved test.

Line of Therapy

first-line

Line: Newly diagnosed AML used with induction and consolidation; maintenance after consolidation permitted

Definitions

FLT3 internal tandem duplication (ITD) mutation — definition

Biomarker definitionFLT3 internal tandem duplication (ITD) is a specific activating mutation in the FLT3 gene required for indicated use of quizartinib (Vanflyta).

Clinical relevanceFLT3-ITD confers sensitivity to FLT3 inhibitors and defines the patient population for Vanflyta therapy (newly diagnosed AML).

Testing standardMutation must be identified by an FDA-approved diagnostic test as part of eligibility assessment.

Treatment linkagePresence of FLT3-ITD is required to use quizartinib with standard cytarabine/anthracycline induction, consolidation, or maintenance.

Background

Quizartinib (Vanflyta) is a targeted FLT3 inhibitor indicated for adult patients with newly diagnosed acute myeloid leukemia (AML) harboring FLT3 internal tandem duplication (ITD) mutations. It is used in combination with standard cytarabine/anthracycline induction and cytarabine consolidation and may be continued as maintenance monotherapy following consolidation. Because QT prolongation is a known dose-related risk, baseline and periodic ECG and electrolyte monitoring are required and use is managed through the REMS program per the prescribing information.

Revision History

2025-09template_conversion_and_updatesLatest

Converted to the new Evolent guideline template, replaced prior guideline UM ONC_1484, updated the indication section to reflect QuANTUM-First incorporation, and added maximum dosage form quantities to exclusion criteria (single-dose and monthly tablet limits).

2024-09exclusion_criteria_update

Updated exclusion criteria (details not otherwise specified in summary).