CurrentCignaPolicy N/A

Vanflyta (quizartinib) prior authorization for FLT3-targeted therapy

Defines prior authorization requirements and coverage criteria for Vanflyta (quizartinib tablets) for adults with FLT3-ITD–positive AML and certain myeloid/lymphoid neoplasms with FLT3 rearrangements under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyVanflyta (quizartinib) prior authorization for FLT3-targeted therapy

Policy CodePolicy N/A

Change TypeNone

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document patient age (≥18) and the required tumor biomarker (FLT3‑ITD or FLT3 rearrangement) to qualify for a 1‑year approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2distinct covered indications

1 yearinitial approval duration

≥18minimum patient age for coverage

FLT3‑positiverequired tumor biomarker for covered uses

Coverage Criteria for Vanflyta (quizartinib)

Regimen phase	Description / drugs	Coverage notes
Induction
Vanflyta (quizartinib) in combination with standard cytarabine plus anthracycline induction chemotherapy (e.g., cytarabine + daunorubicin or idarubicin).
Covered per FDA-approved indication for newly diagnosed FLT3-ITD–positive AML in adults when authorization criteria are met; prior authorization required.

Vanflyta (quizartinib) is not medically necessary for uses beyond the specific indications described in this policy. The drug is approved for use in adults with newly diagnosed FLT3-ITD–positive acute myeloid leukemia in the settings described by the FDA label; use as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation is not indicated and improvement in overall survival in that post‑HSCT setting has not been demonstrated. Requests for Vanflyta outside the covered indications are subject to denial as not medically necessary.

Use of Vanflyta for ANY other use(s) beyond the listed FDA‑approved indication for FLT3‑ITD–positive AML and the specified myeloid/lymphoid neoplasm indication supported by evidence is considered not medically necessary and will not be covered under this policy. Coverage criteria will be updated if new published data become available.

Provider Actions and Authorization Requirements

Policy Summary

PayerCigna

PolicyVanflyta (quizartinib) prior authorization for FLT3-targeted therapy

Policy CodePolicy N/A

Change TypeNone

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document patient age (≥18) and the required tumor biomarker (FLT3‑ITD or FLT3 rearrangement) to qualify for a 1‑year approval.

SourceLink

On This Page

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Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are issued for 1 year when the specified age and biomarker criteria are met.

Vanflyta (quizartinib) requires prior authorization.
Approvals: 1 year when criteria met.

Documentation Required

Required Clinical Documentation

Provider must submit documentation demonstrating the patient meets the covered indication criteria below.

Document patient age (≥ 18 years).
Document tumor biomarker: FLT3‑ITD mutation for AML, or eosinophilia plus FLT3 rearrangement for other myeloid/lymphoid neoplasms.
Include pathology or molecular testing reports showing the FLT3 alteration.

Denial Risk

Non‑Covered Uses / Denial Risk

Requests for Vanflyta for any use not explicitly listed as covered (FDA-approved AML with FLT3‑ITD or the specified myeloid/lymphoid neoplasm with eosinophilia and FLT3 rearrangement) are not covered.

Not covered: Any other indications or off‑label uses not specified as covered.
Coverage criteria will be updated as new published data become available.

Note

Provider Action

Provider action placeholder: reserve for any additional actionable notes.

Key Definitions

FLT3-ITD — definition

TermFLT3-ITD (FMS-like tyrosine kinase 3 internal tandem duplication)

DefinitionAn internal tandem duplication mutation in the FLT3 gene associated with certain cases of acute myeloid leukemia (AML).

Role for coverageRequired tumor biomarker for the FDA‑approved Vanflyta indication in newly diagnosed AML; must be detected by an FDA‑approved test.

Age requirement linked to biomarkerCoverage for the FLT3‑ITD–positive FDA indication applies to adults (≥18 years).

FLT3 rearrangement — definition

TermFLT3 rearrangement

DefinitionA genetic rearrangement involving the FLT3 gene observed in some myeloid or lymphoid neoplasms with eosinophilia.

Role for coverageRequired tumor biomarker for the policy's supportive‑evidence indication covering certain myeloid or lymphoid neoplasms with eosinophilia.

Clinical contextNCCN guidelines discuss use of Vanflyta for eosinophilic neoplasms with FLT3 rearrangements (chronic or blast phase).

Tumor Biomarker Requirements

FLT3-ITD — mutation-positive requirement for FDA-approved AML indication

Coverage requirementPatient must have FLT3‑ITD mutation‑positive disease to meet the FDA‑approved Vanflyta indication for AML.

Age restrictionPatient must be an adult (≥18 years) for FDA‑approved AML coverage under this policy.

Approval durationApprovals are issued for 1 year when criteria are met.

FLT3 rearrangement — requirement for myeloid/lymphoid neoplasm indication

Coverage requirementThe tumor must have an FLT3 rearrangement for the policy's supportive‑evidence indication covering certain myeloid or lymphoid neoplasms with eosinophilia.

Concurrent clinical criteriaPatient must have eosinophilia and be an adult (≥18 years) to meet this indication.

Approval durationApprovals are issued for 1 year when all criteria are met.

Line of Therapy Considerations

Line of Therapy

Line-of-therapy context: NCCN-recommended settings (induction in combination with chemotherapy, reinduction, consolidation, maintenance in select settings, and relapsed/refractory use) may apply; policy coverage is determined by age and biomarker criteria rather than restricting to a specific line of therapy.

Guideline-based contexts cited; approvals are biomarker- and age-based and issued for 1 year when criteria are met

Covered Regimens and Administration

Regimen phase	Description / drugs	Coverage notes
Induction
Vanflyta (quizartinib) given in combination with standard cytarabine plus anthracycline induction (e.g., cytarabine + daunorubicin or idarubicin) per FDA label and NCCN recommendations.
Approve for 1 year when patient is ≥18 years and has FLT3-ITD–positive AML; prior authorization required.

Background

Vanflyta (quizartinib) is a kinase inhibitor indicated, for adults with newly diagnosed AML that is FLT3‑ITD–positive, in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation. The FDA label specifies that Vanflyta is not indicated as maintenance following allogeneic hematopoietic stem cell transplantation, and a survival benefit in that setting has not been demonstrated.