UnitedHealthcare Vanflyta Prior Auth Coverage Update | OpenPayer

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UnitedHealthcare Vanflyta Prior Auth Coverage Update | OpenPayer

Coverage Criteria for Vanflyta (quizartinib)

Initial Therapy — Acute Myeloid Leukemia

Covered when ALL of the following are met

AML initial authorization: (1) Diagnosis of acute myeloid leukemia (AML); AND (2) Disease is FLT3 internal tandem duplication (ITD) positive

Authorization will be issued for 12 months

Reauthorization — Acute Myeloid Leukemia

Covered when ALL of the following are met

AML reauthorization: Patient does not show evidence of progressive disease while on Vanflyta therapy

Authorization will be issued for 12 months

Initial Therapy — Myeloid/Lymphoid Neoplasms with Eosinophilia

Covered when ALL of the following are met

Neoplasms initial authorization: (1) Diagnosis of lymphoid, myeloid, or mixed lineage neoplasms with eosinophilia in the chronic or blast phase; AND (2) Patient has an FLT3 rearrangement

Authorization will be issued for 12 months

Reauthorization — Myeloid/Lymphoid Neoplasms with Eosinophilia

Covered when ALL of the following are met

Neoplasms reauthorization: Patient does not show evidence of progressive disease while on Vanflyta therapy

Authorization will be issued for 12 months

Patients less than 19 years of age

Covered when ALL of the following are met

Pediatric: Patient is less than 19 years of age

Authorization will be issued for 12 months; prescriptions for members under 19 process without coverage review

NCCN Recommended Regimens

NCCN regimens: Drug recognized by NCCN Drugs and Biologics Compendium with Category 1, 2A, or 2B

Authorization will be issued for 12 months; state mandates and member benefits may impact coverage

Vanflyta is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with Vanflyta in this setting has not been demonstrated.

Initial Therapy Criteria

Initial Therapy — consolidated initial authorization criteria for covered indications

Initial authorization criteria for covered indications

Initial therapy options: Initial authorization may be granted for (A) AML with FLT3-ITD positive disease OR (B) lymphoid/myeloid/mixed lineage neoplasms with eosinophilia and FLT3 rearrangement

Each authorization is issued for 12 months

Reauthorization / Continuation Therapy

Reauthorization / Continuation Therapy — rules for ongoing therapy

Reauthorization rules

Continuation: Patient does not show evidence of progressive disease while on Vanflyta therapy

Authorization renewed for 12 months

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vanflyta (quizartinib). Providers must submit documentation proving the diagnosis and FLT3 testing results where applicable. For pediatric members (<19 years), indicate age and note that approvals are issued for 12 months.

Affected populations: pediatric members <19, adults with AML, and patients with neoplasms with eosinophilia
Documentation: diagnostic report, FLT3 ITD or FLT3 rearrangement test results (FDA-approved test if for initial AML indication)
Authorization duration: 12 months for initial and reauthorization approvals

Documentation Required

AML initial authorization — provider action

For initial AML authorizations, providers must document both: (1) a diagnosis of acute myeloid leukemia (AML) and (2) that the disease is FLT3 internal tandem duplication (ITD) positive. Approvals are issued for 12 months. If the member is <19 years old, note age; pediatric approvals also issue for 12 months.

Step Therapy / Regimen Recognition

Coverage statement	Notes
Use consistent with NCCN-recommended regimens (recognized by the NCCN Drugs & Biologics Compendium with Category 1, 2A, or 2B)	Authorization will be issued for 12 months. State mandates, federal requirements, and member benefit plan coverage may impact availability.
Applies when the drug is used in regimens aligned with NCCN recommendations for the relevant indication (e.g., relapsed/refractory AML or neoplasms with eosinophilia as recognized by NCCN).	Other policies and utilization management programs may apply.

Quantity Limits

Vanflyta (quizartinib) — supply/quantity limits note

Quantity limit statusSupply limit may be in place

Unit periodper month

Program noteUnitedHealthcare may apply supply limits as part of automated approval or program-specific processes

Definitions

FLT3-ITD — definition and required marker for AML initial authorization

DefinitionFLT3 internal tandem duplication (ITD): a molecular alteration in the FLT3 gene required for coverage in AML initial authorization

Authorization requirementInitial authorization for newly diagnosed AML requires documentation that disease is FLT3-ITD positive (detected by an FDA-approved test)

Authorization durationAuthorization will be issued for 12 months

Source contextFLT3-ITD requirement reflects the Vanflyta indication for newly diagnosed AML as described in the product background and initial authorization criteria

Background and Rationale

Vanflyta (quizartinib) is a kinase inhibitor indicated for use in adults with newly diagnosed FLT3-ITD–positive acute myeloid leukemia in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation. The National Comprehensive Cancer Network (NCCN) additionally recommends Vanflyta for relapsed/refractory AML and for certain lymphoid, myeloid, or mixed lineage neoplasms with eosinophilia that harbor FLT3 rearrangements.

Revision History and Policy Changes

2025-09-01annual review - clinical criteria updatedLatest

Updated AML criteria and added criteria for Myeloid/Lymphoid Neoplasms with Eosinophilia per NCCN recommendations; background and references updated.

2024-09-01annual review - coverage added

Added coverage for relapsed/refractory disease per NCCN recommendations and updated references.

2023-09-01program created