CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vanflyta (quizartinib) — Drug Policy (coverage criteria)

Defines accepted indications, inclusion and exclusion criteria, and authorization authority for Vanflyta (quizartinib) for adult patients, primarily for FLT3-ITD–positive newly diagnosed acute myeloid leukemia, and describes documentation/compendia sources that support use.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVanflyta (quizartinib) — Drug Policy (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 27, 2024

Next Review DateSep 18, 2024

Key ActionSubmit medication requests to Evolent/UM for Utilization Management Department review; final approval is by the Utilization Management Committee.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

53 mgsingle-dose maximum excluded in policy

FLT3-ITD–positive AMLprimary FDA-covered indication

FDA + CMS + NCCN/ASCOaccepted evidence sources for use

UM Committeefinal approval authority

Coverage Criteria

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Covered Indications and Continuation Exemption

Covered when ALL of the following are met

Covered indication - newly diagnosed AML: Patient is an adult with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test; Vanflyta (quizartinib) is used with standard cytarabine and anthracycline induction and cytarabine consolidation, or as maintenance monotherapy following consolidation chemotherapy.

Reflects FDA-approved indication per prescribing information and policy language.

Continuation (exemption) criteria: Continuation requests for a not-approvable medication are exempt from this policy if ALL of the following are met: (1) the member has not experienced disease progression on the requested medication; (2) the medication was used within the last year without a lapse of more than 30 days of active authorization; and (3) no additional medications are being added to the continuation request.

Applies to renewal requests per policy II.A.

The policy excludes requests when there is disease progression while taking Vanflyta (quizartinib). Requests are also excluded if the requested dosing would exceed the policy's single‑dose limit of 53 mg. Finally, use of Vanflyta for investigational or off‑label indications that lack sufficient supporting evidence or are not generally accepted by the medical community is excluded; the policy defines sufficiency using multiple evidentiary considerations (see below).

Off‑label or investigational requests that do not meet the policy's sufficiency criteria are not approvable. The policy specifies that acceptable supporting evidence must address whether the patient and cancer characteristics are adequately represented, whether the regimen studied reflects the requested therapy, whether reported outcomes are clinically meaningful (ASCO‑style thresholds such as a hazard ratio <0.80 or survival benefit of ≥3 months for OS/PFS are examples), and whether study design and size provide reliable inference. Case reports and meeting abstracts without full peer‑reviewed articles are specifically noted as inadequate evidence.

Initial Therapy — FLT3-ITD Acute Myeloid Leukemia

Initial therapy - FLT3-ITD AML

Initial therapy covered use

Initial therapy for FLT3-ITD AML: Use Vanflyta (quizartinib) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for adult patients with newly diagnosed AML that is FLT3-ITD–positive as detected by an FDA-approved test.

Reflects the FDA-approved indication per policy and prescribing information.

Continuation Therapy

Continuation therapy exemption

Continuation (renewal) requests may be exempt from full policy review under specified conditions.

Continuation exemption: Member has not experienced disease progression on the requested medication AND medication was used within the last year without a lapse of more than 30 days of active authorization AND no additional medications are being added to the continuation request.

See policy II.A for details.

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vanflyta (quizartinib). Evolent is responsible for processing all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Final approval authority rests with the Utilization Management Committee.

All medication requests must be submitted to Evolent for review
Continuation (renewal) requests may be exempt when criteria are met (see continuation exemption callout)
Requests not reviewed/approved by Evolent may be denied and are not reimbursable

Note

Continuation (Renewal) Exemption Criteria

Continuation (renewal) requests are exempt from re-review under this policy when ALL of the following are true: the member has not experienced disease progression while on the requested medication; the medication was used within the last year with no lapse of more than 30 days of an active authorization; and no additional medications are being added to the continuation request.

No disease progression on the requested medication
Used within the last year with ≤ 30-day lapse of active authorization
No additional medications added to the continuation request

Documentation Required

Required Supportive Evidence

Use of Vanflyta must be supported by one of the following sources: FDA-approved product labeling; CMS-recognized compendia; NCCN or ASCO clinical guidelines; or 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
Peer-reviewed literature meeting CMS Chapter 15 requirements

Denial Risk

Denial Triggers / Exclusion Criteria

Requests should be denied when exclusion criteria are met, including disease progression while on Vanflyta, dosing that exceeds the single-dose limit (53 mg), or investigational/off-label uses lacking sufficient evidence as defined below.

Disease progression while taking Vanflyta (quizartinib)
Dosing exceeds single-dose limit of 53 mg
Investigational or off-label use not supported by CMS compendia or acceptable peer-reviewed literature

Definitions

Definition — FLT3‑ITD positive AML

TermFLT3 internal tandem duplication–positive acute myeloid leukemia (FLT3‑ITD–positive AML)

Definition / clinical labelAdult newly diagnosed acute myeloid leukemia (AML) with FLT3 internal tandem duplication (ITD) detected by an FDA‑approved test

Relevant use in policyIndication for Vanflyta used with standard cytarabine/anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy

Supporting referencesVanflyta prescribing information; QuANTUM‑First pivotal trial (Lancet 2023)

Background

Quizartinib (Vanflyta) is a targeted FLT3 inhibitor used in the treatment of FLT3 internal tandem duplication (ITD)–positive acute myeloid leukemia in adults. The policy frames Vanflyta's role in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation, consistent with its approved indication; it also relies on pivotal trial evidence and standard compendia/guidelines to support coverage decisions.