Subject: Specialty Quantity Limit Vanflyta 6097-H P2025

Drug

VANFLYTA  (quizartinib)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

Covered Quantities

Medication	Standard Limit
Vanflyta (quizartinib) 26.5 mg tablets	56 per 28 days
Vanflyta (quizartinib) 17.7 mg tablets	56 per 28 days

FDA-recommended Dosing

The recommended dosage of Vanflyta is as follows:

Induction

35.4 mg orally once daily for two weeks of each cycle for a max of 2 cycles

Consolidation

35.4 mg orally once daily for two weeks of each cycle for a max of 4 cycles

Maintenance

• Administer 26.5 mg orally once daily on days 1-14 of the first cycle
• Increase the dose to 53 mg orally once daily on day 15 of the first cycle if QTcF is ≤ 450 ms
• Administer daily for up to 36 maintenance cycles

Dose modifications

Dose modifications are recommended for adverse reactions (including prolonged QT interval) and concomitant use with strong CYP3A inhibitors.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Vanflyta [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; June 2024

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 07, 2025