VANFLYTA (quizartinib)

VANFLYTA (quizartinib)

Self-Administration – Oral

Diagnosis considered for coverage:

• Acute Myeloid Leukemia: Indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test. Limitations of Use: 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.

Coverage Criteria:

• Diagnosis of acute myeloid leukemia (AML), AND
• Patient has a FMS-like tyrosine kinase 3 (FLT3) internal tandem duplication (FLT3-ITD) mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test (e.g., LeukoStrat CDx FLT3 Mutation Assay) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), AND
• Both of the following:
  • Used in combination with standard cytarabine and anthracycline (e.g., daunorubicin, idarubicin) induction and cytarabine consolidation, AND 
  • Used as maintenance monotherapy following consolidation chemotherapy 

Reauthorization Criteria:

• Patient does not show evidence of progressive disease while on therapy 

Coverage Duration: 

• Initial: 12 months
• Reauthorization: 12 months

Authorization is not covered for the following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

• 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.

Additional Information: 

• Boxed Warning: QT prolongation, Torsades de Pointes, and cardiac arrest
  • Vanflyta prolongs the QT interval in a dose- and concentration-related manner. Prior to Vanflyta administration and periodically, monitor for hypokalemia or hypomagnesemia, and correct deficiencies. Perform ECGs to monitor the QTc at baseline, weekly during induction and consolidation therapy, weekly for at least the first month of maintenance, and periodically thereafter.
  • Torsades de pointes and cardiac arrest have occurred in patients receiving Vanflyta. Do not administer Vanflyta to patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome.
  • Do not initiate treatment with Vanflyta or escalate the Vanflyta dose if the QT interval corrected by Fridericia's formula (QTcF) is greater than 450 ms.
  • Monitor ECGs more frequently if concomitant use of drugs known to prolong the QT interval is required.
  • Reduce the Vanflyta dose when used concomitantly with strong CYP3A inhibitors, as they may increase quizartinib exposure.
  • Because of the risk of QT prolongation, VANFLYTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Vanflyta REMS.

Policy Updates:

• 03/01/2024 – New policy approved by P&T.

References:

1.    Vanflyta Prescribing Information. Daiichi Sankyo, Inc., Basking Ridge. July 2023. 
2.    clinicaltrials.gov. Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) (QuANTUM-First). Available at: https://clinicaltrials.gov/study/NCT02668653?term=nct02668653&rank=1. Accessed August 29, 2023.