Daunorubicin and cytarabine (Vyxeos) is a liposomal combination of an anthracycline topoisomerase inhibitor (daunorubicin) and a nucleoside metabolic inhibitor (cytarabine) in a 1:5 molar ratio. This ratio has been shown to have synergistic effects at killing leukemia cells in vitro and in murine models.
Daunorubicin has antimitotic and cytotoxic activity by forming complexes with DNA, inhibiting topoisomerase II activity. Thus affecting regulation of gene expression, and producing DNA-damaging free radicals. Cytarabine is a cell cycle phase-specific antineoplastic agent, affecting cells only during the S-phase of cell division. Cytarabine acts primarily through inhibition of DNA polymerase. Animal data shows the liposomes enter and persist in the bone marrow, where they are taken up intact by bone marrow cells. In these studies it has been show that the liposomes are taken up by leukemia cells to a greater extent than by normal bone marrow cells. After cellular internalization, liposomes undergo degradation releasing daunorubicin and cytarabine within the intracellular environment.
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Daunorubicin and cytarabine (Vyxeos) may be considered medically necessary for individuals 18 years and older with ANY ONE of the following:
AND ALL of the following:
Daunorubicin and cytarabine (Vyxeos) may be considered medically necessary for ANY of the following indications:
Daunorubicin and cytarabine (Vyxeos) is considered experimental/investigational for all other indications and therefore, non-covered. Scientific evidence does not support the use for any other indications than those listed above.
Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.