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Daunorubicin and Cytarabine Liposomal (Vyxeos)

Section: Injections
Effective Date: February 01, 2020
Revised Date: January 27, 2020

Description

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.

Criteria

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.

FDA Indications

Daunorubicin and cytarabine (Vyxeos) may be considered medically necessary for individuals 18 years and older with ANY ONE of the following:

  • Therapy-related acute myeloid leukemia (t-AML); or
  • AML with myelodysplasia-related changes (AML-MRC).

AND ALL of the following:

  • Inadequate response, intolerance, high risk for intolerance or relapse, or contraindication to the use of daunorubicin and cytarabine separately; and
  • Clinician agrees NOT to interchange with other daunorubicin and/or cytarabine containing products; and
  • Clinician provides documentation of ECG and assessment of cardiac function by multi-gated radionuclide angiography (MUGA) scan or echocardiography (ECHO) prior to administration of daunorubicin and cytarabine (Vyxeos); and
  • Clinician confirms monitoring of complete blood counts and urine copper levels on a regular basis.

NCCN Indications

Daunorubicin and cytarabine (Vyxeos) may be considered medically necessary for ANY of the following indications:

  • Treatment inducation for individuals with cytotoxic therapy-related AML or individuals with antecedent Myelodysplastic Syndrome (MDS) or chronic myelomonocytic leukemia (CMML) or cytogenetic changes that are consistent with MDS:
    • In individuals less than 60 years of age without core binding factor (CBF) abnormalities; or
    • In individuals 60 years or older for intensive remission induction therapy with unfavorable cytogenetic/molecular markets/antecedent hematologic disorder/therapy-related AML; or
  • For re-induction after standard-dose cytarabine induction for individuals with cytotoxic therapy-related AML or patients with antecedent MDS/CMML or cytogenetic changes that are consistent with MDS:
    • In individuals less than 60 years of age with significant residual disease without a hypocellular marrow and without CBF abnormalities; or
    • In individuals 60 years or older with residual disease; or
  • For post-remission therapy for individuals with cytotoxic therapy-related AML or patients with antecedent MDS/CMML or cytogenetic changes that are consistent with MDS:
    • For individuals less than 60 years of age without CBF abnormalities, treatment-related disease and/or poor-risk cytogenetics and/or molecular abnormalities; or
    • For individuals 60 years or older with complete response to previous intensive therapy.

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.

Procedure Codes

J9153

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.

Diagnosis Codes

C92.00 C92.01 C92.02 C92.50 C92.51 C92.52 C92.60
C92.61 C92.62 C92.A0 C92.A1 C92.A2 C93.00 C93.01
C94.00 C94.01 C94.20 C94.21

Professional Statements and Societal Positions Guidelines

NA

Links