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| Medical Policy: | I-193-001 |
| Topic: | Daunorubicin and Cytarabine Liposomal (Vyxeos) |
| Section: | Injections |
| Effective Date: | August 20, 2018 |
| Issue Date: | August 20, 2018 |
| Last Reviewed: | July 2018 |
Daunorubicin and cytarabine (VyxeosTM) 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.
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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
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
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.
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.
NOTE: Dosage recommendations per the FDA label.
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| Place of Service: Inpatient/Outpatient |
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Outpatient HCPCS (C Codes) |
| C9024 |
| Links |
- Link to Provider Resource Center for the Medical Policy Update
08/2018, Coverage Guidelines Established for Daunorubicin and cytarabine (Vyxeos)
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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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