Daunorubicin and Cytarabine Liposomal (Vyxeos) (ARCHIVED)

Policy ID: I-193-004

Section: Injections

Effective Date: February 01, 2019

Revised Date: May 18, 2022

Revision Effective Date: June 30, 2022

Last Reviewed: May 24, 2022

Applies To: Commercial and Medicaid Expansion

This policy has been retired effective June 30, 2022. Click the Archive tab above for more information.

Policy ID: I-193-003

Section: Injections

Effective Date: February 01, 2019

Revised Date: August 31, 2020

Revision Effective Date: October 01, 2020

Last Reviewed: September 21, 2021

Archived Date: June 30, 2022

Applies To: Commercial and Medicaid Expansion

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<82>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.

Food and Drug Administration (FDA) Indications

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

Newly diagnosed therapy-related acute myeloid leukemia (t-AML); or
AML with myelodysplasia-related changes (AML-MRC); and
Inadequate response, intolerance, high risk for intolerance or relapse, or contraindication to the use of daunorubicin and cytarabine separately; or

National Comprehensive Cancer Network (NCCN) Recommendations

Acute Myeloid Leukemia

Treatment induction for individuals with therapy-related AML or individuals with antecedent myelodysplastic syndrome/chronic myelomonocytic leukemia (MDS/CMML) or cytogenetic changes that are consistent with MDS (AML-MRC):
- In individuals less than 60 years of age without core binding factor (CBF) abnormalities; or
- In individuals 60 years or older who are candidates for intensive remission induction therapy; or
For re-induction (*preferred if given in induction) for individuals with therapy-related AML or individuals with antecedent MDS/CMML or cytogenetic changes that are consistent with MDS (AML-MRC):
- 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 (*preferred if given in induction) for individuals with therapy-related AML or individuals with antecedent MDS/CMML or cytogenetic changes that are consistent with MDS (AML-MRC):
- For individuals less than 60 years of age without CBF abnormalities, treatment-related disease and/or unfavorable cytogenetics and/or molecular abnormalities; or
- For individuals 60 years or older with complete response to previous intensive therapy.

Daunorubicin and cytarabine liposomal (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.

*Note: Language derived from National Comprehensive Cancer Network (NCCN) guidelines.

Diagnosis Codes

C92.00

C92.01

C92.50

C92.51

C92.60

C92.61

C92.A0

C92.A1

C93.00

C93.01

C94.00

C94.01

C94.20

C94.21

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-14-2019 Adopted policy

Internal Medical Policy Committee 1-22-2020 Annual review, changed J9153 to pre-certification drug

Internal Medical Policy Committee 7-22-2020 Criteria and diagnosis revised

Internal Medical Policy Committee 9-21-2020 Added AND statement "Inadequate response, intolerance, high risk for intolerance or relapse, or contraindication to the use of daunorubicin and cytarabine separately;" to FDA indications

Internal Medical Policy Committee 9-21-2021 Annual Review-no changes in criteria

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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