BlueCross BlueShield of Tennessee Medical Policy Manual

Daunorubicin and Cytarabine Liposome for Injection

NDC CODE(S)

68727-0745-xx VYXEOS 144 (44-100) mg SOLR (JAZZ PHARMACEUTICALS)

DESCRIPTION

Daunorubicin and cytarabine liposome for injection is a combination of daunorubicin and cytarabine at a molar ratio of 1 to 5 encapsulated in liposomes for administration by intravenous infusion.  Daunorubicin is an anthracycline topoisomerase inhibitor.  Cytarabine is a nucleoside metabolic inhibitor.  At that particular fixed ratio, they work together synergistically at killing leukemia cells.  Daunorubicin inhibits DNA polymerase activity and produces DNA-damaging free radicals.  Cytarabine works as a cell cycle phase-specific antineoplastic agent during the S-phase of cell division.  Liposomes enter and re taken up by the bone marrow where they persist.  They appear to be taken up by leukemic cells more readily than normal bone marrow cells.  They then undergo degradation and release the daunorubicin and cytarabine within the bone marrow cellular environment.  

REFER TO DECISION SUPPORT TREE

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

All Indications

Dose and Schedule - Total lifetime cumulative exposure of daunorubicin as a single anthracycline must be less than 600 mg/m2 through the total treatment

First Induction

(daunorubicin 44 mg/m2 & cytarabine 100 mg/m2) liposome days 1, 3 and 5 - 2 doses

Second Induction*

(daunorubicin 44 mg/m2 & cytarabine 100 mg/m2) liposome days 1 and 3 - 2 doses

Consolidation 

(daunorubicin 29 mg/m2 & cytarabine 65 mg/m2) liposome days 1 and 3 - 2 doses per cycle

*Only for individuals failing to achieve a response with the first induction cycle

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENT

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCE

U. S. Food and Drug Administration. (2017, August). Center for Drug Evaluation and Research. VYXEOS™ (daunorubicin and cytarabine) liposome for injection, for intravenous use. Retrieved August 7, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209401s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  9/12/2017

MOST RECENT REVIEW DATE:  9/12/2017

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

Pharmaceutical Decision Support Tree

Daunorubicin and Cytarabine Liposome for Injection (VYXEOS™)

  1. Is this the initial request for the agent?

If yes, go to question #2

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the individual 18 years of age or older with a baseline left ventricular ejection fraction (LVEF) within normal limits?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of acute myeloid leukemia (AML) that is ANY ONE of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Will treatment be in combination with other chemotherapy?

If yes, this does not meet medical necessity and/or medical appropriateness criteria

If no, go to question #5

  1. Is the request for the following?

First Induction

(daunorubicin 44 mg/m2 & cytarabine 100 mg/m2) liposome days 1, 3 and 5 - 2 doses

Second Induction (only if failed to achieve a response with the first induction cycle)

(daunorubicin 44 mg/m2 & cytarabine 100 mg/m2) liposome days 1 and 3 - 2 doses

Consolidation  

(daunorubicin 29 mg/m2 & cytarabine 65 mg/m2) liposome days 1 and 3 - 2 doses per cycle

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.