BlueCross BlueShield of Tennessee Medical Policy Manual

Vincristine Sulfate Liposome Injection

NDC CODE(S)

20536-0322-XX - Marqibo 5 mg/31 mL liposome injection kit (Talon)

DESCRIPTION

Vincristine sulfate is a vinca alkaloid isolated from the periwinkle plant (Catharanthus roseus).  Non-liposomal vincristine sulfate binds to tubulin within cells resulting in altered microtubule structure and function.  It stabilizes the cellular spindle apparatus and prevents chromosome segregation leading to metaphase arrest and inhibits mitosis.  By encapsulating vincristine in sphingomyelin/cholesterol liposomes, the plasma clearance is slowed and the vincristine sulfate remains active longer in the body.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Acute Lymphocytic Leukemia (ALL)

2.25 mg/m2 intravenously over 1 hour once every 7 days

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

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).

No controlled studies were found in the published literature that validate the use of vincristine sulfate liposome injection in the treatment/prevention of any other conditions/diseases.

SOURCES

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016). Vincristine sulfate liposome. Retrieved November 22, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Vincristine sulfate liposome injection. Retrieved November 22, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2012, August). Center for Drug Evaluation and Research. Marqibo® (vincristine sulfate liposome injection) for intravenous infusion. Retrieved November 22, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202497s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  9/6/2012

MOST RECENT REVIEW DATE:  12/1/2016

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

Vincristine Sulfate Liposome Injection (Marqibo®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #6

  1. Does the individual have a diagnosis of Acute Lymphoblastic Leukemia (ALL) which is ANY ONE of the following?

If yes, go to question #3

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

  1. Is the individual 18 years of age or older with disease 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. Is there documentation that the agent will NOT be used in combination with other chemotherapy?

If yes, go to question #5

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

  1. Is the request for 40 billable units or less every 28 days for dosage of 2.25 mg/m2 intravenously over 1 hour once every 7 days in an authorization period of six months with possible renewal?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

  1. Does the individual continue to meet initial approval criteria in questions 2 through 5?

If yes, go to question #7

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

  1. Is response to treatment indicated by stabilization of disease and/or absence of progression of disease?

If yes, go to question #8

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

  1. Is there absence of unacceptable toxicity from the drug such as peripheral motor and sensory, central and autonomic neuropathy; myelosuppression; neutropenia; thrombocytopenia; anemia; tumor lysis syndrome; elevated liver function tests (ALT, AST, and bilirubin)?

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.