BlueCross BlueShield of Tennessee Medical Policy Manual

Vincristine Sulfate Liposome Injection

NDC CODE(S)

20536-0322-XX - Marqibo 5 MG/31ML SUSP (SPECTRUM PHARMACEUTICALS)

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.

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

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed.

Click here to view DOSAGE LIMITS

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 validates the use of vincristine sulfate liposome injection in the treatment/prevention of any other conditions/diseases.

SOURCES 

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017). Vincristine sulfate liposome. Retrieved January 17, 2018 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Vincristine sulfate liposome injection. Retrieved January 17, 2018 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 January 18, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202497s000lbl.pdf.     

ORIGINAL EFFECTIVE DATE:  9/6/2012

MOST RECENT REVIEW DATE:  3/13/2018

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.

This document has been classified as public information.

 

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

Diagnosis

Billable Units

Days' Supply

Acute Lymphoblastic Leukemia (ALL)

1 mg = 1 billable unit

40 billable units every 28 days