20536-0322-XX - Marqibo 5 MG/31ML SUSP (SPECTRUM PHARMACEUTICALS)
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.
Vincristine sulfate liposome injection for the treatment of acute lymphoblastic leukemia (ALL) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Vincristine sulfate liposome injection for the treatment of other conditions/diseases is considered investigational.
Vincristine sulfate liposome injection is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Individual does not have any pre-existing demyelinating conditions (e.g. Charcot-Marie-Tooth Syndrome)
Diagnosis of Acute Lymphoblastic Leukemia (ALL) which is ALL of the following
Used as single agent therapy
In relapsed or refractory disease and ANY ONE of the following:
Philadelphia chromosome-negative (Ph-)
Philadelphia chromosome-positive (Ph+) AND refractory to tyrosine kinase inhibitor therapy
Vincristine sulfate liposome injection is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Response to treatment is indicated by stabilization of disease and/or absence of progression of disease
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), etc.
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.
Refer to DOSAGE LIMITS below
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.
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.
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).
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018). Vincristine sulfate liposome. Retrieved February 20, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Vincristine sulfate liposome injection. Retrieved February 20, 2019 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 February 20, 2019 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202497s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 9/6/2012
MOST RECENT REVIEW DATE: 3/12/2019
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.
Maximum billable units per dose and over time by indication as a Medical Benefit