Eribulin mesylate (Halaven®) is a potent antimitotic agent with a distinct mechanism from other known antimitotic agents, such as taxanes, vinca alkaloids, and epothilones. Eribulin mesylate (Halaven) blocks cell cycle progression in the G2-M phase. It inhibits the growth phase of microtubules and sequesters tubulin in nonproductive aggregates, ultimately leading to disruption of mitotic spindles and apoptotic cell death after prolonged mitotic blockage. It accomplishes this primarily by disrupting the complex growth and shortening events of microtubules known as dynamic stability.
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.
Eribulin mesylate (Halaven) may be considered medically necessary for ANY of the following indications:
Food and Drug Administration (FDA) Indication
Soft Tissue Sarcoma:
National Comprehensive Cancer Network (NCCN) Indications
Invasive Breast Cancer:
Soft Tissue Sarcoma:
Uterine Neoplasms-Uterine Sarcoma:
The use of eribulin mesylate (Halaven) for any other indication is considered experimental/investigational, and therefore, non-covered. The safety and efficacy for any other indications has not been established by the peer-reviewed literature.
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. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.
Covered Diagnosis Codes for Procedure Code J9179
Professional Statements and Societal Positions Guidelines