62856-0389-XX Halaven 1 MG/2ML SOLN (EISAI)
Eribulin mesylate is a synthetic analog of halichondrin B, a product isolated from the marine sponge Halichondria okadai. A microtubule dynamics inhibitor, eribulin mesylate prevents the growth phase of microtubules without affecting the shortening phase. Its effects are exerted via a tubulin-based antimitotic mechanism which leads to cell-cycle block, disruption of mitotic spindles and ultimately, apoptotic cell death after prolonged mitotic blockage.
Eribulin mesylate for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Soft tissue sarcoma
Eribulin mesylate for the treatment of other conditions/diseases is considered investigational.
Eribulin mesylate is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Diagnosis of ANY ONE of the following:
Breast cancer if ANY ONE of the following:
Used as subsequent therapy in metastatic disease for individuals who have previously received therapy with an anthracycline and a taxane
Disease is recurrent or metastatic and used as a single agent for human epidermal growth factor receptor 2 (HER2)-negative disease if ANY ONE of the following:
Hormone receptor negative
Hormone receptor positive with visceral crisis or endocrine therapy refractory
Disease is recurrent or metastatic and used in combination with trastuzumab for HER2-positive disease if ANY ONE of the following:
Hormone receptor negative
Hormone receptor positive with or without endocrine therapy
Liposarcoma with ALL of the following:
Individual has unresectable, metastatic or recurrent disease
Individual received prior anthracycline-based therapy
Must be used as a single agent
Soft tissue sarcoma for single-agent palliative therapy for disease further classified as ANY ONE of the following sub-types:
Unresectable or progressive retroperitoneal/intra-abdominal disease
Metastatic disease or recurrent disease with disseminated metastases of the extremity, superficial trunk, head or neck
Eribulin mesylate is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Disease response as defined by lack of disease progression, improvement in tumor size and/or improvement in symptoms
Absence of unacceptable toxicity from the drug, e.g., severe QT-prolongation, severe neutropenia, etc.
DOSAGE & ADMINISTRATION
Dose is 1.4mg/m² intravenously on days 1 and 8, repeated every 21 days
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed
Refer to DOSAGE LIMITS below
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).
Lexi-Comp Online. (2019). AHFS DI. Eribulin mesylate. Retrieved June 10, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, April). Eribulin. Retrieved June 10, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Eribulin mesylate. Retrieved June 10, 2019 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2016, October). Center for Drug Evaluation and Research. Halaven® (eribulin mesylate) injection. Retrieved June 10, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s016lbl.pdf.
ORIGINAL EFFECTIVE DATE: 5/14/2011
MOST RECENT REVIEW DATE: 10/31/2019
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; 1 billable unit = 0.1 mg