BlueCross BlueShield of Tennessee Medical Policy Manual

Eribulin Mesylate  (Halaven®)

NDC CODE(S)

62856-0389-XX HALAVEN 1MG/2ML Solution (EISAI)

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL CRITERIA

Breast Cancer

Liposarcoma

Soft Tissue Sarcoma

RENEWAL CRITERIA

DOSAGE/ADMINISTRATION

INDICATION

DOSE

All Indications

Administer 1.4 mg/m², intravenously, on days 1 and 8, repeated every 21 days until disease progression or unacceptable toxicity

LENGTH OF AUTHORIZATION

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

DOSING LIMITS

Max Units (per dose and over time) [HCPCS Unit]:

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).

SOURCES

1.     Halaven [package insert]. Woodcliff Lake, NJ; Eisai Inc; December 2017. Accessed February 2021.

2.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) eribulin. National Comprehensive Cancer Network, 20210. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2021.

3.     Cortes J, O’Shaughnessy J, Loesch D, et al; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011;377(9769):914-923.

4.     Schöffski P, Chawla S, Maki RG, et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016;387(10028):1629-1637.

5.     Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma Version 2.2020. National Comprehensive Cancer Network, 20201. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed February 2021.

6.     Schöffski P, Ray-Coquard IL, Cioffi A, et al. Activity of eribulin mesylate in patients with soft-tissue sarcoma: a phase 2 study in four independent histological subtypes. Lancet Oncol. 2011;12(11):1045-1052.

7.     Lexi-Comp Online. (2020, March). AHFS DI. Eribulin mesylate. Retrieved March 5, 2021 from Lexi-Comp Online with AHFS.

8.     MICROMEDEX Healthcare Series. Drugdex Evaluations. (2021, February). Eribulin. Retrieved March 5, 2021 from MICROMEDEX Healthcare Series.  

ORIGINAL EFFECTIVE DATE:  5/14/2011

MOST RECENT REVIEW DATE:    6/30/2021

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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.

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