BlueCross BlueShield of Tennessee Medical Policy Manual

Eribulin Mesylate

NDC CODE(S)

62856-0389-XX Halaven 1 MG/2ML SOLN (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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All Indications

Dose is 1.4mg/m² on days 1 and 8, repeated every 21 days

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 validate the use of eribulin mesylate for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2017, March). AHFS DI. Eribulin mesylate. Retrieved June 27, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, June). Eribulin. Retrieved June 27, 2017 from MICROMEDEX Healthcare Series.  

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Eribulin mesylate. Retrieved June 27, 2017 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 27, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201532s016lbl.pdf.

ORIGINAL EFFECTIVE DATE:  5/14/2011

MOST RECENT REVIEW DATE:  9/12/2017

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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.

Pharmaceutical Decision Support Tree

Eribulin Mesylate (Halaven ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #7

  1. Is the individual 18 years of age or older?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of recurrent or metastatic invasive breast cancer that is ANY ONE of the following?

If yes, go to question #6

If no, go to question #4

  1. Does the individual have a diagnosis or unresectable, metastatic or recurrent liposarcoma if ALL of the following?

If yes, go to question #6

If no, go to question #5

  1. Is the request for single-agent palliative therapy for soft tissue sarcoma further classified as ANY ONE of the following subtypes?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 80 billable units every 21 days for dosage of 1.4 mg/m2 on days 1 and 8, repeated every 21 days for an authorization period of six months?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 6?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is disease response shown as defined by lack of disease progression, improvement in tumor size and/or improvement in patient symptoms?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the drug, e.g., severe QT-prolongation, severe neutropenia, etc.?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.