BlueCross BlueShield of Tennessee Medical Policy Manual

Ixabepilone

NDC CODE(S)

70020-1910-XX Ixempra Kit 15 MG SOLR and IXEMPRA 15 MG VIAL (R-PHARM US)

 

70020-1911-XX Ixempra Kit 45 MG SOLR and IXEMPRA 45 MG VIAL (R-PHARM US)

DESCRIPTION

Ixabepilone, a semisynthetic analog of epothilone B, is the first FDA-approved epothilone antineoplastic agent.   Ixabepilone functions as a microtubule stabilizer or microtubule inhibitor. Microtubules are important cellular structures that are involved in cell division.  By binding to subunits of microtubules within cells, ixabepilone stabilizes the formation of microtubule bundles, thus inhibiting the natural action of the microtubules. This leads to G2/M phase cell cycle arrest during mitosis (cell division) leading to apoptosis or cell death.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*Anthracycline resistance/failure is defined as progression of disease while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting.

**Taxane resistance is defined as progression of disease while on therapy or within 12 months in the adjuvant setting, or 4 months in the metastatic setting.

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All indications

40 mg/m² administered intravenously (IV) over 3 hours every 21 days.

Doses for individuals with a BSA > 2.2 m2 should be calculated based on 2.2 m2

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.

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

Lexi-Comp Online. (2019, February). AHFS Dl. lxabepilone. Retrieved April 22, 2019 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, April). lxabepilone.  Retrieved April 22, 2019 from MICROMEDEX  Healthcare Series.

National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. lxabepilone. Retrieved April 22, 2019 from the National Comprehensive Cancer Network.

U.S. Food and Drug Administration (2011, October). Center for Drug Evaluation and Research. Ixempra® kit (ixabepilone) for injection, for intravenous infusion only. Retrieved April 22, 2019 from

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022065s006lbl.p

ORIGINAL EFFECTIVE DATE: 12/1/2016

MOST RECENT REVIEW DATE:  9/30/2019

ID_MRx

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.

 

 

 


DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1 mg

Diagnosis

MAXIMUM UNITS

All indications

90 billable  units every 21 days