|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)|
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.
Ixabepilone for the treatment of breast cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Ixabepilone for the treatment of other conditions/diseases is considered investigational.
Ixabepilone is considered medically appropriate if ALL of the following are met:
Individual is 18 years of age or older
If used in combination with capecitabine, the individual does not have an AST or ALT > 2.5 x ULN or bilirubin > 1 x ULN
Diagnosis of Breast Cancer with ANY ONE of the following:
Metastatic or recurrent disease if ANY ONE of the following:
Used as a single agent for human epidermal growth factor receptor 2 (HER2)-negative disease that is ANY ONE of the following:
Hormone receptor negative
Hormone receptor positive for ANY ONE of the following:
Endocrine therapy refractory
Used in combination with trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive disease that is ANY ONE of the following:
Hormone receptor-positive with or without endocrine therapy
Locally advanced or metastatic disease and individual has failed on an anthracycline *and a taxane** (or taxane resistant and further anthracycline therapy is contraindicated) for ANY ONE of the following:
Used in combination with capecitabine
Used as a single agent after failure on capecitabine
*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.
Ixabepilone is considered medically appropriate for continuation of therapy if ALL of the following are met:
Individual continues to meet initial approval criteria
Disease response to treatment is indicated as defined by stabilization of disease, decrease in tumor size or tumor spread
Absence of unacceptable toxicity from the agent as evidenced by, but not limited to, peripheral neuropathy, myelosuppression (e.g., neutropenia, leukopenia, anemia, thrombocytopenia), hepatic impairment, hypersensitivity reactions, cardiac ischemia, impaired cardiac function
DOSAGE & ADMINISTRATION
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.
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, 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 fromhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022065s006lbl.p
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 9/30/2019
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 = 1 mg