BlueCross BlueShield of Tennessee Medical Policy Manual

Ixabepilone

NDC CODE(S)

70020-1910-xx Ixempra 15mg powder for injection R-Pharm US

 

70020-1911-xx Ixempra 45mg powder for injection 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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

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

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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of ixabepilone for the treatment or prevention of other cancers or diseases/conditions.

SOURCES

Lexi-Comp Online. (2016, March). AHFS Dl. lxabepilone. Retrieved June 22, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX  Healthcare Series. Drugdex Drug Evaluations. (2016, June). lxabepilone.  Retrieved June 21, 2016 from MICROMEDEX  Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium™. lxabepilone. Retrieved June 22, 2016 from the National Comprehensive Cancer Network .

U.S. Food and Drug Administration (2011, October). Center for Drug Evaluation and Research. lxempra kit (ixabepilone) for injection, for intravenous infusion only. Retrieved June 21, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022065s006lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  12/1/2016

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.

Pharmaceutical Decision Support Tree

Ixabepilone (Ixempra®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #11

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

If yes, go to question #3

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

  1. Is the request for treatment as monotherapy?

If yes, go to question #4

If no, go to question #7

  1. Does the individual show evidence of being refractory or resistant to ALL of the following?

If yes, go to questions #9

If no, go to question #5

  1. Does the individual show evidence of human epidermal growth factor receptor 2-negative disease with symptomatic visceral disease or visceral crisis?

If yes, go to question #9

If no, go to question #6

  1. Does the individual show evidence of human epidermal growth factor receptor 2-negative disease that is ANY ONE of the following?

If yes, go to question #9

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

  1. Is the request for treatment as combination therapy with capecitabine for tumors that are refractory or resistant to ALL of the following?

If yes, go to question #9

If no, go to question #8

  1. Is the request for treatment as combination therapy with trastuzumab for human epidermal growth factor receptor 2-positive trastuzumab-exposed disease with ANY ONE of the following?

If yes, go to question #9

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

  1. Is the dosage requested 40 mg/m2 intravenously over 3 hours every 21 days or, if individual’s BSA is greater than 2.2 m2, is dosage is calculated based on 2.2 m2?

If yes, go to question #10

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

  1. Is the authorization for 6 months or less with billable units requested 90 or less every 21 days (1 billable unit = 1 mg) or 720 billable units or less for 6 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 medically appropriate criteria as necessary in questions 1 through 10?

If yes, go to question #12

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

  1. Does the individual show disease response to treatment is indicated as defined by ANY ONE of the following?

If yes, go to question #13

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

  1. Does the individual show absence of unacceptable toxicity from the agent as evidenced by, but not limited to, ANY ONE of the following?

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.