BlueCross BlueShield of Tennessee Medical Policy Manual

Cabazitaxel

NDC CODE(S)

00024-5824-xx Jevtana® 60mg solution for injection Sanofi-Aventis

DESCRIPTION

Cabazitaxel is an antineoplastic agent in the taxane class.  It is a semi-synthetic agent prepared with a precursor extracted from the needles of certain yew trees.  Its antineoplastic activity is as a microtubule inhibitor.  Cabazitaxel binds to cellular tubulin which promotes the assembly of microtubules but inhibits microtubular function and breakdown.  This halts the cellular mitotic and interphase functions and leads to apoptosis.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Prostate cancer 25 mg/m2 every 3 weeks in combination with oral prednisone 10 mg daily

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).

There is insufficient evidence found in the published literature supporting the use of cabazitaxel in the treatment of other conditions/diseases.

SOURCES

Lexi-Comp Online. (2016, March). AHFS DI. Cabazitaxel. Retrieved June 13, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, June). Cabazitaxel. Retrieved June 13, 2016 from MICROMEDEX Healthcare Series. 

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Cabazitaxel. Retrieved June 13, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2015, June). Center for Drug Evaluation and Research. Jevtana® (cabazitaxel). Retrieved June 13, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201023s015lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  2/27/2018

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

Cabazitaxel (Jevtana®)

  1. Is this request for initial therapy?

If yes, go to question #2

If no, go to question #6

  1. Does the individual have a hormone refractory metastatic prostate cancer?

If yes, go to question #3

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

  1. Has the individual had prior treatment with a docetaxel-based chemotherapy regimen?

If yes, go to question #4

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

  1. Will the individual have administration in combination with prednisone but with no other chemotherapy agents?

If yes, go to question #5

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

  1. Is the request for 60 billable units or less (1 billable unit = 1mg) per 21 days for a dosage of 25 mg/m2 every 3 weeks in combination with oral prednisone 10 mg daily for 6 months or less?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

  1. Is the disease responsive to treatment, as defined by lack of disease progression, improvement in tumor size and/or improvement in symptoms?

If yes, go to question #7

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

  1. Was there absence of unacceptable toxicity from the drug, including, but not limited to life-threatening bone marrow repression with neutropenia and/or hypersensitivity reactions?

If yes, go to question #8

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

  1. Is the request for 60 billable units or less (1 billable unit = 1mg) per 21 days for a dosage of 25 mg/m2 every 3 weeks in combination with oral prednisone 10 mg daily for 6 months or less?

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.