Subject: Jevtana (cabazitaxel)

Drug

Jevtana  (cabazitaxel)

Policy:

Note: The provision of physician samples does not guarantee coverage under the provisions of the pharmacy benefit. All criteria below must be met in order to obtain coverage of Jevtana (cabazitaxel).

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Jevtana (cabazitaxel) is subject to precertification. If precertification requirements apply Aetna considers these drugs to be medically necessary for those members who meet the following precertification criteria:

 

I. INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indication¹
Jevtana is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.

All other indications are considered experimental/investigational and are not a covered benefit.

Compendial Use²

1. Second-line or subsequent treatment for castration-resistant distant metastatic disease previously treated with a docetaxel-based regimen or in patients who are not candidates for, or are intolerant of docetaxel.
2. Subsequent treatment for castration-resistant distant metastatic disease previously treated with enzalutamide (Xtandi) or abiraterone (Zytiga)

 

II. CRITERIA FOR INITIAL APPROVAL^1-2

Metastatic castration-resistant prostate cancer (CRPC)
Authorization of 6 months may be granted for the treatment of metastatic castration resistant prostate cancer when previously treated with either of the following:

1. A docetaxel-containing regimen or in patients who are not candidates for or who are intolerant to docetaxel.
2. Enzalutamide (Xtandi) or abiraterone (Zytiga)
    


III. CONTINUATION OF THERAPY  

Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

 

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Jevtana [package insert]. Bridgewater, NJ: sanofi-aventis; March 2020.
2. The NCCN Drugs & Biologics Compendium^® © 2019 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed July 19, 2020.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

December 4, 2020