Subject: Zaltrap 1667-A SGM P2021

Drug

ZALTRAP  (ziv-aflibercept)

Policy:

1. 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. 
   
   A.  FDA-Approved Indication
        Zaltrap is indicated for use in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) in patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.
   
   B.  Compendial Uses
        1.  Colorectal cancer with unresectable metachronous metastases and previous adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) within the past 12 months, as primary treatment
             in combination with irinotecan or FOLFIRI (fluorouracil, leucovorin, and irinotecan)
        2.  Colorectal cancer, advanced or metastatic disease in combination with irinotecan or with FOLFIRI regimen not previously treated with irinotecan-based therapy, as subsequent therapy for disease progression
    
   All other indications are considered experimental/investigational and not medically necessary.
   
   
   
2. CRITERIA FOR INITIAL APPROVAL
    
   Colorectal cancer (CRC)
   Authorization of 12 months may be granted for treatment of advanced or metastatic CRC in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) or in combination with irinotecan.
   
   
   
3. CONTINUATION OF THERAPY
    
   Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication in Section II 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.  Zaltrap [package insert]. Bridgewater, NJ: Sanofi-aventis U.S. LLC; December 2020.

2.  The NCCN Drugs & Biologics Compendium 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed February 25, 2021.

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.

August 01, 2021