Subject: Lonsurf_1896-A_SGM_P2021

Drug

LONSURF  (trifluridine and tipiracil)

Policy:

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. 

A.  FDA-Approved Indications  
     Lonsurf is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy
     that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

     Lonsurf is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF
     biological therapy, and if RAS wild-type, an anti-EGFR therapy.

B.  Compendial Uses
     1.  Advanced or metastatic colon cancer
     2.  Advanced or metastatic rectal cancer
     3.  Esophageal and esophagogastric junction cancers
     4.  Gastric cancer 

      All other indications are considered experimental/investigational and not medically necessary. 

II.  CRITERIA FOR INITIAL APPROVAL 

A.  Colorectal Cancer (CRC)
     Authorization of 12 months may be granted for treatment of advanced or metastatic colorectal cancer when all of the following criteria are met:
     1.  Member was previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy; AND
     2.  An anti-VEGF biological therapy; AND
     3.  If member is RAS wild type, failure of a cetuximab or panitumumab-containing regimen. 

B.  Gastric or Gastroesophageal Junction Adenocarcinoma
     Authorization of 12 months may be granted for treatment of unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma
     when the member has been previously treated with at least two prior lines of chemotherapy. 

III. CONTINUATION OF THERAPY 

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed 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. Lonsurf [package insert]. Princeton, NJ: Taiho Oncology, Inc.; December 2019.
2. The NCCN Drugs & Biologics Compendium^® © 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed July 7, 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.

January 01, 2022