Subject: Lonsurf 1896-A SGM P2023a

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
               1.  Lonsurf is indicated as a single agent or in combination
                    with bevacizumab 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.

               2.  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.

          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, including
               appendiceal adenocarcinoma and anal adenocarcinoma,
               when the member has progressed on previous treatment
               with all the following regimens unless the member has a
               contraindication or intolerance:
               1.  Fluoropyrimidine-, oxaliplatin- and irinotecan-based
                    chemotherapy (with or without bevacizumab); and
               2.  If RAS wild type, an anti-epidermal growth factor receptor
                    (EGFR) therapy, such as Erbitux (cetuximab) or Vectibix
                    (panitumumab), for rectal cancer, appendiceal
                    adenocarcinoma, anal adenocarcinoma, or left-sided
                    colon cancer.

          B.  Esophagogastric Junction, Gastric or Gastroesophageal
               Junction Adenocarcinoma
               Authorization of 12 months may be granted as a single agent
               for treatment of esophagogastric junction, gastric or
               gastroesophageal junction adenocarcinoma when the
               member has been previously treated with at least two prior
               lines of chemotherapy and either of the following criteria are
               met:
               1.  The disease is unresectable locally advanced, recurrent,
                    or metastatic or
               2.  The member is not a candidate for surgery


  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.; August 2023.
2. The NCCN Drugs & Biologics Compendium^® © 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed November 24, 2023.
3. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Anal Carcinoma. Version 3.2023. Accessed November 24, 2023. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf
4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Colon Cancer. Version 4.2023. Accessed November 24, 2023. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf

 

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.

February 06, 2024