WHA

Lonsurf (trifluridine and tipiracil)

Indications for Prior Authorization

Lonsurf (trifluridine and tipiracil)
  • For diagnosis of Metastatic Colorectal Cancer (mCRC)
    Indicated for the treatment of adult patients with mCRC, as a single agent or in combination with bevacizumab, who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an antiEGFR therapy.

  • For diagnosis of Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
    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.

Criteria

Lonsurf

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Colorectal Cancer (mCRC)

  • Diagnosis of metastatic colorectal cancer (mCRC)
    • AND
  • One of the following:
    • Used as a single agent
      • OR
    • Used in combination with bevacizumab
    AND
  • Patient has been previously treated with both of the following:
    • Fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy (e.g., FOLFOX, FOLFIRI, FOLFOXIRI)
    • Anti-VEGF therapy (e.g., Avastin [bevacizumab], Zaltrap [ziv-aflibercept])
    AND
  • One of the following:
    • Presence of RAS mutant tumors as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [A]
      • OR
    • Both of the following:
      • Presence of RAS wild-type tumors as confirmed by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [B]
        • AND
      • Patient has been previously treated with an anti-EGFR therapy (e.g., Vectibix [panitumumab], Erbitux [cetuximab])
Lonsurf

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

  • One of the following:
    • Diagnosis of metastatic gastric cancer
      • OR
    • Diagnosis of metastatic gastroesophageal junction adenocarcinoma
    AND
  • Patient has been previously treated with two of the following:
    • Fluoropyrimidine-based chemotherapy (e.g., fluorouracil)
    • Platinum-based chemotherapy (e.g., carboplatin, cisplatin, oxaliplatin)
    • Taxane (e.g., docetaxel, paclitaxel) or irinotecan-based chemotherapy
    • HER2/neu-targeted therapy (e.g., trastuzumab) (if appropriate)
Lonsurf

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

  • Patient does not show evidence of progressive disease while on therapy

  • Guideline ID
    GL-375414

  • Formulary
    premium

  • Effective date
    Nov 1, 2025

  • P&T approval date
    Nov 18, 2015

P & T Revisions

2025-08-27, 2025-03-28, 2024-09-03, 2024-01-08, 2023-08-28, 2023-06-20, 2022-09-08, 2021-08-30, 2021-05-21

  1. Lonsurf Prescribing Information. Taiho Oncology, Inc. Princeton, NJ. August 2023.
  2. National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium [internet database]. National Comprehensive Cancer Network, Inc.; 2025. Updated periodically. Available by subscription at: www.nccn.org. Accessed August 25, 2025.
  3. Zhou B, Der CJ, Cos AD. The role of wild type RAS isoforms in cancer. Semin Cell Dev Bio. 2016 Jul 13; 58: 60-69.
  4. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Colon Cancer. Version 4.2025. June 27, 2025. Plymouth Meeting, PA: National Comprehensive Cancer Network. Available at: https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed August 26, 2025.
  1. RAS represents three distinct genes: KRAS, NRAS, and HRAS. The RAS genes encode four RAS proteins: HRAS, NRAS, KRAS4A, KRAS4B. RAS mutations are responsible for ~30% of human cancers. [3]
  2. All patients with mCRC should have primary tumor or metastasis sites genotyped for RAS. RAS testing is recommended in all patients at the time of diagnosis of mCRC. Patients with RAS mutations should not be treated with cetuximab (Erbitux) or panitumumab (Vectibix). [4]
  • 2025-08-27: Update to standard genetic mutation verbiage with no change to clinical intent. Examples added for gastric indication. Combined reauth criteria for all indications. Background updates.
  • 2025-03-28: Removal of EHB formulary
  • 2024-09-03: 2024 Annual Review. Clarified criteria to state diagnosis of “metastatic” gastroesophageal junction adenocarcinoma.
  • 2024-01-08: Revised criteria language to align more accurately with Fruzaqla - changed "Trial and failure, intolerance or contraindication to" to "patient has been previously treated with...". Updated references.
  • 2023-08-28: 2023 Annual Review
  • 2023-06-20: Removal of specialist requirement
  • 2022-09-08: Annual Review - No criteria changes
  • 2021-08-30: 2021 Annual Review
  • 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria