Pharmacy Prior Authorization Criteria

Lonsurf (trifluridine and tipiracil)

Indications for Prior Authorization

Lonsurf (trifluridine and tipiracil)

• For diagnosis of Metastatic Colorectal Cancer
  Indicated for the treatment of adult patients with metastatic colorectal cancer (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 Cancer
  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

• 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:
• Patient has RAS mutant tumors
OR
• Both of the following:
• Patient has RAS wild-type tumors
AND
• Patient has been previously treated with an anti-EGFR therapy (e.g., Vectibix [panitumumab], Erbitux [cetuximab])

Lonsurf

Prior Authorization (Reauthorization)

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

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

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
• Platinum-based chemotherapy
• Taxane or irinotecan-based chemotherapy
• HER2/neu-targeted therapy (if appropriate)

Lonsurf

Prior Authorization (Reauthorization)

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

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

P & T Revisions

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

References

1. Lonsurf Prescribing Information. Taiho Oncology, Inc. Princeton, NJ. August 2023.
2. National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium [internet database]Available at https://www.nccn.org/professionals/drug_compendium/content/ Accessed August 8, 2024

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Revision History

• 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

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