CurrentCignaPolicy N/A

POLICY: Oncology -Lonsurf Prior Authorization Policy

Cigna prior authorization policy governing medical necessity coverage criteria for Lonsurf (trifluridine and tipiracil) for FDA‑approved indications (metastatic colorectal/appendiceal/rectal cancer and metastatic gastric/gastroesophageal junction adenocarcinoma) and exclusion of other uses. Approvals are provided for specified durations.

Policy Summary

PayerCigna

PolicyPOLICY: Oncology -Lonsurf Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual Revision (revised criteria/notes)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; document prior therapies as required by indication and request approvals for the specified durations (typically 1 year).

SourceLink

POLICY UPDATE CHANGES

Annual Revision: Colon, Rectal, or Appendiceal Cancer: Added appendiceal to the condition of approval.

Annual Revision: Moved examples of chemotherapy regimens into a Note for Gastric or Gastroesophageal Junction Adenocarcinoma.

2Covered Indications (broad categories)

1 yearTypical approval duration

2023Policy last review year (2023)

Coverage Summary

Scope: Cigna prior authorization policy governing medical necessity coverage criteria for Lonsurf (trifluridine and tipiracil) for FDA‑approved indications: metastatic colorectal/rectal/appendiceal cancer and metastatic gastric/gastroesophageal junction adenocarcinoma, and exclusion of other uses. Coverage stance: covered_with_criteria. Typical approval duration: 1 year. Synopsis: Lonsurf is approved for metastatic colorectal/rectal/appendiceal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy (and prior anti-VEGF and anti-EGFR if RAS wild-type), and for metastatic gastric/GEJ adenocarcinoma after at least two prior chemotherapy regimens. NCCN guidance references support Lonsurf as subsequent therapy in these settings.

Provider Actions

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Lonsurf. All approvals are provided for the durations specified in the policy (approve for 1 year for covered indications).

Documentation Required

Documentation of prior therapies

Provider must document prior therapies as required by indication. For colon, rectal, or appendiceal cancer: document prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan; and if the tumor/metastases are RAS wild-type (KRAS and NRAS mutation negative), document trial of an anti‑EGFR agent (cetuximab or panitumumab). For gastric or gastroesophageal junction adenocarcinoma: document prior treatment with at least two chemotherapy regimens.

Prior fluoropyrimidine (examples include capecitabine or 5‑fluorouracil)
Oxaliplatin
Irinotecan
If RAS wild-type: prior anti‑EGFR therapy (cetuximab or panitumumab) for colorectal/appendiceal/rectal cancer
At least two prior chemotherapy regimens for gastric/GEJ adenocarcinoma

Clinical Evidence & Guidelines

Evidence: Prescribing information: Lonsurf tablets prescribing information, Taiho Oncology; August 2023. Guideline references: NCCN Colon/Rectal (v1.2024), NCCN Gastric (v3.2023), and NCCN Esophageal/EGJ (v4.2023). NCCN notes recommend Lonsurf as subsequent (third-line or later) therapy in advanced/metastatic colorectal and gastric/EGJ settings (single agent or with bevacizumab in colorectal; single agent for third line or subsequent gastric/EGJ therapy).

Background & Definitions

Background: Lonsurf (trifluridine and tipiracil) is indicated for metastatic colorectal cancer in adults previously treated with oxaliplatin-, fluoropyrimidine-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and if RAS wild-type, an anti-EGFR therapy; and for metastatic gastric or gastroesophageal junction adenocarcinoma in adults previously treated with at least two lines of chemotherapy. Per NCCN, Lonsurf is recommended as subsequent therapy in these settings. Scope context: this policy defines required prior therapies and documents approvals for specified durations (typically 1 year).

Term	Definition
Fluoropyrimidine	Examples include capecitabine and 5-fluorouracil (5-FU).
RAS wild-type	Tumors or metastases that are KRAS and NRAS mutation negative.

Revision History

02/15/2023review