CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lonsurf (trifluridine and tipiracil) — Coverage Criteria

Defines clinical indications, exclusions, coding, and prior authorization expectations for Lonsurf (trifluridine and tipiracil) for members across applicable lines of business; applies to providers requesting coverage through Evolent for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLonsurf (trifluridine and tipiracil) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is required; continuation requests may be exempt if no progression on therapy and authorization lapsed fewer than 30 days in the past year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2primary cancer indications listed (colorectal; gastric/GEJ)

J8999drug billing code listed

80 mgsingle dose trifluridine-based limit

80 / 60maximum tablets per month

Commercial, Exchange, Medicaidapplicable lines of business

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Coverage Criteria for Lonsurf (trifluridine and tipiracil)

Colorectal Cancer — Initial/Eligible Use

Covered for metastatic/advanced colorectal cancer when ALL of the following are met

Colorectal cancer coverage: Member has unresectable/advanced/metastatic colorectal cancer and Lonsurf (trifluridine and tipiracil) is being used as a single agent or in combination with bevacizumab/bevacizumab biosimilar

AND patient previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biologic, and if RAS wild-type, an anti-EGFR therapy

Gastric/GEJ Adenocarcinoma — Line-specific Use

Covered for gastric/GEJ adenocarcinoma when ALL of the following are met

Gastric/GEJ coverage: Member is not a surgical candidate or has unresectable/locally advanced/recurrent/metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma and Lonsurf (trifluridine and tipiracil) is being used as monotherapy

AND given as third-line or subsequent therapy following two prior lines of therapy

Requests will be excluded or denied when any of the following apply: Lonsurf (trifluridine and tipiracil) is being used after disease progression with the same regimen; dosing exceeds the single‑dose limit of 80 mg (based on the trifluridine component); or monthly dispensing would exceed the maximum tablet limits of 80 tablets (20 mg formulation) or 60 tablets (15 mg formulation).

Investigational or off‑label uses of Lonsurf that are not supported by adequate evidence are considered not approvable. The policy defines insufficient evidence as lack of representation of the patient/cancer characteristics in published data, inadequate representation of the administered regimen in the evidence, or absence of clinically meaningful outcomes (e.g., per ASCO guidance). Case reports, meeting abstracts without full peer‑reviewed publication, or other uncontrolled anecdotal reports do not constitute sufficient evidence. Uses unsupported by CMS‑recognized compendia or acceptable peer‑reviewed literature should be declined.

Regimen	Indication / Required prior therapy	Coverage status
Trifluridine/tipiracil (Lonsurf) ± bevacizumab/bevacizumab biosimilar
Refractory metastatic/unresectable colorectal cancer; member previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti‑VEGF biologic, and if RAS wild‑type an anti‑EGFR therapy
Covered with criteria

Regimen	Indication / Line of therapy	Coverage status
Trifluridine/tipiracil (Lonsurf) monotherapy
Unresectable/locally advanced/recurrent/metastatic gastric or GEJ adenocarcinoma; used as third‑line or subsequent therapy following two prior lines of therapy
Covered with criteria

Billing and Coding

Drug HCPCS CodeHCPCSCovered

J8999

trifluridine and tipiracil

Single dose trifluridine limit

Single-dose trifluridine limit80 mg (based on the trifluridine component)

RationalePolicy exclusion explicitly sets dosing above this limit as not approvable.

DocumentationPrescriptions exceeding the 80 mg single-dose threshold will trigger exclusion/denial per policy.

Maximum tablets per month

Maximum tablets per month (20 mg formulation)80 tablets per month

Maximum tablets per month (15 mg formulation)60 tablets per month

Policy consequence

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lonsurf (trifluridine and tipiracil). Continuation requests may be exempt when the member has not experienced disease progression on the requested medication, the requested medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the continuation request.

Prior authorization required
Continuation exemption: no progression, <30-day lapse rule, no new meds added

Documentation Required

Supporting Evidence Required

Authorization requires documentation consistent with one or more of the following sources: FDA-approved product labeling; CMS-recognized compendia; National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines; or peer‑reviewed literature that meets CMS standards (see policy for criteria on sufficiency of evidence).

Key Definitions

Unresectable/advanced/metastatic disease

Definition of unresectable/advanced/metastatic diseaseNot amenable to curative surgery or is locally advanced, recurrent, or metastatic as specified for colorectal cancer

Clinical contextLonsurf used as single agent or with bevacizumab/bevacizumab biosimilar for previously treated patients

Prior therapy requirementMember previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biologic; if RAS wild-type, an anti-EGFR therapy

Line-of-Therapy Specifications

salvage

Salvage (colorectal): Used as salvage therapy after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and an anti-VEGF biologic; if RAS wild-type, prior anti-EGFR therapy required

Permits single-agent Lonsurf or combination with bevacizumab/bevacizumab biosimilar

salvage

Salvage (gastric/GEJ): Used as salvage (third-line or subsequent) therapy for unresectable/locally advanced/recurrent/metastatic gastric or GEJ adenocarcinoma following two prior lines of therapy

Monotherapy use specified

Biomarker and Molecular Testing Requirements

RAS

RAS biomarker requirementRAS wild-type status required when anti-EGFR therapy has been given previously

Role in sequencingIf RAS is wild-type, prior receipt of an anti-EGFR agent is part of the required prior therapies for colorectal cancer coverage

Evidence linkageRAS status is explicitly included in colorectal cancer eligibility language for Lonsurf use

Background and Drug Information

Lonsurf (trifluridine and tipiracil) is an oral cytotoxic combination used in later‑line settings for gastrointestinal malignancies. It is indicated for refractory metastatic colorectal cancer and for previously treated metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma; the policy’s exclusion criteria reiterate clinical constraints on its use and dosing to align with evidence and safety considerations.

Policy Revision History

September 2025template_conversion_and_updatesLatest

Converted to new Evolent guideline template; replaced prior UM ONC_1311 Lonsurf policy; updated indication section, maximum dosage form quantities in exclusion criteria, and references.

September 2024verbiage_update

Updated NCH verbiage to Evolent.