CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lonsurf (trifluridine/tipiracil) — Coverage Criteria

Defines medical necessity criteria, exceptions, and authorization process for Lonsurf (trifluridine/tipiracil) for oncology indications for Neighborhood Health Plan of Rhode Island members; applies to utilization management and pharmacy prior authorization processes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLonsurf (trifluridine/tipiracil) — Coverage Criteria

Policy CodePolicy N/A

Change TypeMinor/administrative (no material clinical changes)

Effective DateSep 27, 2024

Next Review DateSep 18, 2024

Key ActionSubmit prior authorization to Utilization Management with supporting evidence (FDA label, CMS compendia, NCCN/ASCO or peer-reviewed literature).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved primary tumor types listed (colorectal; gastric/GEJ)

80 mgsingle-dose tablet maximum (trifluridine component)

80/120maximum monthly tablet limits stated

CMS/NCCN/ASCOEvidence sources required to support off-label uses

Coverage Criteria

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Colorectal Cancer (Initial therapy)

Covered when ALL of the following are met:

Colorectal coverage criteria: 1) Member has unresectable/advanced/metastatic colorectal cancer; AND 2) Lonsurf (trifluridine/tipiracil) is being used as a single agent or in combination with bevacizumab/bevacizumab biosimilar; AND 3) Member has been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biologic therapy, and, if RAS wild-type, an anti-EGFR therapy.

Gastric/GEJ Adenocarcinoma (Initial therapy)

Covered when ALL of the following are met:

Gastric/GEJ coverage criteria: 1) Member is not a surgical candidate or has unresectable/locally advanced/recurrent/metastatic gastric or GEJ adenocarcinoma; AND 2) Lonsurf (trifluridine/tipiracil) is being used as monotherapy as third-line or subsequent therapy following two prior lines of therapy.

Continuation Therapy

Continuation requests are exempt from new-authorization criteria when ALL are met:

Continuation criteria: 1) The requested medication was used within the last year; AND 2) The member has not experienced disease progression and/or intolerance to the requested medication; AND 3) Additional medication(s) are not being added to the continuation request.

Requests will be denied when Lonsurf (trifluridine/tipiracil) is being used after disease progression with the same regimen. The policy also specifies dosing and quantity limits: a single-dose maximum of 80 mg (based on the trifluridine component) and monthly tablet maximums of 80 tablets per month when using 20 mg strength or 120 tablets per month when using 15 mg strength. Investigational or off‑label uses lacking sufficient supporting evidence (as defined by CMS‑recognized compendia, acceptable peer‑reviewed literature, and the policy’s evidence criteria) are excluded and may trigger denial.

Initial therapy limitations

Initial therapy coverage is limited to specified lines of therapy per tumor type.

Initial therapy: Coverage for initial therapy is limited to the tumor-specific indications: colorectal cancer per the colorectal criteria set, and gastric/GEJ adenocarcinoma as third-line or subsequent monotherapy per the gastric/GEJ criteria set.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization via Utilization Management is required for Lonsurf (trifluridine/tipiracil). Final approval is granted by the Utilization Management Committee.

Prior authorization required
Final approval by Utilization Management Committee

Step Therapy

Therapy Line Requirements

Lonsurf must be used as third-line or subsequent therapy per tumor type where specified. For colorectal cancer, Lonsurf is indicated for unresectable/advanced/metastatic disease after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and if RAS wild-type, an anti-EGFR therapy. For gastric/GEJ adenocarcinoma, Lonsurf is used as monotherapy as third-line or subsequent therapy after two prior lines of therapy.

Colorectal cancer: use after fluoropyrimidine-, oxaliplatin-, irinotecan-based chemo, anti-VEGF, and if RAS wild-type, anti-EGFR
Gastric/GEJ adenocarcinoma: monotherapy as third-line or subsequent therapy following two prior lines

Documentation Required

Supportive Evidence Required

Requests must be supported by FDA-approved labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS evidence standards (see exclusions for insufficient evidence). Documentation demonstrating how the patient's clinical characteristics and prior therapies align with the cited evidence should be provided.

Acceptable sources: FDA labeling, CMS-recognized compendia, NCCN, ASCO, or acceptable peer-reviewed literature
Provide documentation that patient clinical characteristics and therapy regimens are represented in the cited evidence
Peer-reviewed evidence must meet CMS standards (clinical relevance, appropriate study design, meaningful outcomes)

Denial Risk

Exclusion-based Denial Triggers

Use after disease progression on the same regimen, dosing above single-dose limits, exceeding monthly tablet maximums, or investigational/off-label uses lacking sufficient evidence may trigger denial.

Denial triggers: use after progression with the same regimen
Dosing exceed single dose limit of 80 mg (trifluridine component)
Treatment exceeding monthly limits: 80 (20 mg) or 120 (15 mg) tablets/month
Investigational or off-label indications without sufficient CMS-recognized evidence

Coding and Dose Limits

Single-dose tablet limit (trifluridine component)

Single-dose maximum (trifluridine component)80 mg per single dose

RationaleLimit is based on the trifluridine component of Lonsurf as specified in exclusion criteria

Action on exceedanceDosing that exceeds this single-dose limit is an exclusion criterion and may trigger denial

Maximum monthly tablet limits

Maximum monthly limit — 20 mg strength80 tablets per month (when using 20 mg tablets)

Maximum monthly limit — 15 mg strength120 tablets per month (when using 15 mg tablets)

Policy consequenceTreatment that exceeds these monthly tablet limits is an exclusion criterion and may be denied

Initial Therapy Criteria

Step therapy / later-line use

Used as later-line therapy after specified prior systemic therapies per tumor type.

Step therapy / later-line use: 1) For colorectal cancer: Lonsurf is indicated after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and prior anti-VEGF therapy, and if RAS wild-type, prior anti-EGFR therapy; AND 2) For gastric/GEJ adenocarcinoma: Lonsurf is used as third-line or subsequent monotherapy following two prior lines of therapy.

Definitions

Unresectable/advanced/metastatic colorectal cancer

DefinitionDisease not amenable to curative resection and with metastatic spread

Context of useApplies to members with colorectal cancer considered for Lonsurf therapy

Related coverage requirementMember must have prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and anti-VEGF therapy; if RAS wild-type, also prior anti-EGFR therapy

Unresectable/locally advanced/recurrent/metastatic gastric or GEJ adenocarcinoma

DefinitionGastric or GEJ adenocarcinoma in patients who are not surgical candidates or have unresectable, locally advanced, recurrent, or metastatic disease

Context of useApplies to members being considered for Lonsurf as third-line or subsequent monotherapy

Related coverage requirementLonsurf use requires prior receipt of two prior lines of therapy for this indication