CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Um Onc_1311 Lonsurf Trifluridine_Tipiracil_09272024

Defines accepted indications, continuation/authorization and exclusion criteria, and approval authority for Lonsurf (trifluridine/tipiracil) for treatment of cancer including FDA-approved and accepted off-label uses supported by recognized compendia or peer-reviewed literature.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1311 Lonsurf Trifluridine_Tipiracil_09272024

Policy CodePolicy N/A

Change TypeRevised dates

Effective DateSep 27, 2024

Next Review Date

Key ActionEvolent must process all medication requests and providers must support use with FDA labeling, CMS compendia, NCCN/ASCO guidelines, or qualifying peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

Committee approval and effective/approval dates updated with Approval Date September 18, 2024 and Effective Date September 27, 2024.

2Covered Indications

4Exclusion Criteria

13Committee Review Dates Listed

Coverage Summary

This policy is covered_with_criteria for Lonsurf (trifluridine/tipiracil) and defines accepted indications, continuation/authorization and exclusion criteria for treatment of cancer including FDA-approved and accepted off-label uses supported by recognized compendia or peer-reviewed literature. Status: CURRENT; Subject: Lonsurf (trifluridine/tipiracil). Effective Date: 2024-09-27; Last committee review/approval: 2024-09-18. Approval and review responsibilities are assigned to the Utilization Management Department and Utilization Management Committee.

Indication: Colorectal Cancer (covered when ALL are met)

Covered when ALL of the following are met:

Member has unresectable/advanced/metastatic colorectal cancer
Lonsurf (trifluridine/tipiracil) is being used as a single agent or in combination with bevacizumab/bevacizumab biosimilar
Member has been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy
Member has been previously treated with an anti-VEGF biological therapy
If RAS wild-type, member has been previously treated with an anti-EGFR therapy

Indication: Gastric or GEJ Adenocarcinoma (covered when ALL are met)

Covered when ALL of the following are met:

Member is not a surgical candidate or has unresectable/locally advanced/recurrent/metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma
Lonsurf (trifluridine/tipiracil) is being used as monotherapy as third-line or subsequent therapy following 2 prior lines of therapy

General Acceptance Criteria

General Acceptance

Use must be supported by one of the following sources:

FDA approved product labeling
CMS-approved compendia
National Comprehensive Cancer Network (NCCN)
American Society of Clinical Oncology (ASCO) clinical guidelines
Peer-reviewed literature that meets requirements of CMS Medicare Benefit Policy Manual Chapter 15

Continuation Therapy Criteria

Continuation Requests Exemption

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

The requested medication was used within the last year
The member has not experienced disease progression and/or no intolerance to the requested medication
Additional medication(s) are not being added to the continuation request

Definition — Continuation request exemption: Continuation for a not-approvable medication is allowed if the medication was used within the last year, the member has not experienced disease progression and/or intolerance to the medication, and no additional medications are being added to the continuation request. Continuation requests may be exempt under these conditions and any exemption determinations and reviews are managed by the Utilization Management Department with final approval by the Utilization Management Committee.

Exclusion / Not Covered Criteria

Exclusion Criteria (NOT covered if ANY of the following apply)

Lonsurf is being used after disease progression with the same regimen
Dosing exceeds single dose limit of Lonsurf 80 mg (based on the trifluridine component)<= 80 mg
Treatment exceeds the maximum limit of 80 (20 mg) or 120 (15 mg) tablets/month<= 80 tablets (20 mg) OR <= 120 tablets (15 mg) per month
Investigational use with an off-label indication that is not sufficient in evidence or is not generally accepted by the medical community
Sufficient evidence defined by criteria: patient/regimen representation, clinically meaningful outcomes per ASCO (e.g., HR<0.80 and ≥3 months OS/PFS benefit), appropriate study design, nonrandomized trials may support, case reports generally inadequate, abstracts without full article inadequate.

Denial Risk

Exclusion-based denials

Claims may be denied when exclusion criteria in the policy are met. Specific exclusion conditions that can lead to denial include use after disease progression on the same regimen; dosing that exceeds the single-dose limit of 80 mg (trifluridine component); exceeding the monthly tablet maximum (80 tablets of 20 mg strength or 120 tablets of 15 mg strength); and investigational or off-label use lacking sufficient evidence or not generally accepted by the medical community.

Use after disease progression with the same regimen
Single-dose limit exceeded: > 80 mg (trifluridine component)
Monthly tablet maximum exceeded: > 80 tablets (20 mg) OR > 120 tablets (15 mg)
Investigational/off-label use without sufficient evidence or not generally accepted

Provider Actions & Authorization

Prior Authorization

Authorization required and Evolent processing

Evolent is responsible for processing all medication requests. Authorization by Evolent is required; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Documentation Required

Supportive evidence requirement

Providers must support use of Lonsurf with acceptable evidence per the policy. Acceptable sources include FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

FDA approved product labeling
CMS‑approved (recognized) compendia
National Comprehensive Cancer Network (NCCN) guidelines
American Society of Clinical Oncology (ASCO) clinical guidelines
Peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards

Clinical Evidence

TAGS 2018TAGS trial (metastatic gastric cancer) — Shitara K et al. Lancet Oncol. 2018

Key evidence references informing this policy include the RECOURSE trial (Mayer RJ et al., NEJM 2015) and the TAGS trial (Shitara K et al., Lancet Oncology 2018). Policy evidentiary acceptance standards require support from FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting the CMS Medicare Benefit Policy Manual Chapter 15 criteria.

Background & Scope

Background: This policy defines accepted indications for Lonsurf including FDA-approved and off-label uses supported by recognized clinical sources (FDA label, CMS compendia, NCCN, ASCO, or acceptable peer-reviewed literature). Covered colorectal and gastric/GEJ indications are specified with required prior therapies and treatment settings, and exclusions include use after progression on the same regimen, dosing or monthly tablet limits, and investigational/off-label uses lacking sufficient evidence. The Utilization Management Department performs reviews and the Utilization Management Committee provides final approval authority.

Revision History

04/05/17committee_review

Committee review date listed.

04/11/18committee_review

Committee review date listed.

04/10/19committee_review

Committee review date listed.

12/11/19committee_review

Committee review date listed.

04/08/20committee_review

Committee review date listed.

04/14/21committee_review

Committee review date listed.

11/15/21committee_review

Committee review date listed.

03/09/22committee_review

Committee review date listed.

05/11/22committee_review

Committee review date listed.

07/13/22committee_review

Committee review date listed.

06/14/23committee_review

Committee review date listed.

09/13/23committee_review

Committee review date listed.

09/18/24approvalLatest

Committee approval and effective/approval dates updated with Approval Date September 18, 2024 and Effective Date September 27, 2024.

09/27/24effectiveLatest

Committee approval and effective/approval dates updated with Approval Date September 18, 2024 and Effective Date September 27, 2024.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1311 Lonsurf Trifluridine_Tipiracil_09272024

Policy CodePolicy N/A

Change TypeRevised dates

Effective DateSep 27, 2024

Next Review Date

Key ActionEvolent must process all medication requests and providers must support use with FDA labeling, CMS compendia, NCCN/ASCO guidelines, or qualifying peer-reviewed literature.

SourceLink

On This Page

OpenPayer

Um Onc_1311 Lonsurf Trifluridine_Tipiracil_09272024

Coverage Summary

General Acceptance Criteria

Continuation Therapy Criteria

Exclusion / Not Covered Criteria

Provider Actions & Authorization

Applicable Codes

Clinical Evidence

Background & Scope

Revision History