ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Truseltiq (infigratinib)

Defines accepted indications, continuation and exclusion criteria, and utilization management authority for Truseltiq (infigratinib) including FDA-approved and off-label uses supported by recognized compendia or literature; includes notes regarding manufacturer withdrawal and FDA withdrawal of approval.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTruseltiq (infigratinib)

Policy CodePolicy N/A

Change TypeRevised; Added dosing/quantity limits

Effective DateNov 29, 2024

Next Review Date

Key ActionDocument molecular testing confirming FGFR2 fusion or other rearrangement to support approval and submit authorization requests to Evolent for review.

SourceLink

POLICY UPDATE CHANGES

Policy updated to reflect committee approval on November 13, 2024 and effective date November 29, 2024.

Inclusion of explicit exclusion criteria for dosing limits and monthly tablet limits.

1Primary Covered Indication (cholangiocarcinoma, FGFR2 fusion)

2Regulatory events noted (manufacturer withdrawal; FDA withdrawal)

6Committee review dates listed

Coverage Summary

Policy covers Truseltiq (infigratinib) for previously treated unresectable or metastatic cholangiocarcinoma with FGFR2 fusion or other FGFR2 rearrangement as the primary accepted indication. The manufacturer withdrew its NDA and permanently discontinued US distribution in October 2022, and the FDA withdrew approval on May 16, 2024. Off‑label uses require support from FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature that meets CMS standards.

Dose and Quantity Limits

Single dose limit125 mg

Monthly tablet limit (25 mg)Maximum 21 tablets per month

Monthly tablet limit (100 mg)Maximum 21 tablets per month

Effective dateNovember 29, 2024

Last review/Committee approval dateNovember 13, 2024

Initial Therapy Criteria

Cholangiocarcinoma - approval criteria

Truseltiq (infigratinib) may be used when ALL of the following are met:

Diagnosis of unresectable or metastatic cholangiocarcinoma
Tumor is FGFR2 fusion positive or has other FGFR2 rearrangement (molecular testing confirming presence required)
Use as monotherapy following disease progression on or after at least one prior systemic treatment
Continuation requests limited to members experiencing documented clinical benefit from the drug
Continuation only; manufacturer withdrew NDA and US distribution permanently discontinued (Oct 2022) and FDA withdrew approval May 16, 2024

Continuation Therapy Criteria

Continuation exemption for not-approvable medication

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

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 having an active authorization
Additional medication(s) are not being added to the continuation request

Continuation requests are permitted only under the policy’s continuation exemption when ALL criteria are met, and specifically are limited to members who are experiencing documented clinical benefit from the drug; this is noted alongside the manufacturer’s permanent US distribution withdrawal (October 2022) and the FDA’s withdrawal of approval (May 16, 2024).

Exclusion Criteria (Not Medically Necessary / Not Approved)

Exclusion criteria (Not medically necessary / Not approved)

Truseltiq is excluded when ANY of the following are present:

Disease progression while taking Truseltiq (infigratinib) or another FGFR inhibitor (e.g., pemigatinib)
Lack of molecular testing confirming the presence of an FGFR2 fusion/other rearrangement in the member's cancer
Concurrent use with other anti-cancer therapies
Dosing exceeds single dose limit of Truseltiq (infigratinib) 125 mg125 mg
Treatment exceeds the maximum limit of 21 (25 mg) and 21 (100 mg) tablets/monthMaximum 21 (25 mg) and 21 (100 mg) tablets per month
Insufficient evidence defined as ALL of the following considerations
- Clinical characteristics of patient and cancer not adequately represented in published evidence
- Administered therapy regimen not adequately represented in published evidence
- Reported study outcomes do not represent clinically meaningful outcomes (ASCO definitions, e.g., HR <0.80 or OS/PFS benefit >=3 months)
- Experimental design inappropriate to address investigative question
- Non-randomized trials may be supportive only if significant number of subjects
- Case reports are generally inadequate as supportive evidence

Provider Actions / Prior Authorization

Prior Authorization

Authorization required for medication requests

Evolent (UM) processes all medication requests for Truseltiq (infigratinib). Medications that are not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Evolent (Utilization Management) processes requests

Documentation Required

Molecular testing documentation required

Document molecular testing that confirms the presence of an FGFR2 fusion or other FGFR2 rearrangement in the member's tumor to support approval for Truseltiq (infigratinib).

Molecular testing report indicating FGFR2 fusion or rearrangement
Pathology or molecular pathology report with test methodology and result

Denial Risk

Denial for progression or concurrent therapy

Requests will be excluded (denied) when there is documented disease progression while taking Truseltiq or another FGFR inhibitor, or when the member is receiving concurrent anti-cancer therapies.

Disease progression on Truseltiq (infigratinib) or another FGFR inhibitor (e.g., pemigatinib)
Concurrent use with other anti-cancer therapies

Billing Rule

Dose and quantity limits enforced

Dose and quantity limits are enforced. A single dose must not exceed 125 mg. Monthly tablet limits are a maximum of 21 tablets of the 25 mg strength and 21 tablets of the 100 mg strength. Claims exceeding these limits may be denied.

Single dose limit: 125 mg
Monthly tablet limit: maximum 21 tablets (25 mg)
Monthly tablet limit: maximum 21 tablets (100 mg)

Documentation Required

Evidence support required for off-label use

Off-label indications for Truseltiq must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature that meets CMS standards (Medicare Benefit Policy Manual Chapter 15).

FDA-approved product labeling
CMS-recognized compendia
NCCN or ASCO clinical guidelines
Peer-reviewed literature meeting CMS Chapter 15 standards

Clinical Evidence

Key supporting evidence includes the phase 2 study by Javle et al. (Lancet Gastroenterol Hepatol. 2021;6(10):803‑815) evaluating infigratinib in previously treated advanced/metastatic cholangiocarcinoma with FGFR2 fusions/rearrangements, and the FDA notice of withdrawn accelerated approval for infigratinib dated May 16, 2024. Continued use is limited and must be supported by evidence consistent with CMS standards (FDA labeling, CMS compendia, NCCN/ASCO, or acceptable peer‑reviewed literature).

Background

Infigratinib (Truseltiq) received accelerated FDA approval for previously treated unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions/rearrangements; the manufacturer withdrew the NDA and U.S. distribution was permanently discontinued in October 2022, and the FDA issued final withdrawal of the approval on May 16, 2024. Use and any continuation requests must follow the policy requirements and supporting evidence standards described by CMS.

Definitions

Continuation request exemptionRequests for continuation of not-approvable medication allowed if the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and additional medication(s) are not being added to the continuation request.

Revision History

October 2022manufacturer_withdrawal

Manufacturer withdrew its New Drug Application and permanently discontinued U.S. distribution of Truseltiq (infigratinib).

May 16, 2024fda_withdrawal

FDA announced the final withdrawal of approval of infigratinib (Truseltiq) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or other rearrangement.

November 13, 2024policy_committee_approval

Evolent Specialty Services Clinical Guideline Review Committee approved the Truseltiq (infigratinib) policy.

November 29, 2024policy_effectiveLatest

Policy update became effective (policy approval date November 13, 2024; effective date November 29, 2024).