CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lytgobi (futibatinib) — Coverage Criteria

Defines clinical coverage, authorization, and exclusions for Lytgobi (futibatinib) for members receiving cancer therapy, including FDA‑approved and accepted off‑label indications per recognized compendia and literature; applies to utilization management review processes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLytgobi (futibatinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 29, 2024

Next Review DateNov 13, 2024

Key ActionObtain prior authorization and provide documentation of FGFR2 rearrangement by an FDA‑approved test.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1FDA‑approved primary covered indication

1 priorPrior systemic therapy required

20 mgSingle dose maximum

140 tabs/moMaximum monthly limit

AllowedContinuation exemption

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Coverage criteria for Lytgobi (futibatinib)

Initial therapy for FGFR2‑rearranged cholangiocarcinoma

Covered when ALL of the following are met:

Cholangiocarcinoma indication: Member has unresectable, advanced, or metastatic cholangiocarcinoma positive for FGFR2 rearrangement detected by an FDA‑approved test

based on policy statement

Prior therapy: Member has disease progression on at least one prior systemic therapy

policy requires prior systemic therapy

Evidence support: Use is supported by FDA labeling, CMS‑approved compendia, NCCN or ASCO guidelines, or acceptable peer‑reviewed literature per Medicare Benefit Policy Manual Chapter 15

see Purpose section for accepted evidence sources

Continuation therapy

Continuation therapy exemption — Covered when ALL of the following are met:

Prior use within 1 year: Requested medication was used within the last year

continuation exemption condition

No progression or intolerance: Member has not experienced disease progression and/or no intolerance to the requested medication

continuation exemption condition

No new medications: Additional medication(s) are not being added to the continuation request

continuation exemption condition

Coverage for Lytgobi excludes concurrent administration with other anti‑cancer therapies. Requests that propose combining Lytgobi (futibatinib) with additional systemic anti‑neoplastic agents will be denied unless separate policy language specifically allows combination use.

Coverage is denied when there is no documentation confirming the presence of an FGFR2 rearrangement by an FDA‑approved test. Providers must supply documentation of an FDA‑approved companion diagnostic demonstrating FGFR2 rearrangement for coverage consideration.

Requests will be denied if the member has experienced disease progression while taking Lytgobi or another FGFR inhibitor (for example, pemigatinib or infigratinib). Progression on prior FGFR‑targeted therapy is a contraindication to continued coverage under this policy.

Dosing that exceeds the established limits is not covered. The policy defines a single dose maximum of 20 mg and a monthly maximum of 140 (4 mg) tablets per month; requests exceeding either threshold will be denied.

Use of Lytgobi for investigational purposes or off‑label indications that lack sufficient evidence or are not generally accepted by the medical community is excluded from coverage. The policy requires supportive evidence from FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature and defines insufficiency by factors such as inadequate representation of patient/ disease characteristics, inappropriate study design, or absence of clinically meaningful outcomes.

When the evidence for an off‑label indication is insufficient according to the policy’s criteria (e.g., limited to case reports or abstracts without full peer‑reviewed articles, inadequate representation in published studies, or lack of clinically meaningful outcomes), the use is considered not medically necessary and will not be covered.

Initial therapy — cholangiocarcinoma

Initial therapy for cholangiocarcinoma

Initial therapy coverage criteria:

Indication: Unresectable, advanced, or metastatic cholangiocarcinoma with FGFR2 rearrangement detected by an FDA‑approved test

policy lists FGFR2 rearrangement requirement

Prior therapy failure: Disease progression on at least one prior systemic therapy

policy requirement

Evidence support: Use supported by FDA labeling or recognized compendia/guidelines or acceptable peer‑reviewed literature per CMS criteria

see Purpose section

Continuation therapy rules

Continuation requests may be approved when all continuation conditions are satisfied:

Used within last year: Requested medication was used within the last year

see continuation exemption

No progression/intolerance: Member has not experienced disease progression and/or no intolerance to the requested medication

see continuation exemption

No additional meds: Additional medication(s) are not being added to the continuation request

see continuation exemption

What providers must do

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lytgobi (futibatinib). All medication requests must be processed by Evolent (Utilization Management Department) and receive final approval from the Utilization Management Committee.

Requests processed by Evolent (UM Department)
Final approval by the Utilization Management Committee

Step Therapy

Prior Systemic Therapy & Molecular Requirement

For cholangiocarcinoma, the member must have disease that is unresectable, advanced, or metastatic and documented FGFR2 rearrangement positivity by an FDA‑approved test. Additionally, the member must have disease progression on at least one prior systemic therapy before Lytgobi (futibatinib) may be authorized.

Indication required: unresectable, advanced, or metastatic cholangiocarcinoma
Must be FGFR2 rearrangement–positive as detected by an FDA‑approved test
Member must have progression on ≥1 prior systemic therapy

Documentation Required

Required Documentation

Documentation must include confirmatory evidence of FGFR2 rearrangement detected by an FDA‑approved companion diagnostic and clinical records supporting the indication (diagnosis, prior systemic therapy details, and evidence of progression). A list of FDA‑approved companion diagnostics is available at www.fda.gov/CompanionDiagnostics.

Confirmatory test report showing FGFR2 rearrangement (FDA‑approved test)
Clinical documentation of unresectable/advanced/metastatic disease
Records demonstrating prior systemic therapy and disease progression
Reference to FDA companion diagnostics list: www.fda.gov/CompanionDiagnostics

Denial Risk

Denial Triggers

Denial triggers include: disease progression while on Lytgobi or another FGFR inhibitor; lack of documentation confirming FGFR2 rearrangement by an FDA‑approved test; concurrent use with other anti‑cancer therapies; dosing or quantity limits exceeded; or investigational/off‑label use lacking sufficient supporting evidence.

Disease progression while on Lytgobi or another FGFR inhibitor (e.g., pemigatinib, infigratinib)
No FDA‑approved test documentation for FGFR2 rearrangement
Concurrent use with other anti‑cancer therapies
Single dose limit exceeded (Lytgobi >20 mg) or monthly tablet limit exceeded (>140 tablets/month)
Investigational or off‑label use without adequate evidence per policy criteria

Step therapy / prior therapy requirements

Step	Requirement	Supporting detail
1
Member must have disease progression on at least one prior systemic therapy for cholangiocarcinoma
Lytgobi (futibatinib) monotherapy is covered for unresectable, advanced, or metastatic cholangiocarcinoma positive for FGFR2 rearrangement when prior systemic therapy has failed

Quantity and dosing limits

Quantity limit — Lytgobi (futibatinib)

Maximum monthly quantity140 tablets per month (4 mg tablets)

Dose limit — Lytgobi (futibatinib)

Single dose maximum20 mg per dose

Key definitions

Definition — FGFR2 rearrangement testing requirement

Required molecular testFGFR2 rearrangement (e.g., gene fusion/activating mutations) must be detected by an FDA‑approved test

Documentation sourceList of FDA‑approved companion diagnostic tests available at www.fda.gov/CompanionDiagnostics

Coverage conditionPositive FGFR2 rearrangement required for coverage of Lytgobi monotherapy in unresectable, advanced, or metastatic cholangiocarcinoma

Exclusion if absentRequests lacking documentation confirming FGFR2 rearrangement by an FDA‑approved test will be excluded

Background

Futibatinib (Lytgobi) is an irreversible fibroblast growth factor receptor (FGFR) 1–4 inhibitor used as monotherapy for tumors with FGFR2 rearrangements, most notably unresectable, advanced, or metastatic cholangiocarcinoma. Coverage under this policy requires molecular confirmation of an FGFR2 rearrangement by an FDA‑approved test and alignment with FDA labeling or accepted compendia/guidelines; investigational or unsupported off‑label uses are excluded.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLytgobi (futibatinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 29, 2024

Next Review DateNov 13, 2024

Key ActionObtain prior authorization and provide documentation of FGFR2 rearrangement by an FDA‑approved test.

SourceLink

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