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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsColorado Rocky Mountain Health Plans Lytgobi Prior…
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    CurrentColorado Rocky Mountain Health PlansPolicy N/A

    Lytgobi (futibatinib) prior authorization

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    Prior authorization and coverage criteria for Lytgobi (futibatinib) for treatment of cholangiocarcinoma; applies to UnitedHealthcare pharmacy clinical programs for affected members (automated approval for patients <19).

    Policy Summary
    PayerColorado Rocky Mountain Health Plans
    PolicyLytgobi (futibatinib) prior authorization
    Policy CodePolicy N/A
    Change TypeMinor update / no material changes
    Effective DateFeb 15, 2026
    Next Review DateN/A
    Key ActionObtain and document FGFR2 fusion/rearrangement testing and confirm second-line or later use when submitting prior authorization.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 moauthorization duration (initial and renewal)
    FGFR2+required tumor biomarker for coverage

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    2nd+ line
    required line of therapy
    Age <19automatic for <19
    NCCNNCCN recognition

    Coverage Criteria for Lytgobi (futibatinib)

    inv-01: Initial Therapy — Covered when ALL of the following are met

    Covered when ALL of the following are met

    Initial Authorization for Adults: Diagnosis of cholangiocarcinoma (intrahepatic or extrahepatic); disease is unresectable OR resected gross residual (R2) OR metastatic; tumor is positive for FGFR2 fusions or rearrangements; used as second-line or subsequent treatment.

    Authorization issued for 12 months.

    inv-02: Pediatric (under 19) — Automatic approval process for minors

    Automatic approval process for minors

    Patients less than 19: Patient is less than 19 years of age.

    Prescription will automatically process without a coverage review; authorization issued for 12 months.

    inv-03: Continuation Therapy / Reauthorization — Covered when ALL of the following are met

    Covered when ALL of the following are met

    Reauthorization: Patient does not show evidence of progressive disease while on Lytgobi therapy.

    Authorization issued for 12 months.

    Some states mandate benefit coverage for off-label use of medications or require use of specific compendia. Where such state mandates apply, they supersede the language in this policy and take precedence over these coverage criteria.

    Lytgobi is not supported by these coverage criteria when used in patients who do not have tumor genomic testing documenting FGFR2 fusions or rearrangements. Additionally, use as first-line therapy is not covered when the criteria specify use as second-line or subsequent. Continued coverage at reauthorization is contingent on lack of disease progression; evidence of progressive disease while on Lytgobi may lead to denial of renewal.

    Initial Authorization

    inv-13: Initial authorization — top-level initial therapy criteria node

    Initial Authorization: Member is diagnosed with cholangiocarcinoma (intrahepatic or extrahepatic); disease is unresectable OR resected gross residual (R2) OR metastatic; tumor is positive for FGFR2 fusions or rearrangements; used as second-line or subsequent treatment.

    Authorization issued for 12 months.

    Reauthorization / Continuation Criteria

    inv-14: Reauthorization — continuation therapy criteria

    Reauthorization: Patient does not show evidence of progressive disease while on Lytgobi therapy.

    Authorization issued for 12 months.

    Provider Actions and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization required for adults. Lytgobi (futibatinib) will be approved only when all initial authorization criteria are met: a diagnosis of cholangiocarcinoma (intrahepatic or extrahepatic); disease that is unresectable, resected with gross residual disease (R2), or metastatic; documented FGFR2 fusions or rearrangements; and use as second-line or subsequent therapy.

    • Initial authorization: Diagnosis of cholangiocarcinoma (intrahepatic or extrahepatic)
    • Disease status: Unresectable OR resected with gross residual (R2) OR metastatic
    • Molecular marker: Documented FGFR2 fusions or rearrangements
    • Line of therapy: Second-line or later
    Documentation Required

    Required Documentation

    Document and submit clinical records that confirm the diagnosis and disease status, plus test results demonstrating FGFR2 fusions or rearrangements. Include prior treatment history to show Lytgobi is being used as second-line or subsequent therapy. Providers should be prepared to provide imaging, pathology reports, molecular testing reports, and medication/claim history upon request.

    Key Definitions

    inv-12: FGFR2 fusions/rearrangements — tumor genomic alterations required for eligibility
    Required tumor genomic alterationDocumented FGFR2 fusions or rearrangements in the tumor (fibroblast growth factor receptor 2)
    Disease diagnosisCholangiocarcinoma (intrahepatic or extrahepatic per NCCN guidance)
    Disease statusUnresectable OR resected gross residual (R2) OR metastatic
    Line of therapyUsed as second‑line or subsequent systemic treatment
    Age considerationsIndication and criteria apply to adults; NCCN guidance extends to extrahepatic disease when FGFR2 fusions/rearrangements present

    Background

    Lytgobi (futibatinib) is a kinase inhibitor indicated for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. The approval is based on response data from trials in this molecularly defined population and continued approval may depend on confirmatory studies. Clinical guidance (NCCN) also recognizes FGFR2-directed therapy for select extrahepatic cholangiocarcinoma in later lines of therapy.

    Step Therapy and Supply Limits

    Program ruleDetails
    Supply limits and/or step therapy may be in place per program
    UnitedHealthcare programs may apply supply limits or step therapy requirements; specific step requirements and supply limits are not enumerated in this policy document

    Site of Care

    Note

    Site-of-care not specified; program-level restrictions may apply

    Site-of-care rules are not specified in this policy; however, program-level supply limits or site restrictions (e.g., infusion center requirements) may apply depending on the program.

    • No explicit site-of-care restriction in this document
    • Program-level site restrictions or supply limits may be enforced
    Policy Summary
    PayerColorado Rocky Mountain Health Plans
    PolicyLytgobi (futibatinib) prior authorization
    Policy CodePolicy N/A
    Change TypeMinor update / no material changes
    Effective DateFeb 15, 2026
    Next Review DateN/A
    Key ActionObtain and document FGFR2 fusion/rearrangement testing and confirm second-line or later use when submitting prior authorization.
    SourceLink
    On This Page
    Coverage Criteria for Lytgobi (futibatinib)Initial AuthorizationReauthorization / Continuation CriteriaProvider Actions and Documentation RequirementsKey DefinitionsBackgroundStep Therapy and Supply LimitsSite of Care
    • Documentation of cholangiocarcinoma diagnosis (specify intrahepatic vs extrahepatic)
    • Clinical documentation of disease status (unresectable, R2 resection, or metastatic)
    • Laboratory/pathology report showing FGFR2 fusion/rearrangement
    • Prior therapy records showing prior systemic treatment(s)
    Denial Risk

    Triggers for Denial

    Applications may be denied if key criteria are not met. Common triggers for denial include: absence of documented FGFR2 fusions or rearrangements, use as first-line therapy, lack of a cholangiocarcinoma diagnosis, or missing required documentation to verify disease status or prior treatments.

    • No documented FGFR2 fusion or rearrangement
    • Prescribed as first‑line therapy
    • Diagnosis other than cholangiocarcinoma
    • Insufficient documentation of disease status or prior treatment history
    Denial Risk

    Progression at Reauthorization

    At reauthorization, approval requires evidence that the patient is benefiting from therapy — reauthorization will be denied if there is documented progressive disease while on Lytgobi. Provide recent imaging or clinical assessments demonstrating no progression when requesting continued authorization.

    • Reauthorization requires no evidence of progressive disease on Lytgobi
    • Submit recent imaging/clinical assessment reports at time of reauthorization
    Note

    Program-Level Limits and Automated Approval

    Program-level operational rules may apply. UnitedHealthcare (program) may use prior claim/medication history, diagnosis codes, and claim logic to approve initial or reauthorization requests. Supply limits and/or step therapy may be enforced per program.

    • Approvals may be processed based on prior claims/medication history and diagnosis codes
    • Supply limits and step therapy may apply