Lytgobi (futibatinib) prior authorization
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).
No material clinical or coverage changes in this revision.
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
Authorization issued for 12 months.
inv-02: Pediatric (under 19) — Automatic approval process for minors
Automatic approval process for minors
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
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
Authorization issued for 12 months.
Reauthorization / Continuation Criteria
inv-14: Reauthorization — continuation therapy criteria
Authorization issued for 12 months.
Provider Actions and Documentation Requirements
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
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.
- 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)
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
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
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
Key Definitions
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 rule | Details |
|---|---|
| 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
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
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