Futibatinib (Lytgobi) coverage for cholangiocarcinoma
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This policy defines medical necessity and prior authorization criteria for futibatinib (Lytgobi) for members of Ambetter Georgia across Commercial, HIM, and Medicaid lines of business; it governs initial and continued coverage for cholangiocarcinoma and guidance for other indications. Providers must supply supporting clinical documentation to obtain approval.
Added 16 mg tablet strength to product availability.
Added minimum dose requirement of 12 mg per day per prescribing information.
Extended initial approval duration from 6 months to 12 months.
Removed 'intrahepatic' restriction from cholangiocarcinoma diagnosis—policy supports both intrahepatic and extrahepatic cholangiocarcinoma use.
Coverage Criteria Overview
inv-01: Initial Therapy
Covered when ALL of the following are met for initial therapy:
Initial Approval - Cholangiocarcinoma
- Diagnosis of unresectable locally advanced or metastatic cholangiocarcinoma
- Prescriber: Prescribed by or in consultation with an oncologist
- Age ≥ 18 years
- Molecular Test: Documentation of FGFR2 fusion or rearrangement
- Prior FGFR inhibitor: Member has not previously received a selective FGFR inhibitor (e.g., Pemazyre)
- Prior therapy: Failure of at least one prior systemic cancer therapy
See Appendix B for examples
- Single agent: Prescribed as a single agent
- Product use: For Lytgobi requests, member must use futibatinib, if available, unless contraindicated or clinically significant adverse effects are experienced
Prescribed regimen must be FDA-approved or recommended by NCCN
- Dose minimum: Dose of Lytgobi is ≥ 12 mg per day>=12 mg/day
- Dose limits: Request must meet either a) dose does not exceed both 20 mg/day and 5 tablets/day OR b) dose is supported by practice guidelines or peer-reviewed literature for off-label use (prescriber must submit evidence)<=20 mg/day; <=5 tablets/day
inv-02: Continuation Therapy
Covered when ALL of the following are met for continued therapy:
Continued Therapy - Cholangiocarcinoma
- Current therapy: Currently receiving medication via Centene benefit, or documentation supports current receipt of Lytgobi for a covered indication and received medication for at least 30 days>=30 days
- Response: Member is responding positively to therapy
- Product use: For Lytgobi requests, member must use futibatinib, if available, unless contraindicated or clinically significant adverse effects are experienced
Prescribed regimen must be FDA-approved or recommended by NCCN
- Dose minimum: Dose of Lytgobi is ≥ 12 mg per day>=12 mg/day
- Dose increase: If request is for a dose increase, new dose must either not exceed both 20 mg/day and 5 tablets/day OR be supported by practice guidelines or peer-reviewed literature (prescriber must submit evidence)<=20 mg/day; <=5 tablets/day
Requests for indications that are not FDA-approved and are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation demonstrating efficacy and safety per the applicable off-label use policies or evidence of coverage documents. Prior authorization is required; approval will only be granted when the requestor provides the documentation required to show the member meets the policy criteria for initial or continued therapy.
Off‑label or non‑FDA uses of futibatinib are not covered under this policy unless the provider submits adequate supporting evidence aligning with the referenced off‑label policies. See related off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid) for the standards and documentation required to consider an off‑label indication.
Initial Therapy
inv-12: Initial Therapy
Initial coverage rules for futibatinib in cholangiocarcinoma:
Initial Therapy
- Diagnosis of unresectable locally advanced or metastatic cholangiocarcinoma
- Prescriber: Prescribed by or in consultation with an oncologist
- Age ≥ 18 years
- Molecular Test: Documentation of FGFR2 fusion or rearrangement
- Prior FGFR inhibitor: Member has not previously received a selective FGFR inhibitor (e.g., Pemazyre)
- Prior therapy: Failure of at least one prior systemic cancer therapy
See Appendix B for examples
- Single agent: Prescribed as a single agent
- Product use: For Lytgobi requests, member must use futibatinib, if available, unless contraindicated or clinically significant adverse effects are experienced
Prescribed regimen must be FDA-approved or recommended by NCCN
- Dose minimum: Dose of Lytgobi is ≥ 12 mg per day>=12 mg/day
- Dose limits: Request must meet either a) dose does not exceed both 20 mg/day and 5 tablets/day OR b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)<=20 mg/day; <=5 tablets/day
| Step | Requirement |
|---|---|
| Prior systemic therapy (permissive) | Failure of at least one prior systemic cancer therapy is required before initial approval of futibatinib (see Appendix B for examples). |
| Prescribed regimen | Prescribed regimen must be FDA‑approved or recommended by NCCN; futibatinib (Lytgobi) should be used if available unless contraindicated or clinically significant adverse effects occur. |
| Age requirement | Member is an adult (age ≥ 18 years). |
| Diagnosis | Unresectable locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement. |
| Prior FGFR inhibitor | Member has not previously received a selective FGFR inhibitor (e.g., Pemazyre). |
| Dose minimum and limits | Dose of Lytgobi is ≥ 12 mg/day; initial dose must either not exceed both 20 mg/day and 5 tablets/day, or the dose must be supported by practice guidelines or peer‑reviewed literature (prescriber must submit evidence). |
Continued Therapy
inv-13: Continued Therapy
Criteria for continued coverage of futibatinib:
Continued Therapy
- Current therapy: Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Lytgobi for a covered indication and has received this medication for at least 30 days>=30 days
- Response: Member is responding positively to therapy
- Product use: For Lytgobi requests, member must use futibatinib, if available, unless contraindicated or clinically significant adverse effects are experienced
Prescribed regimen must be FDA-approved or recommended by NCCN
- Dose minimum: Dose of Lytgobi is ≥ 12 mg per day>=12 mg/day
- Dose increase: If request is for a dose increase, new dose must either not exceed both 20 mg/day and 5 tablets/day OR be supported by practice guidelines or peer-reviewed literature (prescriber must submit evidence)<=20 mg/day; <=5 tablets/day
Dose Limits and Coding
Provider Requirements and Documentation
Prior Authorization Required — Approval Linked to Criteria
Prior authorization is required for futibatinib (Lytgobi); approval is granted only when the member meets the policy's specified initial or continued therapy criteria (see coverage criteria for diagnosis, molecular testing, prior therapy, prescriber, age, dosing, and approval duration).
Required Product Use and Regimen Standards
For Lytgobi requests the policy requires use of futibatinib (if available) for the member unless contraindicated or clinically significant adverse effects occur; the prescribed regimen must be FDA‑approved or recommended by NCCN and meet the policy dose standards.
- Member must use futibatinib if available unless contraindicated or intolerant (Initial criteria #8; Continued criteria #3).
- Prescribed regimen must be FDA‑approved or recommended by NCCN (dose support requirement).
- Dose limits: generally ≤ 20 mg/day and ≤ 5 tablets/day unless supported by practice guidelines or peer‑reviewed literature.
Required Supporting Documentation (office notes, labs, tests)
Provider must submit supporting clinical documentation (such as office chart notes, laboratory results, or other clinical information) demonstrating the member meets all approval criteria, including diagnosis, FGFR2 fusion/rearrangement test results, prior therapy history, prescriber specialty, age, dosing, and treatment response for continuations.
- Examples: office notes, lab results, molecular testing showing FGFR2 fusion/rearrangement, records of prior systemic therapy, and documentation of therapy response.
- Documentation must support duration requirements (e.g., ≥ 30 days of therapy for continuation) and dosing thresholds (≥ 12 mg/day; any dose increases must meet limits or be supported by evidence).
Documentation & Indication‑based Denial Risk
Requests lacking required supporting clinical documentation or requests for non‑FDA approved indications not addressed by this policy (without appropriate off‑label policy support or evidence) may be denied.
- Non‑FDA approved indications require sufficient documentation of efficacy and safety per referenced off‑label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage.
- Missing documentation of key approval elements (diagnosis, FGFR2 test, prior therapy, dosing, prescriber) increases risk of denial.
Key Definitions
Background
Futibatinib (Lytgobi) is an oral FGFR inhibitor approved under specific indications for cholangiocarcinoma. Use of futibatinib for indications not covered by the FDA label is handled according to the off‑label policies referenced in this document; such uses require documentation of efficacy and safety consistent with those policies before authorization will be considered.
Site of Care
No site‑of‑care restriction specified
Policy text does not impose a site‑of‑care restriction for futibatinib; no specific site‑of‑care requirements are specified.
Policy Revision History
Policy created (initial creation).
References reviewed and updated during 1Q 2024 annual review (no significant clinical changes).
1Q 2025 annual review: removed 'intrahepatic' restriction from cholangiocarcinoma diagnosis to align with NCCN guidance; removed Truseltiq as an FGFR inhibitor example and updated Appendix B with NCCN-supported primary treatment regimen examples; references reviewed and updated.
1Q 2026 annual review: added 16 mg tablet strength to product availability; added minimum required dose of 12 mg/day per prescribing information; extended initial approval duration from 6 months to 12 months.
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