CurrentCignaPolicy N/A

Oncology - Lytgobi Prior Authorization Policy

Defines Cigna's prior authorization requirements for Lytgobi (futibatinib) for treatment of FGFR2 fusion/rearranged intrahepatic cholangiocarcinoma in adults; applies to prescription benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyOncology - Lytgobi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document patient is ≥18, has unresectable locally advanced or metastatic disease with FGFR2 fusion/rearrangement, and received at least one prior systemic regimen.

SourceLink

1 yrapproval duration

≥18min age

prior systemic therapyline of therapy

FGFR2 fusion/rearrangementbiomarker

11/13/2024review date

Coverage Criteria for Lytgobi (futibatinib)

FDA‑Approved Indication

Covered when ALL of the following are met

FDA-approved indication for cholangiocarcinoma: A) Patient is ≥ 18 years of age; AND B) Patient has unresectable locally advanced or metastatic disease; AND C) Tumor has FGFR2 gene fusions or other rearrangements, as detected by an approved test; AND D) Patient has been previously treated with at least one systemic regimen.

Approve for 1 year when all conditions met

Use of Lytgobi (futibatinib) for any indication other than the FDA‑approved cholangiocarcinoma indication is considered experimental, investigational, or unproven and will not be covered. Criteria will be updated if new published data become available.

Regimen	Indication	Coverage status	Notes
Lytgobi (futibatinib) tablets
Previously treated unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement
Covered
Approve for 1 year when ALL of the following are met: patient ≥ 18 years; unresectable locally advanced or metastatic disease; tumor has FGFR2 gene fusions or other rearrangements detected by an approved test; patient has been previously treated with at least one systemic regimen (examples: gemcitabine + cisplatin; 5‑fluorouracil + oxaliplatin or cisplatin; capecitabine + cisplatin or oxaliplatin; gemcitabine + Abraxane; gemcitabine + cisplatin + Abraxane).

Policy Summary

PayerCigna

PolicyOncology - Lytgobi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Provider Responsibilities and Authorization Details

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for prescription benefit coverage of Lytgobi; all approvals are provided for the duration noted in the policy.

Note

Approval duration — 1 year

Approve therapy for 1 year when the patient meets all FDA‑approved indication criteria (age, disease extent, FGFR2 fusion/rearrangement, and prior systemic therapy).

Step Therapy

Prior systemic therapy required

Patient must have been previously treated with at least one systemic regimen prior to Lytgobi.

Policy examples of systemic regimens: gemcitabine + cisplatin; 5‑fluorouracil + oxaliplatin or cisplatin; capecitabine + cisplatin or oxaliplatin; gemcitabine + albumin‑bound paclitaxel (Abraxane) or capecitabine or oxaliplatin; gemcitabine + cisplatin + Abraxane.

Documentation Required

Required clinical documentation

Documentation must confirm the patient is ≥ 18 years old, has unresectable locally advanced or metastatic disease, tumor FGFR2 gene fusion or other rearrangement detected by an approved test, and prior treatment with at least one systemic regimen.

Denial Risk

Non‑covered indications — other uses

Use of Lytgobi for any indication other than the FDA‑approved cholangiocarcinoma indication is considered experimental, investigational, or unproven and will not be covered.

Genomic Testing Requirement

inv-11: FGFR2 fusion or rearrangement — detected by an approved test

Required biomarkerTumor has FGFR2 gene fusions or other rearrangements detected by an approved test

Purpose of biomarker requirementQualifies the tumor for targeted therapy with Lytgobi (futibatinib)

Test qualificationAlteration must be identified by an approved test as specified in the FDA‑approved indication

Coverage linkagePresence of FGFR2 fusion/rearrangement is a condition for approval under the FDA‑approved indication

Line of Therapy Requirement

Second-line

Line of therapy: Used for patients with disease progression on or following systemic therapy; patient must have been previously treated with at least one systemic regimen.

Examples of systemic regimens provided in policy

Definitions

inv-09: FGFR2 fusion or rearrangement definition — genomic alterations detected by an approved test that qualify the tumor

DefinitionGenomic alterations in the FGFR2 gene (fusions or other rearrangements) detected by an approved test that qualify the tumor for targeted therapy with Lytgobi.

Clinical contextLytgobi is indicated for previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements in adults.

Guideline contextNCCN recommends Lytgobi for progression on or following systemic therapy in intrahepatic or extrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements.

Background

Lytgobi (futibatinib) is an oral FGFR2 inhibitor indicated for adults with previously treated, unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements. NCCN guidance supports use after disease progression on or following systemic therapy.