LYTGOBI (futibatinib)

LYTGOBI (futibatinib)

Self-Administration – oral

Diagnosis considered for coverage:

Intrahepatic cholangiocarcinoma: Indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

Coverage Criteria:

For diagnosis of intrahepatic cholangiocarcinoma:

• Dose does not exceed 20 mg (five 4 mg tablets) per day; AND

• Patient is 18 years of age or older; AND

• Prescribed by or in consultation with one of the following:

  • Gastroenterologist

  • Hepatologist

  • Oncologist; AND

• Chart note documentation provided confirms diagnosis of intrahepatic cholangiocarcinoma; AND

• Disease is one of the following:

  • Unresectable, locally advanced

  • Metastatic; AND

• Disease has presence of a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangements. AND

• Patient has been previously treated (e.g., gemcitabine + cisplatin, durvalumab + gemcitabine + cisplatin, 5-FU, capecitabine, gemcitabine, paclitaxel, oxaliplatin, cisplatin)

Reauthorization Criteria:

For diagnosis of intrahepatic cholangiocarcinoma:

• Dose does not exceed 20 mg (five 4 mg tablets) per day; AND

• Disease does not show signs of progression while on therapy.

Coverage Duration: 

• Initial: 1 year

• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

An FDA-approved test for detection of FGFR2 gene fusions or other rearrangements in patients with unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma for selecting patients for treatment with LYTGOBI is not available. The presence of FGFR2 fusions or other rearrangements was determined using next generation sequencing (NGS) testing.

Policy Updates:

• 05/16/2023  – New policy approved by P&T.

References:

• Lytgobi Prescribing Information. Taiho Oncology, Inc. Princeton, NJ. September 2022.