1779 – Testing of tumour tissue to detect FGFR2 fusions or rearrangements in people with cholangiocarcinoma, to determine eligibility for treatment with PBS subsidised futibatinib

Page last updated: 16 October 2024

Application Detail

Description of Medical Service

The test is to detect fusions or rearrangements in the FGFR2 gene in tumour tissue. Testing may be performed using next generation sequencing (NGS) or fluorescence in situ hybridisation (FISH). This test is for patients with locally advanced or metastatic cholangiocarcinoma and is used to determine eligibility for a potential new PBS subsidised treatment, futibatinib.

Description of Medical Condition

Cholangiocarcinoma is a rare type of cancer that develops in the bile ducts. The bile ducts are a group of thin tubes that carry bile (a digestive fluid) from the liver and gallbladder to the intestines.

Reason for Application

New MBS item (MSAC-PBAC co-dependent submission)

Medical Service Type

Investigative technology

Previous Application Number/s

Not Applicable

Associated Documentation

Application Summary and PICO Set

Application Summary (PDF 149 KB)
Application Summary (Word 28 KB)

Application PICO Set (PDF 353 KB)
Application PICO Set (Word 108 KB)

Consultation Survey

Consultation Survey

PASC Consultation
PASC consultation closed Friday 12 July 2024. Any consultation received after this date will automatically be included in the MSAC consultation for this application.

MSAC Consultation
MSAC consultation closes Friday 14 February 2025

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process

PICO Confirmation

PICO Confirmation (PDF 760 KB)
PICO Confirmation (Word 422 KB)

Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

15-16 August 2024

ESC

13-14 February 2025

MSAC

3-4 April 2025