1750 - Testing of tumour tissue to detect IDH1 mutations in patients with cholangiocarcinoma to determine eligibility for ivosidenib on the Pharmaceutical Benefits Scheme

Page last updated: 15 November 2024

Application Detail

Description of Medical Service

Testing of tumour tissue by a pathologist, for patients with locally advanced or metastatic Cholangiocarcinoma, to detect IDH1 mutations. Confirmation of the disease will be required to determine eligibility for treatment with TibsovoŽ (ivosidenib), which is seeking PBS listing through a codependent submission.

Description of Medical Condition

Cholangiocarcinoma is a type of cancer that encompasses all tumours originating from the epithelium of the bile duct. Bile ducts are a group of thin tubes that carry bile (a digestive fluid) from the liver and gallbladder into the intestines.

Reason for Application

New MBS item

Medical Service Type

Investigative technology

Previous Application Number/s

Not Applicable

Associated Documentation

Application Summary and PICO Set

Application Summary (PDF 401 KB)
Application Summary (Word 27 KB)

PICO Set (PDF 834 KB)
PICO Set (Word 300 KB)

Consultation Survey

Consultation Survey (PDF 654 KB)
Consultation Survey (Word 27 KB)

PASC Consultation
Consultation closed

MSAC Consultation
MSAC consultation input closed Friday, 14 June 2024.

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 (Word 728 KB)
PICO Confirmation (PDF 973 KB)

Assessment Report

-

Public Summary Document

Public Summary Document - August 2024 (PDF 573 KB)
Public Summary Document - August 2024 (Word 143 KB)

Meetings for this Application

PASC

10-11 August 2023

ESC

13-14 June 2024

MSAC

1-2 August 2024
28-29 November 2024