Application Detail

Description of Medical Service

A test to determine the Claudin (CLDN18.2) status of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) negative gastric or gastro-oesophageal junction adenocarcinoma. The test is an assay and will be performed as part of the diagnostic biopsy. The results of the test will determine whether the patient will be eligible for treatment with PBS subsidised zolbetuximab.

Description of Medical Condition

Gastric or gastro-oesophageal junction cancer occurs in the epithelial lining of the stomach and the gastro-oesophageal junction between the stomach and the oesophagus. Tumours in the gastro-oesophageal junction may be classified as either gastro-oesophageal junction cancer or oesophageal cancer, depending on how far from the junction they arise. Cancer is considered HER-2 negative if the cancer cells do not have abnormal levels of HER2 proteins.

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 401 KB)
Application Summary (Word 34 KB)

PICO Set (PDF 1288 KB)
PICO Set (Word 647 KB)

Consultation Survey

Consultation Survey

PASC Consultation
PASC consultation closed 15 March 2024

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 775 KB)
PICO Confirmation (Word 457 KB)

Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

18–19 April 2024

ESC

13-14 February 2025

MSAC

3-4 April 2025