Applications

1767 – Immunohistochemistry testing for Claudin 18 expression in patients with gastric or gastro-oesophageal junction cancers, to determine eligibility for PBS subsidised zolbetuximab treatment

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Assessment
  • Type New application
  • Pre-PASC consultation Closed
  • Pre-MSAC consultation Open
  • Outcome Pending

Application details

Applicant

Astellas Pharma Australia Pty Ltd

Reason for application

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

Service or technology in this application

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.

Type: Investigative technology

Medical condition this application addresses

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.

Consultation survey and deadlines

The following consultation deadlines apply:

  • Pre-PASC consultation: Closed 15 March 2024
  • Pre-MSAC consultation deadline: Friday 14 February 2025 11:59 pm AEDT

For other ways to provide input, see how to have your say.

We welcome input from everyone. We are especially keen to hear from those with lived experience of the health condition, service or technology the applications are addressing.

Find out more about consultation.

Meetings to consider this application

  • PASC meeting: 18 to 19 April 2024
  • ESC meeting: 13 to 14 February 2025
  • MSAC meeting: 3 - 4 April 2025