1175 – Testing for HER-2 status in Advanced or Metastatic Breast Cancer (stage IIIA-IV) to Access lapatinib

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 Complete
  • Type New application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome -

Application details

Reason for application

New MBS item.

Service or technology in this application

The provision of ISH diagnostic test required to detect amplification of HER-2, a gene associated higher aggressiveness and poorer prognosis in breast cancer. A core or surgical biopsy of the tumor tissue is analysed for evidence of HER-2 over expression or positivity. Three types of ISH testing are used in Australia, these include: 1) fluorescent ISH; 2) chromogenic ISH; and 3) silver ISH.

Type: Co-dependent technology

Medical condition this application addresses

It is proposed that ISH diagnostic testing be made available to determine the HER-2 status of patients with advanced or metastatic breast cancer (stage IIIA-IV). The ISH diagnostic test will be used to identify patients that are likely to benefit from lapatinib treatment.

Application documents

PICO confirmation

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Meetings to consider this application

  • PASC meeting: 
    • 1 – 2 December 2011
    • 12 – 13 April 2012
  • ESC meeting: -
  • MSAC meeting: -