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

Page last updated: 11 October 2016

Application Detail



Description of Medical Service

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.

Description of Medical Condition

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.

Reason for Application

New MBS item

Medical Service Type

Co-dependent technology

Previous Application Number

Not Applicable

Associated Documentation

Application Form


PICO Confirmation

Final Decision Analytic Protocol (PDF 1545 KB)
Final Decision Analytic Protocol (Word 887 KB)

Assessment Report


Public Summary Document


Meetings for this Application


1 – 2 December 2011
12 – 13 April 2012