Australian Government - Department of Health

Medical Services Advisory Committee (MSAC)

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

Application Number

1175
Application NameIn situ hybridization (ISH) diagnostic testing to determine HER-2 status in patients with advanced or metastatic breast cancer (stage IIIA-IV) to inform eligibility to lapatinib
Description of Medical ServiceThe 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 ConditionIt 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.
ProtocolsPDF version Consultation Decision Analytic Protocol (PDF 473 KB)
Word version Consultation Decision Analytic Protocol (Word 1226 KB)

PDF version Final Decision Analytic Protocol (PDF 1545 KB)
Word version Final Decision Analytic Protocol (Word 887 KB)
Consultation27 January – 10 March 2012
Reports-
MSAC Outcomes-

Meetings for this Application

Meeting Type:Date:
PASC1 – 2 December 2011, 12 – 13 April 2012
ESC N/A
MSAC N/A

Page currency, Latest update: 07 November, 2014