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

Page last updated: 11 July 2016

Application Detail

Status

Closed

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

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PICO Confirmation

Consultation Decision Analytic Protocol (PDF 473 KB)
Consultation Decision Analytic Protocol (Word 1226 KB)

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

Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

1 – 2 December 2011
12 – 13 April 2012

ESC

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MSAC

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