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

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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