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.
Reason for ApplicationNew MBS item
Medical Service TypeCo-dependent technology
Previous Application NumberNot Applicable
PICO ConfirmationFinal Decision Analytic Protocol (PDF 1545 KB)
Final Decision Analytic Protocol (Word 887 KB)
Public Summary Document-
Meetings for this Application
PASC1 – 2 December 2011
12 – 13 April 2012