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 ConfirmationConsultation 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)
Public Summary Document-
Meetings for this Application
PASC1 – 2 December 2011
12 – 13 April 2012