MSAC Public Summary Document Application No. 1342.1 - Gene expression profiling of 21 genes in breast cancer to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit Sponsor/Applicant/s: Genomic Health Inc Date of MSAC consideration: MSAC 61st Meeting, 3-4 April 2014 Purpose of application The original application was submitted in November 2012 by Genomic Health Inc. and requested the Medicare Benefits Schedule (MBS) listing for a 21-gene expression profiling test (Oncotype DX®) in a subset of early breast cancer patients with node negative or up to 3 positive nodes oestrogen receptor-positive (ER+) or progesterone receptor-positive (PR+) and human epidermal growth factor receptor 2-negative (HER2-) disease. Background The application has been previously considered by MSAC in November 2013, which advised the Minister that MSAC did not support public funding. consideration, a re-application addressing concerns was Following MSAC’s MSAC’s submitted by the applicant in February 2014. Prerequisites to implementation of any funding advice The proposed 21-gene expression profiling test is not subject to regulation by the Australian Therapeutic Goods Administration (TGA) as it is conducted in a single laboratory located in California in the United States of America (USA). It is registered only in the USA. The California-based Genomic Health laboratory is certified to perform the proposed 21-gene expression profiling test by the United for Medicare and Medical Service States’ Centers (CMS), is accredited by the College of American Pathologists (CAP) under the USA Clinical Laboratory Improvement Amendment (CLIA) of 1988, and operates in accordance with USA federal and state laws. Proposal for public funding The original application proposed the following MBS item descriptor. Proposed MBS item descriptor MBS [item number] Pathology Group P7 Genetics
MSAC Public Summary Document Application No. 1342.1 - Gene expression profiling of 21 genes in breast cancer to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit Sponsor/Applicant/s: Genomic Health Inc Date of MSAC consideration: MSAC 61st Meeting, 3-4 April 2014 Purpose of application The original application was submitted in November 2012 by Genomic Health Inc. and requested the Medicare Benefits Schedule (MBS) listing for a 21-gene expression profiling test (Oncotype DX®) in a subset of early breast cancer patients with node negative or up to 3 positive nodes oestrogen receptor-positive (ER+) or progesterone receptor-positive (PR+) and human epidermal growth factor receptor 2-negative (HER2-) disease. Background The application has been previously considered by MSAC in November 2013, which advised the Minister that MSAC did not support public funding. Following MSAC’s consideration, a re-application addressing MSAC’s concerns was submitted by the applicant in February 2014. Prerequisites to implementation of any funding advice The proposed 21-gene expression profiling test is not subject to regulation by the Australian Therapeutic Goods Administration (TGA) as it is conducted in a single laboratory located in California in the United States of America (USA). It is registered only in the USA. The California-based Genomic Health laboratory is certified to perform the proposed 21-gene expression profiling test by the United States’ Centers for Medicare and Medical Service (CMS), is accredited by the College of American Pathologists (CAP) under the USA Clinical Laboratory Improvement Amendment (CLIA) of 1988, and operates in accordance with USA federal and state laws. Proposal for public funding The original application proposed the following MBS item descriptor. Proposed MBS item descriptor MBS [item number] Pathology Group P7 Genetics
1342.1-PSD%20-%20OncotypeDX%20(D14-1189577).DOCX