A $5000 test that can indicate whether a breast-cancer patient needs chemotherapy has been rejected for a government subsidy even though it could potentially save thousands of women from having to undergo the harrowing cancer treatment.
The Federal Government’s Medical Services Advisory Committee said there was not enough evidence to support a Medicare rebate for the test.
But breast cancer support groups are furious with the decision.
And US breast cancer expert Dr Eric Winer, from the Dana-Farber Cancer Institute in Boston, said he was “shocked” by the MSAC decision.
In the US, all insurers paid for the genetic test for women with HER2-positive breast cancer when the cancer had not spread to the patients’ lymph nodes, he said
“I think it’s a mistake,” he said. “To put it simply for a sizeable group of patients the decision tools you have will continue to be from the year 2000, instead of taking advantage of new tools for treatment decision.”
The Oncotype DX test analyses 21 genes from a breast tumour and can help predict the risk that a woman’s breast cancer may recur, and the likely benefit chemotherapy may have in reducing that risk.
Specialised Therapeutics performs the test in a single laboratory in the US and it has not been approved for use by regulatory authorities such as the US Food and Drug Administration nor by the Australian Therapeutic Goods Administration.
A clinical trial of 10,273 women with breast cancer found nine years after diagnosis the rate of disease-free survival was similar for women with a mid range score in the gene test. Disease-free survival for those who received hormone therapy only was 83 per cent compared with women who received both hormone therapy and chemotherapy (84.3 per cent).
Specialised Therapeutics Australia Pty Ltd had applied for public funding of the Oncotype DX test in Australia but MSAC rejected the application on Thursday night.
A spokeswoman for Breast Cancer Network Australia said they were disappointed the test had been rejected. “We urge the companies supplying these tumour profiling tests to get together with the Government to find a way forward,” BCNA chief executive Kirsten Pilatti said.