Call for breast cancer assay to be reimbursed

Medical experts have called for the Oncotype DX Breast Cancer Assay, developed by US-based company Genomic Health, to be considered for reimbursement in Australia.

Women diagnosed with ER-positive, HER2-negative breast cancer are advised to have the test soon after surgery and before commencing follow-up treatment. Performed on tumour tissue that was removed during the original surgery, the multigene test predicts a patient’s likely benefit from chemotherapy and the overall risk of breast cancer recurrence.

The internationally endorsed test thus helps a patient and her doctor make more informed, personalised treatment decisions about whether or not to proceed with chemotherapy. As explained by Associate Professor Michael Hughes, a leading Australian breast cancer surgeon, “Patients are often placed in the situation where they need to balance the side effects of chemotherapy against any potential benefit.

“Chemotherapy comes at a cost physically, psychologically, socially and financially. Very occasionally, the health side effects can be catastrophic. The usual immediate physical effects of chemotherapy are fatigue, nausea, hair loss, nerve changes and low immunity, leading to infections and hospital admissions. In the long term, chemotherapy can result in infertility and premature menopause, as well as permanent changes in the blood cells. Chemotherapy also means time away from work for the patient and often for their carers as well. There is a significant disruption to family life.”

Oncotype DX provides each patient a Recurrence Score — a number between 0 and 100 based on their own tumour biology — which indicates the risk of their cancer returning and, in turn, the potential benefit of undertaking chemotherapy. Recent studies demonstrate that the assay has changed treatment decisions in approximately 50% of patients.

Women in many countries, including the US, Canada, England, Ireland, Switzerland, Spain, Israel and Greece, can have the test free of charge, as it is reimbursed by governments in these regions. The reimbursement program is said to be a cost-effective one, due in part to the reduced use of chemotherapy.

In Australia, where the assay is not reimbursed, it comes at a cost of $4500. Some doctors are, in fact, reluctant to discuss the technology with patients because of the high cost involved — as a result, fewer than 400 Australian women take the test every year.

Specialised Therapeutics Australia, a biopharmaceutical company which has been distributing the test in Australia since 2014, made a reimbursement submission to the Medical Services Advisory Committee (MSAC) in June 2015. A final decision on whether Oncotype DX will be reimbursed for Australian women will be made at the MSAC meeting in Canberra from 26–27 November.