Genomic Health has announced the presentation of 11 studies with the Oncotype DX breast cancer test at the 14th St. Gallen Breast Cancer Conference in Vienna, Austria. Studies presented include results from a real-life observational study in Ireland1 demonstrating significant reductions in chemotherapy and resulting cost savings when the test is used in early stage breast cancer.
"Ireland was the first public healthcare system to reimburse this test in Europe, and the results demonstrate not only the impact of the personalised information Oncotype DX provides on treatment decisions, but also the significant cost savings associated with the use of the test over time," said Dr Janice Walshe, Study Lead, Consultant Medical Oncologist, St Vincent's University Hospital, Dublin, Ireland.
The study included 633 patients and was conducted to analyse both the clinical and budget impact of the test on adjuvant treatment decisions in the first 18 months since reimbursement, using real-world data from all comprehensive cancer centers across Ireland. From the 583 patients with node negative disease who were included in the analysis, the results found that 345 patients (59%) underwent a change in their treatment decision. Based on Oncotype DX Recurrence Score® results, 339 patients who were likely to derive minimal or no benefit from chemotherapy but would have been recommended this form of treatment prior to testing were changed to hormone therapy alone while six patients, who would otherwise not have been recommended chemotherapy in the absence of testing, were advised to receive it following testing. Overall, the study found that use of the Oncotype DX test led to a 58% net reduction in chemotherapy use, and net cost savings of around €800,000 from the perspective of the national public payer.
The Oncotype DX breast cancer test is the only genomic test validated for its ability to predict the likelihood of chemotherapy benefit as well as risk of recurrence in early-stage breast cancer.
Healthcare systems across Europe are recognising the value of the test, which is incorporated in all major international clinical guidelines. Most recently, the National Health Service (NHS) in England agreed to an access program for the Oncotype DX breast cancer test beginning April 1, 2015. The access program allows NHS hospitals to implement the National Institute for Health and Care Excellence's (NICE) guidance2, which recommends only the Oncotype DX breast cancer test for assisting in chemotherapy treatment decisions for patients with certain types of early breast cancer.
In addition to England and Ireland, the Oncotype DX breast cancer test is covered in Switzerland through the mandatory health insurance system for all eligible patients as of January 1, 2015 and is reimbursed by the public insurance system in half of the regions of Spain.
"We are delighted that healthcare systems across Europe are recognising the value of a personalised approach to breast cancer treatment and, specifically, genomic testing with Oncotype DX," said Denis Horgan, Executive Director of the European Alliance for Personalised Medicine - EAPM. "This is encouraging, as decisions based on an individual patient's needs will help to ensure better patient outcomes. We certainly hope to see such tests becoming part of routine clinical practice in Europe."
"Criteria currently used for making treatment decisions in clinical practice are not predictive of benefit from chemotherapy and may result in substantial overtreatment," said Juliette Plun-Favreau, Senior Director Reimbursement and Market Access, Genomic Health. "The Oncotype DX test has consistently been shown to be cost-effective across multiple healthcare systems in various settings, regardless of the country or local cost data. There is evidently a clear need for a personalised approach as part of routine decision-making - not just in Europe but globally, and we look forward to continuing to work with the relevant authorities to make the test available to patients on a wider scale."