New real-world clinical practice study highlights the value of the Oncotype DX® breast cancer test for patients, physicians and the health-care system
- Further demonstrates the test's ability to impact treatment decisions with an overall reduction in chemotherapy use
- Underscores the value of broader access for patients
GENEVA, March 20, 2015 /PRNewswire/ -- Genomic Health today 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 health-care 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."
About Genomic Health
Genomic Health, Inc. is a world-leading provider of genomic-based diagnostic tests that inform treatment decisions and help to ensure each patient receives appropriate treatment for early stage cancer. The company is applying its state-of-the-art scientific and commercial expertise and infrastructure to translate significant amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey; from screening and surveillance, through diagnosis and treatment selection. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com. To learn more about Oncotype DX, visit: www.OncotypeDX.com
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the belief that increasing evidence of the value Oncotype DX is delivering to patients and healthcare systems along with the company's reimbursement success will fuel the company's business in Western Europe, allowing the company to capture a significant opportunity for future revenue growth. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests and expand into new markets domestically and internationally; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; the company's ability to obtain capital when needed and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's annual report on Form 10-K for the year ended December 31, 2014. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
1 Smyth L, Economic Impact of 21-gene Recurrence Score testing on Early Stage Breast Cancer in Ireland. St. Gallen 2015
2 NICE diagnostics guidance [DG10]. Available at: http://www.nice.org.uk/guidance/DG10
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