- 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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