21. 08. 2019 | Back to news overview
Reimbursement Decision Follows IQWiG's Recommendation Based on TAILORx Study Results
German Federal Joint Committee (G-BA) issued a positive
reimbursement decision for the Oncotype DX Breast Recurrence Score® test during
its plenary meeting session on June 20. According to the decision, Oncotype DX®
will be the only multigene test reimbursed by statutory sick funds with wide
national coverage, for use in all patients with primary node-negative, hormone
receptor-positive, HER2-negative early-stage breast cancer when a decision for
or against chemotherapy cannot be made based on clinical and pathological
parameters alone. The G-BA decision will become effective following its
publication by the Ministry of Health in the Federal Gazette (Bundesanzeiger).
This decision follows the conclusion of the German Institute
for Quality and Efficiency in Health Care (IQWiG) that only the Oncotype DX
test has sufficient evidence to guide breast cancer adjuvant chemotherapy
decisions based on results from the landmark TAILORx study1. Results from a
recently published2 subset analysis of TAILORx confirm the original findings
from the trial, showing that only the Breast Recurrence Score® test can assess
the expected benefit of chemotherapy and that clinical and pathological
features generally only provide prognostic information.
"Breast cancer is the most commonly diagnosed cancer among
women in Germany. Patients should only receive chemotherapy with all its side
effects if they are going to get a substantial benefit," said Renate
Haidinger, President of the German Breast Cancer Association. "A gene
expression test, such as Oncotype DX, can play a critical role in making this
decision and we look forward to educating patients in Germany about its value
and availability through reimbursed access."
"The decision of the G-BA is an important step forward
to personalized care for German breast cancer patients," said Prof. Ulrike
Nitz, head of the breast cancer unit at Bethesda Hospital, Moenchengladbach,
Germany. "Oncotype DX provides best available information about an
individual patient's response to chemotherapy. It allows us to target treatment
much more effectively and should be routinely used for all eligible
patients."
Healthcare systems across Europe are recognizing the value
of the test, which is incorporated in all major international clinical
guidelines, including St. Gallen, ESMO and NICE in Europe, and ASCO and NCCN in
the U.S. In addition to Germany, the Oncotype DX Breast Recurrence Score test
is currently reimbursed by public healthcare systems in seven other European
countries, including the United Kingdom, Ireland, Spain and Switzerland. Nearly
one million patients around the world have used the test to inform their
treatment decision.
"We welcome the G-BA decision, which represents the
culmination of several years of work and dedication to our mission of improving
the quality of treatment decisions for cancer patients worldwide," said
Torsten Hoof, senior vice president, international, Genomic Health. "We
look forward to working with sick funds in Germany to facilitate quick and
equitable access throughout the country and to continuing to work with the
relevant authorities to make Oncotype DX available to patients on a wider scale
in Western Europe and around the world."