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."