07. 09. 2018 | Back to news overview

German Health Technology Assessment Body (IQWiG) Concludes Only Oncotype DX® has Sufficient Evidence to Guide Breast Cancer Adjuvant Chemotherapy Decisions Based on Landmark TAILORx Study Results

Publication of an updated assessment of breast cancer gene expression profiling tests by the German Institute for Quality and Efficiency in Health Care (IQWiG). In its analysis, IQWiG concluded that, based on results from the TAILORx study, the Oncotype DX Breast Recurrence Score® test can support patients with primary node-negative, hormone-receptor positive, HER2-negative breast cancer in the decision for or against chemotherapy.

IQWiG's technical assessment will inform the Federal Joint Committee (G-BA) official reimbursement procedure. In July 2018, the G-BA publicly stated that a final decision on reimbursement of breast cancer gene expression profiling tests is expected by the end of 2018. "With IQWiG's recognition of the unique value the Oncotype DX test provides, we believe we are one step closer to ensuring reimbursed access to tens of thousands of breast cancer patients diagnosed in Germany each year as is the case in other countries around the world including the U.S., Canada, the UK, France, Spain and Switzerland," said Torsten Hoof, senior vice president international, Genomic Health. "We look forward to G-BA's final reimbursement decision later this year as we continue to see the impact of the landmark TAILORx study results on clinical practice around the world."

IQWiG's conclusion is based on results from TAILORx, the largest randomized adjuvant breast cancer treatment trial ever conducted, which were recently published in The New England Journal of Medicine. This independently-conducted, prospective, Phase III study followed more than 10,000 women with node-negative, hormone-receptor positive, HER2-negative early-stage breast cancer for an average of nine years. Study results demonstrated that the Oncotype DX Breast Recurrence Score test provides definitive long-term evidence about the magnitude of chemotherapy benefit, identifying the vast majority of women with early-stage breas cancer who receive no significant benefit from chemotherapy, as well as the important minority of womern for whom chemotherapy can be life-saving. Thus, the test cant greatly reduce both overtreatment and undertreatment with chemotherapy.