IQWiG: Oncotype DX assay effective for breast cancer.- Genomic Health.

Genomic Health announced the publication of an updated assessment of breast cancer gene expression profiling tests with the Oncotype DX Breast Cancer assay by the German Institute for Quality and Efficiency in Health Care (IQWiG). In their 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. IQWiG's conclusion is based on results from TAILORx, the largest randomized adjuvant breast cancer treatment trial ever conducted that were recently published in The New England Journal of Medicine.

This prospective, phase III study followed more than 10,000 women with node-negative, hormone-receptor positive (HR+), HER2-negative early breast cancer for an average of nine years. Study results demonstrate 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 breast cancer who receive no significant benefit from chemotherapy, as well as the important minority of women for whom chemotherapy can be life-saving. Thus, the test can greatly reduce both over- and undertreatment with chemotherapy.