In late June 2019, the Federal Joint Committee (G-BA) took its first decision on the use of biomarker-based tests. Patients with breast cancer in the early stages, in which the risk of relapse cannot be determined with certainty, in the future can be provided with a biomarker test as a statutory health insurance (SHI) benefit. The results should support the joint decision-making of patients and doctors in cases of uncertainty regarding the expected individual benefit of chemotherapy. For medical education, before the test is carried out, the G-BA requires the obligatory use of patient information, which is provided on the website of the G-BA.
Every year, around 70,000 women in Germany are diagnosed with early breast cancer. Roughly estimated in about 20,000 of these patients, the treating physicians cannot give a clear therapy recommendation for or against adjuvant chemotherapy based on the clinico-pathological criteria.
The application for the evaluation of biomarker-based tests for the decision for or against adjuvant systemic chemotherapy in primary breast cancer was submitted by the GKV-Spitzenverband in October 2013. The G-BA accepted the application and decided to initiate a consultation procedure.
After commissioning by the G-BA, IQWiG researched and evaluated the current state of medical knowledge on biomarker-based breast cancer tests. In its final report of December 2016, IQWiG concluded that there was no evidence at this time for benefit or harm of a biomarker-based strategy for the decision for or against adjuvant chemotherapy in primary breast cancer. Reference has been made to ongoing studies, including MINDACT and TAILORx. In 2018, the results of the sizeable TAILORx study were published. On behalf of the G-BA, the IQWiG presented the evaluation of new study results in an addendum to the final report in September 2018.
The G-BA decision involves the use of a biomarker test in patients with a tumor sensitive to estrogen and progesterone and no proven growth receptors. Biomarker tests investigate whether the activity of specific genes in the cancer cells - and thus the risk of relapse of the tumor - is particularly high. The biomarker tests available on the market are based on different analysis methods, for example, immunohistochemistry, gene expression analysis, or an enzyme-linked immunosorbent assay (ELISA). The decision taken by the G-BA includes the application of the specific procedure of the Oncotype DX Breast Recurrence Score® test, based on gene expression analysis. The use of the test at the expense of the SHI presupposes that the recommendation for or against chemotherapy cannot be clearly made based on clinico-pathological criteria. The G-BA will continue to discuss further procedures and areas of application in primary breast cancer.
The resolution will be submitted to the Federal Ministry of Health for review and will come into force after non-objection and publication in the Federal Gazette. The use of a biomarker-based test may be provided as a contract medical service after the Evaluation Committee decision on the level of medical compensation in the Uniform Rating Scale (EBM).
The full details in German can be found here.
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