The reimbursement of the Oncotype DX® test will change in Germany

On September 15, 2021, the Evaluation Committee (Bewertungsausschuss) has decided to introduce in the EBM (German Uniform Evaluation Standard) the new code for Oncotype DX® testing, 19506 “Biomarker-based test using the Oncotype DX Breast Recurrence Score® procedure…” with a tariff of €2,640. This change is introduced in the updated EBM version, which was published on October 1, 2021.

Previously, the biomarker-based tests, covered by the EBM, were performed only in the USA; now, the procedure is also established in Germany. Therefore, the EBM codes 19501 “Processing of a tissue sample for carrying out a biomarker-based test in the case of primary hormone receptor-positive, HER2/neu-negative, node-negative and non-metastatic breast cancer…” and 19502 “Biomarker-based test using the Oncotype DX Breast Recurrence Score® procedure…”, which were intended to cover the costs for conducting the test in the USA, will be deleted in the updated EBM version, which is expected to be published on January 1, 2022. To enable a smooth transition period, the code 19506 was included in the EBM on October 1, 2021.

The "Oncotype DX Breast Recurrence Score" test is a biomarker-based test to determine the risk of recurrence of a specific form of early breast cancer. The use of this test is intended to support the decision for or against adjuvant systemic chemotherapy. The test can only be used in patients with a primary hormone receptor-positive, HER2-negative, nodal-negative, and non-metastatic breast cancer, provided that the recommendation for or against adjuvant systemic chemotherapy for primary breast cancer alone cannot be made based on clinical and pathological criteria.

The Federal Joint Committee (G-BA) has decided that Oncotype DX, the first biomarker-based test, will be provided as a statutory health insurance (SHI) benefit in June 2019. In October 2020, the G-BA decided that three more biomarker-based tests in breast cancer (EndoPredict®, MammaPrint®, and Prosigna®) will be covered by the statutory health insurance as well.

The full details in German can be found here.

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