Reimbursement for biomarker tests in breast cancer expanded in Germany

On July 17, 2025, the Federal Joint Committee (G-BA) decided that the use of the Oncotype DX Breast Recurrence Score® test as the sole test for deciding for or against adjuvant systemic chemotherapy will be reimbursed only for patients with primary hormone receptor-positive, HER2-negative breast cancer involving one to three lymph nodes. Previously, reimbursement was limited to patients without lymph node involvement.

For other tests like EndoPredict, MammaPrint, and Prosigna, sufficient evidence is currently limited to postmenopausal patients without lymph node involvement.

The decision further specifies that all the tests listed above may be used exclusively in postmenopausal or premenopausal patients if ovarian suppression, such as drug-induced suppression of ovarian function, has been planned or already initiated. The tests will not be reimbursed for all other patient groups.

The Federal Ministry of Health will review the decision within two months. If no objections are raised, it will become effective upon publication in the Federal Gazette. Following this, the Evaluation Committee will determine within six months whether and how the EBM catalog should be updated accordingly.

The full details in German can be found here and here.

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