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Germany to Consider New Study Results to Decide on Reimbursement of Breast Cancer Biomarker Tests

NEW YORK (GenomeWeb) – The German Federal Joint Committee (G-BA), the authority that decides which therapies and medical services are covered under Germany's public health insurance system, said yesterday that it has commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to evaluate additional study results on the use of biomarker-based tests in primary breast cancer.

Specifically, IQWiG will consider results from the TAILORx study, which used Genomic Health's Oncotype DX test and was published in the New England Journal of Medicine last month, and results from a study published in January in the Journal of Clinical Oncology that used NanoString Technologies' Prosigna test. The institute's report is due in August.

The G-BA said that it plans to consider the new results in its final decision, expected in the fourth quarter of this year.

The committee, which represents doctors, hospitals, health insurance funds, and patients, is currently evaluating the benefits and potential harm resulting from the use of biomarker-based tests to help doctors decide whether patients with primary breast cancer should receive adjuvant chemotherapy after surgery.

In late 2016, IQWiG, a government contractor, published its final report, based on then-current medical research, stating that biomarker tests provided neither benefit nor harm. The report considered different types of available biomarker tests, including those relying on immunohistochemistry, gene expression analysis, and ELISA.

Based on feedback it received, the G-BA decided to consider the new study results for its decision on reimbursement.