German Federal Joint Committee (G-BA) Issues Nationwide Reimbursement Decision for EndoPredict® Breast Cancer Prognostic Test

Myriad Genetics announced today that the German Federal Joint Committee (G-BA) has successfully completed the method evaluation assessment for the EndoPredict® breast cancer prognostic test. The positive decision means that EndoPredict can be made available to all patients with statutory health insurance in Germany as a benefit of the statutory health insurance scheme. 

EndoPredict is a second-generation biomarker test used to determine the risk of recurrence in patients with early-stage breast cancer (ER+/HER2-). The genomic test helps patients and physicians jointly decide for, or against, chemotherapy when uncertainties exist in the assessment of the expected benefit of chemotherapy.

"This decision (by G-BA) makes it possible for a biomarker test to be carried out quickly in Germany, providing more certainty with the difficult decisions relating to the pros and cons of chemotherapy," says Univ Prof. Dr. Marion Kiechle, Director of the Gynaecological Clinic of the University Hospital Rechts der Isar of the TU Munich.

Every year, approximately 70,000 women in Germany are diagnosed with early-stage, breast cancer. For up to 20,000 of these patients, clinical-pathological criteria alone are not sufficient to confidently make chemotherapy treatment decisions. The Federal Joint Committee supports the use of biomarkers, now including EndoPredict, to identify those patients who will likely benefit from chemotherapy treatment. 

EndoPredict has been part of the recommendations of the leading national (AGO, S3) and international (St.Gallen, ESMO, ASCO and NCCN) guidelines for many years and is already available to affected women in public health systems in France, England, Italy, Spain, Switzerland and Austria.

Raymond Francot, executive vice president of Myriad International Said: "We are pleased to make EndoPredict broadly available to gynecologists and pathologists in Germany within the framework of the GKV, This decision expands access to critical, life-changing insights for patients and their providers, and adds valuable information to aid in personalized treatment selection.”

About EndoPredict®

EndoPredict is a second-generation, 12-gene molecular prognostic test for patients diagnosed with breast cancer. The test provides vital information that helps clinicians devise personalized treatment plans for their patients. EndoPredict has been validated in more than 4,000 patients with node-negative and node-positive cancer and has been used clinically in more than 30,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety.

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