NEW YORK (GenomeWeb) – Genomic Health said today that the German Federal Joint Committee (G-BA) has issued a positive reimbursement decision for its Oncotype DX Breast Recurrence Score test following a conclusion by the German Institute for Quality and Efficiency in Health Care (IQWiG) that there is sufficient evidence supporting the ability of the test to guide breast cancer adjuvant chemotherapy decisions.
Genomic Health has said that the IQWiG assessment was based on results from the TAILORx trial published last summer in the New England Journal of Medicine and simultaneously presented at the meeting of the American Society of Clinical Oncology.
G-BA made its resulting decision — which will become final following publication by the Ministry of Health in Germany's Federal Gazette — during a plenary meeting session today. Under the determination, Oncotype DX becomes the only multigene test reimbursed in Germany "by statutory sick funds with wide national coverage, for use in all patients with primary node-negative, hormone receptor-positive, HER2-negative early-stage breast cancer when a decision for or against chemotherapy cannot be made based on clinical and pathological parameters alone."
Torsten Hoof, international senior vice president at Genomic Health, said in a statement that the decision represents a culmination of several years of work on the company's part.
"We look forward to working with sick funds in Germany to facilitate quick and equitable access [as we continue] to work with the relevant authorities to make Oncotype DX available to patients on a wider scale in Western Europe and around the world," he added.
In expectation of the finalization and decision by G-BA, investment firm Piper Jaffray earlier today upgraded its rating on Genomic Health's stock to overweight, maintaining a price target for shares of $72.