Federal joint committee accepts application and confirms potential benefit
Terumo Europe announced today that the Federal Joint Committee of Germany (G-BA) accepted the company's application according to chapter 137e of the federal social codebook number 5 (§137e SGB V). The G-BA confirmed the potential benefit of Selective Internal Radiation Therapy (SIRT, also known as Radioembolization, RE or Transarterial radioembolization, TARE) in patients with unresectable Hepatocellular Carcinoma (HCC) for the purpose of tumor downstaging and bridging to liver transplantation.
"This marks the first time a medical device manufacturer requested and received a confirmation of potential benefit for SIRT in Germany. It is an important milestone towards a secure reimbursement of this treatment option based on the 137e evidence generation process" said Nathalie Verin, Director of Market Access at Terumo Europe. She further added, "Terumo's application underlines the company's firm belief in its Holmium Platform (consisting of three integrated products: QuiremSpheres™ Holmium-166 microspheres, QuiremScout™ Holmium-166 microspheres and Q-Suite™ Imaging software), the latest generation of radioactive microspheres for SIRT."
Laurent Domas, Vice President of Global Interventional Oncology Strategy & Therapy Development, Terumo Europe said, "Terumo is committed to developing clinical evidence that supports the use of its therapeutic solutions for patients with cancer. We expect that the clinical development plan of the Holmium Platform will support identifying those patient populations that will most benefit from our Holmium SIRT treatment platform. We are confident this will further strengthen our unique offering of individualized dosimetry treatment as well as post-treatment follow-up."
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for 100 years. Based in Tokyo and operating globally, Terumo employs more than 25,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.
Terumo Europe N.V. is a core player in the EMEA healthcare market by providing best in class quality medical products and services. We are a strong actor of the Terumo Group by contributing to innovation and sustainable growth. Terumo Europe produces, distributes, markets, and sells a vast range of medical devices in five main business units: Interventional Systems, Pharmaceutical Solutions, Medical Products, Cardiovascular Products and Diabetes Management. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium), production facility in Knowsley (UK), European Distribution Center in Genk (Belgium) and sales offices across EMEA. www.terumo-europe.com
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