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TiGenix NV (NYSE EURONEXT: TIG) provides an update on the launch of ChondroCelect and the status of reimbursement applications.
TiGenix has begun the commercial launch of its lead product, ChondroCelect, for the treatment of cartilage damage in the knee, in the initial target markets which include Germany, Belgium, United Kingdom and the Netherlands. The first commercial patients have been treated and initial revenues have been generated. Reimbursement dossiers have also been submitted in the target markets and negotiations on pricing and reimbursement with local health insurance authorities and payers are ongoing and are progressing as planned, with feedback expected in the second half of this year.
The first “pre-reimbursement” commercial ChondroCelect patients have been treated under a variety of payment and reimbursement mechanisms, ranging from self-pay, private insurance, workers compensation, payment from hospital or primary care trust budgets in the UK and reimbursement by one of the German health insurance funds.
In Germany, ChondroCelect has been awarded “innovative new treatment method” status (“Neue Untersuchungs und Behandlungsmethode” or “NUB”) by the German Institute for the Hospital Remuneration System (InEK Gmbh). The NUB status has been approved in thirty hospitals in Germany and gives these hospitals the right to negotiate reimbursement of ChondroCelect with their health insurance funds. Most of these negotiations are expected to take place in the second and third quarter of this year.
To support to launch and sales of ChondroCelect, TiGenix is reinforcing its commercial team in Germany, the Netherlands, Scandinavia, Spain and France. This specialised sales team will support the launch of ChondroCelect in about 80 targeted reference centres across Europe. TiGenix expects a gradual treatment uptake in the second half of the year as reimbursement decisions are confirmed in the target markets.
“With ChondroCelect being the first cell-based therapeutic product registered by EMEA, we are entering a new era in regenerative medicine. As of now, we are able to offer our patients this truly validated, regenerative solution for their cartilage. As a surgeon, I see it as a privilege to be a pioneer in bringing this new technology into the general surgical practice of our center,” comments Dr. Philipp Niemeyer, Department of Orthopedic Surgery and Traumatology, Freiburg University Hospital, the first surgeon to administer ChondroCelect after the approval.
Gil Beyen, Chief Executive Officer of TiGenix adds: “The first steps of commercial launch of ChondroCelect in these markets are important milestones for TiGenix. Pricing and reimbursement discussions are progressing as planned and we are pleased to already have established sales in our first target markets. After 10 years of development it is good to see that ChondroCelect is becoming available to orthopedic surgeons and their patients.”
Source: Tigenix
Tags: new products
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