The German federal reimbursement agency, the Institut für das Entgeltsystem im Krankenhaus, gave "Value 4" status to the Chemosat procedure. Although the decision does not mandate reimbursement, according to a press release, participating cancer centers can negotiate coverage for the procedure with insurers.
"This is excellent news for both patients in Germany and Delcath, as it represents a significant positive step in our efforts to fully commercialize Chemosat in Europe," president & CEO Eamonn Hobbs said in prepared remarks. "This is the first reimbursement mechanism for our procedure in Germany, the biggest market for Chemosat in the European Union. It is important to note that the application for coverage was supported by 47 cancer centers across the country, which we believe speaks to the medical need physicians in Germany see for Chemosat. We will continue to work closely with the participating hospitals to achieve reimbursement with the insurers. With a direct sales force in place and training of the additional centers in Germany on the way, we are now in a good position to begin growing this market for Chemosat."
The news sent DCTH shares up 8.0% to $1.63 apiece as of about 3:30 p.m. today.
Delcath won expanded CE Mark approval in the European Union for Chemosat last October, followed a month later by regulatory approval from Australia’s Therapeutic Goods Administration and a nod from the FDA. The federal watchdog agency set June 13, 2013, as the date for standard review of Delcath’s recently new drug application for the Chemosat treatment.
The device uses a system of tubes to localize the delivery of toxic chemotherapy agents by isolating the liver from the rest of the body’s bloodstream.