German Reimbursement For Delcath’s Chemosat Liver Cancer Drug Delivery System

In short

Delcath Systems, Inc. has announced that the Institut für das Entgeltsystem im Krankenhaus (InEk), the German federal reimbursement agency, has established a reimbursement pathway for the treatment of patients with liver metastases with the Delcath Hepatic CHEMOSAT® Delivery System for melphalan hydrochloride.

Background

Oncology specialist Delcath’s proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents.

In 2010, Delcath announced that its randomised Phase 3 clinical trial for patients with metastatic melanoma in the liver had successfully achieved the study’s primary endpoint of extended hepatic progression-free survival. The Company also completed a multi-arm Phase 2 trial to treat other liver cancers.

The decision by the InEK followed an endorsement by the German Radiology Association, which prompted 47 cancer centres throughout Germany to submit applications under the Neue Untersuchungs- und Behandlungsmethoden (NUB) scheme for new technology reimbursement at specific hospitals. The Value 4 status given to the CHEMOSAT procedure, while not mandating reimbursement, allows participating cancer centers to negotiate reimbursement coverage for the CHEMOSAT procedure with all insurers serving their region. Under the NUB scheme, reimbursement pathways will potentially be available for treatment with CHEMOSAT regardless of primary cancer origin.

Company comments

Eamonn P. Hobbs, President & CEO of Delcath said, “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. 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.”

Regulatory status

Delcath obtained authorisation to affix a CE Mark for the Generation Two CHEMOSAT® delivery system for melphalan hydrochloride in April 2012. The device is not approved for sale in the United States.

Source: Delcath Systems