Trastuzumab (Herceptin®) is a monoclonal antibody treatment option for breast cancer patients costing up to 5-10 times more than state-of-the-art chemotherapy. A significantly improved outcome for defined groups of patients who are HER2/neu-positive was previously shown for advanced/metastatic breast cancer and recently also for adjuvant therapy in several large phase III trials. However, financial limitations of any health system, even in wealthy nations such as Germany, can prevent optimal treatment. The German Social Security Code requires cost-effectiveness of all medical treatment. Financing of off-label pharmaceuticals is strictly limited by law. In contrast to advanced breast cancer for which trastuzumab is licensed, in the adjuvant setting it is restricted to off-label use and could result in a massive financial loss for the health care provider. So, indication and reimbursement for innovative therapies during the interim phase between clinical trials and official approval remain difficult. In this review, the current situation in Germany and the experience with financing and reimbursement of the costs of trastuzumab in the adjuvant and advanced setting as well as the search for financial solutions are described. Dr. med. Volker R. Jacobs, MBA Oberarzt Forschung and Klinikmanagement Frauenklinik der Technischen Universität München Ismaninger Strasse 22, 81675 München, Germany Tel. +49 894140-5425, Fax -4831 E-mail volkerjacobs@hotmail.com Current Status of Financing and Reimbursement of Trastuzumab (Herceptin®) for Adjuvant and Advanced Therapy of Breast Cancer in Germany Volker R. Jacobs Frauenklinik der Technischen Universität München, Germany © 2006 S. Karger GmbH, Freiburg Accessible online at: www.karger.com/brc Fax +49 761 4 52 07 14 E-mail Information@Karger.de www.karger.com Breast Care     «

Trastuzumab (Herceptin®) is a monoclonal antibody treatment option for breast cancer patients costing up to 5-10 times more than state-of-the-art chemotherapy. A significantly improved outcome for defined groups of patients who are HER2/neu-positive was previously shown for advanced/metastatic breast cancer and recently also for adjuvant therapy in several large phase III trials. However, financial limitations of any health system, even in wealthy nations such as Germany, can prevent opt...     »