A major challenge facing both HTA authorities and manufacturers is integrating new and innovative treatments into the healthcare system. A new article from Xcenda explores pathways to market for state-of-the-art treatments and advanced therapy medicinal products (ATMPs) in the German context. In this context, exceptions must often be made to standard procedure.
According to Dr. Ulrike Kuchenbecker “Pharmaceutical manufacturers should request guidance from authorities to determine whether their product must go through the AMNOG procedure or not. Furthermore, it is important to consider the possibility that the G-BA may request a collection of additional post-authorization data. In the case that additional data collection is planned by the manufacturer, it may be advisable to ask the G-BA for consultation. For strategic planning, it will be important for manufacturers to understand the outlook for ATMP pricing and reimbursement within Germany, and the negotiation process.”
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