1. Comparing the registration to reimbursement pathway for new active substances in Europe
Germany
Poland
To help provide a better understanding of the European health technology assessment (HTA) environment, a previously developed systematic process mapping methodology has been applied to create process maps for 33 European jurisdictions as part of the CIRS Atlas Project©. These maps adhere to predefined specifications to ensure maximum comparability between the national registration to reimbursement pathways for new active substances (NASs). Each map outlines the order and direction of interactions between the sponsor (red arrows) of a NAS with the required agencies (blue arrows) and how the agencies interact with each other. Seven key functions allow identification of where in the system such functions occur and how they interact. For the HTA function, a task bar was developed in order to characterise a selection of defining elements of the process. The upcoming CIRS Atlas Project© now includes a function to enable the comparison of either two or four selected maps. Using the German and Polish national registration to reimbursement systems this slide demonstrates the usability of this comparison tool. The uniform specification used to create the maps allows the user to quickly deduce key similarities and differences between the two systems. For example, both systems include a single national decision maker rather than multiple regional decision makers such as found in the Italian and Spanish systems. The user can also quickly identify a key difference in the German and Polish HTA processes using the HTA key activities toolbars. The Polish HTA agency (AHTAPol) evaluates both the therapeutic and economic value of a NAS, whereas, the German HTA agency (IQWIG) focuses on the medical benefits of a NAS.