Training @ Staburo: AMNOG and HTA

How beneficial are new drugs? This question gained more and more importance, after the German authorities introduced the AMNOG law in 2011, to restructure the market and the reimbursement system. Since then, it is obligatory that every new introduced medication runs through the process of an early benefit assessment, where at the end a decision is made, if there is a beneficial need for the new introduced drug. Based on this benefit, the market price of the product is negotiated.

The training was structured in two major parts. In the beginning, the whole process was shown with the major players in the process (like the G-BA and IQWiG) and the process of the early benefit assessment itself. Here, the relevant statistics topics where highlighted. Furthermore, the whole process was presented.

The second part was about the statistics workflow needed for analyses in module 4 of the dossier. Here, the mandatory endpoints, like survival and quality of life, where shown in combination with the analysis to perform to proof the benefit of the new drug. In addition to the analysis of the mandatory and supportive analysis, a short overview of the work package in statistics was presented, beginning with the planning of the confirmatory trial and the tasks during the whole process, until the decision about the benefit is made.

In the end of the presentation, recent decisions of the G-BA and the IQWiG were shown, also to highlight potential problems, which can occur during the process.