BVMed Conference on Benefit Analysis: Will there Be a Studies Fund for Benefit Analysis?

The Joint Federal Committee (JFC) and the CDU/CSU parliamentary group endorse the establishment of a fund to finance studies to be conducted under the trial regulation of new methods using medical technologies. JFC chairman Dr. Rainer Hess and the CDU member of parliament Dietrich Monstadt expressed their support of the idea at a medtech conference on the benefit analysis of medical devices in Berlin in the end of May. Monstadt mentioned a sum of 36 million Euros (0.02 percent of healthcare spending) now under consideration. This measure aspires to primarily promote the participation of smaller companies in the trial regulations.

JFC chairman Hess said that the code of procedure on the new trial regulation will presumably be decided at the July meeting. BVMed Managing Director and member of the Board Joachim M. Schmitt advocated an appropriate benefit analysis with differentiated procedures for medical devices according to risk class and degree of modification. Monstadt added that the AMNOG methods for drugs were not transferable to medical devices. The two kinds of products are simply too different to be treated alike.

The health economist Prof. Dr. Graf von der Schulenburg believes that the change ushers in a „new era“ for the medtech industry. According to him, this topic will engage companies intensively from now on, and also cost them money. Dr. Dietrich Bühler of the National Associations of SHI limited the range of application for the trial regulation, arguing that it only concerns medtech innovations that represent a new strategy with a new aim of treatment, and not new medical technologies in general. It remains controversial what point in time would be best for conducting a medtech benefit analysis. Von der Schulenburg argued that an analysis could not take place in the beginning due to the „learning curve of the users“.

In opposition to this stance, health insurance fund representative Bühler endorsed conducting the benefit analysis „already before marketing“ since then „reimbursement would work“. Prof. Dr. Moritz Wente from Aesculap and Isabel Henkel from Johnson & Johnson pointed out that medtech companies would need clear options and security before undertaking to pursue innovations. Methodological problems and other open questions would have to be solved first.

With the Law on the Stabilization and Structural Reform of the Statutory Health Insurance in effect since 2012, the legislators have provided the JFC with the possibility of a trial regulation for new examination and treatment methods using medical technologies. The topic of „benefit analysis“ will therefore play a larger role for medtech companies in the future, and should be taken into consideration right from the start.

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