[Psychotropic drug research in Germany: challenges of early benefit assessment and precision psychiatry].

BACKGROUND

The path to more precise and innovative psychotropic drugs is arduous and lengthy due to the complexity of mental illnesses and high regulatory hurdles. Nevertheless, several drugs have been developed and approved in the USA and the EU in recent years; however, not all of them were able to prevail in the benefit assessment in Germany. In order to exchange ideas about new precision medicine approaches as well as problems in the development and market access of psychotropic drugs and their possible solutions, the German Society of Psychiatry and Psychotherapy, Psychosomatics and Neurology (DGPPN) in cooperation with the House of Pharma & Healthcare hosted the round table on the future of psychotropic drug research in Frankfurt on 24 August 2023. Participants from clinical care, academic research, the pharmaceutical industry and patient representatives came together.

RESEARCH QUESTION: What initiatives are necessary in the field of psychiatry research and regulation in order to successfully develop psychotropic drugs in Germany and to be able to introduce them into care?

MATERIAL AND METHOD: The article represents a synthesis of the lecture and discussion contributions of the 1‑day event.

RESULTS

Current challenges are due to the fact that the biological mechanisms of mental illnesses are complex and heterogeneous and are insufficiently mapped by the current diagnostic entities. The benefit assessment of a preparation by the Federal Joint Committee (G-BA) often fails if an appropriate comparator therapy (zVT) cannot be reasonably selected or tested in a study. Platform studies (APT), which test the efficacy of several preparations at the same time with a control arm, can speed up the approval process and are meaningful. Consultations by the G‑BA in advance should be binding. The integration of empirical expertise can significantly enrich psychotropic drug research.

CONCLUSION

Continuous dialogue between authorities, economy, science, politics and representatives of those affected is needed to promote the development and approval of psychotropic drugs and thus improve the quality of life of patients.