AMNOG-News: Amendments of the Rules of Procedure - Changes in the Value Dossier
About the author
Prof. Matthias P. Schönermark, M.D., Ph.D.
Founder and Managing Director
Founder and Managing Director
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
Fax: +49 511 64 68 14 18
In addition to editorial, formal and methodological adjustments, supplementary presentations and analyses of data will become mandatory for the pharmaceutical company. In the updated dossier format, adequate analyses must be carried out to address potential divergences occurring between the observation periods of individual study participants / patient groups to assess potential bias. Furthermore, for specific endpoints for which values are determined based on scales, additional analyses are to be made over the entire course of the study, and supplementary evaluations of all collected data cut-offs of each endpoint must be presented.
Two other important changes that come into effect with the adjustments are the provision of individual patient information from the clinical trial reports to the G-BA (still handled confidentially), which previously had not been made available to the G-BA. Also, information about adverse events will no longer be possible to "hide" e.g. in module 5, as all side effects will now be published in the publicly available module 4.
It remains to be seen, which changes may still be made until the decision comes into force and to what extent the new requirements will be implemented in the new dossier format. To cope with the upcoming amendments and their effect on the preparation of the dossier and the further benefit assessment, the SKC Beratungsgesellschaft mbH continues to closely follow the decision-making process and starts to engage with relevant stakeholders at an early stage to resolve any challenge ahead of time.
BY Prof. Matthias P. Schönermark, M.D., Ph.D., managing director and Dr. Alexandra Kuhn
Sources:
G-BA: Verfahrensordnung: Änderung der Anlage I und II zum 5. Kapitel (German only)