VerSi-MS-PV

Making medical care secure – Feasibility study on the suitability of different data sources as a basis for improving the pharmacovigilance of innovative therapies using multiple sclerosis as an example

There's currently no cure for multiple sclerosis, but it can be treated well. For the treatment of MS, numerous new drugs have been approved in the last 10 years, further drugs will follow in the coming years. With the exception of results from clinical studies, there is often no or little experience in the use of new therapies - especially with regard to adverse effects.

The VerSI-MS-PV project investigates how the adverse effects of these new treatment options can be better captured in MS patients. As is the case with other diseases, a reporting system has been established for so-called spontaneous reports of side effects by prescribing physicians. But there is no systematic obligation to record adverse effects. The project therefore analyses various data sources from outpatient care of MS patients in established practices and treatment centres. This includes register data in which the course of disease and treatment successes are documented and the usual accounting data of the insured - in this case the BKK insured. Among other things, the analysis provides information on when and why the therapy was changed and how often adverse effects occur.  New diseases and hospitalizations are also considered.

In case of success, it will be possible to gain insights into how the spontaneous reporting system for drug safety can be supplemented by standard care data in disease areas with rapidly changing treatment options. This could be used to derive corresponding information for the legislator.

In addition to the MSFP, the project consortium also includes the BKK Dachverband e.V., thePaul-Ehrlich-Institut and the Zentralinstitut für die kassenärztliche Versorgung in Deutschland. The consortium is led by the Medical Faculty of the Medizinische Fakultät der Westfälischen Wilhelms-Universität Münster (Prof. Dr. Klaus Berger).

Roles

The MSFP, together with the participating centres, is responsible for the recruitment of patients for primary data collection in the project and is also responsible for merging data from the BKKs and the MS registry.

 

Duration

The project duration is scheduled for 36 month.

The project started in June 2019.

Funding

This study is supported by the Innovationsausschuss des Gemeinsamen Bundesausschusses.