Multiple sclerosis (MS) is a prevalent chronic inflammatory disease of the central nervous system, affecting over 250,000 people in Germany. This condition often leads to severe physical impairments, including muscle weakness and vision problems. The Innovation Committee at the Federal Joint Committee has funded various projects to address MS, including one focused on health services research. This particular project has shown that routine data can significantly enhance the understanding of side effects associated with MS drug therapies.
The Health Data Use Act has been instrumental in facilitating access to and processing of health data, making it easier for researchers to gather and analyze information. As part of this initiative, the project’s results will be forwarded to the Federal Institute for Drugs and Medical Devices (BfArM). The aim is to determine if these findings can be utilized by BfArM’s new central data access and coordination office. Within the next 12 months, BfArM is expected to provide feedback on the feasibility and potential implementation of these results.
VerSI-MS-PV: Making Care Safe
The VerSI-MS-PV project, supported by the Innovation Committee, investigates the feasibility of using various data sources to improve pharmacovigilance for innovative MS therapies. Given that MS progresses in phases and varies greatly among individuals, monitoring drug side effects becomes crucial. The disease’s complex nature means that patients often experience different degrees of physical impairments, making comprehensive drug safety data essential.
In recent years, numerous new drugs have been approved for MS treatment, expanding the range of therapeutic options. Although these drugs are approved based on their tolerability, effectiveness, and safety, some rare side effects only become apparent during routine clinical use. Reporting these side effects to the Paul Ehrlich Institute’s (PEI) spontaneous reporting system is not mandatory, highlighting the need for additional data sources from both outpatient and inpatient care settings.
Project Outcomes and Future Implications
To address this gap, the VerSI-MS-PV project analyzed billing data from 44 company health insurance funds, 12 statutory health insurance physician associations, two MS patient registers, and the PEI’s spontaneous reporting system. The findings revealed that data from standard care could effectively supplement the PEI’s spontaneous reporting system, thereby improving drug safety. The project established a documentation platform within the MS register, which will continue to collect and evaluate pharmacovigilance data, ensuring ongoing monitoring and communication of side effects through designated channels.
The project’s outcomes will be communicated to the Innovation Committee, and the MS register platform will persist beyond the project’s conclusion. The results highlight the potential of integrating health data to enhance drug safety, providing deeper insights into therapy changes and side effects in MS treatment. This approach could serve as a model for other chronic conditions, demonstrating the value of comprehensive data analysis in improving patient care and safety.
Resource: Gemeinsamer Bundesausschuss, July 12, 2024
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