The BfArM investigates within its research focus “pharmacogenomics and individualized medicine” to what extent genetic predisposition contributes to pharmacoresponse. Because genetics have an influence on how drugs are metabolized by the human body. So-called “ultrarapid metabolizers” metabolize drugs much faster than most people. This increases the risk of certain side effects; there may even be no therapeutic effect at all. In contrast, so-called “poor metabolizers” have a lower enzyme activity than most people. This can also lead to side effects, as high drug levels may arise even at normal doses.
The EMPAR research project, which has been scheduled for a three-year period, will specifically address the question of whether these genetic differences have an impact on the use of statutory health insurance services. It may be that poor-metabolizers demand different statutory health insurance services than ultrarapid-metabolizers because they have different experiences with the tolerability and efficacy of therapies.
To investigate such topics, the DZNE’s working group on “Pharmacoepidemiology” applies multivariate analyses using genetic data relevant for drug therapy and claims data provided by the Techniker Krankenkasse (TK). For the research project, the TK will contact insured individuals aged 60 years and older who take at least one drug, whose metabolization is known to depend on genetic variants. If the patients agree to participate, they provide a buccal swab. Analysis of this sample reveals how they actually metabolize the drug.
“In the future, such analyses can help to use medical services and medication more accurately and individually to match the needs of insured persons,” says DZNE researcher Dr. Britta Hänisch. “Thus, the project contributes to drug safety.”
“The long-term goal is to examine the use of pharmacogenetic testing of metabolic profiles in routine care,” says Prof. Dr. Julia Stingl, Vice-President of the BfArM and project manager. “If drug therapy is more precisely applied to patients, this means an increase in the quality of patient care. At the same time, therapies could also become more economical, for example by applying optimal drug dosage. Furthermore, there could be less adverse drug events.” Adverse drug events are estimated to account for 5 to 10 percent of all hospital admissions. They do not only harm the health of patients but also cause costs in the health care system.
BfArM President Prof. Dr. Karl Broich sees the funding provided by the Innovation Fund as recognition of the institute’s expertise: “The BfArM is making an important contribution through its own independent research in order to further increase both the quality and safety of drugs. The project is an example of how we use our research activities within the framework of our regulatory work in the best possible way in the interest of patients.”
Prof. Dr. Pierluigi Nicotera, Scientific Director and Chairman of the Executive Board of the DZNE, stresses: “Precision medicine can make a significant contribution to improving the treatment of people with dementia and other neurological disorders. We are therefore very pleased to be part of this project. At the same time, the project illustrates the strategic collaboration between DZNE and BfArM.”
Background on the Innovation Fund (Innovationsfonds)
The Innovation Fund was established by the Federal Government. From 2016 to 2019 it will annually grant 300 million euros to eligible projects, including 75 million euros for health care research. The overall objective is to improve services provided by the German statutory health insurance.
The Innovation Committee (Innovationsausschuss) set up at the Federal Joint Committee. It sets the priorities and criteria for funding and decides on applications. Funds for the Innovation Fund are provided by the statutory health insurance and by the Health Fund (Gesundheitsfonds). In 2016, 296 applications for health care research were submitted to the Innovation Committee, of which 62 projects receive funding, including the EMPAR project.
