Can Routine Data be used to Determine the Target Population of Patients with Type 2 Diabetes in Early Benefit Assessments in Germany?

Since 2011, early benefit assessment of all new drugs launched in Germany is mandatory. The exact determination of the appropriate target population (i. e. patients eligible for a drug) plays an important role for subsequent price negotiations. In type 2 diabetes, the size of the target population varies considerably between company dossiers submitted for assessment. Our aim was to explore whether routine data from all persons insured in German statutory health insurance (SHI) funds can be used to derive information on the size of the target population with type 2 diabetes.We explored how the data available at the German Institute of Medical Documentation and Information (DIMDI) can be used to obtain the information required. A data-based concept was chosen and the selection criteria were developed in a multidisciplinary project group. Before finalizing the database query, the criteria were evaluated in a test database and the database query was then repeatedly modified.At the time of the design of our analysis in 2017, the most recent data available at DIMDI were for 2013. The algorithm we developed for identifying patients with type 2 diabetes and classifying them according to their medication, based primarily on the combination of ICD and ATC codes, enabled us to determine the size of target populations for different indications in diabetes mellitus type 2.Our methodological approach seems to be suitable to determine target populations in type 2 diabetes.