PCN214 - Epidemiology for Oncological Drugs Regarding the Benefit Dossier Preparation in Germany

Abstract

An early benefit assessment of drugs after launch has been implemented since 2011 in Germany. The Institute for Quality and Efficiency in Health Care (IQWiG) assesses the benefit of the drug based on a dossier submitted by the pharmaceutical manufacturer. Based on this assessment and the statements by industry, scientific community and patient organizations the Federal Joint Committee (G-BA) reviews and decides on the extent of the additional benefit. The dossier needs also to contain information about the number of patients treated with the new drug. The objective is to investigate the sources considering the calculation of patient numbers for oncological drugs. A review of oncological drugs which passed through the benefit assessment was conducted to evaluate which data sources and methods were used to calculate the potential patient number. The results were compared with IQWiG’s assessment and the final decision by G-BA, to detect possible methodological difficulties. The data sources regarding German epidemiological data were mainly collected through publicly available sources such as national and local cancer registries. Difficulties occurred with small cancer entities or when specific data regarding patient subpopulations (e.g. through age, tumor stages, ECOG performance status or previous therapies) was needed. The pharmaceutical manufacturer’s calculations were often challenged by IQWiG and G-BA without suggesting a precise alternative or more suited data source. The data collection and data availability within the benefit dossier process for oncological drugs is in most cases challenging and the efforts needed should not be underestimated. Authorities, industry and medical community should work on a common solution for a more valid and reliable calculation of the potential patient number in oncology.