Php190 - The Perception of Professionals of How People With Disability Are Perceived by the Public

Abstract

this analysis is the systematic collection of indication fields in German prescribing information over time and the linkage with existing evidence for approval. Questions to be answered include how indication fields develop over time, whether there are specifications or generalizations and if these are adequately covered by approval evidence, i.e. submitted trials? METHODS: The German "Rote Liste" and "Fachinfo" (https://online.rote-Liste.de and https://fachinfo.de) were searched from 19-FEB to 9-MAR 2018 for current prescribing information. The search was limited to the following diseases: Acute coronary syndrome, COPD, diabetes, epilepsy, multiple sclerosis, hepatitis, HIV, melanoma, lung/prostate/breast cancer. Indication fields and years of approval were extracted. Indication fields were compared for drugs within one indication. If changes in indication fields were detected, it was checked whether approval evidence supported these developments (taken from EMA European Public Assessment Reports). RESULTS: A total of 356 indication fields were evaluated. Comparable generalizations were present for various diseases. However, a large number of diseases showed differences, mainly triggered by varying severity of disease or formulations. As to approval evidence, especially diabetes mellitus type-2 drugs were approved for indications not completely supported by submitted trials. The poster will present further data on other indications and reasoning. CONCLUSIONS: Indication fields develop over time and are partially not completely supported by underlying approval evidence. Between-drug-comparability within one indication could also be enhanced. Missing evidence and between-drug-differences pose a challenge for drug pricing processes, not only in Germany.