Evaluating Patients’, Physicians’ And Pharmacists’ Perception Regarding Generic Medicines In Ethiopia: Findings And Implications

Abstract

data" in 2015 public availability of such evidence has been highlighted. However, publication of clinical data is not a new issue and has been practiced before by HTA agencies like G-BA and IQWiG in Germany. The aim of this study is to determine the information provided in both, German dossiers/benefit assessments and the EMA database, comparing reporting quality. Methods: All documents were retrieved from the G-BA homepage and the EMA database until March 15th 2017. The following sources for extraction had to be available: Dossier module 4 and benefit assessment (G-BA), any clinical data available on the EMA database. Extraction included 16 study methods and 8 results items (method used by Koehler et al. BMJ 2015; 350: h796). Reporting quality was rated as "completely reported", "partly reported" or "not reported". Results: Overall only 2 drugs had both available, G-BA dossier/ assessment and EMA clinical data (Elotuzumab and Carfilzomib). For these 2 drugs 15 clinical studies were assessed. Both sources reached high grades of completeness. G-BA dossiers/assessments (2 studies) were 100% completely reported for methods (32 out of 32 items) and 87.5% completely reported for results (14 out of 16 items). For EMA clinical data (13 studies), the rate was 86.1% for methods (179 out of 208 items) and 97.1% for results (101 out of 104 items). ConClusions: Regarding reporting quality, no major differences between G-BA dossiers/assessments and EMA clinical data was observed. Both publicly available sources provide sufficient information on new drugs. Nevertheless, each datasource has advantages and deficits. AMNOG documents are available in German language only and the EMA database currently only contains a very limited number of newly approved drugs.