Since AMNOG (Arzneimittelmarktneuordnungsgesetz) was introduced in 2011, pharmaceutical manufacturers are required to submit a benefit dossier for each innovative drug to the Federal Joint Committee (G-BA, Gemeinsamer Bundesausschuss). The benefit assessment results serve as the basis for subsequent price negotiations with the Head Association of the Statutory Health Insurance (GKV-Spitzenverband). Orphan drugs receive an additional benefit by default, but may receive a nonquantifiable one due to limited availability of clinical evidence. Where evidence is preliminary or insufficient, the G-BA may apply a time limit to a product’s resolution, requiring the product to undergo another early benefit assessment after the expiration of the initial assessment.
In this study, we investigate the incidence of time-limited resolutions and the role of the orphan status and therapeutic area. We aim to better understand the reasoning driving time-limited assessment outcomes. Ultimately, we explore the impact of the final, updated benefit rating after the re-assessment on price.
Dr. Annabelle Fowler featured in ERE spotlight series
The feature highlights Dr. Fowler’s path to becoming an expert witness, her approach to solving complex problems, and what she enjoys most about her work....