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.
How COVID-19 could revolutionize the UK pharmaceutical procurement landscape: A DOAC procurement case study
Direct oral anticoagulants (DOACs) are widely used pharmaceutical products which represent a significant cost to the healthcare system. In 2021, National...