AMNOG: Auswirkungen eines geringen und nicht quantifizierbaren Zusatznutzens auf die Preisverhandlung
Originale
Key Words AMNOG | Nutzenbewertung | geringer Zusatznutzen | nicht quantifizierbarer Zusatznutzen | Preisverhandlung
Abstract
AMNOG: Impact of marginal additional benefit and not quantifiable additional benefit on the price negotiation process
In the frame of early benefit assessment, both the existence and the levels of the additional benefit are assessed by the Federal Joint Committee. The aim of this project is to analyse the impact of a marginal additional benefit and a not quantifiable additional benefit on the price negotiation process. Drugs with price negotiations completed until 10/2016 and assessed as providing a marginal and not quantifiable additional benefit throughout all indications and subpopulations were included. Orphan Drugs (OD) and Non-Orphan Drugs (NOD) within the same category were analysed separately. The outcome was the mean discount after negotiation. Additionally, the potential influence factors “size of the population”, “certainty of results” and “indication area (oncological/non-oncological)” were taken into account. A descriptive analysis of NOD was conducted, whereas for OD, multiple linear regressions were performed. 30 drug assessments were included. The mean values of the discounts of OD/NOD with marginal and not quantifiable additional benefit were comparable. Both, the indication area (OD/NOD) and the size of the population (OD), had no impact on the price negotiation process. However, NOD with marginal additional benefit showed a trend for a higher discount with bigger population size and lower certainty of results.
Korrespondenz:
Prof. Dr. Eva Susanne Dietrich, An der Immenburg 4, 53121 Bonn, Germany; e-mail: pharmacoeconomics@web.de
Zusammenfassung
Im Rahmen der frühen Nutzenbewertung beschließt der Gemeinsame Bundesausschuss nicht nur über das Vorliegen, sondern auch über das Ausmaß des Zusatznutzens. Ziel dieses Projekts war es, den Einfluss der Ausmaßkategorien „gering“ vs. „nicht quantifizierbar“ auf das Ergebnis der Preisverhandlung zu untersuchen. Dafür wurden Arzneimittel mit einer bis
