Early benefit assessment in Germany under the legislative framework of AMNOG (Arzneimittelmarktneuordnungsgesetz) requires direct comparisons of the new drug with appropriate comparators determined by the Federal Joint Committee (G-BA). In case no head-to-head studies are available for direct...

The German AMNOG healthcare reform includes a mandatory early-benefit-assessment (EBA) at launch. As per German social code, EBA is based on registration trials and includes evaluation of the patient-relevant effect of the new medicines compared to an appropriate comparator as defined by the...

Die Umfrage unter einzelnen gesetzlichen Krankenkassen in Deutschland hatte zwei wesentliche Ziele: Zum einen sollten rückblickend die Prozesse, Wirkmechanismen und Ergebnisse des AMNOG betrachtet werden, um zu erheben, wie dies aus der Perspektive einzelner gesetzlicher Krankenkassen...

Background: The purpose of this study was to analyse the impact of commissioned addenda by the Federal Joint Committee (FJC) to the HTA body (IQWiG) and their agreement with FJC decisions and to identify potential additional decisive factors of FJC. Methods: All available relevant documents up...

Introduction In Germany, all new, innovative medicines are subject to an early benefit assessment by the German Federal Joint Committee with subsequent price negotiation and optional arbitration. The purpose of this study was to identify drivers of negotiated (including arbitrated) prices of...

Early benefit assessment in Germany under the legislative framework of AMNOG (Arzneimittelmarktneuordnungsgesetz) requires direct comparisons of the new drug with appropriate comparators determined by the Federal Joint Committee (G-BA). In case no head-to-head studies are available for direct...

The German AMNOG healthcare reform includes a mandatory early-benefit-assessment (EBA) at launch. As per German social code, EBA is based on registration trials and includes evaluation of the patient-relevant effect of the new medicines compared to an appropriate comparator as defined by the...

Background: The purpose of this study was to analyse the impact of commissioned addenda by the Federal Joint Committee (FJC) to the HTA body (IQWiG) and their agreement with FJC decisions and to identify potential additional decisive factors of FJC. Methods: All available relevant documents up...

D61; H51; I18. </AbstractSection> Copyright Dabisch et al.; licensee Springer. 2014

Die Umfrage unter einzelnen gesetzlichen Krankenkassen in Deutschland hatte zwei wesentliche Ziele: Zum einen sollten rückblickend die Prozesse, Wirkmechanismen und Ergebnisse des AMNOG betrachtet werden, um zu erheben, wie dies aus der Perspektive einzelner gesetzlicher Krankenkassen...