Abstracts by keywords: benefit assessment
Deutschland zählt zu den bedeutendsten Arzneimittelmärkten Europas und zeichnet sich durch eine unmittelbare Erstattungsfähigkeit neu zugelassener Arzneimittel zum Zeitpunkt der Markteinführung aus. Seit Inkrafttreten des Arzneimittelmarktneuordnungsgesetzes (AMNOG) im Jahr 2011 unterliegen neue Arzneimittel einer Nutzenbewertung durch den Gemeinsamen Bundesausschuss (G-BA), welche die Grundlage für die anschließenden Preisverhandlungen bildet. Ziel dieses Systems ist es, Preisaufschläge ausschließlich […]
05.10.2026
Der Gesetzgeber hat mit dem 2019 eingeführten Instrument der anwendungsbegleitenden Datenerhebung (AbD) die Möglichkeit geschaffen, vergleichende Daten in der laufenden Versorgung zu erheben. Die AbD dient der Generierung von Evidenz und dem Zweck der Nutzenbewertung nach dem AMNOG (Arzneimittelmarktneuordnungsgesetz) als Grundlage erneuter Erstattungsbetragsverhandlungen. Ein zentraler Punkt für die Realisierbarkeit einer AbD sind die derzeitigen Anforderungen an den Nachweis eines quantifizierbaren Zusatznutzens. In einer Simulationsstudie wurden die derzeit im Methodenpapier des IQWiG geforderten rigiden Effektschwellen, aber auch modifizierte Anforderungen untersucht. Eingeflossen sind alle abgeschlossenen Orphan-Drug-Verfahren seit Einführung der frühen Nutzenbewertung im Jahr 2011. Die Studie zeigt, dass das derzeit vom IQWiG vorgeschlagene Vorgehen für die AbD verhältnismäßig große Patientenzahlen erfordert, die vor allem bei Orphan Drugs häufig kaum zu erreichen sind. Anhand der simulierten, veränderten Kriterien wird ein alternatives Vorgehen vorgeschlagen, das der besonderen Situation einer AbD als adjustiertem, jedoch nicht-randomisiertem Vergleich gerecht werden könnte.
02.04.2024
For drugs for the treatment of rare diseases (orphan drugs), the requirements of early benefit assessment according to Section 35a SGB V represent a particular challenge. The Institute for Quality and Efficiency in Health Care (IQWiG) concludes in working paper GA21-01 on orphan drugs, which are in the As part of a re-evaluation of a regular benefit assessment, the additional benefit of the initial benefit assessment for market access was fictitious.
02.04.2023
The following concept is intended to contribute to the methodological discussion about the use of application-related data in benefit assessment. Based on an overview of the current handling of non-randomized data by relevant health technology assessment (HTA) organizations as well as an overview of possible methodological evaluation procedures, recommendations are formulated on evidence generation, evidence assessment and necessary G-BA specifications that must be taken into account of the data for the quantifiability of an additional benefit.
04.04.2019
There has been a clear volume dynamic on the German pharmaceutical market for several years [1]. In addition, factors such as demographic change, medical-technical progress and the increase in outpatient therapy options lead to increasing pharmaceutical expenditure [2]. The legislature took up this progressive development by introducing the Medicines Market Reorganization Act (AMNOG) in 2011. Since then, new medications have been evaluated for their additional benefits. It turns out that a large number of new pharmaceutical products continue to come onto the German market, the additional benefit of which often cannot be proven or for which only a small additional benefit has been identified [3]. In addition, in the period from 2013 to the beginning of 2014, drugs that had already been approved were assessed as part of the AMNOG with regard to their additional benefit (so-called existing market call).1 The only group of active ingredients whose process was completed include the DPP-4 inhibitors (also gliptins).
06.12.2017
We are in the 4th year of AMNOG. After 38 months, 68 benefit assessments were available. Their results have been and continue to be widely discussed. The topic of price negotiations and the resulting savings potential are also regularly the focus of interest. But what about the effects of the AMNOG processes on everyday care? How have new active ingredients become established on the market depending on their benefit assessment? This article aims to provide the first (cautious) highlights of this – from the perspective of a data service provider.
24.01.2013
Medicines are among the most effective therapeutic measures used in the German healthcare system. However, the therapeutic progress that has been achieved in this area is also associated with considerable costs. The challenge for the healthcare system is to allow all patients to participate in this effective measure and in the progress that has been achieved, despite limited financial resources. The pharmaceutical expenditure of the statutory health insurance (GKV) has been rising continuously for years. This increase is only interrupted by legal regulations such as a price moratorium or manufacturer discounts, which usually have a short-term but not lasting effect and are also usually compensated by above-average increases in expenditure after the measures have expired. An expert report commissioned by TK by Prof. Stargard, University of Hamburg, Chair of Health Care Management shows that the end of the price moratorium and the reduction of the manufacturer discount, which has meanwhile increased, will result in additional expenditure of up to 1.4 billion euros for the health insurance companies would have drawn. The increase in drug spending is mainly caused by new drugs.