Abstracts by key term: 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
Quality and benefit are also frequently used terms in the healthcare system, with which we emphasize that significant resources are used to ensure optimal “quality of care” and to create “benefits” for those affected. Examples are the proportion of medical manpower (approx. 20%) that is committed to quality assurance and the expenses that arise as part of the approval of medicines for the creation of benefit dossiers (approx. 1 million euros/dossier). Quality and benefit are are therefore used as different dimensions of added health value, whereby quality could be a necessary prerequisite for providing benefit, but benefit is not necessarily a prerequisite for quality. The increasing scarcity of resources in health systems requires not only the critical analysis of new expenditure, but also the justification of existing expenditure. The not insignificant expenditure on ensuring the quality and benefit of health services can no longer be accepted as an end in itself1. On the one hand, they must be subjected to a “clinical-economic” analysis, through which the effort and the returns achieved for patients and society are compared. In addition, the differentiated analysis of quality and benefit opens up new considerations for financing health services. In order to carry out this analysis, it is first necessary to describe what is meant by “quality” and “benefit” in the healthcare system.
31.03.2015
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.
24.01.2013
With the founding of the IQWiG 5 years ago, the legislator pursued the purpose of being able to further postpone rationing in the health care system by using funds more rationally. In order to have a decision-making basis that is independent of industry in particular, IQWiG should evaluate therapies independently from a specialist perspective. Meanwhile, the drug assessment of the Institute itself is in the public criticism, it tendentious. A not medical, but legal assessment of IQWiG's drug assessment practice actually shows discrepancies between the legal requirements and assessment practice, particularly with regard to the definition of the order and the choice of method.
01.08.2009
With the most recent health care reform (GKV-WSG), the tasks of the Institute for Quality and Efficiency in Health Care (IQWiG) were expanded: Previously, it could only evaluate drugs with regard to their medical benefits. In the future, the institute should also put the costs of the medication in relation to the previously determined benefits. According to the law, these cost-benefit assessments are intended, on the one hand, to set maximum amounts for certain medications. On the other hand, they can support the Federal Joint Committee (G-BA) in assessing the cost-effectiveness of medical procedures. The proposed concept favors “efficient frontier analysis” as a method. The second element is a “budget impact analysis” to estimate how decisions affect healthcare spending.