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Abstracts by keywords: Medicinal products

The fixed-amount regulation in the AMNOG market – a practical perspective

This article examines the practical implementation of the interface between the price regulation instruments AMNOG and the fixed price in the German pharmaceutical market from 2011 to July 2024. It examines three typical case scenarios of the linking of the price regulation instruments and analyzes the procedural practices of self-administration based on previous application.

03.12.2024
Analysis of orphan drug procedures in early benefit assessment: RCTs versus best available comparative evidence

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
Legal framework and assessment practice of IQWiG

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

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