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Early benefit assessment of new drugs: The impact on healthcare in Germany

Authors: Michael Köhler, Annette Christoph

The early benefit assessment of new drugs was introduced in Germany in 2011. The main rationale was to support pricing negotiations between the statutory health insurance (SHI) system and the pharmaceutical industry. The early benefit assessment provides publicly available documents to inform healthcare decision makers at both population and individual levels. Besides drug pricing decisions by the SHI, the early benefit assessment contributes to other areas such as the development of clinical practice guidelines and shared decision making between the physician and patient. This article describes the process and content of the early benefit assessment, including details on the standardi sed dossier submitted by the pharmaceutical company, the dossier assessment conducted by the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen), and the final decision by the decision-making body, the Federal Joint Committee (Gemeinsamer Bundesausschuss). A case example of a dossier assessment is also presented.

Medical Writing. 2021;30(3):22–26

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