Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation

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Ruof, Joerg; Schwartz, Friedrich Wilhelm; Schulenburg, J. -Matthias; Dintsios, Charalabos-Markos: Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation. In: European Journal of Health Economics 2014 (2014), S. 577-589. DOI: https://doi.org/10.1007/s10198-013-0495-y

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Sum total of downloads: 225




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Since the introduction of the German health care reform in January 2011, an early benefit assessment (EBA) is required for all new medicines. Pharmaceutical manufacturers have to submit a benefit dossier for evaluation by the Institute for Quality and Efficiency in Health Care (IQWiG). A final decision is made by the Federal Joint Committee (G-BA). The aim of this investigation was to analyse the outcomes 18 months after introduction of the new legislation and to identify critical areas requiring further discussion and development. All EBAs commenced prior to June 2012 were included. The G-BA website was used to obtain manufacturers' benefit dossiers, IQWiG assessments, and G-BA decisions. Four areas of interest were analysed: levels of additional benefit, appropriate comparative therapy (ACT), patient-relevant endpoints, and adverse events. Twenty-seven EBAs were analysed. IQWiG stated a benefit in 50 % of EBAs, whereas G-BA stated a benefit in 63 %, but only in 50 % of identified subgroups and 40 % of patients involved. In 12 EBAs, the ACT suggested by G-BA differed from the comparator used in phase III trials. The G-BA reported no benefits on health-related quality of life. Discrepancies arose in morbidity outcomes such as 'progression-free survival' and 'sustained virological response'. Categorisation and balancing of adverse events was conducted within various assessments. Considerable variance was observed in the levels of additional benefit reported by pharmaceutical manufacturers, IQWiG and G-BA. The areas of disagreement included ACT selection, definition of subgroups and patient-relevant endpoints, and classification and balancing of adverse events.
License of this version: CC BY 4.0 Unported
Document Type: Article
Publishing status: publishedVersion
Issue Date: 2014
Appears in Collections:Wirtschaftswissenschaftliche Fakultät

distribution of downloads over the selected time period:

downloads by country:

pos. country downloads
total perc.
1 image of flag of Germany Germany 142 63.11%
2 image of flag of United States United States 29 12.89%
3 image of flag of Russian Federation Russian Federation 9 4.00%
4 image of flag of China China 5 2.22%
5 image of flag of Israel Israel 4 1.78%
6 image of flag of Honduras Honduras 4 1.78%
7 image of flag of Ireland Ireland 3 1.33%
8 image of flag of Czech Republic Czech Republic 3 1.33%
9 image of flag of Switzerland Switzerland 2 0.89%
10 image of flag of Canada Canada 2 0.89%
    other countries 22 9.78%

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