Details
| Original language | English |
|---|---|
| Pages (from-to) | 577-589 |
| Number of pages | 13 |
| Journal | European Journal of Health Economics |
| Volume | 15 |
| Issue number | 6 |
| Early online date | 16 Jun 2013 |
| Publication status | Published - Jul 2014 |
Abstract
Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.
Keywords
- (Early) benefit assessment, AMNOG, Appropriate comparative therapy, Health care reform, Market access
ASJC Scopus subject areas
- Economics, Econometrics and Finance(all)
- Economics, Econometrics and Finance (miscellaneous)
- Medicine(all)
- Health Policy
Sustainable Development Goals
Cite this
- Standard
- Harvard
- Apa
- Vancouver
- BibTeX
- RIS
In: European Journal of Health Economics, Vol. 15, No. 6, 07.2014, p. 577-589.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Early benefit assessment (EBA) in Germany
T2 - analysing decisions 18 months after introducing the new AMNOG legislation
AU - Ruof, Jörg
AU - Schwartz, Friedrich Wilhelm
AU - Schulenburg, J. Matthias
AU - Dintsios, Charalabos Markos
N1 - Funding Information: Medical writing services were provided by nspm ltd, Meggen, Switzerland, with financial support from Roche Pharma AG.
PY - 2014/7
Y1 - 2014/7
N2 - Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.
AB - Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.
KW - (Early) benefit assessment
KW - AMNOG
KW - Appropriate comparative therapy
KW - Health care reform
KW - Market access
UR - http://www.scopus.com/inward/record.url?scp=84905568232&partnerID=8YFLogxK
U2 - 10.1007/s10198-013-0495-y
DO - 10.1007/s10198-013-0495-y
M3 - Article
C2 - 23771769
AN - SCOPUS:84905568232
VL - 15
SP - 577
EP - 589
JO - European Journal of Health Economics
JF - European Journal of Health Economics
SN - 1618-7598
IS - 6
ER -