ArticleThe European journal of health economics : HEPAC : health economics in prevention and care2014
Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation.
Article in The European journal of health economics : HEPAC : health economics in prevention and care, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.
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Who cites it
32 citing papers in PubMed.
- Rheumatology Care in an Aging World: Global Perspectives on Payment Models and Access for Older Adults.Rheumatic diseases clinics of North America · 2026Review
- France versus Germany: differences and similarities in determining the added therapeutic value of medicines.The European journal of health economics : HEPAC : health economics in prevention and care · 2026Article
- A comparative analysis of health technology assessment decision-making for cancer drugs in Germany and England.Frontiers in public health · 2026Article
- Challenges and Criteria for Single-Arm Trials Leading to an Added Benefit in German Health Technology Assessments.PharmacoEconomics · 2025Article
- Primary endpoint acceptance and its association with benefit ratings and market access in German health technology assessments: a retrospective cohort study.The Lancet regional health. Europe · 2025Article
- Acceptance of Evidence Transfer Within German Early Benefit Assessment of New Drugs for Pediatric and Adolescents Target Populations.PharmacoEconomics · 2025Article
- Prices of Orphan Drugs in Four Western European Countries Before and After Market Exclusivity Expiry: A Cross-Country Comparison of List Prices and Purchase Prices.Applied health economics and health policy · 2023Article
- Do France, Germany, and Italy agree on the added therapeutic value of medicines?International journal of technology assessment in health care · 2023Article
- Launch sequencing of pharmaceuticals with multiple therapeutic indications: evidence from seven countries.BMC health services research · 2023Article
- Value and Price of Multi-indication Cancer Drugs in the USA, Germany, France, England, Canada, Australia, and Scotland.Applied health economics and health policy · 2022Article
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- The timelines for the price and reimbursement authorization in Italy 2018-2020.Frontiers in medicine · 2022Article
- Key drivers of innovativeness appraisal for medicines: the Italian experience after the adoption of the new ranking system.BMJ open · 2021Article
- The Assessment of the Innovativeness of a New Medicine in Italy.Frontiers in medicine · 2021Article
- The impact of additive or substitutive clinical study design on the negotiated reimbursement for oncology pharmaceuticals after early benefit assessment in Germany.Health economics review · 2020Article
- Different interpretation of additional evidence for HTA by the commissioned HTA body and the commissioning decision maker in Germany: whenever IQWiG and Federal Joint Committee disagree.Health economics review · 2019Article
- Patient-reported data informing early benefit assessment of rare diseases in Germany: A systematic review.Health economics review · 2019Article
- Methodological problems in the method used by IQWiG within early benefit assessment of new pharmaceuticals in Germany.The European journal of health economics : HEPAC : health economics in prevention and care · 2019Article
- Leveraging EUnetHTA's conceptual framework to compare HTA decision drivers in France, Italy, and Germany from a manufacturer's point of view.Health economics review · 2018Article
- "Market withdrawals" of medicines in Germany after AMNOG: a comparison of HTA ratings and clinical guideline recommendations.Health economics review · 2018Article
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesSince 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.
methodsAll 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.
resultsTwenty-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.
conclusionsConsiderable 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.
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