Dokument: The impact of the new ‘guard rails’ for price negotiations on pharmaceutical expenditure in Germany: A simulation exercise and retrospective analysis
| Titel: | The impact of the new ‘guard rails’ for price negotiations on pharmaceutical expenditure in Germany: A simulation exercise and retrospective analysis | |||||||
| URL für Lesezeichen: | https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=72276 | |||||||
| URN (NBN): | urn:nbn:de:hbz:061-20260213-104728-7 | |||||||
| Kollektion: | Publikationen | |||||||
| Sprache: | Englisch | |||||||
| Dokumententyp: | Wissenschaftliche Texte » Artikel, Aufsatz | |||||||
| Medientyp: | Text | |||||||
| Autoren: | Dintsios, C.M. [Autor] Kranich, C. [Autor] Möller, D. [Autor] | |||||||
| Dateien: |
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| Stichwörter: | Pharmaceutical price regulation , AMNOG , Statutory health insurance financial stabilization act , Budget impact analysis , Simulation | |||||||
| Beschreibung: | Background
Due to increasing pharmaceutical expenditures, Germany implemented 'guardrails' for price negotiations at the end of 2022, as part of the ‘Statutory Health Insurance Financial Stabilization Act’. They regulate the pricing of benefit-assessed pharmaceuticals with comparators under data exclusivity, to generate savings Objective We aimed at quantifying the targeted savings from a payer perspective. Methods A retrospective implementation of the ‘guard rails’ for new benefit-assessed pharmaceuticals in the period 2020 – 2022 on a subpopulation basis after application of specific exclusion criteria was chosen to estimate their potential savings by means of a simulated budget impact analysis. Comprehensive prescription data and pharmaceutical retail prices were utilized to ensure comparability over time. Results The analysis included 38 products with 82 subpopulations encompassing approximately 870,000 patients. The difference between negotiated prices and those regulated by the ‘guard rails’ in terms of annual therapeutic costs was statistically significant (p=0.01, CI95%: €1145,925.47 – €8914,501.69). If the ‘guard rails’ had been implemented earlier, pharmaceutical expenditure for the assessed subpopulations could have been reduced by €191.14 million, with oncological products accounting for €117.20 million (61.3% of total savings) in the examined period. Conclusions Despite the significant potential savings identified in this analysis, the actual annual savings are inconsistent and challenging to predict as they largely depend on the number of new product launches and the extent of their added benefit demonstrated. The application of the ‘guard rails’ remains rather complex and legally ambiguous, suggesting that further contentious discussions are likely in the future. | |||||||
| Rechtliche Vermerke: | Originalveröffentlichung:
Kranich, C., Möller, D., & Dintsios, C.-M. (2025). The impact of the new ‘guard rails’ for price negotiations on pharmaceutical expenditure in Germany: A simulation exercise and retrospective analysis. Health Policy, 165, Article 105537. https://doi.org/10.1016/j.healthpol.2025.105537 | |||||||
| Lizenz: |  Dieses Werk ist lizenziert unter einer Creative Commons Namensnennung 4.0 International Lizenz | |||||||
| Fachbereich / Einrichtung: | Medizinische Fakultät | |||||||
| Dokument erstellt am: | 13.02.2026 | |||||||
| Dateien geändert am: | 13.02.2026 |
