Benefit assessment in Germany: implications for price discounts

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Theidel, U.; von der Schulenburg, J.-M.: Benefit assessment in Germany: implications for price discounts. In: Health Economics Review 6 (2016), Nr. 1, 33. DOI: https://doi.org/10.1186/s13561-016-0109-3

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Zum Zitieren der Version im Repositorium verwenden Sie bitte diesen DOI: https://doi.org/10.15488/2648

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Kleine Vorschau
Zusammenfassung: 
Background: The AMNOG regulation, introduced in 2011 in Germany, changed the game for new drugs. Now, the industry is required to submit a dossier to the GBA (the central decision body in the German sickness fund system) to show additional benefit. After granting the magnitude of the additional benefit by the GBA, the manufacturer is entitled to negotiate the reimbursement price with the GKV-SV (National Association of Statutory Health Insurance Funds). The reimbursement price is defined as a discount on the drug price at launch. As the price or discount negotiations between the manufacturers and the GKV-SV takes place behind closed doors, the factors influencing the results of the negotiation are not known. Objectives: The aim of this evaluation is to identify factors influencing the results of the AMNOG price negotiation process. Methods: The analysis was based on a dataset containing detailed information on all assessments until the end of 2015. A descriptive analysis was followed by an econometric analysis of various potential factors (benefit rating, size of target population, deviating from appropriate comparative therapy and incorporation of HRQoL-data). Results: Until December 2015, manufacturers and the GKV-SV finalized 96 negotiations in 193 therapeutic areas, based on assessment conducted by the GBA. The GBA has granted an additional benefit to 100/193 drug innovations. Negotiated discount was significantly higher for those drugs without additional benefit (p= 0.030) and non-orphan drugs (p= 0.015). Smaller population size, no deviation from recommended appropriate comparative therapy and the incorporation of HRQoL-data were associated with a lower discount on the price at launch. However, neither a uni- nor the multivariate linear regression showed enough power to predict the final discount. Conclusions: Although the AMNOG regulation implemented binding and strict rules for the benefit assessment itself, the outcome of the discount negotiations are still unpredictable. Obviously, negotiation tactics, the current political situation and soft factors seem to play a more influential role for the outcome of the negotiations than the five hard and known factors analyzed in this study. Further research is needed to evaluate additional factors.
Lizenzbestimmungen: CC BY 4.0 Unported
Publikationstyp: Article
Publikationsstatus: publishedVersion
Erstveröffentlichung: 2016
Die Publikation erscheint in Sammlung(en):Wirtschaftswissenschaftliche Fakultät

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Herkunft der Downloads nach Ländern:

Pos. Land Downloads
Anzahl Proz.
1 image of flag of Germany Germany 79 57,66%
2 image of flag of United States United States 25 18,25%
3 image of flag of China China 6 4,38%
4 image of flag of Russian Federation Russian Federation 4 2,92%
5 image of flag of Austria Austria 4 2,92%
6 image of flag of No geo information available No geo information available 3 2,19%
7 image of flag of Spain Spain 3 2,19%
8 image of flag of Portugal Portugal 2 1,46%
9 image of flag of United Kingdom United Kingdom 2 1,46%
10 image of flag of France France 2 1,46%
    andere 7 5,11%

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