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Walzer Stefan (State University Baden-Wuerttemberg, Loerrach, Germany), Annemanns Lieven (Ghent University, Ghent, Belgium ; Brussels University, Brussels, Belgium), Parow Detlef (Ghent University, Ghent, Belgium ; Brussels University, Brussels, Belgium), ZoellneZoellner r York (Hamburg University of Applied Sciences, Germany), Shekarriz Sarah (Hamburg University of Applied Sciences, Germany), Antonanzas Fernando (University of La Rioja, Spain)
The German AMNOG and its Current Potential Implications on the Spanish and Belgian Pricing and Reimbursement Decisions
Journal of Health Policy and Outcomes Research, 2013, nr 1, s. 64-71
Słowa kluczowe
Technologia medyczna, Przemysł farmaceutyczny
Medical technology, Pharmaceutical industry
Unia Europejska (UE)
European Union (EU)
Background: EU policymakers have implemented mechanisms to slow down the rate of increase in health care costs. The most recent reform that came into effect in Germany was the Act to Reorganise the Pharmaceutical Market (AMNOG - Das Arzneimittelmarktneuordnungsgesetz (). Methods: Exemplarily for countries, which used Germany as a price reference country, Spain and Belgium were chosen for pilot evaluation if AMNOG might have any further impact on reimbursement and pricing decisions in these countries. The general market access and potential impacts on clinical development programs will be discussed and evaluated. Results: In Spain, GBA assessments may influence the central decisions in pricing and reimbursement in the sense that lower prices will be expected for new drugs in the benchmarking process. In Belgium, AMNOG will also have an impact: the Price Commission will possibly observe lower prices than before, what may lead to other decisions for approved Belgian prices. More importantly, the decisions in Germany, related to added benefits of new drugs, might influence the Commission members. Finally, clinical developments of new compounds may also be influenced by AMNOG, regarding the requests of reimbursement decision makers for special clinical trial designs. Conclusions: The potential impact on additional clinical benefits and price decisions with the Spitzenverband der Krankenkassen may be observed in some other countries as well. Furthermore, the impact on future clinical development programs of new compounds might as well be significant. Further research and experience in Germany and other countries is needed and awaited. (original abstract)
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