Die Preise neuer Arzneimittel im Vergleich zu ihren therapeutischen Alternativen

People in countries of the global south are affected by a unique spectrum of diseases, while costs for health care are a huge burden in the context of poverty. Furthermore, non-communicable diseases increasingly play a role in these countries. The management of translational research, potential clinical applications and marketing of new drugs in Germany is thus getting more and more important for global health. Regarding this, universities have a particular responsibility for two reasons. First, through basic research, they contribute significantly to the development of new medicines. Second, the university is a public institution and has thus the responsibility to return the gained knowledge to the public. Marketing of publicly funded innovations should provide benefits to patients in wealthy and poor countries alike. As a first step towards this goal, we demand the introduction of a globally responsible licensing policy at German universities. Different mechanisms which have been described in the German speaking areas such as "Equitable Licensing" provide a basis for the realization of this ambitious aim and have been introduced successfully at the universities of Muenster, Tuebingen and Freiburg.

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Benefit assessment in Germany: implications for price discounts

Theidel¹,

Schulenburg

2016

Health Econ Rev

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BackgroundThe 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.ObjectivesThe aim of this evaluation is to identify factors influencing the results of the AMNOG price negotiation process.MethodsThe 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).ResultsUntil 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.ConclusionsAlthough 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.

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Die Preise neuer Arzneimittel im Vergleich zu ihren therapeutischen Alternativen

Cited by 4 publications

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Benefit assessment in Germany: implications for price discounts

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