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Benefit assessment in Germany: implications for price discounts

Overview of attention for article published in Health Economics Review, August 2016
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Title
Benefit assessment in Germany: implications for price discounts
Published in
Health Economics Review, August 2016
DOI 10.1186/s13561-016-0109-3
Pubmed ID
Authors

Ulrike Theidel, J-Matthias Graf von der Schulenburg

Abstract

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. The aim of this evaluation is to identify factors influencing the results of the AMNOG price negotiation process. 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). 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. 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.

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 63 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 63 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 13 21%
Student > Doctoral Student 8 13%
Student > Ph. D. Student 6 10%
Student > Master 4 6%
Other 3 5%
Other 6 10%
Unknown 23 37%
Readers by discipline Count As %
Pharmacology, Toxicology and Pharmaceutical Science 9 14%
Economics, Econometrics and Finance 9 14%
Social Sciences 5 8%
Agricultural and Biological Sciences 3 5%
Nursing and Health Professions 3 5%
Other 9 14%
Unknown 25 40%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 02 August 2016.
All research outputs
#18,466,751
of 22,881,964 outputs
Outputs from Health Economics Review
#333
of 430 outputs
Outputs of similar age
#283,793
of 366,909 outputs
Outputs of similar age from Health Economics Review
#18
of 21 outputs
Altmetric has tracked 22,881,964 research outputs across all sources so far. This one is in the 11th percentile – i.e., 11% of other outputs scored the same or lower than it.
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We're also able to compare this research output to 21 others from the same source and published within six weeks on either side of this one. This one is in the 1st percentile – i.e., 1% of its contemporaries scored the same or lower than it.