PMID- 32451745
OWN - NLM
STAT- MEDLINE
DCOM- 20210615
LR  - 20220608
IS  - 1618-7601 (Electronic)
IS  - 1618-7598 (Print)
IS  - 1618-7598 (Linking)
VI  - 21
IP  - 7
DP  - 2020 Sep
TI  - Predictors of negotiated prices for new drugs in Germany.
PG  - 1049-1057
LID - 10.1007/s10198-020-01201-z [doi]
AB  - INTRODUCTION: In Germany, all new, innovative medicines are subject to an early 
      benefit assessment by the German Federal Joint Committee with subsequent price 
      negotiation and optional arbitration. The purpose of this study was to identify 
      drivers of negotiated (including arbitrated) prices of new, non-orphan innovative 
      medicines in Germany. METHODS: The analysis considered all non-orphan drugs that 
      underwent a benefit appraisal between January 2011 and June 2016, and displayed a 
      reimbursement price in the German Drug Directory (Lauer-Taxe((R))) in November 
      2017. Negotiated annual treatment costs were analyzed with respect to 11 
      explanatory variables in regression models. RESULTS: The total sample included 
      106 non-orphan drugs. The analysis showed a significant and positive association 
      of log-transformed negotiated annual treatment cost of new medicines with 
      log-transformed annual treatment cost of its comparator(s), extent of added 
      benefit, and log-transformed size of the target population. Analyzing the effects 
      of specific endpoints instead of the overall added benefit revealed that the 
      single endpoint with the largest impact on price is adverse events (AEs). 
      Surprisingly, an increase in AEs significantly increased the price. Various 
      subgroup and sensitivity analyses demonstrated the robustness of the results. The 
      adjusted R squared for all models was above 80%. CONCLUSIONS: The analysis was 
      able to confirm that variables whose consideration is mandated by law are, in 
      fact, the key drivers of negotiated prices. Somewhat puzzling, the analysis also 
      found an increase in AEs to move prices significantly upward.
FAU - Gandjour, Afschin
AU  - Gandjour A
AD  - Frankfurt School of Finance and Management, Frankfurt am Main, Germany.
FAU - Schussler, Sofia
AU  - Schussler S
AD  - Frankfurt School of Finance and Management, Frankfurt am Main, Germany.
FAU - Hammerschmidt, Thomas
AU  - Hammerschmidt T
AD  - Faculty of Applied Health and Social Sciences, Technical University of Applied 
      Sciences Rosenheim, Rosenheim, Germany.
FAU - Dintsios, Charalabos-Markos
AU  - Dintsios CM
AUID- ORCID: 0000-0003-3469-092X
AD  - Institute for Health Services Research and Health Economics, Centre for Health 
      and Society, Faculty of Medicine, Heinrich-Heine University Dusseldorf, Gebaude 
      12.49, Moorenstrasse 5, 40225, Dusseldorf, Germany. dintsios@hhu.de.
LA  - eng
PT  - Journal Article
DEP - 20200525
PL  - Germany
TA  - Eur J Health Econ
JT  - The European journal of health economics : HEPAC : health economics in prevention 
      and care
JID - 101134867
SB  - IM
MH  - Costs and Cost Analysis/*statistics & numerical data
MH  - Drug Costs/*statistics & numerical data
MH  - Germany
MH  - Humans
MH  - *Negotiating
MH  - Quality of Life
PMC - PMC7423852
OTO - NOTNLM
OT  - AMNOG
OT  - Germany
OT  - Innovative medicines
OT  - Negotiation
OT  - Prediction
OT  - Pricing
COIS- Next to his academic affiliation, CMD is employed by Bayer Vital GmbH, 
      Leverkusen, Germany. TH has received fees for consulting and lectures from 4SC, 
      Acorda, Amgen, AstraZeneca, GlaxoSmithKline, MSD, Novartis, Pfizer, ViiV 
      Healthcare, the vfa (German Association of Research-Based Pharmaceutical 
      Manufacturers) and the Bavarian State Chamber of Pharmacists as well as the 
      consulting companies IQVIA, Market Access Transformation, and PRMA Consulting. 
      All other authors declare that they have no competing interests.
EDAT- 2020/05/27 06:00
MHDA- 2021/06/16 06:00
PMCR- 2020/05/25
CRDT- 2020/05/27 06:00
PHST- 2019/07/19 00:00 [received]
PHST- 2020/05/13 00:00 [accepted]
PHST- 2020/05/27 06:00 [pubmed]
PHST- 2021/06/16 06:00 [medline]
PHST- 2020/05/27 06:00 [entrez]
PHST- 2020/05/25 00:00 [pmc-release]
AID - 10.1007/s10198-020-01201-z [pii]
AID - 1201 [pii]
AID - 10.1007/s10198-020-01201-z [doi]
PST - ppublish
SO  - Eur J Health Econ. 2020 Sep;21(7):1049-1057. doi: 10.1007/s10198-020-01201-z. 
      Epub 2020 May 25.