Download PDF
Gesundheitsökonomie & Qualitätsmanagement 2022; 27(02): 81-87
DOI: 10.1055/a-1676-7895
Originalarbeit

AMNOG Arbitral Awards: Analysis of the Decisions of the Arbitration Board Ten Years after AMNOG Implementation

AMNOG-Schiedssprüche: Analyse der Entscheidungen der Schiedsstelle 10 Jahre nach Implementierung des AMNOG
Fabian Dorff
1   FOM University of Applied Sciences
,
David Matusiewicz
1   FOM University of Applied Sciences
2   Institute for Health & Social Sciences
,
Christian Thielscher
1   FOM University of Applied Sciences
› Author Affiliations
› Further Information
Also available at
    Permissions and Reprints

Abstract

Aim The analysis investigates the arbitral awards of the last ten years with regards to the characteristics of pharmaceuticals, contractual details and decisions of the arbitration board.

Method Arbitral awards until end of 2020 were considered for the analysis. Data were gathered from the arbitral awards, the corresponding G-BA resolutions and the Lauer-Taxe.

Results Nearly 50 % of the arbitral awards were based on an additional benefit. Besides the reimbursement price the duration of the contract, sales volume and redemption of the manufacturer’s discount were most commonly set by the arbitration board. Rebates set by the arbitration board seem to be higher than overall AMNOG rebates and appear to vary depending on the extent of the additional benefit.

Conclusion While the arbitral awards show a strong variability and individuality a few patterns can be identified.

Zusammenfassung

Zielsetzung Die Analyse untersucht die Schiedssprüche der letzten 10 Jahre im Hinblick auf die Merkmale der Arzneimittel, Vertragsbestandteile und die Entscheidungen der Schiedsstelle.

Methodik Schiedssprüche bis Ende 2020 wurden berücksichtigt. Die Daten wurden den Schiedssprüchen, den zugehörigen G-BA-Beschlüssen und der Lauer-Taxe entnommen.

Ergebnisse Fast 50 % der Schiedssprüche liegt ein Zusatznutzen zugrunde. Neben dem Erstattungsbetrag waren die Vertragslaufzeit, die Absatzmengen und die Ablösung der Herstellerabschläge die am häufigsten festgesetzten Vertragsbestandteile. Festgesetzte Abschläge scheinen höher zu sein als die Abschläge im AMNOG insgesamt und scheinen abhängig vom Ausmaß der Zusatznutzen zu variieren.

Schlussfolgerung Obwohl die Schiedssprüche deutliche Unterschiede und eine hohe Individualität aufweisen, konnten einige Muster identifiziert werden.

Key words

AMNOG - arbitral awards - arbitration board

Schlüsselwörter

AMNOG - Schiedssprüche - Schiedsstelle


Publication History

Article published online:
26 November 2021

© 2021. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • References

  • 1 Ludwig S, Dintsios CM. Arbitration Board Setting Reimbursement Amounts for Pharmaceutical Innovations in Germany When Price Negations between Payers and Manufacturers Fail: An Empirical Analysis of 5 Years’ Experience. Value Health 2016; 19: 1016-1025
    CrossrefPubMedGoogle Scholar
  • 2 Ruof J, Schwartz FW, Schulenburg JM. et al. Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation. Eur J Health Econ 2014; 15: 577-589
    CrossrefPubMedGoogle Scholar
  • 3 Leverkus F, Chuang-Stein C. Implementation of AMNOG: An industry perspective. Biom J 2016; 58: 76-88
    CrossrefPubMedGoogle Scholar
  • 4 Staab TR, Walter M, Mariotti Nesurini S. et al. “Market withdrawals” of medicines in Germany after AMNOG: a comparison of HTA ratings and clinical guideline recommendations. Health Econ Rev 2018; 8: 23
    CrossrefPubMedGoogle Scholar
  • 5 Dintsios CM, Beinhauer I. The impact of additive or substitutive clinical study design on the negotiated reimbursement for oncology pharmaceuticals after early benefit assessment in Germany. Health Econ Rev 2020; 10: 7
    CrossrefPubMedGoogle Scholar
  • 6 Ruof J, Staab T, Dintsios CM. et al. Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany – are additional data requirements by the Federal Joint Committee justified?. Health Econ Rev 2016; 6: 46
    CrossrefPubMedGoogle Scholar
  • 7 Staab T, Isbary G, Amelung VE. et al. Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients – an analysis of three disease areas: oncological, metabolic, and infectious diseases. BMC Health Serv Res 2016; 16: 651
    CrossrefPubMedGoogle Scholar
  • 8 Skipka G, Wieseler B, Kaiser T. et al. Methodological approach to determine minor, considerable, and major treatment effects in the early benefit assessment of new drugs. Biom J 2016; 58: 43-58
    CrossrefPubMedGoogle Scholar
  • 9 Lauenroth VD, Stargardt T. Pharmaceutical Pricing in Germany: How Is Value Determined within the Scope of AMNOG?. Value Health 2017; 20: 927-935
    CrossrefPubMedGoogle Scholar
  • 10 Dintsios CM, Worm F, Ruof J. et al. Different interpretation of additional evidence for HTA by the commissioned HTA body and the commissioning decision maker in Germany: whenever IQWiG and Federal Joint Committee disagree. Health Econ Rev 2019; 9: 35
    CrossrefPubMedGoogle Scholar
  • 11 Theidel U, von der Schulenburg JM. Benefit assessment in Germany: implications for price discounts. Health Econ Rev 2016; 6: 33
    CrossrefPubMedGoogle Scholar
  • 12 Gandjour A, Schüßler S, Hammerschmidt T. et al. Predictors of negotiated prices for new drugs in Germany. Eur J Health Econ 2020; 21: 1049-1057
    CrossrefPubMedGoogle Scholar
  • 13 Federal Joint Committee (G-BA). Verfahren der Nutzenbewertung nach § 35a SGB V.. Available at: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/ [Accessed July 10, 2021]
    PubMedGoogle Scholar
  • 14 Greiner W, Witte J, Gensorowsky D. et al. Zahlen, Daten, Fakten. In: Storm A. (ed). AMNOG-Report 2020. Heidelberg: medhochzwei Verlag GmbH; 2020: 213-232
    Google Scholar
  • 15 Hammerschmidt T. Analyse der AMNOG-Erstattungsbeträge im europäischen Preisumfeld. Gesundheitsökonomie und Qualitätsmanagement 2017; 22: 43-53
    PubMedGoogle Scholar