IDEAS home Printed from https://ideas.repec.org/a/spr/hecrev/v6y2016i1d10.1186_s13561-016-0109-3.html
   My bibliography  Save this article

Benefit assessment in Germany: implications for price discounts

Author

Listed:
  • Ulrike Theidel

    (Xcenda GmbH)

  • J-Matthias Graf von der Schulenburg

    (Leibniz Universität Hannover)

Abstract

Background 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. Objectives The aim of this evaluation is to identify factors influencing the results of the AMNOG price negotiation process. Methods 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). Results 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. Conclusions 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.

Suggested Citation

  • Ulrike Theidel & J-Matthias Graf von der Schulenburg, 2016. "Benefit assessment in Germany: implications for price discounts," Health Economics Review, Springer, vol. 6(1), pages 1-12, December.
    • Handle: RePEc:spr:hecrev:v:6:y:2016:i:1:d:10.1186_s13561-016-0109-3
    DOI: 10.1186/s13561-016-0109-3
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1186/s13561-016-0109-3
    File Function: Abstract
    Download Restriction: no
    File URL: https://libkey.io/10.1186/s13561-016-0109-3?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    References listed on IDEAS

    as
    1. Herr, Annika, 2012. "Rationalisierung und Wettbewerb im Arzneimittelmarkt," DICE Ordnungspolitische Perspektiven 31, Heinrich Heine University Düsseldorf, Düsseldorf Institute for Competition Economics (DICE).
    2. Henschke, Cornelia & Sundmacher, Leonie & Busse, Reinhard, 2013. "Structural changes in the German pharmaceutical market: Price setting mechanisms based on the early benefit evaluation," Health Policy, Elsevier, vol. 109(3), pages 263-269.
    3. Ruof, Jörg & Knoerzer, Dietrich & Dünne, Anja-Alexandra & Dintsios, Charalabos-Markos & Staab, Thomas & Schwartz, Friedrich Wilhelm, 2014. "Analysis of endpoints used in marketing authorisations versus value assessments of oncology medicines in Germany," Health Policy, Elsevier, vol. 118(2), pages 242-254.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Wettstein, Dominik J. & Boes, Stefan, 2022. "How value-based policy interventions influence price negotiations for new medicines: An experimental approach and initial evidence," Health Policy, Elsevier, vol. 126(2), pages 112-121.
    2. Yvonne-Beatrice Böhler & Christian Lamping & Philipp Christoph Wichard & Philipp Christoph Wichardt, 2019. "Pharmaceutical Prices: The Impact of the Launch Strategy - An Analysis of German Data," CESifo Working Paper Series 7879, CESifo.
    3. Böhler, Yvonne-Beatrice & Lamping, Christian & Wichardt, Philipp C., 2019. "Pharmaceutical prices: The impact of the launch strategy. An analysis of German data," Kiel Working Papers 2141, Kiel Institute for the World Economy (IfW Kiel).

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Leopold, C. & Vogler, S. & Habl, C. & Mantel-Teeuwisse, A.K. & Espin, J., 2013. "Personalised medicine as a challenge for public pricing and reimbursement authorities – A survey among 27 European countries on the example of trastuzumab," Health Policy, Elsevier, vol. 113(3), pages 313-322.
    2. Olberg, Britta & Perleth, Matthias & Busse, Reinhard, 2014. "The new regulation to investigate potentially beneficial diagnostic and therapeutic methods in Germany: Up to international standard?," Health Policy, Elsevier, vol. 117(2), pages 135-145.
    3. Vogler, Sabine & Zimmermann, Nina & de Joncheere, Kees, 2016. "Policy interventions related to medicines: Survey of measures taken in European countries during 2010–2015," Health Policy, Elsevier, vol. 120(12), pages 1363-1377.
    4. Christine Blome & Matthias Augustin & Hidayet Metin & David Lohrberg, 2017. "Four years of early benefit assessment of new drugs in Germany: a qualitative study on methodological requirements for quality of life data," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 18(2), pages 181-193, March.
    5. Franziska Worm & Charalabos-Markos Dintsios, 2020. "Determinants of Orphan Drug Prices in Germany," PharmacoEconomics, Springer, vol. 38(4), pages 397-411, April.
    6. Oriana Ciani & Bogdan Grigore & Hedwig Blommestein & Saskia de Groot & Meilin Möllenkamp & Stefan Rabbe & Rita Daubner-Bendes & Rod S. Taylor, 2021. "Validity of Surrogate Endpoints and Their Impact on Coverage Recommendations: A Retrospective Analysis across International Health Technology Assessment Agencies," Medical Decision Making, , vol. 41(4), pages 439-452, May.
    7. Coenen, Michael & Haucap, Justus, 2013. "Kommunal- statt Missbrauchsaufsicht: Zur Aufsicht über Trinkwasserentgelte nach der 8. GWB-Novelle," DICE Ordnungspolitische Perspektiven 53, Heinrich Heine University Düsseldorf, Düsseldorf Institute for Competition Economics (DICE).
    8. C. M. Dintsios & I. Beinhauer, 2020. "The impact of additive or substitutive clinical study design on the negotiated reimbursement for oncology pharmaceuticals after early benefit assessment in Germany," Health Economics Review, Springer, vol. 10(1), pages 1-25, December.
    9. Niehaus, Ines & Dintsios, Charalabos-Markos, 2018. "Confirmatory versus explorative endpoint analysis: Decision-making on the basis of evidence available from market authorization and early benefit assessment for oncology drugs," Health Policy, Elsevier, vol. 122(6), pages 599-606.
    10. Katharina E. Fischer & Tom Stargardt, 2014. "Early Benefit Assessment of Pharmaceuticals in Germany," Medical Decision Making, , vol. 34(8), pages 1030-1047, November.
    11. Fischer, Katharina Elisabeth & Heisser, Thomas & Stargardt, Tom, 2016. "Health benefit assessment of pharmaceuticals: An international comparison of decisions from Germany, England, Scotland and Australia," Health Policy, Elsevier, vol. 120(10), pages 1115-1122.
    12. Stephan Eger & Jörg Mahlich, 2014. "Pharmaceutical regulation in Europe and its impact on corporate R&D," Health Economics Review, Springer, vol. 4(1), pages 1-9, December.
    13. Bogdan Grigore & Oriana Ciani & Florian Dams & Carlo Federici & Saskia Groot & Meilin Möllenkamp & Stefan Rabbe & Kosta Shatrov & Antal Zemplenyi & Rod S. Taylor, 2020. "Surrogate Endpoints in Health Technology Assessment: An International Review of Methodological Guidelines," PharmacoEconomics, Springer, vol. 38(10), pages 1055-1070, October.
    14. Jörg Ruof & Thomas Staab & Charalabos-Markos Dintsios & Jakob Schröter & Friedrich Wilhelm Schwartz, 2016. "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 Committ," Health Economics Review, Springer, vol. 6(1), pages 1-11, December.
    15. Hörn, Helmut & Nink, Katrin & McGauran, Natalie & Wieseler, Beate, 2014. "Early benefit assessment of new drugs in Germany – Results from 2011 to 2012," Health Policy, Elsevier, vol. 116(2), pages 147-153.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:hecrev:v:6:y:2016:i:1:d:10.1186_s13561-016-0109-3. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com/economics/journal/13561 .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.