IDEAS home Printed from https://ideas.repec.org/a/eee/hepoli/v165y2026ics016885102500291x.html

The impact of the new ‘guard rails’ for price negotiations on pharmaceutical expenditure in Germany: A simulation exercise and retrospective analysis

Author

Listed:
  • Kranich, C.
  • Möller, D.
  • Dintsios, C.M.

Abstract

Due to increasing pharmaceutical expenditures, Germany implemented 'guardrails' for price negotiations at the end of 2022, as part of the ‘Statutory Health Insurance Financial Stabilization Act’. They regulate the pricing of benefit-assessed pharmaceuticals with comparators under data exclusivity, to generate savings

Suggested Citation

  • Kranich, C. & Möller, D. & Dintsios, C.M., 2026. "The impact of the new ‘guard rails’ for price negotiations on pharmaceutical expenditure in Germany: A simulation exercise and retrospective analysis," Health Policy, Elsevier, vol. 165(C).
    • Handle: RePEc:eee:hepoli:v:165:y:2026:i:c:s016885102500291x
    DOI: 10.1016/j.healthpol.2025.105537
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S016885102500291X
    Download Restriction: Full text for ScienceDirect subscribers only
    File URL: https://libkey.io/10.1016/j.healthpol.2025.105537?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
    ---><---

    As the access to this document is restricted, you may want to

    for a different version of it.

    References listed on IDEAS

    as
    1. Charalabos-Markos Dintsios & Nadja Chernyak, 2022. "How Far is Germany From Value-Based Pricing 10 Years After the Introduction of AMNOG?," Applied Health Economics and Health Policy, Springer, vol. 20(3), pages 287-290, May.
    2. 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.
    3. Afschin Gandjour & Sofia Schüßler & Thomas Hammerschmidt & Charalabos-Markos Dintsios, 2020. "Predictors of negotiated prices for new drugs in Germany," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 21(7), pages 1049-1057, September.
    4. Thomas R. Staab & Miriam Walter & Sonja Mariotti Nesurini & Charalabos-Markos Dintsios & J.-Matthias Graf von der Schulenburg & Volker E. Amelung & Jörg Ruof, 2018. "“Market withdrawals” of medicines in Germany after AMNOG: a comparison of HTA ratings and clinical guideline recommendations," Health Economics Review, Springer, vol. 8(1), pages 1-11, December.
    5. Jörg Ruof & Friedrich Schwartz & J.-Matthias Schulenburg & Charalabos-Markos Dintsios, 2014. "Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 15(6), pages 577-589, July.
    6. Franziska Worm & Charalabos-Markos Dintsios, 2020. "Determinants of Orphan Drug Prices in Germany," PharmacoEconomics, Springer, vol. 38(4), pages 397-411, April.
    Full references (including those not matched with items on IDEAS)

    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. 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. Jörg Tomeczkowski & Tanja Heidbrede & Birte Eichinger & Ulrike Osowski & Friedhelm Leverkus & Sarah Schmitter & Charalabos-Markos Dintsios, 2025. "Challenges and Criteria for Single-Arm Trials Leading to an Added Benefit in German Health Technology Assessments," PharmacoEconomics, Springer, vol. 43(10), pages 1223-1233, October.
    3. Matthias Herpers & Charalabos-Markos Dintsios, 2019. "Methodological problems in the method used by IQWiG within early benefit assessment of new pharmaceuticals in Germany," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 20(1), pages 45-57, February.
    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. Nicolas S. H. Xander & Tom Belleman & Maximilian Salcher-Konrad & Anne Hendrickx & Jeffrey Chen & Anne-Sophie Klein Gebbink & Peter Schneider & Kate Morgan & Oliver Groene & Isabelle Durand-Zaleski & , 2026. "Price determinants and pricing policies concerning potentially innovative health technologies: a scoping review," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 27(2), pages 479-508, March.
    6. Melanie Büssgen & Tom Stargardt, 2023. "Does health technology assessment compromise access to pharmaceuticals?," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 24(3), pages 437-451, April.
    7. 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.
    8. Sabine Vogler & Katharina Habimana & Manuel Alexander Haasis & Stefan Fischer, 2024. "Pricing, Procurement and Reimbursement Policies for Incentivizing Market Entry of Novel Antibiotics and Diagnostics: Learnings from 10 Countries Globally," Applied Health Economics and Health Policy, Springer, vol. 22(5), pages 629-652, September.
    9. Omer Ben-Aharon & Oren Shavit & Racheli Magnezi, 2017. "Does drug price-regulation affect healthcare expenditures?," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 18(7), pages 859-867, September.
    10. 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.
    11. 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.
    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. Hostenkamp, Gisela & Fischer, Katharina Elisabeth & Borch-Johnsen, Knut, 2016. "Drug safety and the impact of drug warnings: An interrupted time series analysis of diabetes drug prescriptions in Germany and Denmark," Health Policy, Elsevier, vol. 120(12), pages 1404-1411.
    14. Lori A Bollinger & Nicole Bellows & Rachael Linder, 2023. "Examining the characteristics of social and behavior change communication intervention costs in low- and middle-income countries: A hedonic method approach," PLOS ONE, Public Library of Science, vol. 18(6), pages 1-14, June.
    15. Chassagnol, F & Marcelli, G & Wagle, J & Giuliani, G & Traub, D & Schaub, V & Ruof, J, 2020. "Review of Relative effectiveness assessments (REAs) of pharmaceuticals at the European network for health technology assessment (EUnetHTA): A first step towards a consolidated European perspective on comparative effectiveness & safety?," Health Policy, Elsevier, vol. 124(9), pages 943-951.

    More about this item

    Keywords

    ;
    ;
    ;
    ;
    ;

    Statistics

    Access and download statistics

    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:eee:hepoli:v:165:y:2026:i:c:s016885102500291x. 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: Catherine Liu or the person in charge (email available below). General contact details of provider: http://www.elsevier.com/locate/healthpol .

    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.