IDEAS home Printed from https://ideas.repec.org/a/spr/hecrev/v10y2020i1d10.1186_s13561-020-00263-2.html
   My bibliography  Save this article

The impact of additive or substitutive clinical study design on the negotiated reimbursement for oncology pharmaceuticals after early benefit assessment in Germany

Author

Listed:
  • C. M. Dintsios

    (Institute for Health Services Research and Health Economics, Heinrich Heine University)

  • I. Beinhauer

    (Health Economics, Cologne, Trainee at Bayer Vital GmbH)

Abstract

Background We analysed the impact of clinical study design for oncological pharmaceuticals on the subsequent price negotiations after early benefit assessment between pharmaceutical companies and the German National Association of Statutory Health Insurance Funds. The analysis was conducted for all oncology pharmaceuticals that underwent the early benefit assessment in Germany since its introduction in 2011 up to September 2016. Methods It was differentiated between additive (new therapy in addition to baseline therapy) and substitutive study designs (baseline therapy to be replaced). The study design was derived from the dossiers of the pharmaceutical companies submitted to the Federal Joint Committee. Subgroup specific costs in case of granted added benefit were calculated as annual therapy costs and compared with the costs of the appropriate comparators to quantify price premiums. Further price influencing factors were analysed in univariate and multivariate regression analysis considering the budget impact for the statutory health insurance as well. Results The mean and the median of the additive premiums for substitutive designs (€50,477.68 and €49,841.24) were higher than for additive designs, if the comparator was different to best supportive care (€48,750.00 and €42,820.44). The mean multiplicative premium for the substitutive designs was 15.07 versus 2.29 for the additive designs. EU-Prices and target population size had a significant effect on the reimbursement. The adjusted R-square in the log Premium OLS-regressions reached 0.708 when including all explanatory variables and considering interaction between target population and annual costs of the comparator. Conclusions Study design as an additional important influencing factor of the negotiations next to those stated in the framework agreement was identified and verified. Therefore, study design should be considered by pharmaceutical companies and by decision makers and payers within strategic price planning as a potential predictor. For some specific categories the number of cases was small. Further analyses should be performed when more oncology pharmaceuticals have passed the early benefit assessment.

Suggested Citation

  • 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.
  • Handle: RePEc:spr:hecrev:v:10:y:2020:i:1:d:10.1186_s13561-020-00263-2
    DOI: 10.1186/s13561-020-00263-2
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1186/s13561-020-00263-2
    File Function: Abstract
    Download Restriction: no

    File URL: https://libkey.io/10.1186/s13561-020-00263-2?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. Inna Dabisch & Jürgen Dethling & Charalabos-Markos Dintsios & Melanie Drechsler & Daniel Kalanovic & Peter Kaskel & Frank Langer & Jörg Ruof & Thorsten Ruppert & Daniel Wirth, 2014. "Patient relevant endpoints in oncology: current issues in the context of early benefit assessment in Germany," Health Economics Review, Springer, vol. 4(1), pages 1-8, December.
    2. 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)

    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. 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.
    2. 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.
    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.
    4. 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.
    5. Ingo Stiller & Arjen Witteloostuijn & Bart Cambré, 2021. "Do current radical innovation measures actually measure radical drug innovation?," Scientometrics, Springer;Akadémiai Kiadó, vol. 126(2), pages 1049-1078, February.
    6. 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.
    7. 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.

    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:10:y:2020:i:1:d:10.1186_s13561-020-00263-2. 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.