IDEAS home Printed from https://ideas.repec.org/a/eee/hepoli/v118y2014i2p242-254.html
   My bibliography  Save this article

Analysis of endpoints used in marketing authorisations versus value assessments of oncology medicines in Germany

Author

Listed:
  • Ruof, Jörg
  • Knoerzer, Dietrich
  • Dünne, Anja-Alexandra
  • Dintsios, Charalabos-Markos
  • Staab, Thomas
  • Schwartz, Friedrich Wilhelm

Abstract

In Germany, a mandatory early benefit assessment (EBA) by the Federal Joint Committee (G-BA) is required for reimbursement of new marketing-authorised medicines. Additional benefit is based on patient-relevant endpoints in mortality, morbidity and health-related quality of life (HRQoL). We aimed to compare endpoints and related benefit categories used in marketing authorisation to those considered by G-BA in the field of oncology.

Suggested Citation

  • 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.
    • Handle: RePEc:eee:hepoli:v:118:y:2014:i:2:p:242-254
    DOI: 10.1016/j.healthpol.2014.08.004
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S016885101400205X
    Download Restriction: Full text for ScienceDirect subscribers only
    File URL: https://libkey.io/10.1016/j.healthpol.2014.08.004?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 search for a different version of it.

    References listed on IDEAS

    as
    1. 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.
    2. 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.
    3. 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.
    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. 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. 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.
    3. 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.
    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. 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.
    6. 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.

    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. 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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.
    6. 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.
    7. 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.
    8. 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.
    9. 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.
    10. 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 ," Health Policy, Elsevier, vol. 124(9), pages 943-951.
    11. C. Thoren & C. Balg & J. Gibbert & S. Mostardt & M. Ripoll & D. Schierbaum & S. Schiller & A. Schwalm, 2020. "Determination of the target population in early benefit assessments in Germany: challenges for non-small-cell lung cancer," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 21(6), pages 881-893, August.
    12. 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.

    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:118:y:2014:i:2:p:242-254. 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.