IDEAS home Printed from https://ideas.repec.org/a/spr/hecrev/v4y2014i1p1-1410.1186-s13561-014-0031-5.html
   My bibliography  Save this article

Relevance of indirect comparisons in the German early benefit assessment and in comparison to HTA processes in England, France and Scotland

Author

Listed:
  • Andrea Lebioda
  • David Gasche
  • Franz-Werner Dippel
  • Karlheinz Theobald
  • Stefan Plantör

Abstract

Early benefit assessment in Germany under the legislative framework of AMNOG (Arzneimittelmarktneuordnungsgesetz) requires direct comparisons of the new drug with appropriate comparators determined by the Federal Joint Committee (G-BA). In case no head-to-head studies are available for direct comparisons, the submission of indirect comparisons is permitted to assess the additional benefit of the new drug. However, the Institute for Quality and Efficiency in Health Care (IQWiG) states a clear preference for head-to-head trials and defines strict requirements for indirect comparisons to be considered in the benefit assessment. Similar requirements also exist in other countries with mandatory health technology assessments (HTA), like France, England and Scotland. Our evaluation shows that a comparison of the different HTA regarding indirect comparisons is difficult. Overall, external preconditions and methodological requirements are demanding and hardly to fulfill by pharmaceutical companies for implementation of indirect comparisons in early benefit assessment. The determination of the appropriate comparators, outcomes, patient subgroups and study choice are the main target within indirect comparisons for the future. To compare and assess submitted indirect comparisons it would be desirable that a transparent process was established, including the mandatory publication of HTA-reports within Europe and international guidelines, accepted by a large number of HTA-agencies. Copyright Lebioda et al.; licensee Springer. 2014

Suggested Citation

  • Andrea Lebioda & David Gasche & Franz-Werner Dippel & Karlheinz Theobald & Stefan Plantör, 2014. "Relevance of indirect comparisons in the German early benefit assessment and in comparison to HTA processes in England, France and Scotland," Health Economics Review, Springer, vol. 4(1), pages 1-14, December.
  • Handle: RePEc:spr:hecrev:v:4:y:2014:i:1:p:1-14:10.1186/s13561-014-0031-5
    DOI: 10.1186/s13561-014-0031-5
    as

    Download full text from publisher

    File URL: http://hdl.handle.net/10.1186/s13561-014-0031-5
    Download Restriction: Access to full text is restricted to subscribers.

    File URL: https://libkey.io/10.1186/s13561-014-0031-5?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.

    Citations

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


    Cited by:

    1. 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.
    2. Tunis, Sean & Hanna, Eve & Neumann, Peter J. & Toumi, Mondher & Dabbous, Omar & Drummond, Michael & Fricke, Frank-Ulrich & Sullivan, Sean D. & Malone, Daniel C. & Persson, Ulf & Chambers, James D., 2021. "Variation in market access decisions for cell and gene therapies across the United States, Canada, and Europe," Health Policy, Elsevier, vol. 125(12), pages 1550-1556.
    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. 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.
    5. Livio Garattini & Anna Padula, 2020. "HTA for pharmaceuticals in Europe: will the mountain deliver a mouse?," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 21(1), pages 1-5, February.
    6. Proksch, Dorian & Busch-Casler, Julia & Haberstroh, Marcus Max & Pinkwart, Andreas, 2019. "National health innovation systems: Clustering the OECD countries by innovative output in healthcare using a multi indicator approach," Research Policy, Elsevier, vol. 48(1), pages 169-179.

    More about this item

    Keywords

    AMNOG; Early benefit assessment; HAS; Indirect comparison; IQWiG; NICE; I18;
    All these keywords.

    JEL classification:

    • I18 - Health, Education, and Welfare - - Health - - - Government Policy; Regulation; Public Health

    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:spr:hecrev:v:4:y:2014:i:1:p:1-14:10.1186/s13561-014-0031-5. 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.

    We have no bibliographic references for this item. You can help adding them by using 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.