IDEAS home Printed from https://ideas.repec.org/a/spr/aphecp/v21y2023i6d10.1007_s40258-023-00827-3.html
   My bibliography  Save this article

The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022

Author

Listed:
  • Michela Meregaglia

    (SDA Bocconi School of Management)

  • Francesco Malandrini

    (SDA Bocconi School of Management)

  • Stefania Angelini

    (Roche S.p.A.)

  • Oriana Ciani

    (SDA Bocconi School of Management)

Abstract

Objectives Health regulators have progressively increased their attention and focus on patient-reported outcomes (PROs), driven by the diffusion of a patient-centred approach to the drug development process. This study investigates the consideration of PROs and their measures (PROMs) in the authorisation of medicines in Europe. Methods All medicines for human use authorised or refused by the European Medicines Agency (EMA) in the period 2017–2022 were identified, and corresponding European Public Assessment Reports (EPARs) were downloaded for review. Medicine and PROs/PROM characteristics were systematically recorded. A multivariate logistic regression was performed to identify variables associated with the use of patient-reported evidence in EPARs. Results Overall, 497 EPARs of authorised medicines and 19 EPARs of refused medicines were analysed; of these, 240 (48.3%) and 10 (52.6%), respectively, reported any use of PROs/PROMs (p = 0.710). For authorised medicines, the likelihood of using PROs/PROMs was negatively affected by generic (OR = 0.01, p

Suggested Citation

  • Michela Meregaglia & Francesco Malandrini & Stefania Angelini & Oriana Ciani, 2023. "The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022," Applied Health Economics and Health Policy, Springer, vol. 21(6), pages 925-935, November.
  • Handle: RePEc:spr:aphecp:v:21:y:2023:i:6:d:10.1007_s40258-023-00827-3
    DOI: 10.1007/s40258-023-00827-3
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40258-023-00827-3
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.

    File URL: https://libkey.io/10.1007/s40258-023-00827-3?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
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    More about this item

    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:aphecp:v:21:y:2023:i:6:d:10.1007_s40258-023-00827-3. 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.

    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 .

    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.