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

Michela Meregaglia, Francesco Malandrini, Stefania Angelini and Oriana Ciani ()
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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

Applied Health Economics and Health Policy, 2023, vol. 21, issue 6, No 9, 925-935

Abstract: 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

Date: 2023
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DOI: 10.1007/s40258-023-00827-3

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