TBD: EMA/EUNETHTA Qualification of the IMI PREFFER Patient Preference Framework: Key Experences, Outcomes, Value and Implications
KU Leuven Belgium
To report (i) key experiences and (ii) outcomes of the EMA/EUnetHTA qualification process, and (iii) the value and implications of the qualification opinion itself on the IMI PREFER patient preference framework and points to consider for method selection.
The PREFER framework, which provides considerations on design, conduct and use of patient preference studies (PPS), and points to consider for method selection, were assessed by EMA and EUnetHTA via a joint qualification procedure.
(i) With respect to key experiences, the EMA/EUnetHTA qualification procedure provided structured interaction between the PREFER consortium, regulators and HTA bodies on PPS design and use, thereby increasing mutual understanding on PPS design and application in regulatory and HTA evaluation. This also led to enhancements to the PREFER framework and expansion of methods included. (ii) With respect to outcomes, the process resulted in a positive qualification opinion from EMA in May 2022. EMA considered the framework comprehensive, useful to enable PPS planning and conduct, and valuable to support interactions between industry, regulators, HTA bodies/payers, academia, and patients. (iii) With respect to the value and implications of the positive qualification opinion itself, it underscores the value of PPS for (a) patients, by structuring their input into regulatory/HTA decision-making using methodologically robust approaches, (b) regulators and HTA assessors, by providing considerations on how to evaluate PPS, (c) PPS researchers, by offering a set of tools to design, conduct, and analyse state-of-the-art PPS, and (d) medical product developers, by providing advice on why, when and how to use PPS in medical product decision-making.
The EMA qualification opinion on IMI PREFER is a major step towards more structured conduct and evaluation of PPS in decision-making. Learnings from this qualification provide insight into the value and appropriate use of PPS in medical product development.