Background: Patient preference (PP)information is not effectively integrated in decision-making throughout the medical product lifecycle (MPLC), despite having the potential to improve patients’ healthcare options. A first step requires an understanding of existing processes and decision-points to know how to incorporate PP information in order to improve patient-centric decision-making. Objectives: The aims were to: 1) identify the decision-making processes and decision-points throughout the MPLC for industry, regulatory authorities, and reimbursement/HTA, and 2) determine which decisionpoints can potentially include PP information. Methods:Ascoping literature review was conducted usingfive scientific databases. Semi-structured interviews were conducted withrepresentatives fromsevenEuropeancountries andthe US,including industry (n = 24), regulatory authorities (n = 23), reimbursement/HTA (n = 23). Finally, validation meetings with key stakeholders (n = 11) were conducted. Results: Six critical decision-points were identified for industry decision-making, three for regulatory decision-making, and six for reimbursement/HTA decision-making. Stakeholder groups agreed that PP information is not systematically integrated, either as obligatory information or pre-set criteria, but would benefit all the listed decision-points in the future. Conclusion: Currently, PP information is not considered as obligatory information to submit for any of the MPLC decision-points. However, PP information is considered an important component by most stakeholders to inform future decision-making across the MPLC. The integration of PP information into 15 identified decision-points needs continued discussion and collaboration between stakeholders

Patient preferences, Patient preference information, Decision-Making, HTA decision-making, Regulatory decision-making, Industry decision-making,
Health Policy
Institute for Medical Technology Assessment (iMTA)

Whichello, C.L, Scholin Bywall, K, Mauer, J, Watt, S, Cleemput, I, Pinto, C.A., … Veldwijk, J. (2020). An overview of critical decision-points in the medical product lifecycle: Where to include patient preference information in the decision-making process?. Health Policy. doi:10.1016/j.healthpol.2020.07.007