Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US

Frontiers in Pharmacology

Jorien Veldwijk¹  Axel J. Hueber²  Bennett Levitan³  Eline van Overbeeke³  Steven Simoens⁴  Isabelle Huys⁵  Esther W. de Bekker-Grob⁵  Irina Cleemput⁶  Jürgen Kübler⁷  Selena Russo⁸  Matthias Englbrecht⁹  Karin Schölin Bywall^1,10  Rosanne Janssens^1,10  Chiara Whichello^1,11  Juhaeri Juhaeri^1,11  Sarah Harding^1,12  Richard Hermann^1,13  Alina Comanescu^1,14  Meredith Smith^1,15 

[1] Bioethics, Uppsala University, Uppsala, Sweden;Development, Titusville, United States;Management and Erasmus Choice Modelling Centre, Erasmus University, Rotterdam, Netherlands;0Astra Zeneca, Gaithersburg, MD, United States;1Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Erlangen, Germany;Applied Research Division for Cognitive and Psychological Science, IEO European Institute of Oncology IRCCS, Milan, Italy;Belgian Health Care Knowledge Centre, Brussels, Belgium;;Center for Research Ethics &;D Epidemiology, Janssen Research &Department of Pharmaceutical and Pharmacological Sciences, University of Leuven, Leuven, Belgium;;Erasmus School of Health Policy &Global Patient Safety and Labeling, Amgen Inc., Thousand Oaks, CA, United States;;Global R&Quantitative Scientific Consulting, Marburg, Germany;Sanofi, Bridgewater, NJ, United States;

关键词: patient preferences;    drug life cycle;    decision-making;    health technology assessment;    benefit risk assessment;    market authorization;   

DOI  :  10.3389/fphar.2019.01009

来源: DOAJ

【 摘 要 】

Objectives: Patient preference information (PPI) is gaining recognition among the pharmaceutical industry, regulatory authorities, and health technology assessment (HTA) bodies/payers for use in assessments and decision-making along the medical product lifecycle (MPLC). This study aimed to identify factors and situations that influence the value of patient preference studies (PPS) in decision-making along the MPLC according to different stakeholders.Methods: Semi-structured interviews (n = 143) were conducted with six different stakeholder groups (physicians, academics, industry representatives, regulators, HTA/payer representatives, and a combined group of patients, caregivers, and patient representatives) from seven European countries (the United Kingdom, Sweden, Italy, Romania, Germany, France, and the Netherlands) and the United States. Framework analysis was performed using NVivo 11 software.Results: Fifteen factors affecting the value of PPS in the MPLC were identified. These are related to: study organization (expertise, financial resources, study duration, ethics and good practices, patient centeredness), study design (examining patient and/or other preferences, ensuring representativeness, matching method to research question, matching method to MPLC stage, validity and reliability, cognitive burden, patient education, attribute development), and study conduct (patients’ ability/willingness to participate and preference heterogeneity). Three types of situations affecting the use of PPS results were identified (stakeholder acceptance, market situations, and clinical situations).Conclusion: The factors and situation types affecting the value of PPS, as identified in this study, need to be considered when designing and conducting PPS in order to promote the integration of PPI into decision-making along the MPLC.

【 授权许可】

Unknown