STAKEHOLDER PERSPECTIVES ON THE INTEGRATION OF PATIENT PREFERENCES IN THE MEDICAL PRODUCT LIFE CYCLE: A MULTIMETHOD APPROACH
Janssens R1, Huys I2, van Overbeeke E1, Whichello C3, de Bekker-Grob E3, Kübler J4, Harding S5, Juhaeri J6, Levitan B7, Cleemput I8, Russo S9, Schölin Bywall K10, Veldwijk J10 1University of Leuven, Leuven, Belgium, 2KU Leuven, Leuven, Belgium, 3Erasmus University Rotterdam, Rotterdam, The Netherlands, 4QSciCon, Marburg, Germany, 5Takeda Development Centre Europe Ltd., London, UK, 6Sanofi, Bridgewater, NJ, USA, 7Janssen R&D, Titusville, NJ, USA, 8Belgian Health Care Knowledge Institute (KCE), Brussels, Belgium, 9European Institute of Oncology, Milan, Italy, 10Uppsala University, Uppsala, Sweden
OBJECTIVES: This study aimed to explore stakeholders’ desires, expectations, concerns and requirements regarding the measurement and use of patient preferences throughout the medical product life cycle. METHODS: This study used a four-step multimethod approach. First, 16 exploratory interviews were conducted. Second, a literature review consulting scientifically published and other publicly available documents was performed. Third, 144 semi-structured interviews were conducted with stakeholders (patients, informal caregivers, patient representatives, physicians, regulators, reimbursement agency representatives, health technology assessment representatives, industry representatives, academics) from Sweden, Romania, Italy, the United Kingdom, the Netherlands, Germany, France and the United States. Fourth, 8 focus groups with different representatives from the same stakeholder groups were designed. RESULTS: The exploratory interviews with patient representatives (n=4), physicians (n=2), regulators (n=2), health technology assessment representatives (n=4), industry representatives (n=3) and academics (n=1) revealed a lack of consensus on the definition for patient preferences. Interviewees agreed on the value of using patient preferences in all stages of the medical product life cycle. The literature review showed that the use of patient preferences to inform industry, marketing authorization, health technology assessment and reimbursement decision-making is desired by stakeholders. Stakeholders’ requirements for measuring and using patient preferences are general, operational and quality requirements. Stakeholders expect that using patient preferences will lead to more meaningful results when used for industry decision-making and a higher legitimacy and public acceptance of marketing authorization and reimbursement decisions. Stakeholders are concerned about methodological and scientific aspects and the lack of guidance for measuring and using patient preferences. Results of the semi-structured interviews and focus groups will also be presented at the ISPOR congress. CONCLUSIONS: Although the use of patient preferences is desired by stakeholders, their concerns and requirements need to be addressed before patient preferences can be integrated throughout the medical product life cycle.