The PREFER framework
The framework and points for consideration on method selection that we asked EMA and EUnetHTA to evaluate describes a structured approach to assess and use patient preferences as input in medical product decision-making. These decisions are taken by industry, regulators, HTA bodies and payers in the development, approval and post-approval phases of a medical product’s life cycle.
The actual framework offers a set of principles, guidelines and tools. It provides a structure to guide those who conduct preference studies through what we have identified as key issues in preference study design, study conduct and analysis. The framework also guides decision-makers through assessing and using preference study results in their decisions. These points to consider provide specific applications of the framework across different preference study examples and methods. Which means they describe which methods work best to address specific questions in given situations. And inform decisions taken by the companies that develop medicines, the regulators that approve medicines, and health technology assessment bodies and payers who decide what becomes available to patients.
To support patient input to this process, we have described the framework in non-expert language that supports communications about our work. We have also published a high level summary in plain language about how to plan and carry out a patient preference study for patients and non-experts who want to know more about our ongoing patient preference case studies.
Introduction to the PREFER framework & what we’d like this to achieve
Conny Berlin, IMI PREFER Project Leader & Global Head, Quantitative Safety and Epidemiology Novartis Pharma AG, Switzerland
How the PREFER framework addresses the study purpose; study organization, design & conduct
Kristin Bullok, Benefit-Risk Management Scientist, Global Patient Safety; Eli Lilly and Company, United States
Points to consider for method selection
Brett Hauber, Senior Director, Patient Preference Elicitation Pfizer, United States
PREFER framework continued: application of preference data to inform regulatory decision-making
Bennett Levitan, Senior Director, Benefit-Risk Assessment, Global R&D Epidemiology; Janssen Research & Development, United States
PREFER framework continued further: application of preference data to inform HTA decision-making
Irina Cleemput, Scientific Programme Director Belgian Health Care Knowledge Centre (KCE), Belgium