OBJECTIVES: Patient preference information (PPI) is useful for understanding what matters most to patients and the trade-offs they make when making a treatment decision. There is growing interest in PPI among regulatory bodies in principle, but the scope and type of PPI included in regulatory submissions and considered in regulatory reviews and label claims has not previously been synthesized.

METHODS: Tarius, a global regulatory intelligence database, was used to identify regulatory documents where ‘patient preference’ was included in the text. Drug databases was to supplement additional information. The search was limited to drugs or biological treatments in the past 10 years. No regulatory body or therapy area was specified.

RESULTS: Out of 223 documents identified, 36 referenced PPI in a meaningful way, with the majority from EMA (n=30); mostly EPAR documents (n=17). Others included US FDA (n=4), CMDh (n=1), and TGA (n=1). Several documents focused on oncology (n=11) or multiple therapy areas (n=9). Eight documents did not discuss specific PPI data or methods, but more broadly discussed benefits of PPI. Of those documents that included PPI data (n=28), the majority referenced revealed preferences, focusing on patient experiences of given treatments (n=26), using a single PPI question (n=8), validated PPI questionnaires (n=5), qualitative interviews (n=4), PROs (n=4), un-validated PPI questionnaires (n=4), or an ‘unspecified’ questionnaire (n=1). Two documents referenced stated PPI data to quantify trade-offs between benefits and risks, using DCE or MCDA methods. Nineteen documents included PPI data for regulatory submission, and 6 label claims referenced PPI data.

CONCLUSIONS: PPI is captured using various methods for regulatory decision-making, with growing support from regulatory bodies highlighting the importance of PPI. However, for label claims and drug approvals, use of PPI is limited. Given the continued interest in PPI from regulatory bodies, considerations on including approaches for future submissions and label claims should be discussed.