OBJECTIVES: Patient Experience Data (PED), including patient preferences (PP), patient-reported outcomes (PROs) and patient input, are instrumental to better understand patients’ needs and inform decision-making processes. However, the absence of coordinated policy actions currently impede the collection and implementation of PED in practice. This study aims to identify challenges, opportunities, and concrete policy ways forward to systematically embed the use of PED in healthcare decision-making.

METHODS: Semi-structured interviews (n=39) were conducted with stakeholders from industry, academia, regulatory authorities, health technology assessment bodies, reimbursement agencies, patient organizations, and clinicians across Europe. The interviews were transcribed ad verbatim and analysed qualitatively using the thematic framework analysis.

RESULTS: Based on interim analysis (n=13), stakeholders raised following barriers: 1) lack of guidance on requirements and quality criteria for collecting and evaluating PED, particularly PP, 2) lack of validated methods and tools for obtaining robust and high-quality PED, e.g., fit-for-purpose PRO measures, and 3) limited knowledge and transparency on the assessment of PED in regulatory, HTA, and payer decision-making. Stakeholders emphasized the importance of raising awareness on the value of PED, providing training on effective patient involvement, and more research on validated methods and tools. However, there was an impasse concerning which stakeholder group should initiate the first actions. For industry, regulatory guidelines were deemed crucial to enhance more systematic implementation of PED, while regulators preferred gaining more experiences and best practices in assessing PED before drafting guidelines. Stakeholders unanimously called for the development of a clear policy strategy that delineates expectations and responsibilities of each stakeholder group.

CONCLUSIONS: This qualitative study highlights that while certain priorities were shared among stakeholders, there was a lack of consensus on other priorities. It underscores the importance of adopting a collaborative and multi-stakeholder approach to enhance awareness and align expectations, ensuring that decision-making is tailored to meet patients’ needs and preferences.