Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: Where Are We Today?

backgroundAs healthcare stakeholders aim to support patient-centered care, patients play an increasingly important role in pharmaceutical and medical technology development and healthcare decision-making. Patient engagement (PE), patient experience data (PED), and meaningful integration of PE to enrich PED have been evolving rapidly. This landscape review focuses on emerging PE/PED practices and guidelines in 2023.

methodsReferences published between January-December 2023 on the use of PE and PED from health technology assessment (HTA) and regulatory bodies in different countries, three peer-reviewed journals, and referred resources from collaborators were analyzed. These references were compared with those in our previous publication (August 2021-January 2023, 17-month period).

resultsOverall, 28 references from HTA/regulatory bodies, 26 from peer-reviewed articles, and 17 referred resources were identified. Eight references on PE and PED integration (PE + PED) were identified in 2023 from HTA/regulatory bodies, compared with none in the previous 17-month analysis. Emerging trends on the role of PE, PED, and real-world evidence in HTA/regulatory deliberations, transparency and geographic variations in the use of such evidence and practices, and gaps thereof have been highlighted.

conclusionsThe increase in PE, PED, and PE + PED references worldwide in 2023 versus the prior 17-month analysis suggests accelerated adoption of PE + PED practices. However, a need remains for comprehensive, actionable guidance on best practices for use of PE and PED for harmonization and incorporation into HTA/regulatory processes. Patient input-essential for evidence-based decision-making-provides valuable insights that enhance care quality, treatment relevance and effectiveness, and builds trust and sustainability.