The role of stakeholder involvement in the evolving EU HTA process:

Area of Science:

• Health economics and outcomes research
• Regulatory science
• Health policy

Background:

• The European Union (EU) Health Technology Assessment (HTA) harmonization process requires effective stakeholder engagement for successful implementation.
• Understanding the current and desired roles of various stakeholders is essential for optimizing this process.

Purpose of the Study:

• To assess the current involvement of key stakeholders in the EU HTA framework.
• To determine suggested future roles, identify challenges, and highlight efficient engagement methods for stakeholders.
• To compare self-perceived involvement with external ratings from HTA bodies, payers, and policymakers.

Main Methods:

• A multi-step procedure was used to develop and circulate a survey to diverse stakeholders within the EU HTA framework.
• Key stakeholder groups included patients, clinicians, regulatory representatives, and Health Technology Developers.
• Two survey versions were used: self-rating by key stakeholders and external rating by HTA bodies, payers, and policymakers. Analyses included predefined statistical and qualitative assessments, leading to the development of a RACI chart.

Main Results:

• Fifty-four responses were received from patients, clinicians, regulators, Health Technology Developers, HTA bodies, payers, and policymakers.
• Self-perceived involvement scores were consistently lower across all key stakeholder groups compared to external ratings.
• A RACI (Responsible/Accountable/Consulted/Informed) chart was developed based on survey insights to define stakeholder roles in the EU HTA process.

Conclusions:

• Significant efforts and a dedicated research agenda are necessary to ensure adequate involvement of key stakeholders in the evolving EU HTA harmonization process.
• Addressing the discrepancy between self-perceived and externally perceived involvement is critical for enhancing stakeholder contribution.
• The findings provide a foundation for developing targeted strategies to improve stakeholder engagement and the overall effectiveness of EU HTA harmonization.