The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy’s multi-stakeholder pre-convention questionnaire

Abstract

Involvement of all relevant stakeholders will be of utmost importance for the success of the developing EU HTA harmonization process. A multi-step procedure was applied to develop a survey across stakeholders/collaborators within the EU HTA framework to assess their current level of involvement, determine their suggested future role, identify challenges to contribution, and highlight efficient ways to fulfilling their role. The ‘key’ stakeholder groups identified and covered by this research included: patients‘, clinicians‘, regulatory, and Health Technology Developer representatives. The survey was circulated to a wide expert audience including all relevant stakeholder groups in order to determine self-perception by the ‘key’ stakeholders regarding involvement in the HTA process (self-rating), and in a second, slightly modified version of the questionnaire, to determine the perception of ‘key’ stakeholder involvement by HTA bodies, payers, and policymakers (external rating). Predefined analyses were conducted on the submitted responses. Fifty-four responses were received (patients 9; clinicians: 8; regulators: 4; HTDs 14; HTA bodies: 7; Payers: 5; policymakers 3; others 4). The mean self-perceived involvement score was consistently lower for each of the ‘key’ stakeholder groups than the respective external ratings. Based on the qualitative insights generated in the survey, a RACI Chart (Responsible/Accountable/Consulted/Informed) was developed for each of the stakeholder groups to determine their roles and involvement in the current EU HTA process. Our findings suggest extensive effort and a distinct research agenda are required to ensure adequate involvement of the key stakeholder groups in the evolving EU HTA process.

An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators

“…In preparation for the discussions, various working groups were identified, and leadership teams were assigned to each working group. A key insight derived from the pre-convention survey [ 13 ] was the relevance of including academic stakeholders in the evolving EU HTA process. However, as the primary role of the EAA and the involved academic participants is rather to facilitate the “inclusive civil society dialogue”, it was decided prior to the convention not to include academic stakeholders as a separate working group, bringing the total to five dedicated working groups.…”

“…Based on the wording of the EU HTAR, the direct impact of EU HTA procedures, and the relevance of EU HTAR outcomes, four key stakeholder groups were identified: (i) patients and patients’ representatives; (ii) clinicians, healthcare practitioners, and medical societies (clinicians’ representatives); (iii) regulators; and (iv) industry associations and health technology developers (HTD, industry representatives). National HTA bodies and payers are considered a separate group, as they are not stakeholders listed within the regulation but are considered stakeholders due to their roles in the access process, conducting the HTA assessment, and, depending on the national system, as decision-makers regarding appraisal and/or pricing and reimbursement [ 13 ]. While national HTA bodies typically assess the (comparative) effectiveness and, in some member states, also the cost-effectiveness and budget impact of health technologies (medical treatments, devices, healthcare interventions) to inform healthcare decision-making, payers can include health insurance companies or government health agencies that provide healthcare services to the general public and might, in certain contexts, also be decision-makers, pertaining to pricing and reimbursement of health technologies.…”

“…While regulators are not covered in recital 44 of the EU HTAR and would be considered collaborators rather than stakeholders, they were included in subsequent analyses due to their critical role in the European market access process [ 6 , 13 ]. The EAA Fall Convention was preceded by the development and conduct of a multi-stakeholder questionnaire.…”

“…The questionnaire results revealed an important difference between the self-perceived involvement of each key stakeholder group within the current HTA process (perceived to be very low) and respective external perceptions of the stakeholders’ involvement by HTA bodies, payers, and health policymakers (rated rather high). Respective results are reported elsewhere [ 13 ] and accumulated in a RACI chart, reflecting the level of “Responsibility”, “Accountability”, “Consultation”, and “Information” for each of the stakeholders/collaborators in the centralized procedure, as per the current EU HTAR [ 6 , 13 ].…”

“…Based on the insights from the pre-convention survey [ 13 ], this study aims to revisit the responses received with respect to the suggested roles and challenges for each stakeholder/collaborator group within the EU HTA process (both in the preparatory and implementation phase) and to identify the most important activities per group to increase their respective level of involvement.…”