The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy’s multi-stakeholder pre-convention questionnaire
ABSTRACTInvolvement 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 involveme...
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2023-12-01
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| Series: | Journal of Market Access & Health Policy |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/20016689.2023.2217543 |
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| author | Lauren Van Haesendonck Jörg Ruof Thomas Desmet Walter Van Dyck Steven Simoens Isabelle Huys Rosa Giuliani Mondher Toumi Christian Dierks Juliana Dierks Antonella Cardone Francois Houÿez Mira Pavlovic Michael Berntgen Peter G.M. Mol Anja Schiel Wim Goettsch Fabrizio Gianfrate Stefano Capri James Ryan Pierre Ducournau Oriol Solà-Morales Elaine Julian |
| author_facet | Lauren Van Haesendonck Jörg Ruof Thomas Desmet Walter Van Dyck Steven Simoens Isabelle Huys Rosa Giuliani Mondher Toumi Christian Dierks Juliana Dierks Antonella Cardone Francois Houÿez Mira Pavlovic Michael Berntgen Peter G.M. Mol Anja Schiel Wim Goettsch Fabrizio Gianfrate Stefano Capri James Ryan Pierre Ducournau Oriol Solà-Morales Elaine Julian |
| author_sort | Lauren Van Haesendonck |
| collection | DOAJ |
| description | ABSTRACTInvolvement 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. |
| format | Article |
| id | doaj-art-b464df9353d045aaaaa896a7a0f4680a |
| institution | DOAJ |
| issn | 2001-6689 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Market Access & Health Policy |
| spelling | doaj-art-b464df9353d045aaaaa896a7a0f4680a2025-08-20T02:54:39ZengMDPI AGJournal of Market Access & Health Policy2001-66892023-12-0111110.1080/20016689.2023.2217543The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy’s multi-stakeholder pre-convention questionnaireLauren Van Haesendonck0Jörg Ruof1Thomas Desmet2Walter Van Dyck3Steven Simoens4Isabelle Huys5Rosa Giuliani6Mondher Toumi7Christian Dierks8Juliana Dierks9Antonella Cardone10Francois Houÿez11Mira Pavlovic12Michael Berntgen13Peter G.M. Mol14Anja Schiel15Wim Goettsch16Fabrizio Gianfrate17Stefano Capri18James Ryan19Pierre Ducournau20Oriol Solà-Morales21Elaine Julian22Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgiumr-connect Ltd, Basel, SwitzerlandDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumHealthcare Management Centre, Vlerick Business School, Brussels, BelgiumDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumGuy’s and St Thomas’ NHS Foundation Trust, London, UKFaculty of Medicine, Public Health Department, Aix-Marseille University, Marseille, FranceDierks+Company, Berlin, GermanyDierks+Company, Berlin, GermanyCancer Patients Europe Brussels, BelgiumEuropean Organisation for Rare Diseases (EURORDIS), Paris, FranceMedicines Development and Training (MDT) Services, Paris, FranceScientific Evidence Generation department, European Medicines Agency (EMA), Amsterdam, The NetherlandsDepartment of Clinical Pharmacy and Pharmacology, University Medical Center Groningen (UMCG), University of Groningen, Groningen, The NetherlandsNorwegian Medicines Agency (NOMA), Oslo, NorwayNational Health Care Institute, Diemen, The NetherlandsUniversity of Ferrara, Ferrara, ItalySchool of Economics and Management, Cattaneo-LIUC University, Castellanza, ItalyHealth Economics and Payer Evidence, Astra Zeneca, Cambridge, UKGlobal Market Access & Pricing, Abbvie AG, Cham, SwitzerlandHiTT Foundation, International University of Catalonia-UIC, Barcelona, Spainr-connect Ltd, Basel, SwitzerlandABSTRACTInvolvement 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.https://www.tandfonline.com/doi/10.1080/20016689.2023.2217543EUHTAHealth policyStakeholder involvementHealth technology assessment |
| spellingShingle | Lauren Van Haesendonck Jörg Ruof Thomas Desmet Walter Van Dyck Steven Simoens Isabelle Huys Rosa Giuliani Mondher Toumi Christian Dierks Juliana Dierks Antonella Cardone Francois Houÿez Mira Pavlovic Michael Berntgen Peter G.M. Mol Anja Schiel Wim Goettsch Fabrizio Gianfrate Stefano Capri James Ryan Pierre Ducournau Oriol Solà-Morales Elaine Julian The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy’s multi-stakeholder pre-convention questionnaire Journal of Market Access & Health Policy EUHTA Health policy Stakeholder involvement Health technology assessment |
| title | The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy’s multi-stakeholder pre-convention questionnaire |
| title_full | The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy’s multi-stakeholder pre-convention questionnaire |
| title_fullStr | The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy’s multi-stakeholder pre-convention questionnaire |
| title_full_unstemmed | The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy’s multi-stakeholder pre-convention questionnaire |
| title_short | The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy’s multi-stakeholder pre-convention questionnaire |
| title_sort | role of stakeholder involvement in the evolving eu hta process insights generated through the european access academy s multi stakeholder pre convention questionnaire |
| topic | EUHTA Health policy Stakeholder involvement Health technology assessment |
| url | https://www.tandfonline.com/doi/10.1080/20016689.2023.2217543 |
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