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Journal of Market Access & Health Policy (JMAHP) is published by MDPI from Volume 12 Issue 1 (2024). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Taylor & Francis.
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Article

The Role of Stakeholder Involvement in the Evolving EU HTA Process: Insights Generated through the European Access Academy’s Multi-Stakeholder Pre-Convention Questionnaire †

by
Lauren Van Haesendonck
1,
Jörg Ruof
2,3,
Thomas Desmet
1,4,
Walter Van Dyck
4,
Steven Simoens
1,
Isabelle Huys
1,
Rosa Giuliani
5,
Mondher Toumi
6,
Christian Dierks
7,
Juliana Dierks
7,
Antonella Cardone
8,
Francois Houÿez
9,
Mira Pavlovic
10,
Michael Berntgen
11,
Peter G.M. Mol
12,
Anja Schiel
13,
Wim Goettsch
14,20,
Fabrizio Gianfrate
15,
Stefano Capri
16,
James Ryan
17,
Pierre Ducournau
18,
Oriol Solà-Morales
19 and
Elaine Julian
2,*add Show full author list remove Hide full author list
1
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
2
r-connect Ltd, Basel, Switzerland
3
Medical School of Hanover, Hanover, Germany
4
Healthcare Management Centre, Vlerick Business School, Brussels, Belgium
5
Guy’s and St Thomas’ NHS Foundation Trust, London, UK
6
Faculty of Medicine, Public Health Department, Aix-Marseille University, Marseille, France
7
Dierks+Company, Berlin, Germany
8
Cancer Patients Europe Brussels, Belgium
9
European Organisation for Rare Diseases (EURORDIS), Paris, France
10
Medicines Development and Training (MDT) Services, Paris, France
11
Scientific Evidence Generation Department, European Medicines Agency (EMA), Amsterdam, The Netherlands
12
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen (UMCG), University of Groningen, Groningen, The Netherlands
13
Norwegian Medicines Agency (NOMA), Oslo, Norway
14
National Health Care Institute, Diemen, The Netherlands
15
University of Ferrara, Ferrara, Italy
16
School of Economics and Management, Cattaneo-LIUC University, Castellanza, Italy
17
Health Economics and Payer Evidence, Astra Zeneca, Cambridge, UK
18
Global Market Access & Pricing, Abbvie AG, Cham, Switzerland
19
HiTT Foundation, International University of Catalonia-UIC, Barcelona, Spain
20
Utrecht Centre for Pharmaceutical Policy, Division of Pharmacoepidemiology and Clinical Pharmacology, University of Utrecht, Utrecht, The Netherlands
 
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*
Author to whom correspondence should be addressed.
†
This article has been republished with minor changes. These changes do not impact the academic content of the article.
J. Mark. Access Health Policy 2023, 11(1), 2217543; https://doi.org/10.1080/20016689.2023.2217543
Submission received: 27 March 2023 / Revised: 15 May 2023 / Accepted: 18 May 2023 / Published: 4 June 2023

Abstract

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.
Keywords: EUHTA; health policy; stakeholder involvement; health technology assessment EUHTA; health policy; stakeholder involvement; health technology assessment

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MDPI and ACS Style

Van Haesendonck, L.; Ruof, J.; Desmet, T.; Van Dyck, W.; Simoens, S.; Huys, I.; Giuliani, R.; Toumi, M.; Dierks, C.; Dierks, J.; et al. The Role of Stakeholder Involvement in the Evolving EU HTA Process: Insights Generated through the European Access Academy’s Multi-Stakeholder Pre-Convention Questionnaire †. J. Mark. Access Health Policy 2023, 11, 2217543. https://doi.org/10.1080/20016689.2023.2217543

AMA Style

Van Haesendonck L, Ruof J, Desmet T, Van Dyck W, Simoens S, Huys I, Giuliani R, Toumi M, Dierks C, Dierks J, et al. 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. 2023; 11(1):2217543. https://doi.org/10.1080/20016689.2023.2217543

Chicago/Turabian Style

Van Haesendonck, Lauren, Jörg Ruof, Thomas Desmet, Walter Van Dyck, Steven Simoens, Isabelle Huys, Rosa Giuliani, Mondher Toumi, Christian Dierks, Juliana Dierks, and et al. 2023. "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 11, no. 1: 2217543. https://doi.org/10.1080/20016689.2023.2217543

APA Style

Van Haesendonck, L., Ruof, J., Desmet, T., Van Dyck, W., Simoens, S., Huys, I., Giuliani, R., Toumi, M., Dierks, C., Dierks, J., Cardone, A., Houÿez, F., Pavlovic, M., Berntgen, M., Mol, P. G. M., Schiel, A., Goettsch, W., Gianfrate, F., Capri, S., ... Julian, E. (2023). 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, 11(1), 2217543. https://doi.org/10.1080/20016689.2023.2217543

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