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Early Dialogues for Pharmaceutical Products in European Network for Health Technology Assessment Joint Action 3: What Was Done and Where to Go in the Future

Published online by Cambridge University Press:  24 March 2022

Margaret Galbraith Open the ORCID record for Margaret Galbraith [Opens in a new window] ,
Chantal Guilhaume  and
Chantal Bélorgey
Margaret Galbraith*
Affiliation:
Division for Assessment and Access to Innovation (DEAI), International Coordination Unit, French National Authority for Health, Saint-Denis, France
Chantal Guilhaume
Affiliation:
Division for Assessment and Access to Innovation (DEAI), International Coordination Unit, French National Authority for Health, Saint-Denis, France
Chantal Bélorgey
Affiliation:
French National Authority for Health, La Plaine, Saint-Denis, France
*
* Author for correspondence: Margaret Galbraith, E-mail: m.galbraith@has-sante.fr
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Abstract

Objectives

The aim of this article is to describe the process, results, and experiences of European Network for Health Technology Assessment (EUnetHTA) Joint Action 3’s (JA3) Early Dialogue (ED) activities and to highlight opportunities for improving the processes.

Methods

A descriptive analysis of the steps of the EUnetHTA ED process and evaluation of the data from the EDs conducted by EU health technology assessment (HTA) bodies, published guidelines, and documents, as well as internal statistics.

Results

In JA3, an Early Dialogues Working Party (EDWP) was established, responsible for developing and improving processes and providing advice to pharmaceutical companies, supported by the ED Secretariat. From June 2017 to May 2021, 113 requests for pharmaceutical EDs were received and 38 conducted. The process was continuously optimized, and different approaches for involving patients were tested. Finally, a centralized procedure was chosen with the key documents produced by two responsible agencies and reviewed by the EDWP. Patient involvement was primarily done by interviewing a national patient representative to obtain general feedback on the disease and the planned study design.

Conclusions

During JA3, EDs were established as an efficient, successful product. Pharmaceutical companies benefited not only from the positions of the individual agencies for the national HTA, but also from the recommendations that were common to all HTA authorities. In addition, regarding the European HTA Regulation, it will be important to conduct Joint Scientific Consultations with a view toward future Joint Clinical Assessments and to further develop processes aligned with the high demand for consultation.

Keywords

Early DialoguesEUnetHTA
Type
Article Commentary
Information
International Journal of Technology Assessment in Health Care , Volume 38 , Issue 1 , 2022 , e30
Copyright
© The Author(s), 2022. Published by Cambridge University Press

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Footnotes

We thank the EUnetHTA EDWP for reviewing and providing valuable input to the draft manuscript.

Luciana Ballini10, Antje Behring4, Carlos Collados1, Veronika Deak4, Veronika Dóczy6, Agniezska Dobrzybska2, Judith Fernandez5, Csilla Galambos6, Krystyna Hviding8, François Maignen7, Gergő Merész6, Deborah Morrison7, David Mwaura8, Mercé Obach3, Sonia Garcia Perez1, Stephanie Said4, Barbara Wernerné Sódar6, Camille Thomassin5, Giorgia Viceconte9, Roser Vilagut3

1Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Calle Campezo, 1 Edificio 8, 28022 Madrid, Spain

2Área de Evaluación de Tecnologías Sanitarias de Andalucía (AETSA), Avda. de la Innovación, Edificio ARENA 1, 41020 Sevilla, Spain

3Agència de Qualitat i Avaluació Sanitàries de Catalunya Servei Català de la Salut (AQuAS-CatSalut), Carrer de Roc Boronat 81, 08005 Barcelona, Spain

4Gemeinsamer Bundesausschuss (G-BA), Gutenbergstraße 13, D-10587 Berlin, Germany

5Haute Autorité de Santé (HAS), 5 Avenue du Stade de France, F-93218 Saint-Denis La Plaine Cedex, France

6National Institute of Pharmacy and Nutrition (NIPN), Zrínyi u.3., 1051 Budapest, Hungary

7National Institute for Health and Care Excellence (NICE), Level 1A, City Tower, Piccadilly Plaza, Manchester M1 4BT, United Kingdom

8Norwegian Medicines Agency (NOMA), Sven Oftedals vei 8, 0950 Oslo, Norway

9Agenzia Italiana del Farmaco (AIFA), Via del Tritone 181, 00187 Rome, Italy

10Regione Emilia Romagna (RER), Viale Aldo Moro 52, 40127 Bologna, Italy

References

European Network for Health Technology Assessment. [Internet] History of EUnetHTA [cited 7 July 2021]. Available at: https://www.eunethta.eu/about-eunethta/history-of-eunethta/. Accessed 7 July 2021.Google Scholar
European Network for Health Technology Assessment. [Internet] JA3 (2016–2021) [cited 7 July 2021]. Available at: https://www.eunethta.eu/ja3-archive/. Accessed 7 July 2021.Google Scholar
Moseley, J, Vamvakas, S, Berntgen, M, et al (2020) Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines. Br J Clin Pharmacol 86, 1034–1051. https://doi.org/10.1111/bcp.14279.CrossRefGoogle ScholarPubMed
European Network for Health Technology Assessment. [Internet] Early dialogues for pharmaceutical products [cited 8 July 2021]. Available at: https://www.eunethta.eu/services/early-dialogues/. Accessed 8 July 2021.Google Scholar
Harousseau, J, Pavlovic, M, Mouas, H, Meyer, F (2015) PHP275—Shaping European early dialogues: The seed project. Value Health 18(7), A562. https://doi.org/10.1016/j.jval.2015.09.1830.CrossRefGoogle Scholar
Tafuri, G, Lucas, I, Estevão, S, et al (2018) The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations. Br J Clin Pharmacol 84(5), 1013–1019. https://doi.org/10.1111/bcp.13524.CrossRefGoogle ScholarPubMed
Wang, T, McAuslane, N, Gardarsdottir, H, et al (2022) Building HTA insights into the drug development plan: Current approaches to seeking early scientific advice from HTA agencies. Drug Discovery Today 27(1), 347–353. https://doi.org/10.1016/j.drudis.2021.09.014.CrossRefGoogle ScholarPubMed
European Network for Health Technology Assessment. [Internet] Early dialogues for pharmaceutical products [cited 8 July 2021]. Available at: https://www.eunethta.eu/services/early-dialogues-for-pharmaceuticals/. Accessed 8 July 2021.Google Scholar
European Network for Health Technology Assessment. [Internet] Guidance on parallel consultation v3 c2020 [cited 8 July 2021]. Available at: https://www.eunethta.eu/wp-content/uploads/2020/07/Guidance-on-parallel-consultation.pdf. Accessed 8 July 2021.Google Scholar
European Network for Health Technology Assessment. [Internet] EUnetHTA guidelines for multi-HTA early dialogues v1 c2020 [cited July 2021]. Available at: https://www.eunethta.eu/wp-content/uploads/2020/07/Guidance-on-parallel-consultation.pdf. Accessed 25 July 2021.Google Scholar
European Network for Health Technology Assessment. [Internet] EUnetHTA JA3 EUnetHTA procedure guidance for handling declaration of interest v1.2 c2021 [cited 8 July 2021]. Available at: https://www.eunethta.eu/wp-content/uploads/2021/06/EUnetHTA_DOI_Procedure_Guidance_version_1_2_final-1.pdf. Accessed 8 July 2021.Google Scholar
REGULATION (EU). 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU [2021] OJ L 458/1. Availabe at: https://eur-lex.europa.eu/eli/reg/2021/2282/oj.Google Scholar
European Network for Health Technology Assessment. [Internet] EUnetHTA Joint Action 3—WP1: A future model of HTA cooperation [cited 18 December 2021]. Available at: https://d2yaq9q3r816qg.cloudfront.net/wp-content/uploads/2021/09/FMC-HTA-WHITE-PAPER-FOR-PUBLICATION.pdf?x16454. Accessed 18 December 2021.Google Scholar
European Network for Health Technology Assessment). [Internet] EUnetHTA 21 [cited 21 September 2021]. Available at: https://www.eunethta.eu/eunethta-21/. Accessed 21 September 2021.Google Scholar