Guiding Principles for Evaluating Vaccines in Joint Health Technology Assessment in the European Union: Preparing for the European Union's Regulation on Health Technology Assessment for Vaccines.

Autor: Largeron N; Sanofi, Espace Henry Vallée, Lyon, France., D'Agostino P; CSL SEQIRUS, Munich, Germany., Chapman R; Evidera Inc, London, England, UK., Danko D; Ideas & Solutions, Budapest, Hungary., Eskola J; National Institute for Health and Wellfare, Helsinki, Finland., Godfroid P; EMEA Pricing and Tender Lead IDV, Johnson & Johnson Innovative Medicine, Diegem, Belgium., Feldmajer G; Evidera Inc, Budapest, Hungary., Hanley R; Head Value Access and Health Economics Global Vaccines, Takeda, Zug, Switzerland., de Pouvourville G; ESSEC Business School, Cergy Pontoise, France., Postma M; Department of Health Sciences, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; Department of Economics, Econometrics and Finance, Faculty of Economics and Business, University of Groningen, Groningen, The Netherlands; Center of Excellence in Higher Education for Pharmaceutical Care Innovation, Universitas Padjadjaran, Bandung, Indonesia., Puig-Barberà J; Vaccines Research Area, FISABIO (Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana), Valencia, Spain., Schaible K; Evidera Inc, Waltham MA, USA., Sabale U; Center for Observational and Real-World Evidence (CORE), MSD, Vilnius, Lithuania., Schmitt J; Global Health Press, Germany/Singapore., de Waure C; Department of Medicine and Surgery, University of Perugia, Perugia, Italy., Vicere A; Vaccines Europe, EFPIA, Brussels, Belgium. Electronic address: anna.vicere@vaccineseurope.eu., Beck E; GSK, Wavre, Belgium.
Jazyk: angličtina
Zdroj: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research [Value Health] 2024 Oct; Vol. 27 (10), pp. 1318-1327. Date of Electronic Publication: 2024 Jul 06.
DOI: 10.1016/j.jval.2024.06.011
Abstrakt: Objectives: The appraisal of vaccines in the European Union (EU) currently involves many different decision-making bodies and processes. The objective of this study was to help inform the development of standardized methodology and vaccine-specific processes for use in the EU Regulation on health technology assessment (HTA).
Methods: Literature reviews and expert consultation were conducted to identify current practices and gaps related to vaccine appraisals and to develop guiding principles for the joint clinical assessment of vaccines.
Results: We found that significant variation exists across the EU member states in the decision-making processes when clinically evaluating vaccines. Three guiding principles consisting of 13 recommendations were developed to help inform the development of decision-making frameworks for the joint clinical assessment of vaccines in the EU: (1) support the creation of appropriate terminology and measurements for clinical appraisals of vaccines; (2) develop inclusive, timely, and transparent vaccine appraisal processes to support stronger evidence generation for vaccine decision making and appraisal; and (3) improve the collection and interoperability of real-world data, including robust surveillance, to foster evidence generation and support the standardization of vaccine clinical appraisals.
Conclusions: Given the significance of vaccines for public health, there is an urgency to develop standardized and vaccine-specific methodologies and processes for use in the EU joint HTA framework. The proposed guiding principles could support the effective implementation of the EU Regulation on HTA for vaccines and have the potential to ensure consistent, transparent, and timely access to new vaccines in the EU.
Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section.
(Copyright © 2024. Published by Elsevier Inc.)
Databáze: MEDLINE
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