EAA outputs include scientific publications
This list includes publications by the European Access Academy covering the learnings from the EAA conventions and pre-convention surveys.
EAA publications:
Gsteiger S., Bucher HC., Ryan J., Ruof J.: Technology Assessment vs. Technology Appraisal - How to Strengthen the Science/Value Dichotomy with EU HTA?. JMAHP 12(4), 369-377 (2024). doi: https://doi.org/10.3390/jmahp12040028
Julian E., Belleman T., Garcia MJ., Rutten-van Mölken M., Doeswijk R., Giuliani R., Wörmann BJ., Widmer D., Tilleul P., Casado Aroyo R., Strammiello V., Morgan K., Guardian M., Ermisch M., Bernardini R., Gianfrate F., Capri S., Uyl-de Groot CA., Pavlovic M., Ruof J.: EU HTA: Avoiding Error and Finding the Right Balance: Insights generated by the European Access Academy. Manuscript submitted for publication. (2024)
Julian E., Solà-Morales O., Garcia MJ., Brinkhuis F., Pavlovic M., Martín Saborido C., Doeswijk R., Giuliani R., Willemsen A., Goettsch W., Wörmann BJ., Dafni U., Bucher HC., Valderrama BP., Bernardini R., Gianfrate F., Uyl.de Groot CA., Ruof J.: The Role of Medical Societies and the Relevance of Clinical Perspective in the Evolving EU HTA Process: Insights generated at the 2023 Fall Convention and Survey of the European Access Academy. JMAHP 12(3), 128-143, (2024). doi: https://doi.org/10.3390/jmahp12030011
Brinkhuis F., Julian E., van den Ham H., Gianfrate F., Strammiello V., Berntgen M., Pavlovic M., Mol P., Wasem J., van Dyck W., Cardone A.,
Dierks C., Schiel A., Bernardini R., Solà-Morales O., Ruof J., Goettsch W.:
Navigating the path towards successful implementation of the EU HTA Regulation: Key takeaways from the 2023 Spring Convention of the European Access Academy.
Health Res Policy Sys
22,74 (2024). doi: https://doi.org/10.1186/s12961-024-01154-2
Brinkhuis F., Ruof J., van den Ham H., Gianfrate F., Strammiello V., Berntgen M., Pavlovic M., Mol P., Wasem J., van Dyck W., Cardone A.,
Dierks C., Schiel A., Solà-Morales O., Goettsch W., Julian E.: Evaluating progress towards EU HTA: Insights generated from the European Access Academy’s multi-stakeholder questionnaire. Health Policy and Technology 13(5) (2024)
Desmet T., Julian, E., 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., Schiel A., Goettsch W., Gianfrate F., Capri S., Ryan J., Ducournau P., Solà-Morales O., Ruof J.: An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators. JMAHP 12(1), 21-34, (2024). doi: https://doi.org/10.3390/jmahp12010004
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., Schiel A., Goettsch W., Gianfrate F., Capri S., Ryan J., Ducournau P., Solà-Morales O., Julian E.: The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy’s multi-stakeholder pre-convention questionnaire. JMAHP 11, 1, (2023). doi: https://doi.org/10.1080/20016689.2023.2217543
Julian E., Gianfrate F., Sola-Morales O., Mol PGM., Bergmann JF., Salmonson T., Hebborn A., Grande M., Ruof J.: How can a Joint European Health Technology Assessment provide an 'Additional Benefit' over the current Standard of National Assessments?. Health Econ. Rev. 12, 30 (2022). doi: https://doi.org/10.1186/s13561-022-00379-7
Julian E., Pavlovic M., Solá-Morales O., Gianfrate F., Toumi M., Bucher H.C., Dierks C., Greiner W., Mol P., Bergmann JF., Salmonson T., Hebborn A., Grande M., Cardone A., Ruof J.: Shaping a research agenda to ensure a successful European health technology assessment: insights generated during the inaugural convention of the European Access Academy. Health Econ. Rev. 12, 54 (2022). doi: https://doi.org/10.1186/s13561-022-00402-x
EAA Convention Proceedings:
EAA Fall Convention October 2024
EU HTA - Transitioning from Preparation to Implementation
Approaching the Pain Points
Download the
Proceedings of the EAA Fall Convention 2024
HERE.
Welcome by Fabrizio Gianfrate (University of Ferrara) and Jörg Ruof (EAA Secretariat)
Dirk Van den Steen
(Deputy Head of Unit at DG Santé, European Commission)
Marco Marchetti
(Co-Chair at HTA Coordination Group)
Robert Giovanni Nisticò (President at AIFA)
Elias Pèan
(Head of Oncology and Radiopharmaceuticals, EMA)
Robin Doeswijk
(Head of European Affairs, EHA)
François Houÿez
(Director of Treatment Information and Access, EURORDIS)
Bernhard Wörmann
(Medical Superintendent at DGHO & Charité University Medicine)
Nathalie Largeron
(Global Head of HTA Strategy, Sanofi)
Panel Discussion
(E. Pèan, R. Doeswijk, F. Houÿez, B. Wörmann, N. Largeron, Video: M. Marchetti)
Paolo Casali
(Director of Medical Oncology Istituto Nazionale Tumori, Milan & Council Member, ESMO
Josie Godfrey (Director, JG Zebra & former Lead of NICE Highly Specialised Technology Programme) & Alessandro Ciardiello (Consultant Ophthalmologist, Ospedale Parodi Delfino & Teacher, University of Tor Vergata)
EAA Spring Convention April 2024
EU HTA - Finding the Right Balance
Download the
Proceedings of the EAA Spring Convention 2024
HERE.
Maureen Rutten-van Mölken
(Head of HTA Department at ESHPM, Erasmus University)
Maya Matthews
(Head of Unit at DG Santé, European Commission)
Bernhard Wörmann
(Medical Superintendant at DGHO & Charité University Medicine)
Antonella Cardone
(CEO at Cancer Patients Europe)
Maiwenn Al
(HTA Department at ESHPM, Erasmus University)
Stefan Lange
(former Deputy Head at IQWiG)
Francesco Pignatti
(Scientific Advisor for Oncology at EMA)
Elisabeth de Vries
(Cancer Medicines Committee & MCBS Working Group at ESMO)
Laetitia Mariani
(HTA Collaborations Lead at Abbvie)
Panel Discussion
(B. Wörmann, A. Cardone, M. Al, S. Lange, F. Pignatti, E. de Vries, L. Mariani)
Carin Uyl-de Groot
(HTA Department at ESHPM, Erasmus University)
Michael Ermisch
(Head of Department AMNOG G-BA at GKV-SV
EAA Fall Convention October 2023
Haemato- / Oncology - A Pace Maker for EU HTA
Download the
Proceedings of the EAA Fall Convention 2023
HERE.
Welcome & Introduction:
Impulse Presentations:
Caroline Pothet
(Head of Advanced Therapies and Haematological Diseases at EMA)
Roisin Adams
(Chair of the HTA Coordination Group)
Elisabeth de Vries
(Cancer Medicines Committee & MCBS Working Group at ESMO)
César Hernández García
(Director General of Common NHS Portfolio and Pharmacy, Ministry of Health Spain)
Martin Kaiser
(European Hematology Association)
Bernhard Wörmann
(Medical Superintendant at German Society for Hematology and Oncology
(DGHO))
Brian Cuffel
(VP & Head of Market Access Oncology at Bayer Pharmaceuticals)
Panel Discussion:
(C. Pothet, R. Adams, E. de Vries, M. Kaiser, B. Wörmann, B. Cuffel; O. Solà-Morales, J. Ruof)
EAA Spring Convention April 2023
Midterms & Status of the Preparation Phase of the EU HTA Regulation
Download the
Proceedings of the EAA Spring Convention 2023
HERE.
Welcome & Introduction:
Impulse Presentations:
Maya Matthews
(Head of Unit at DG Santé, European Commission)
Michael Berntgen
(Head of Scientific Evidence Generation Department, EMA)
Valentina Strammiello
(Director of Programmes, European Patients’ Forum)
Renato Bernardini
(Professor of Pharmacology, University of Catania School of Medicine & Deputy President, AIFA)
Michal Ermisch
(Division of Pharmaceuticals, National Association of Statutory Health Insurance Funds, Germany)
Ansgar Hebborn
(Head, European Access Policy Affairs, Roche & Chair of the HTA Working Group, EFPIA)
Andrew Wilson
(Chair, Pharmaceutical Benefits Advisory Committee, Australian Department of Health and Aged Care & Co-Director, Menzies Centre for Health Policy and Economics, University of Sydney)
Panel Discussion:
(M. Matthews, M. Berntgen, V. Strammiello, R. Bernardini, M. Ermisch, A. Hebborn, A. Wilson)
EAA Fall Convention October 2022
Stakeholder Involvement & Europe's Evolving HTA Framework
Download the
Proceedings of the EAA Fall Convention 2022
HERE.
Impulse Presentations:
Rosa Giuliani
(Director of Public Policy at ESMO)
François Houÿez
(Director of Treatment Information and Access at EURORDIS)
Michael Berntgen
(Head of Scientific Evidence Generation Department, EMA)
Renato Bernardini
(Member & Dean, Board of Directors at AIFA)
Marc Van De Casteele
(Coordinator Assessment of Pharmaceuticals for Reimbursement at RIZIV-INAMI)
James Ryan
(Co-Lead, HTA Working Group Workstream on Methodology at EFPIA & Director, HTA Policy at AstraZeneca)
Dinner Speech:
Marcus Guardian
(Chief Operating Officer, EUnetHTA21 Consortium)
EAA Spring Convention May 2022
Europe's evolving HTA Regulation & it's relevance for 'Beating Cancer'
Download the Proceedings of the inaugural Convention of the EAA HERE.
Impulse Presentations:
Ioana Siska
(Policy Officer, European Commission, DG Santé, Medical Devices and Health Technology Assessment Unit)
Antonella Cardone
(Patient Advocacy Expert at Pancreatic Cancer Europe)
Solange Peters
(Professor of Medical Oncology and President of ESMO)
Anja Schiel
(Lead Methodologist in Regulatory and Pharmacoeconomic Statistics NoMA)
Michael Ermisch
(Division of Pharmaceuticals, National Association of Statutory Health Insurance Funds, Germany)
Richard Price
(Head of Policy; European Cancer Organisation)
Ansgar Hebborn
(Head, European Access Policy Affairs, Roche & Chair of the HTA Working Group, EFPIA)
Other relevant publications:
Albin N., Chassagnol F., Bergmann JF.: Early Access to Health Products in France: Major advances of the French ‘Conseil stratégique des industries des santé (CISIS) to be implemented (modalities, regulations, funding). Therapie. 74(1), 103-117 (2019). doi: 10.1016/j.therap.2018.12.002
Allen A., Patrick H., Ruof J., Buchberger B., Varela-Lema L., Kirschner J., Braune S., Roßnagel F., Giménez E., Cuscó XG., Guilhaume C.: Development and Pilot Test of the Registry Evaluation and Quality Standards Tool: An Information Technology-Based Tool to Support and Review Registries. Value in Health (2022 Mar 8) Online ahead of print. doi: 10.1016/j.jval.2021.12.018.
Chassagnol F., Marcelli G., Wagle J., Giuliani G., Traub D., Schaub V., et al.: Review of Relative effectiveness assessments (REAs) of pharmaceuticals at the European network for health technology assessment (EUnetHTA): a first step towards a con-solidated European perspective on comparative effectiveness & safety? Health Policy 124(9), 943–951 (2020). doi: 10.1016/j.healthpol.2020.06.013
Giuliani G, Chassagnol F, Traub D, Gyldmark M, Hebborn A, Ducournau P, Ruof J.:
Leveraging EUnetHTA's conceptual framework to compare HTA decision drivers in France, Italy, and Germany from a manufacturer's point of view.
Health Econ Rev. Sep 21;8(1):24 (2018). doi: 10.1186/s13561-018-0201-y
Gyldmark M., Lampe K., Ruof J., Pöhlmann J., Hebborn A., Kristensen FB.: IS THE EUNETHTA HTA CORE MODEL® FIT FOR PURPOSE? EVALUATION FROM AN INDUSTRY PERSPECTIVE. Int J Technol Assess Health Care. 34(5):458-463 (2018). doi: 10.1017/S0266462318000594
Jonker CC., de Vries, ST., van den Berg HM., McGettigan P., Hoes AW., Mol PGM.: Capturing Data in Rare Disease Registries to Support Regulatory Decision Making: A Survey Among Industry and Other Stakeholders. Drug Safety 44: 853 - 861 (2021). doi: 10.1007/s40264-021-01081-z
Julian E., Rasch A., Bussilliat P., Ruof J.: Acceptance of best-available evidence in benefit assessment of medicinal products: An analysis of procedures without availability of a randomized-controlled trial. Gesundh ökon Qual man (2023). doi: 10.1055/a-2142-0794
Sola-Morales O., Volmer T., Mantovani L.: Perspectives to mitigate payer uncertainty in health technology assessment of novel oncology drugs. J Mark Access Health Policy 22;7(1) (2019). doi: 10.1080/20016689.2018.1562861