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European Health Technology Assessment (EU HTA)
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European Health Technology Assessment (EU HTA)

A special issue of Journal of Market Access & Health Policy (ISSN 2001-6689).

Deadline for manuscript submissions: closed (28 February 2025) | Viewed by 5676

Special Issue Editors

Prof. Dr. Jörg Ruof

E-Mail Website
Guest Editor
1. Medical School of Hanover, 30625 Hanover, Germany
2. European Access Academy, 4059 Basel, Switzerland
Interests: health economic; health technology assessment; health services; health outcomes and management
Prof. Dr. Mondher Toumi

E-Mail Website
Guest Editor
Public Health Department, Aix-Marseille University, 13002 Marseille, France
Interests: health economics; outcome research; pricing; market access; epidemiology; risk management; governmental affairs; competitive intelligence

Special Issue Information

Dear Colleagues,

The Health Technology Assessment (HTA) process in Europe has been emerging over the past two decades, with various pilot projects and joint actions paving the way for a unified approach.

The EU-HTA initiative aims to establish a harmonized framework for assessing the clinical and economic value of health technologies, make innovative health technologies more widely available to patients, reduce the duplication of efforts by national HTA bodies, and ensure resource efficiency across member states. This process is expected to significantly shape market access strategies in Europe over the next decade.

While the EU-HTA process differs from the drug regulatory process overseen by the EMA, the latter’s experience can serve as a valuable benchmark for the future evolution of EU-HTA. Like the EMA, the EU-HTA initiative is likely to go through various phases, including conception, initiation, positioning, and maturation, before establishing itself as a well-respected international organization advising Member States and informing the European Commission.

We are now setting the foundation of the EU-HTA that will shape the future. It has become a pivotal topic in the field of HTA, as it has the potential to streamline the evaluation process, promote transparency, and facilitate harmonized access to innovative healthcare solutions for patients across Europe.

While a wealth of information is available through various sources, such as the EU’s official website, scientific publications, blogs, conferences, and webinars, there is a need for a comprehensive resource that consolidates relevant information and diverse perspectives on the EU-HTA. By gathering insights from multiple stakeholders, we can gain a deeper understanding of the current status, challenges, opportunities, and future prospects of this initiative.

With the EU HTA Assessments starting from January 2025, we believe that it is the right time to make a pause and consider a multi-stakeholder perspective on this status, an analysis of challenges and opportunities, and some prospective views about EU-HTA. We are pleased to announce that the European Access Academy (EAA) and the Market Access Society (MAS) have joined forces to edit a Special Issue of the Journal of Market Access and Health Policy focused on the EU-HTA.

We encourage you to consider contributing to this Special Issue and sharing your expertise and/or perspective with the broader market access and HTA communities. Your role and insights are invaluable in shaping the discourse around this transformative regulation. Please feel free to reach out to us with any questions or to discuss potential contribution ideas. We look forward to receiving your valuable contributions.

Prof. Dr. Jörg Ruof
Prof. Dr. Mondher Toumi
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Journal of Market Access & Health Policy is an international peer-reviewed open access quarterly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1500 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • EU HTA regulation, EU HTA process
  • innovative health technologies
  • patient access, European Access Environment
  • HTA procedures
  • EU HTA initiative
  • HTA bodies
  • European Access Academy
  • Market Access Society
  • HTA community

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Published Papers (8 papers)

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Editorial

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3 pages, 656 KiB  
Editorial
Agenzia Italiana del Farmaco (AIFA): Developments and Strategy in a Transitioning European HTA Landscape
by Robert Nisticò
J. Mark. Access Health Policy 2025, 13(1), 5; https://doi.org/10.3390/jmahp13010005 - 5 Feb 2025
Viewed by 626
Abstract
The Agenzia Italiana del Farmaco (AIFA) is the national public body that regulates medicines for human use in Italy [...] Full article
(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))
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Research

Jump to: Editorial, Other

9 pages, 195 KiB  
Article
ARM’s Perspective on the First Joint Clinical Assessments for ATMPs: Challenges and Opportunities on the Path Ahead
by Paolo Morgese, Stephen Majors and Dilip Patel
J. Mark. Access Health Policy 2025, 13(2), 14; https://doi.org/10.3390/jmahp13020014 - 3 Apr 2025
Viewed by 235
Abstract
Advanced Therapy Medicinal Products (ATMPs) are revolutionising modern medicine. By addressing the root cause rather than the symptoms of disease, ATMPs hold the promise of long-lasting benefits or even cures for severe, genetic, and rare diseases—including rare cancers—for patients with few or no [...] Read more.
Advanced Therapy Medicinal Products (ATMPs) are revolutionising modern medicine. By addressing the root cause rather than the symptoms of disease, ATMPs hold the promise of long-lasting benefits or even cures for severe, genetic, and rare diseases—including rare cancers—for patients with few or no viable treatment options. At the same time, the inherent complexities of ATMPs pose challenges to traditional HTA frameworks. Unlike conventional treatments, ATMPs are often one-time therapies with a high magnitude of effect. However, their long-term durability remains uncertain at launch. The Joint Clinical Assessment (JCA), under the EU’s Health Technology Assessment (HTA) Regulation, represents a once-in-a-generation opportunity to consolidate the strengths of national HTA processes into a unified framework that accounts for the specificities of ATMPs and streamlines decision-making, cementing Europe’s position as a pioneer in innovative HTA approaches. While concerns remain regarding the suitability of current JCA methodologies for ATMPs, the HTA Regulation continues to bring the HTA ecosystem closer together, with numerous benefits already emerging from EU-wide collaboration on JCAs. This article outlines the HTA challenges posed for and by ATMPs, and ARM’s perspective on the JCA’s implementation. A ‘fit for purpose’ JCA holds the promise to unlocking these therapies’ benefits for individuals across Europe. Full article
(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))
12 pages, 763 KiB  
Article
Ensuring the Efficiency and Effectiveness of Joint Clinical Assessment in National HTA Decision-Making: Insights from the 2024 CIRS Multi-Stakeholder Workshop
by Ting Wang and Neil McAuslane
J. Mark. Access Health Policy 2025, 13(1), 9; https://doi.org/10.3390/jmahp13010009 - 3 Mar 2025
Viewed by 440
Abstract
Background: This study explored the readiness and strategic considerations of companies and key stakeholders for the implementation of the Joint Clinical Assessment (JCA) under the European Health Technology Assessment Regulation (HTAR). It examined the implications of the JCA process for jurisdictional submission strategies, [...] Read more.
Background: This study explored the readiness and strategic considerations of companies and key stakeholders for the implementation of the Joint Clinical Assessment (JCA) under the European Health Technology Assessment Regulation (HTAR). It examined the implications of the JCA process for jurisdictional submission strategies, and decision-making across Europe. The study aimed at identifying key measures for an efficient and effective JCA process to enable national rollout. Methods: A survey was conducted with international pharmaceutical companies, followed by a multi-stakeholder workshop that expanded on the findings. The survey and workshop focused on key areas such as time to market, submission strategies, and the role of JCA in national decision-making processes. Descriptive and qualitative analyses were performed to identify recommendations for measuring and improving the JCA process. Results: 13 companies responded to the survey, respondents were generally prepared for the JCA process (readiness rated 6–7/10), but concerns persist about timeline uncertainties and timely JCA report delivery. In the short term, success for the HTAR from the company perspective is measured by positive recommendations across EU jurisdictions. Long term, the focus shifts to aligning HTA methodologies and evidence requirements across the EU. Establishing metrics to assess the efficiency and effectiveness of the JCA is a key step in the HTAR’s ongoing learning journey. To enhance the efficiency of the JCA process, a list of metrics is recommended for continuous improvement, as well as establishing training programs to strengthen member states’ capabilities, fostering open dialog for sharing technology-specific insights, and creating open-source tools to support companies. Additionally, research should be conducted to understand agencies’ expectations of the JCA and how they will use its reports, grouping agencies by archetype to identify trends. A key recommendation is the development of a product-based scorecard to evaluate JCA submissions and reviews from various perspectives, ensuring the process meets stakeholders’ needs and can be effectively utilized in national decision-making. Conclusions: The JCA process offers a significant opportunity to streamline HTA decision-making across Europe. This study highlights several key measures and consideration for its successful rollout, including the need for clearer communication about the role of JCA in national decisions, measurement of rollout time components, and the development of quality evaluation frameworks. A collaborative, iterative approach, where stakeholders continually refine the system, will be essential for its effectiveness. Addressing these challenges will enable the JCA to enhance efficiency, consistency, and ultimately improve access to treatments for patients. Full article
(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))
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17 pages, 1547 KiB  
Article
Avoiding Error and Finding the Right Balance in European Health Technology Assessments: Insights Generated by the European Access Academy
by Elaine Julian, Tom Belleman, Maria João Garcia, Maureen Rutten-van Mölken, Robin Doeswijk, Rosa Giuliani, Bernhard J. Wörmann, Daniel Widmer, Patrick Tilleul, Ruben Casado Arroyo, Valentina Strammiello, Kate Morgan, Marcus Guardian, Michael Ermisch, Renato Bernardini, Fabrizio Gianfrate, Stefano Capri, Carin A. Uyl-de Groot, Mira Pavlovic and Jörg Ruof
J. Mark. Access Health Policy 2025, 13(1), 6; https://doi.org/10.3390/jmahp13010006 - 10 Feb 2025
Viewed by 621
Abstract
Background: We examined four potential challenges for the implementation of the European Union (EU) Regulation 2021/2282 on Health Technology Assessment (EU HTAR): interaction with the European Medicines Agency (EMA), expert input, the interface of European health technology assessment (EU HTA) joint procedures with [...] Read more.
Background: We examined four potential challenges for the implementation of the European Union (EU) Regulation 2021/2282 on Health Technology Assessment (EU HTAR): interaction with the European Medicines Agency (EMA), expert input, the interface of European health technology assessment (EU HTA) joint procedures with those within Member States, and the management of conflict of interest. This research aims to explore how to address these challenges in a balanced manner and prioritise key actions for effective collaboration in the context of the EU HTA. Methods: The methodology included a pre-convention survey among relevant stakeholders as well as working groups and the plenary ranking of discussion outcomes at the European Access Academy (EAA) Spring Convention 2024. Results: In the survey, 65.5% of respondents indicated that experts are currently not sufficiently included in the upcoming joint scientific consultations and clinical assessments; only 37.9% suggested that the EU HTA joint procedures would accelerate national appraisal decision-making, and 58.6% believed that the principles of ‘transparency’ and ‘competency’ are balanced in the EU HTA position on conflict of interest. The top priority action points identified in the working groups were the involvement of the best available expertise, the early and inclusive involvement of experts, strengthened early scientific dialogue, and the fostering of the political willingness/financial support of EU Member States to increase capacities. Conclusions: The key topics identified were an approach to conflict of interest that balances transparency obligations and the need for expertise, strengthens the involvement of clinical and patient experts, intensifies early interaction between the EMA and EU HTA, and increases the involvement of the EU Member States. Full article
(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))
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Other

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14 pages, 1840 KiB  
Opinion
Strengthening the EU Health Technology Assessment Regulation: Integrating National Immunization Technical Advisory Groups for Comprehensive Vaccine Assessments
by Jasmijn Beekman, Adrianne de Roo, Sharon Wolters, Ramesh Marapin, Gabriel Gurgel do Amaral, Evgeni Dvortsin, Sibilia Quilici, Chiara de Waure, Elena Petelos, Maarten Postma and Anna Viceré
J. Mark. Access Health Policy 2025, 13(2), 16; https://doi.org/10.3390/jmahp13020016 - 18 Apr 2025
Viewed by 53
Abstract
Background: Given their crucial role in vaccine assessment, National Immunization Technical Advisory Groups (NITAGs) should be considered in the Regulation on Health Technology Assessment (EU HTAR) to maximize the benefits of the EU HTAR for vaccines. This review and perspective piece identifies the [...] Read more.
Background: Given their crucial role in vaccine assessment, National Immunization Technical Advisory Groups (NITAGs) should be considered in the Regulation on Health Technology Assessment (EU HTAR) to maximize the benefits of the EU HTAR for vaccines. This review and perspective piece identifies the gaps arising from NITAGs potential lack of involvement and proposes strategies for involving them. Methods: A targeted literature and guideline review was conducted to evaluate NITAGs’ current and future role in relation to the EU HTAR. The impact of the EU HTAR on diverse national HTA frameworks was explored in a three-country case study. Recommendations were developed to leverage strengths and address weaknesses to ensure consistent and cohesive vaccine assessments. Results: The case study revealed potential overlaps between NITAGs and the EU HTAR, particularly regarding horizon scanning and joint scientific consultations. The involvement of NITAGs in national assessments varies, influencing how well joint clinical assessment reports will ultimately align with and be applicable to individual Member States. Conclusions: Stronger consideration of vaccines within the EU HTAR and NITAG involvement can streamline assessments, reduce duplication, and improve alignment between European and national processes. Strategic actions, including capacity building and collaborations between NITAGs, are key in facilitating this process. Full article
(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))
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5 pages, 159 KiB  
Opinion
Public Health Decision-Maker Perspective on Joint Clinical Assessments in Central European EU Member States
by Gergő Merész, Dávid Dankó and Márk Péter Molnár
J. Mark. Access Health Policy 2025, 13(1), 10; https://doi.org/10.3390/jmahp13010010 - 4 Mar 2025
Viewed by 364
Abstract
The HTA R introduces provisions that may benefit member states, in particular the opportunity to share national or regional assessment reports, cooperate outside of clinical domains, or use the methodological guidelines on a local level for technologies that are not subject to joint [...] Read more.
The HTA R introduces provisions that may benefit member states, in particular the opportunity to share national or regional assessment reports, cooperate outside of clinical domains, or use the methodological guidelines on a local level for technologies that are not subject to joint assessment. Challenges related to the timelines, differences between assessment scopes, and diverging guidance may jeopardize the full potential of the HTA R in Central European EU member states. However, these are more likely to be related to the commitment and vigilance of local competent authorities. We attempt to address these opportunities and mark some challenges imposed by the application of the HTA R by taking the perspective of public health decision-makers in Central European EU member states. We conclude that the foundations for capitalizing on the opportunities offered by the HTA R are already laid in the region, and we foresee policymakers and payers sharing the responsibility of acting as drivers of change in health policy to reduce the duplication (or multiplication) of efforts by HTDs, as well as to increase the efficient use of HTA bodies’ resources. Full article
(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))
6 pages, 537 KiB  
Opinion
The EU Health Technology Assessment Regulation Halo Effect: Are Cross-Functional Teams Ready?
by Sian Tanner, Rebecca Coady, Ana Lisica, Edel Falla and Anke van Engen
J. Mark. Access Health Policy 2025, 13(1), 3; https://doi.org/10.3390/jmahp13010003 - 30 Jan 2025
Viewed by 846
Abstract
The focus of manufacturers preparing for implementation of the EU HTA Regulation (HTAR) in 2025 has understandably been on their market access teams, and how they can be best equipped to adapt to this significant change. Considering the critical nature of market access [...] Read more.
The focus of manufacturers preparing for implementation of the EU HTA Regulation (HTAR) in 2025 has understandably been on their market access teams, and how they can be best equipped to adapt to this significant change. Considering the critical nature of market access in ensuring innovation reaches patients, it should be no surprise that the EU HTAR will have impacts far beyond this function. Here, we utilize published EU HTAR guidance, a pragmatic literature review, internal analysis, and insights from engagements with manufacturers, to outline some of the key cross-functional considerations arising from JSC and JCA, and how manufacturers should account for these in their EU HTAR readiness plans. Full article
(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))
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9 pages, 237 KiB  
Opinion
Technology Assessment vs. Technology Appraisal—How to Strengthen the Science/Value Dichotomy with EU HTA?
by Sandro Gsteiger, Heiner C. Bucher, James Ryan and Jörg Ruof
J. Mark. Access Health Policy 2024, 12(4), 369-377; https://doi.org/10.3390/jmahp12040028 - 18 Nov 2024
Viewed by 1398
Abstract
Many countries around the world use health technology assessment (HTA) to inform reimbursement and pricing decisions. HTA is often split into two steps, called assessment and appraisal. While the term HTA itself has been defined by international consortia, there is heterogeneity in the [...] Read more.
Many countries around the world use health technology assessment (HTA) to inform reimbursement and pricing decisions. HTA is often split into two steps, called assessment and appraisal. While the term HTA itself has been defined by international consortia, there is heterogeneity in the way different stakeholders use the terms assessment and appraisal. This creates ambiguity regarding which activities are included in technology assessment. With the new EU HTA Regulation, the HTA community should urgently seek to clarify the distinction between assessment and appraisal, as the regulation aims to centralize the clinical part of technology assessment at the European level. Failure to clarify this terminology will put the ambition of the regulation such as increased efficiency and reduction in duplication at risk. In this article, we argue that the distinction between assessment and appraisal should be seen as a science/value dichotomy. We discuss the transition from centralized assessment activities to country-level appraisal, which should culminate in a categorization of the overall added benefit in a local context. Finally, we touch on the important dimension of uncertainty always present in medical decision making. Full article
(This article belongs to the Special Issue European Health Technology Assessment (EU HTA))
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