European Health Technology Assessment (EU HTA)

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

Deadline for manuscript submissions: 31 December 2024 | Viewed by 1253

Special Issue Editors


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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

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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

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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 (1 paper)

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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 738
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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