The European Health Technology Assessment for emerging medicinal products
Background, Objectives, Processes and Implications
The European Health Technology Assessment (EU-HTA) aims to harmonise and strengthen health technology assessment (HTA) across Europe, enhancing efficiency and reducing duplication of work for national HTA authorities. According to Article 114 of the Treaty on the Functioning of the European Union, the European Commission will introduce this new HTA regulation in stages. Starting January 12th, 2025, the regulation will apply to cancer treatments and advanced therapy medicinal products (ATMPs). Orphan drugs will follow on January 13th, 2028, and all other medicinal products on January 13th, 2030. This regulation establishes a permanent framework for joint scientific consultations and joint clinical assessments (JCAs).
Currently, HTA practices vary significantly across EU member states, with three primary strategies: comparative clinical effectiveness (e.g., Germany, France), cost-effectiveness (e.g., Netherlands, Sweden), and budget impact of drugs (e.g., Spain, many East-European countries). Smaller countries often do not have their own HTA approach and use assessments from larger countries as references.
The new EU-HTA framework, evolving from the initial steps taken by EUnetHTA’s Joint Actions, introduces the concept of Joint Clinical Assessments (JCAs). These assessments focus on clinical evidence, specifically the comparison of the new drug’s effectiveness and safety against the current standard of care, using the PICO framework (Population, Intervention, Comparator, Outcomes). Due to diverse healthcare systems and financial capacities, the EU member states did not agree on a uniform EU-wide HTA process to replace national HTAs entirely. Instead, the JCA will serve as an informational base for national HTA assessments without being binding.
National HTA agencies can complement JCAs with their evaluations, such as cost-effectiveness or budget impact analyses, but they must not duplicate the clinical domain assessments conducted jointly.
This paper explores several key components:
Key Components of the EU-HTA Framework: Including the JCA process, stakeholder involvement, and the role of scientific evidence in drug evaluation.
Challenges and Future Perspectives: Discussing the challenges and future perspectives of the JCA in the context of evolving healthcare landscapes.
Implications for Pharmaceutical Companies: Exploring how pharmaceutical companies can deal with the challenges presented by the new EU-HTA framework.
The paper primarily focuses on drug evaluation rather than medical devices, providing a detailed analysis of the anticipated impact of the new regulations on various stakeholders within the healthcare sector.
🎧 This white paper is also available as an audiobook in multiple languages: English, German, French, Mandarin, and Spanish.