On the 12th of January 2025, the new EU Health Technology Assessment (HTA) Regulation (EU-HTAR) became effective. With the introduction of the EU-HTAR, pharmaceutical companies engaged in clinical trials have entered a new era of requirements and planning.
This regulation aims to harmonise and streamline the assessment processes for health technologies across EU member states, ensuring that new and innovative treatments reach patients more swiftly and equitably.
What is included in the new EU-HTAR?
The framework for the joint HTA cooperation includes:
- Joint clinical assessments (JCAs)
- Joint scientific consultations (JSCs)
- Identification of emerging health technologies
- Common procedures and methodologies across Europe
Understanding the EU-HTA regulation
The EU-HTA Regulation represents a major shift toward harmonising the assessment process of health technologies. It mandates joint clinical assessments (JCAs), establishing the benefit compared to existing treatments (clinical domains), for new active substance centrally authorised medicinal products and certain high-risk medical devices (class IIB and III).
These assessments are conducted at the EU level and will provide an overview of the clinical aspects that member states can use in their own decision-making processes. The national authorities will assess the non-clinical domains, including the economic, social, and ethical aspects, to decide on reimbursement.
HTA domains and reimbursement in Europe
Previously, European countries have been responsible for their own assessment on relative clinical effectiveness, safety and health economics (HTA domains), which form the basis of their reimbursement decisions in the country. As a result, a variety of conclusions can be drawn based on the same data, though a large variation also occurs in the requirements for what is needed for an assessment.
Clinical domains
- Health problems and currently used health technologies (e.g.medicines, medical devices, surgical procedures).
- Description of health technology under assessment.
- Relative clinical effectiveness.
- Relative safety.
Non-clinical domains
- Economic evaluation
- Ethical aspects
- Organisational aspects
- Social aspects
- Legal aspects
EU-HTAR implementation timeline
The new EU-HTAR will be implemented in several steps. The pilot phases have taken place between 2010 and 2023, resulting in methodological guidelines.
For MedTech products that fall under the regulation, implementation is planned to start in Q1 2026.
2025
Oncology and advanced therapeutic medicinal products (ATMPs)
2028
Orphan medicinal products (OMPs)
2030
All other medicinal products authorized by the European Medicines Agency (EMA)
Conclusion
From a short-term perspective, the new EU-HTAR comes with several challenges. Currently, there are large differences in how ready the member states are for the implementation and uptake of the new regulation. For example, there are very few slots available for JSCs. On the other hand, Health Technology Developers (HTDs) are facing tight timelines, find that there is limited opportunity for engagement and face uncertainties about how national authorities will use the JCA report in their national pricing and reimbursement process.
Opportunities of the new regulation can be seen from a longer time perspective. The aim is to harmonise processes and make the assessment process more efficient for EU member states. It will improve the equality of patient access across the member states, it allows less established agencies to develop and thereby strengthen the quality of HTA across the EU. In the long run, the joint assessment process can enable medicinal products to reach patients in more European markets faster.
Are you looking for HTA support?
Arex can help with internal awareness in your organisation and set up processes for cross-functional and cross-geographic collaborations between Regulatory Affairs and Market Access.
Our Market Access team and Regulatory Affairs team have the skills and experience to support your HTA projects.
Read more about our services here:
