Introduction
Health Technology Assessments (HTA) are a vital process within healthcare systems, evaluating the value of medical interventions, such as drugs and medical devices, based on their clinical, economic, and ethical impacts. Traditionally, HTAs have been conducted on a national level across Europe, leading to significant variations in how health technologies are assessed and adopted between different countries. [1]
Since Sweden established the first national HTA agency in the 1980s, the number of institutions involved in HTAs has grown significantly across Europe. Today, most European Member States have either implemented a formal HTA program or are exploring the possibility of developing HTA capabilities to better inform health policy decisions. [2] However, a transformative shift is on the horizon with the introduction of the New HTA framework in Europe.
What is the New HTA in Europe?
The New HTA framework, formalized under the EU Regulation on Health Technology Assessment (HTAR) passed in 2021, introduces a more unified and streamlined approach. The central element of this framework is the Joint Clinical Assessment (JCA), which will be mandatory for specific categories of health technologies. Starting in January 2025, the JCA will be required for advanced therapeutic medicinal products and oncology drugs. From 2028, orphan drugs and class IIb or III medical devices will be included in the mandatory JCAs process, with class D in-vitro devices following by 2030.
The JCA is conducted at the EU level, rather than by individual member states, providing a single, standardized assessment of the clinical effectiveness and added value of modern technologies. This assessment is intended to serve as a foundational reference for all member states, although they retain the ability to conduct additional assessments based on national priorities or requirements.
Key Components of the New HTA
- Joint Clinical Assessment (JCA): The JCA is the cornerstone of the New HTA, providing a single, EU-wide assessment of the clinical effectiveness and added value of new health technologies. This centralized approach is designed to replace the multiple national assessments currently required, simplifying the process for pharmaceutical companies and healthcare providers.
- PICO Framework: The JCA process is structured around the PICO framework—Population, Intervention, Comparator, and Outcomes. These components are defined through Joint Scientific Consultations (JSCs), which involve the European Medicines Agency (EMA), national HTA bodies, and industry stakeholders. The PICO framework ensures that assessments are tailored to the specific needs of the target population, providing a comprehensive evaluation of the product’s value.
Below, Eileen Holmes, PhD, Associate Director, Statistics at Phastar discusses the key aspects of the PICO framework during our recent webinar. Catch up on the full webinar here.
Conclusion
The New HTA in Europe represents a significant shift in how health technologies are evaluated and adopted. By introducing a mandatory, EU-wide Joint Clinical Assessment (JCA), the regulation aims to harmonize the HTA process, reduce duplication, and improve access to innovative treatments across the EU. Understanding the key components of the New HTA is crucial for stakeholders as they prepare for the changes ahead.
Have questions about the New HTA framework or how it could impact your clinical development? Contact us today to learn how Phastar can support your journey through these regulatory changes.
[1] European Network for Health Technology Assessment (EUnetHTA). (n.d.). About EUnetHTA. Retrieved August 23, 2024, from https://www.eunethta.eu/about-eunethta/
[2] Velasco Garrido, M., Børlum Kristensen, F., Palmhøj Nielsen, C., & Busse, R. (Eds.). (2008). Health technology assessment and health policy-making in Europe: Current status, challenges and potential. Observatory Studies Series, 14. European Observatory on Health Systems and Policies. ISBN: 9789289042932.
