What is Health Technology Assessment (HTA)?
HTA is an evidence-based method assessing medical, economic, and social impacts of health technologies like medicines and devices. It helps evaluate if new technologies work better or worse than existing ones.
HTA plays a crucial role for EU Member States in deciding the use and pricing of new health technologies, ensuring quality and sustainability in healthcare.
Who benefits from the new regulation?
Patients and clinicians gain from access to high-quality assessments enabling quicker access to innovative treatments. Member States can collaborate more effectively, while developers enjoy clearer requirements and efficiency advantages.
What parts does the new regulation cover?
The regulation concerns the clinical aspects of HTA, ensuring evaluations of effectiveness and safety compared to current technologies. It introduces joint assessments starting with cancer treatments, promoting early innovation uptake.
How do Member States use these reports?
They incorporate joint assessments into national decisions, adapting as needed for local healthcare environments and reporting on integration into national processes.
The new HTA framework strengthens cooperation among Member States, ensuring a streamlined, timely approach to assessment, effective from January 2025.