HTAR, the new EU regulation on health technology assessment (HTA) was adopted in 2022 and following a lot of preparatory work including implementing acts it came into force on the 12 January, 2025 regarding oncology and advanced therapy medicinal products. Orphan products will be covered by the joint clinical assessments (JCA) from 2028.
HTA is a procedure when the aspect of costs, effectiveness, and the added value of a product is assessed to determine whether the product will be available (and reimbursed) in the market. It will be a possibility to ask for joint scientific consultation (JSC) when health technology developers can ask recommendations on their development plans which can contribute to a better prepared dossier for the subsequent JCA.
There were a couple of previous collaboration and networks between EU member states (eg. EUnetHA) to share knowledge, promote good practices in methods and processes, however, the new hybrid modell introduced by HTAR brings in lots of novelties and will hopefully streamline the process. To contribute to a fast market access, it is important to note that the product approval by the European Medicince Agency and the HTA process will be concurrent.
The clinical assessment of the products will be conducted on EU level while the assessment of non-clinical, such as economic, social and ethical aspects will remain member state’s competency.
The Member State Coordination Group on HTA will be helped by the HTA Stakeholder Network which consists of various experts including patient associations.
You can learn more about HTA here and from the HTA factsheet.
