EU HTA Regulation to be applied to Fimea’s assessment of hospital-only medicinal products

The application of the European Union (EU) Health Technology Assessment (HTA) Regulation will start in January 2025. According to the regulation, joint clinical assessments (JCAs) will be carried out on medicines approved through the centralised procedure of the European Medicines Agency (EMA). The procedure will be applied in stages. In the early stages, the application is limited to new anti-cancer medicines and advanced therapies. 

In the procedure, a joint clinical assessment is produced, which assesses the therapeutic effects of the medicine compared to its current treatment alternatives. Other assessment areas, such as economic evaluation, valuation, preparation of recommendations and decision-making, remain the responsibility of each Member State. The first joint clinical assessments will be available at the end of 2025, at the earliest.

The application of the regulation will cause some changes to Fimea’s assessment procedures for hospital-only medicinal products. The most significant changes are Fimea’s participation in the defining of joint clinical assessments for new medicines used in hospitals and Fimea taking the available joint clinical assessments into account in its own assessments.

Fimea has published a short description of the changes mentioned above. The description is aimed at pharmaceutical companies affected by the assessments and other parties related to the assessment processes. Implementation related to the inclusion of the joint clinical assessment into the national assessment activities will be further specified later, if necessary.

Process descriptions for the assessment of hospital-only medicinal products 
Taking the EU HTA Regulation into consideration in the assessment of hospital-only medicinal products (pdf)
European Union Health Technology Assessment Regulation 
The European Commission's guidelines for joint clinical assessments