PP115 Analysis Of Previous Joint Clinical Assessment And Potential Transferability To Four European Countries: Case Study And Conceptual Approach

Introduction The European Network for Health Technology Assessment (EUnetHTA) has led together, with member states, several joint actions, including Joint Clinical Assessments (JCA), under the form of project-based voluntary cooperation, which outputs and transferability those projects in other countries remains somehow limited. In June 2021, Council reached an agreement on (HTA) regulation, is entering into force gradually. Initially limited to oncology products, then extended orphan/advanced therapy, after a five eight-year additional period, it will apply all centrally approved products. JCA consist focused scientific analysis relative effectiveness assessment, health condition, technology description, clinical effectiveness, safety. These analyses also include information relating degree certainty. We consider that evidence appraisal might have limitations, would not be generalizable. aim determine potential drivers barriers HTA EU4, employing case example where was conducted. Methods Employing JCA, we compare conducted EU4 (Germany, France, Italy, Spain). Overview background involved system provided, followed by outcome main requirements, reimbursement outcome, pricing agreements. Results Study results supporting outcomes may focus population assessed, comparator considered, uncertainty management. A conceptual adaptation about scope EU regulation discussed, understand its advantages individual HTAs Europe remaining gaps effectively inform or decision-making process. Conclusions can further help areas generation requirements.