Presentation (CTI)

OBJECTIVES: The new Joint Clinical Assessment (JCA) framework in the European Union (EU) started in January 2025 to support member states’ national HTA process. While the JCA will not create a single EU-reimbursement decision, it will create a single EU-clinical value assessment for innovative therapies. The objective of this research is to analyze historical national HTA decisions from EU-4 countries over the past five years and the implications on future submissions.
METHODS: We used our proprietary generative AI platform (OMNIA) to analyze publicly available final HTA outcomes for innovative therapies in France (FR), Germany (DE), Italy (IT) and Spain (ES) from the period January 1, 2020, to December 31, 2024. For this analysis, HTA reports were broken down by Anatomic Therapeutic Chemical (ATC), study design, comparator used in the assessment, and final reimbursement decisions.
RESULTS: A total of 2,326 reports from FR (1,042, 44.8%), DE (619, 26.6%), IT (222, 9.5%), and ES (443, 19.03%) were included. Majority of studies were randomized controlled trials (RCT) followed by single arm trials (56.6%, 60.9%, 74.3%, and 68.2% and 19.9%, 13.7%, 21.6%, and 17.4%, for FR, DE, IT, ES, respectively. Of the RCT, active comparator(s) were reported in 29.4%, 35.0%, 32.9%, 39.3% in FR, DE, IT, ES, respectively. Positive HTA outcomes (full, partial, or conditional reimbursement, innovative designation) was granted in 47%, 65.1%, 60.4% and 17.6% in FR, DE, IT, ES, respectively (36.6% pending for ES based on IPT data only).
CONCLUSIONS: Analysis showed variability in the HTA reviews across EU-4 countries, and the impact on outcomes decisions at the national level. The findings provide insights on how JCA submissions should proactively optimize EU-wide comparator and evidence strategies to mitigate downstream risks to national reimbursement decisions. Utilizing generative AI tools early in the process can provide timely, critical insights to predict positive outcome.