Presentation (CTI)

OBJECTIVES: As of January 2025, the new European Health Technology Assessment Regulation (HTAR) has entered into force. During the first year of implementation, the European Medicines Agency (EMA) has estimated that 17 Joint Clinical Assessments (JCAs) will be initiated for oncological New Therapeutic Entities (NTEs). This study, as an update to a previous analysis, aims to predict the number of JCAs for oncological NTEs and indication extensions in the subsequent years (2026-2029).
METHODS: Among all active clinical trials listed in IQVIA Pipeline Link database, we selected products in development for their first indication in Phase II or III trials. We identified those likely to apply for marketing authorization between 2026-2029, based on historical data from IQVIA database on Italian negotiation dynamics. We also considered the probability of transition (PoT) from Phase II to III and the likelihood of approval (LoA), as reported in literature. Lastly, we estimated the number of JCAs for indication extension by 2029.
RESULTS: Out of 1,426 Phase II or III trials in oncology, 707 were related to the first indication. Based on development timelines, 522 could undergo EMA evaluation in 2026-2029. Considering PoT and LoA, we estimate that 54 oncological and 18 oncohematological products will undergo JCA during this period. Furthermore, we project 38 JCAs for indication extension by 2029, including those for cancer medicines subject to JCA in 2025.
CONCLUSIONS: Our analysis suggests that over the four-year period following the first year of HTAR implementation, an average of 18 JCAs per year will be conducted for oncological NTEs. These projections, consistent with EMA estimate for 2025, suggest a slight increase in the number of JCAs in the years ahead. It is important to note that this estimate will be in addition to JCAs for non-oncological ATMPs and orphan drugs - the latest being included in JCA process from 2028.