The Horizon of Oncology: Estimating the Impact of New EU Regulation on Health Technology Assessment for 2025-2028

OBJECTIVES: The new EU Regulation on Health Technology Assessment (HTAR) that will be enforced from 12^th January 2025 will require Joint Clinical Assessments (JCA) for NTEs in oncology and ATMPs. This study aims to predict the number of oncological New Therapeutic Entities (NTEs) and their extension of indication that could be assessed under this new pathway between 2025 and 2028.

METHODS: Among all active clinical trials (CT) included in the IQVIA Pipeline Link database, we focused on products in development for their first indication in Phase II or Phase III CTs. We identified products likely to apply for marketing authorization (MA) between 2025 and 2028, based on historical data from an IQVIA proprietary database on Italian negotiation dynamics. We also considered the probability of transition from Phase II to Phase III trial (PoT), and the likelihood of approval (LoA) for oncological medicines derived from literature. Lastly, we estimated how many NTEs might undergo JCA process for following indications by 2028, based on historical data.

RESULTS: Of 1,288 Phase II or Phase III CTs regarding oncological medicines, 639 trials are related to products under development for their first indication. Based on timing, 320 might apply for MA between 2025 and 2028. Given PoT and LoA, we estimated that 36 oncological and 13 onco-hematological NTEs will undergo EMA evaluation in the considered period, with favorable outcomes. We also estimated that 30 evaluation processes will be undertaken for extension of indication by 2028.

CONCLUSIONS: Our analysis suggests that during the initial phase of HTAR implementation, 79 JCA procedures will be carried out. Collaboration across EU on these processes is expected to enhance efficiency and promote equal access across European markets. Since our estimates rely on historical data, the recent surge in R&D investments in oncology could potentially result in a rise in the number of approved NTEs.