Presentation (CTI)

OBJECTIVES: The EU Joint Clinical Assessment (JCA) framework centralizes clinical evidence assessment across Member States, with a subgroup of JCA, assigning national HTA bodies as assessors and co-assessors. As JCAs move into early implementation and submission, the assignment patterns may offer insight into disease priorities and assessment leadership. This study presents a landscape assessment of ongoing JCA submissions, focusing on disease areas and assessor-co-assessor allocations.
METHODS: A landscape assessment of ongoing JCA submissions was conducted using publicly available European Commission data up to the present date, providing a descriptive summary of the ongoing submissions.
RESULTS: Twelve ongoing JCA submissions were identified, with oncology accounted for most assessments (n=9), including small-cell lung cancer, melanoma, glioma, bladder cancer, prostate cancer, and breast cancer. Non-oncology submissions (n=3) covered a smaller yet more diverse set of indications, including rare diseases and neurological conditions such as spinal muscular atrophy, respiratory papillomatosis, and synovial sarcoma or leiomyosarcoma. Most submissions involved chemical products (n=7), followed by advanced therapy medicinal products (n=3) and biologics (n=2). In terms of assessor allocation, the Institute for Quality and Efficiency in Health Care (Germany), was most often appointed as lead assessor (n=3), primarily for oncology submissions. The National Centre for Pharmacoeconomics (Ireland), the Federation of Social Insurances (Austria) (n=2 each), and other individual agencies were appointed as assessors across both oncology and non-oncology indications. In contrast, co-assessor roles were more broadly allocated, with nine different national HTA bodies acted as co-assessors across the 12 submissions, with no agency serving more than twice.
CONCLUSIONS: The early landscape evidence from ongoing JCA submissions highlights a strong focus on oncology and a centralized yet collaborative assessor structure. As the JCA process matures and additional submissions are evaluated, these patterns and insights may evolve, highlighting the need for ongoing monitoring of disease focus and assessor allocation.