EU JOINT CLINICAL ASSESSMENT IN ONCOLOGY: UPDATED EVIDENCE FROM THE FIRST 18 MONTHS OF IMPLEMENTATION
Author(s)
Shilpi Swami, MSc1, Rosalind Augustine, MA2, Raju Gautam, PhD1.
1ConnectHEOR, London, United Kingdom, 2ConnectHEOR, Delhi, India.
1ConnectHEOR, London, United Kingdom, 2ConnectHEOR, Delhi, India.
OBJECTIVES: To update a review of EU Joint Clinical Assessments (JCAs) for oncology products, extending coverage from December 2025 to June 2026 to identify emerging trends.
METHODS: Publicly available sources were searched to mid-June 2026, including European Commission HTA Coordination Group publications, assessor agency communications, regulatory documents, and HTA methodology and guidance documents. Data was extracted across four domains: product, JCA process, evidence characteristics, and regulatory anchors. Findings were compared to the prior analysis (cut-off: December 2025).
RESULTS: As of mid-June 2026, 18 JCAs were identified (15 ongoing, 1 completed, 1 discontinued, 1 withdrawn), representing an 80% increase from the prior analysis (n=10). The majority of JCAs addressed oncology indications (n=15), including lung (n=4; NSCLC and SCLC), ovarian (n=2), melanoma, bladder, breast, paediatric glioma, soft tissue sarcoma, lymphoma, and CSCC (n=1 each). Orphan designation was observed in half of the assessments (n=9). First-line positioning accounted for 39% (n=7). Evidence was predominantly supported by randomized controlled trials (61%; n=11) and 39% (n=7) relied on single-arm studies. JCAs were mainly for chemical entities (50%; n=9), biological products (22%; n=4) and advanced therapy medicinal products (ATMPs) (27%; n=5). Primary endpoints included PFS (44%; n=8), OS (17%; n=3), ORR (27%; n=5), with reliance on surrogate endpoints more frequent in single-arm submissions. Indirect comparisons or external control data were proposed in most cases (n=13). Key themes included variability in comparator selection (n=11), strict application of PICO criteria across states, and growing expectations for external control data and RWE. The first JCA report was recently published in June 2026, for tovorafenib in paediatric low-grade glioma.
CONCLUSIONS: After 18 months of implementation, initial JCA assessments highlight heightened scrutiny of clinical evidence and increased demands on manufacturers regarding study design and comparator choice. Prospective PICO prediction and early regulatory-HTA alignment are critical for orphan-designated products, where evidence uncertainty at submission remains high.
METHODS: Publicly available sources were searched to mid-June 2026, including European Commission HTA Coordination Group publications, assessor agency communications, regulatory documents, and HTA methodology and guidance documents. Data was extracted across four domains: product, JCA process, evidence characteristics, and regulatory anchors. Findings were compared to the prior analysis (cut-off: December 2025).
RESULTS: As of mid-June 2026, 18 JCAs were identified (15 ongoing, 1 completed, 1 discontinued, 1 withdrawn), representing an 80% increase from the prior analysis (n=10). The majority of JCAs addressed oncology indications (n=15), including lung (n=4; NSCLC and SCLC), ovarian (n=2), melanoma, bladder, breast, paediatric glioma, soft tissue sarcoma, lymphoma, and CSCC (n=1 each). Orphan designation was observed in half of the assessments (n=9). First-line positioning accounted for 39% (n=7). Evidence was predominantly supported by randomized controlled trials (61%; n=11) and 39% (n=7) relied on single-arm studies. JCAs were mainly for chemical entities (50%; n=9), biological products (22%; n=4) and advanced therapy medicinal products (ATMPs) (27%; n=5). Primary endpoints included PFS (44%; n=8), OS (17%; n=3), ORR (27%; n=5), with reliance on surrogate endpoints more frequent in single-arm submissions. Indirect comparisons or external control data were proposed in most cases (n=13). Key themes included variability in comparator selection (n=11), strict application of PICO criteria across states, and growing expectations for external control data and RWE. The first JCA report was recently published in June 2026, for tovorafenib in paediatric low-grade glioma.
CONCLUSIONS: After 18 months of implementation, initial JCA assessments highlight heightened scrutiny of clinical evidence and increased demands on manufacturers regarding study design and comparator choice. Prospective PICO prediction and early regulatory-HTA alignment are critical for orphan-designated products, where evidence uncertainty at submission remains high.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR21
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Approval & Labeling
Disease
Oncology