EARLY EXPERIENCE WITH THE EUROPEAN UNION JOINT CLINICAL ASSESSMENT (EUJCA): IMPLICATIONS FOR ONCOLOGY PRODUCTS
Author(s)
Shilpi Swami, MSc1, Rosalind Augustine, MSc2, Raju Gautam, PhD1;
1ConnectHEOR, London, United Kingdom, 2ConnectHEOR, Delhi, India
1ConnectHEOR, London, United Kingdom, 2ConnectHEOR, Delhi, India
OBJECTIVES: EU JCA came into effect from January 2025 for oncology products, marking a major shift toward centralized clinical evidence assessment at the EU level, with the aim of reducing duplication across national health technology assessment (HTA) bodies and improving consistency in clinical evidence evaluations across member states. We aimed to review early JCAs conducted and assess how oncology products are being evaluated.
METHODS: A targeted review of EU JCAs initiated from January 2025 onwards was conducted. Publicly available sources (European Commission HTA Coordination Group publications, assessor agency communications, regulatory documents, and HTA methodology and guidance documents) were used to extract information.
RESULTS: As of mid-December 2025, 10 JCAs were identified (1 withdrawn, 9 ongoing). These JCAs comprised cancers of lung and ovarian (n=2 each), bladder, pediatric brain/CNS tumors, breast, melanoma, soft tissue sarcoma, and spinal muscular atrophy (n=1 each). Orphan designation was observed in 60% (6/10) of the JCAs. Half (5/10) of JCAs were positioned in the first-line setting. Clinical evidence was supported by randomized controlled trials predominantly (80%: 8/10) [20%: 2/10 had single-arm trials]. JCAs were mainly for chemical entities (60%: 6/10), biological products (20%: 2/10), and advanced therapy medicinal products (ATMPs; 20%: 2/10). Key themes included reliance on surrogate endpoints (PFS [50%: 5/10], OS [30%: 3/10], ORR [20%: 2/10]), increased scrutiny of comparator selection, strict PICO across member states, and growing expectations for external control data and real-world evidence. Variability in assessor focus and PICO definitions was observed. Comparator selection for second-line orphan products (40%: 4/10) showed greater heterogeneity across assessments.
CONCLUSIONS: The initial JCA experience suggests greater rigor in evidence scrutiny and increased complexity for manufacturers developing oncology products in clinical evidence planning and comparator selection. Early evidence planning and HTA alignment will be critical for future oncology and non-oncology submissions.
METHODS: A targeted review of EU JCAs initiated from January 2025 onwards was conducted. Publicly available sources (European Commission HTA Coordination Group publications, assessor agency communications, regulatory documents, and HTA methodology and guidance documents) were used to extract information.
RESULTS: As of mid-December 2025, 10 JCAs were identified (1 withdrawn, 9 ongoing). These JCAs comprised cancers of lung and ovarian (n=2 each), bladder, pediatric brain/CNS tumors, breast, melanoma, soft tissue sarcoma, and spinal muscular atrophy (n=1 each). Orphan designation was observed in 60% (6/10) of the JCAs. Half (5/10) of JCAs were positioned in the first-line setting. Clinical evidence was supported by randomized controlled trials predominantly (80%: 8/10) [20%: 2/10 had single-arm trials]. JCAs were mainly for chemical entities (60%: 6/10), biological products (20%: 2/10), and advanced therapy medicinal products (ATMPs; 20%: 2/10). Key themes included reliance on surrogate endpoints (PFS [50%: 5/10], OS [30%: 3/10], ORR [20%: 2/10]), increased scrutiny of comparator selection, strict PICO across member states, and growing expectations for external control data and real-world evidence. Variability in assessor focus and PICO definitions was observed. Comparator selection for second-line orphan products (40%: 4/10) showed greater heterogeneity across assessments.
CONCLUSIONS: The initial JCA experience suggests greater rigor in evidence scrutiny and increased complexity for manufacturers developing oncology products in clinical evidence planning and comparator selection. Early evidence planning and HTA alignment will be critical for future oncology and non-oncology submissions.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HTA57
Topic
Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas