READINESS OF HEALTH TECHNOLOGY DEVELOPERS FOR EU JOINT CLINICAL ASSESSMENT: EVIDENCE REQUIREMENTS, OPERATIONAL CHALLENGES, AND NATIONAL HTA IMPLICATIONS
Author(s)
Geetika Sharma, Masters of Science(MS)1, Monica Verma, MPH2, Anand Jha, MBA3.
1Ansea Consultants Pte Ltd, Pune, India, 2Associate Director, Ansea Consultants Pte Ltd, Singapore, Singapore, 3Ansea Consultants Pte Ltd, Singapore, Singapore.
1Ansea Consultants Pte Ltd, Pune, India, 2Associate Director, Ansea Consultants Pte Ltd, Singapore, Singapore, 3Ansea Consultants Pte Ltd, Singapore, Singapore.
OBJECTIVES: Regulation (EU) 2021/2282 has shifted EU Health technology assessment (HTA) from voluntary cooperation model to mandatory Joint Clinical Assessment (JCA), beginning in 2025 for oncology medicines and advanced therapy medicinal products. This transition creates new requirements for evidence planning, multi-country PICO alignment, dossier preparation, and national HTA adaptation. This study assessed what JCA “readiness” now means for health technology developers, focusing on evidence requirements, operational bottlenecks, and the residual adaptation.
METHODS: A targeted document analysis was conducted using primary EU sources published since implementation of Regulation (EU) 2021/2282 implementation including the JCA procedural guidance, scoping guidance, dossier-template guidance, methodological Q&A, the 2026 HTACG work program, and first published medicinal-product JCA report (tovorafenib). National HTA guidance from NICE, G-BA, IQWiG, HAS, and AIFA was reviewed to map alignment and divergence in comparators, outcomes, indirect comparisons, real-world evidence, and transparency requirements.
RESULTS: EU JCA requires a PICO-specific dossier for an inclusive, multi-member-state assessment scope, with systematic searches across bibliographic databases, trial registries, HTA reports, EMA files, and patient registries; standard dossier submission is due within 100 days of the first request and no later than 45 days before envisaged CHMP opinion. In tovorafenib JCA, five PICOs were defined but comparative results were submitted for one, assessors issued two formal information requests and the only comparative analysis relied on an unanchored Matching-Adjusted Indirect Comparison (MAIC) with an effective sample size of 5.81. National expectations remain partly divergent: Germany prioritizes nationally specified comparators and adjusted indirect evidence, France emphasizes clinically relevant comparators and overall survival in advanced cancer, and Italy requires broader clinical and economic reimbursement documentation.
CONCLUSIONS: JCA readiness should be treated as a launch capability rather than a submission event, requiring early comparator planning, robust evidence-synthesis, proactive confidentiality management, and pre-defined national overlays for post-JCA access discussions.
METHODS: A targeted document analysis was conducted using primary EU sources published since implementation of Regulation (EU) 2021/2282 implementation including the JCA procedural guidance, scoping guidance, dossier-template guidance, methodological Q&A, the 2026 HTACG work program, and first published medicinal-product JCA report (tovorafenib). National HTA guidance from NICE, G-BA, IQWiG, HAS, and AIFA was reviewed to map alignment and divergence in comparators, outcomes, indirect comparisons, real-world evidence, and transparency requirements.
RESULTS: EU JCA requires a PICO-specific dossier for an inclusive, multi-member-state assessment scope, with systematic searches across bibliographic databases, trial registries, HTA reports, EMA files, and patient registries; standard dossier submission is due within 100 days of the first request and no later than 45 days before envisaged CHMP opinion. In tovorafenib JCA, five PICOs were defined but comparative results were submitted for one, assessors issued two formal information requests and the only comparative analysis relied on an unanchored Matching-Adjusted Indirect Comparison (MAIC) with an effective sample size of 5.81. National expectations remain partly divergent: Germany prioritizes nationally specified comparators and adjusted indirect evidence, France emphasizes clinically relevant comparators and overall survival in advanced cancer, and Italy requires broader clinical and economic reimbursement documentation.
CONCLUSIONS: JCA readiness should be treated as a launch capability rather than a submission event, requiring early comparator planning, robust evidence-synthesis, proactive confidentiality management, and pre-defined national overlays for post-JCA access discussions.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
P55
Topic
Health Technology Assessment, Real World Data & Information Systems
Topic Subcategory
Systems & Structure, Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas