Presentation (CTI)

OBJECTIVES: Since becoming operational under the European Union HTA Regulation, the JCA has centralised clinical evidence evaluation across Member States, with submission patterns and outcomes potentially revealing disease focus, assessment capacity, and operational challenges. This study characterises the evolving landscape, examines assessment outcomes, and identifies early implementation learnings from the first wave of submissions.
METHODS: A landscape assessment of JCA submissions was conducted using publicly available European Commission information published through 26 June 2026. Data on therapeutic area, indication, product type, assessor roles, and submission status were extracted and analysed. Submission trends, outcomes, and HTA participation were assessed descriptively, with qualitative review identifying implementation learnings.
RESULTS: Eighteen JCA submissions were identified, of which 83% were oncology-centric and half were chemical products. Lead assessor roles were assigned primarily to G-BA/IQWiG, while co-assessor roles were more broadly distributed. Of the identified submissions, one (tovorafenib) has been completed, while 14 are still ongoing. Three submissions were discontinued due to applicant-initiated withdrawal of the marketing authorisation application (sasanlimab), and non-compliance with JCA dossiers requirements (catequentinib, tacquell), which include insufficient relative effectiveness evidence, indirect treatment comparison justification, and systematic literature review reporting. Furthermore, the completed tovorafenib submission expanded a single indication into eight PICOs based on country-specific comparators. Key assessment challenges included reliance on single-arm evidence, limitations of unanchored indirect comparisons, insufficient comparator data, methodological shortcomings, and incomplete patient-relevant outcome reporting; only one PICO had acceptable comparative evidence. These findings underscore the need for health technology developers to ensure robust, transparent evidence, strong methodological justification, and comprehensive dossiers to meet JCA requirements.
CONCLUSIONS: This study highlights an oncology-centric submission landscape, where early findings from a single completed assessment suggest stringent evidentiary expectations for demonstrating relative treatment value, analytical robustness, and thorough outcome reporting, emphasizing the importance of early HTA alignment and high-quality, evidence-driven dossier development for JCA.