Does the Joint Clinical Assessment (JCA) Enable Health Equity Across Europe? A Review of HTA Practices in the EU
Author(s)
Emma Hawe, BSc, MSc, Alona Masheiko, PharmD, PhD, Rebecca Sloan, MSc, MD, Catrin Treharne, BSc, MSc.
Health Analytics, Lane Clark & Peacock LLP, London, United Kingdom.
Health Analytics, Lane Clark & Peacock LLP, London, United Kingdom.
OBJECTIVES: The European Union’s new Joint Clinical Assessment (JCA) requires manufacturers to submit a harmonised clinical dossier within 100 days of European Medicines Agency (EMA) filing, providing all 27 Member States simultaneous access to identical clinical evidence. Intended to narrow inequities in access to medicines, its impact remains unknown. This study reviews how health equity is considered across national health technology assessments (HTAs) and evaluates the JCA’s capacity to support equity-relevant evidence generation.
METHODS: A targeted review of EU HTA regulations and guidance documents (n=19), including Regulation 2024/1381 on JCAs, “Guidance on Outcomes”, “Guidance on Filling in the JCA Dossier Template”, and draft “Procedural Guidance on Scoping and Subgroup Analyses”, was complemented by HTA manuals from 24/27 Member States and a literature search in PubMed (n=9) and EMBASE (n=2) covering 2020-2025.
RESULTS: Only Belgium, Croatia, Ireland, and Spain explicitly reference health equity goals in their HTA methods; all four retain the standard assumption of equal QALY weights while encouraging supplementary reporting on unmet need in underserved groups. At the EU level, the outcomes guidance requires JCAs to capture the full range of clinically and patient‑relevant outcomes including clinician-reported outcomes, patient-reported outcomes, observer-reported outcomes and to pre‑specify subgroups (e.g., age, sex, genetic markers) whenever meaningful heterogeneity is anticipated, thereby aligning the evidence base with equity concerns. Nevertheless, the JCA dossier template treats these subgroup and outcome requirements as optional rather than mandatory. Rare‑disease populations receive no dedicated provisions, and Member States remain free to interpret or supplement the joint evidence differently.
CONCLUSIONS: Although the JCA aims to promote equitable access, systematic inclusion of equity considerations within its assessment framework is not mandated. Responsibility for identifying and addressing health disparities remains with individual Member States through their national HTA processes, leading to variation in how equity is incorporated across the EU.
METHODS: A targeted review of EU HTA regulations and guidance documents (n=19), including Regulation 2024/1381 on JCAs, “Guidance on Outcomes”, “Guidance on Filling in the JCA Dossier Template”, and draft “Procedural Guidance on Scoping and Subgroup Analyses”, was complemented by HTA manuals from 24/27 Member States and a literature search in PubMed (n=9) and EMBASE (n=2) covering 2020-2025.
RESULTS: Only Belgium, Croatia, Ireland, and Spain explicitly reference health equity goals in their HTA methods; all four retain the standard assumption of equal QALY weights while encouraging supplementary reporting on unmet need in underserved groups. At the EU level, the outcomes guidance requires JCAs to capture the full range of clinically and patient‑relevant outcomes including clinician-reported outcomes, patient-reported outcomes, observer-reported outcomes and to pre‑specify subgroups (e.g., age, sex, genetic markers) whenever meaningful heterogeneity is anticipated, thereby aligning the evidence base with equity concerns. Nevertheless, the JCA dossier template treats these subgroup and outcome requirements as optional rather than mandatory. Rare‑disease populations receive no dedicated provisions, and Member States remain free to interpret or supplement the joint evidence differently.
CONCLUSIONS: Although the JCA aims to promote equitable access, systematic inclusion of equity considerations within its assessment framework is not mandated. Responsibility for identifying and addressing health disparities remains with individual Member States through their national HTA processes, leading to variation in how equity is incorporated across the EU.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR63
Topic
Health Policy & Regulatory, Health Technology Assessment, Organizational Practices
Topic Subcategory
Health Disparities & Equity
Disease
No Additional Disease & Conditions/Specialized Treatment Areas