Evaluating the Role of Societal Perspectives in the EU Joint Clinical Assessment Framework and in EU-27 Health Technology Assessment Guidelines
Author(s)
Emily Ng, MSc1, Rebecca Sloan, MSc, MD2, Catrin Treharne, BSc, MSc3, Emma Hawe, BSc, MSc1.
1LCP Health Analytics, London, United Kingdom, 2Value Based Healthcare consultant and clinical advisor, LCP, Winchester, United Kingdom, 3LCP Health Analytics, LONDON, United Kingdom.
1LCP Health Analytics, London, United Kingdom, 2Value Based Healthcare consultant and clinical advisor, LCP, Winchester, United Kingdom, 3LCP Health Analytics, LONDON, United Kingdom.
OBJECTIVES: To map how broader value elements—caregiver burden, productivity, and other societal costs—are addressed in the EU Joint Clinical Assessment (JCA) dossier and in all EU27 national HTA guidelines, and to summarise 2019-2025 peer-reviewed evidence on methodological challenges, data gaps and potential solutions.
METHODS: A targeted literature review in EMBASE and PubMed (2019-2025) and a comprehensive review of guideline documents from EMA, EUnetHTA and every national HTA agency website was performed. AI-assisted data extraction with full
human QC was performed to capture required perspective, caregiver burden, productivity, and any additional broader value references. Narrative synthesis identified recurring challenges and proposed remedies.
RESULTS: 24 guidelines were reviewed, HTA guidelines were not identified for Cyprus, Luxembourg, or Malta. Nine guidelines require or strongly recommend a societal perspective. Productivity impacts are explicitly referenced in 16 guidelines and caregiver burden or family spillover effects in 14; three guidelines do not address either. Only the Netherlands and Spain embed both elements in their reference case. The JCA template confines assessment to clinical domains; consideration of broader value is limited to a brief qualitative “organisational and societal impact” paragraph, with no structure for quantitative inputs. Methodological differences occur due to concerns around double counting and differing definitions: measurement of productivity using human or friction cost, and definition of societal perspective. Emerging solutions include caregiver-specific instruments, real-world registries, and transferability adjustment factors, but uptake remains limited.
CONCLUSIONS: Broader value is recognised in principle across Europe but operationalised inconsistently. The current JCA process provides minimal mechanism to capture societal benefits, risking divergent national decisions and undervaluation of technologies with substantial caregiver or productivity effects. Embedding an optional structured “broader value module” in the JCA dossier, harmonising definitions of societal perspective, and investing in cross-country data infrastructure—especially for rare diseases—would facilitate more consistent, comprehensive value assessments.
METHODS: A targeted literature review in EMBASE and PubMed (2019-2025) and a comprehensive review of guideline documents from EMA, EUnetHTA and every national HTA agency website was performed. AI-assisted data extraction with full
human QC was performed to capture required perspective, caregiver burden, productivity, and any additional broader value references. Narrative synthesis identified recurring challenges and proposed remedies.
RESULTS: 24 guidelines were reviewed, HTA guidelines were not identified for Cyprus, Luxembourg, or Malta. Nine guidelines require or strongly recommend a societal perspective. Productivity impacts are explicitly referenced in 16 guidelines and caregiver burden or family spillover effects in 14; three guidelines do not address either. Only the Netherlands and Spain embed both elements in their reference case. The JCA template confines assessment to clinical domains; consideration of broader value is limited to a brief qualitative “organisational and societal impact” paragraph, with no structure for quantitative inputs. Methodological differences occur due to concerns around double counting and differing definitions: measurement of productivity using human or friction cost, and definition of societal perspective. Emerging solutions include caregiver-specific instruments, real-world registries, and transferability adjustment factors, but uptake remains limited.
CONCLUSIONS: Broader value is recognised in principle across Europe but operationalised inconsistently. The current JCA process provides minimal mechanism to capture societal benefits, risking divergent national decisions and undervaluation of technologies with substantial caregiver or productivity effects. Embedding an optional structured “broader value module” in the JCA dossier, harmonising definitions of societal perspective, and investing in cross-country data infrastructure—especially for rare diseases—would facilitate more consistent, comprehensive value assessments.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA135
Topic
Clinical Outcomes, Health Technology Assessment, Methodological & Statistical Research
Topic Subcategory
Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas