EU HTA JCA PICO Consolidation Process Examples: Key Trends and Remaining Uncertainties
Author(s)
Kalpana D'Oca, MSc1, Eline Darquennes, PharmD, MSc2, Aristeidis Draganigos, MSc3, Chloé Garrigues, PharmD, MSc4, Natalie Steck, PhD5.
1MSD (UK) Limited, London, United Kingdom, 2MSD Belgium, Boitsfort, Belgium, 3MSD Greece, Athens, Greece, 4MSD, Paris, France, 5MSD, Zurich, Switzerland.
1MSD (UK) Limited, London, United Kingdom, 2MSD Belgium, Boitsfort, Belgium, 3MSD Greece, Athens, Greece, 4MSD, Paris, France, 5MSD, Zurich, Switzerland.
OBJECTIVES: PICO consolidation is a crucial final step of the EU HTA Joint Clinical Assessment (JCA) PICO scoping process. Health Technology Developers (HTDs) may use simulation of PICO scoping/consolidation as a strategic tool to guide development of high quality, robust JCA submissions. We aimed to identify trends in the JCA PICO consolidation process by (1) reviewing previously published exercises and (2) conducting an internal HTD PICO scoping exercise designed to follow official guidance from the EU HTA Coordinating Group (CG) on the consolidation process.
METHODS: We reviewed previous JCA PICO scoping/consolidation exercises based on (1) published HTA documentation, with member states PICO’s extracted and consolidated based on EUnetHTA guidelines or (2) published exercises conducted by EUnetHTA, EFPIA or the EU HTA CG, and summarised identified trends. For comparative purposes, we also reviewed an internally run PICO scoping/consolidation exercise.
RESULTS: 14 publications (representing 35 individual PICO exercises across 21 indications; 74% in the oncology therapy area) were reviewed. On average, 7 countries participated per exercise (range: 3-23), with 8 consolidated PICOs per analysis on average (range: 1-15). The internal exercise focused on an immuno-oncology asset in 1L metastatic non-small cell lung cancer (mNSCLC). PICO scoping/consolidation simulated as per published guidance resulted in 67 PICOs (from 25 countries), largely driven by biomarker expression level /histology-based subpopulations (60/67).
CONCLUSIONS: Limited examples of published JCA PICO scoping/consolidation exercises, particularly with fewer countries involved, hinder robust analysis and predictions regarding real-life JCA PICO consolidation outcomes. Furthermore, results from the internal exercise conducted for a dynamic indication raise questions about whether all distinct sub-populations would be included, or if the number of PICOs would be refined during consolidation discussions. Greater clarity in the JCA PICO consolidation process is needed to ensure that HTDs are adequately prepared with appropriate and proportionate evidence to address the final JCA assessment scope.
METHODS: We reviewed previous JCA PICO scoping/consolidation exercises based on (1) published HTA documentation, with member states PICO’s extracted and consolidated based on EUnetHTA guidelines or (2) published exercises conducted by EUnetHTA, EFPIA or the EU HTA CG, and summarised identified trends. For comparative purposes, we also reviewed an internally run PICO scoping/consolidation exercise.
RESULTS: 14 publications (representing 35 individual PICO exercises across 21 indications; 74% in the oncology therapy area) were reviewed. On average, 7 countries participated per exercise (range: 3-23), with 8 consolidated PICOs per analysis on average (range: 1-15). The internal exercise focused on an immuno-oncology asset in 1L metastatic non-small cell lung cancer (mNSCLC). PICO scoping/consolidation simulated as per published guidance resulted in 67 PICOs (from 25 countries), largely driven by biomarker expression level /histology-based subpopulations (60/67).
CONCLUSIONS: Limited examples of published JCA PICO scoping/consolidation exercises, particularly with fewer countries involved, hinder robust analysis and predictions regarding real-life JCA PICO consolidation outcomes. Furthermore, results from the internal exercise conducted for a dynamic indication raise questions about whether all distinct sub-populations would be included, or if the number of PICOs would be refined during consolidation discussions. Greater clarity in the JCA PICO consolidation process is needed to ensure that HTDs are adequately prepared with appropriate and proportionate evidence to address the final JCA assessment scope.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA128
Topic
Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
Oncology