HOW MANY PICOS CAN ONE ASSESSMENT CARRY? SCOPE AND FEASIBILITY IN EU JOINT CLINICAL ASSESSMENT
Author(s)
Imen Reguei, PharmD1, Zeineb Hammami, Eng1, Lylia Chachoua, PharmD2, Pascal Auquier3, Mondher Toumi, MSc, PhD, MD4.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Paris, France, 3France, 4Aix-Marseille University, Marseille, France.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Paris, France, 3France, 4Aix-Marseille University, Marseille, France.
OBJECTIVES: A single Joint Clinical Assessment (JCA) was meant to replace duplicated national reviews — but how many PICOs can one assessment realistically carry? The EU HTA Regulation (HTAR) requires assessment scopes to reflect Member States' needs through the Population-Intervention-Comparator-Outcome (PICO) framework. This study examined whether operational PICO scoping remains compatible with the workload assumptions underpinning the HTAR and whether extensive subgroup requests generate a burden exceeding the system's original design parameters.
METHODS: A legal-policy analysis was conducted using Regulation (EU) 2021/2282, implementing legislation, published methodological guidance, European Commission impact-assessment documents, and early operational JCA experience. Particular attention was given to the interaction between Member State PICO requests and subgroup specifications. The observed operational model was compared with the workload assumptions described during the legislative development of the HTAR and assessed against principles of feasibility and proportionality.
RESULTS: The analysis identified a structural divergence between the anticipated and operational assessment scope. While early stakeholder communications suggested a manageable number of PICOs per assessment, the aggregation of Member State subgroup requests creates a combinatorial expansion of analytical requirements. Multiple stratification requests based on biomarkers, prior therapies, disease stage, age, and treatment line transform a limited assessment scope into a substantially larger evidence-generation exercise. This multiplication increases demands on manufacturers and assessors without a corresponding adjustment of procedural timelines. The principal driver of scope inflation is not the number of comparators but the accumulation of subgroup analyses, many of which operate below conventional statistical thresholds for robust inference.
CONCLUSIONS: Inclusiveness without prioritisation risks defeating the very goal of reducing duplication. Explicit prioritisation criteria, proportionality filters, and statistical-feasibility thresholds would keep PICO scoping both manageable and scientifically valid.
METHODS: A legal-policy analysis was conducted using Regulation (EU) 2021/2282, implementing legislation, published methodological guidance, European Commission impact-assessment documents, and early operational JCA experience. Particular attention was given to the interaction between Member State PICO requests and subgroup specifications. The observed operational model was compared with the workload assumptions described during the legislative development of the HTAR and assessed against principles of feasibility and proportionality.
RESULTS: The analysis identified a structural divergence between the anticipated and operational assessment scope. While early stakeholder communications suggested a manageable number of PICOs per assessment, the aggregation of Member State subgroup requests creates a combinatorial expansion of analytical requirements. Multiple stratification requests based on biomarkers, prior therapies, disease stage, age, and treatment line transform a limited assessment scope into a substantially larger evidence-generation exercise. This multiplication increases demands on manufacturers and assessors without a corresponding adjustment of procedural timelines. The principal driver of scope inflation is not the number of comparators but the accumulation of subgroup analyses, many of which operate below conventional statistical thresholds for robust inference.
CONCLUSIONS: Inclusiveness without prioritisation risks defeating the very goal of reducing duplication. Explicit prioritisation criteria, proportionality filters, and statistical-feasibility thresholds would keep PICO scoping both manageable and scientifically valid.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
P63
Topic
Health Policy & Regulatory
Disease
No Additional Disease & Conditions/Specialized Treatment Areas