HOW MANY PICOS IS TOO MANY? QUANTIFYING THE EVIDENCE BURDEN OF THE EU JOINT CLINICAL ASSESSMENT
Author(s)
Saurabh Aggarwal, BS, MS, PhD1, Amrit Bela, BS1, Ozlem Topaloglu, PhD, MPH2.
1NOVEL Health Strategies, Chevy Chase, MD, USA, 2NOVEL Health Strategies, Bethesda, MD, USA.
1NOVEL Health Strategies, Chevy Chase, MD, USA, 2NOVEL Health Strategies, Bethesda, MD, USA.
OBJECTIVES: A key operational challenge in the EU Joint Clinical Assessment (JCA) is PICO multiplication, where population, intervention, comparator and outcome questions expand as Member State clinical practice and evidence needs are consolidated. We synthesized published PICO scoping exercises and simulations to quantify the expected burden and identify the drivers of PICO growth.
METHODS: We conducted a structured review of published JCA PICO scoping exercises, simulations and consolidation analyses. We extracted the number of participating countries, consolidated PICOs, population definitions, comparators and outcomes. Drivers of PICO multiplication were identified narratively and grouped as population, comparator, outcome or indication related factors.
RESULTS: Published evidence indicates substantial variation in PICO burden. A review of 14 publications covering 35 PICO exercises across 20 indications found a mean of seven participating countries and approximately eight consolidated PICOs per analysis. Oncology represented most exercises. In a first line immuno oncology metastatic non small cell lung cancer simulation, 67 PICOs were generated across 25 countries, largely driven by biomarker and histology defined subpopulations. Earlier scoping exercises reported up to six populations, 11 comparators and 15 outcomes from HTA body input, while industry simulations identified up to 10 populations and 23 comparators. Population and comparator heterogeneity were the dominant drivers. Each additional comparator can increase the need for direct or indirect comparative analyses, particularly where trial arms do not match national standards of care.
CONCLUSIONS: PICO multiplication is measurable and can range from single digits to dozens of PICOs per assessment. The burden is most pronounced in biomarker rich oncology, where subpopulation and comparator definitions interact. Early PICO anticipation, country level comparator surveillance and scenario based indirect comparison planning are essential to manage JCA evidence requirements.
METHODS: We conducted a structured review of published JCA PICO scoping exercises, simulations and consolidation analyses. We extracted the number of participating countries, consolidated PICOs, population definitions, comparators and outcomes. Drivers of PICO multiplication were identified narratively and grouped as population, comparator, outcome or indication related factors.
RESULTS: Published evidence indicates substantial variation in PICO burden. A review of 14 publications covering 35 PICO exercises across 20 indications found a mean of seven participating countries and approximately eight consolidated PICOs per analysis. Oncology represented most exercises. In a first line immuno oncology metastatic non small cell lung cancer simulation, 67 PICOs were generated across 25 countries, largely driven by biomarker and histology defined subpopulations. Earlier scoping exercises reported up to six populations, 11 comparators and 15 outcomes from HTA body input, while industry simulations identified up to 10 populations and 23 comparators. Population and comparator heterogeneity were the dominant drivers. Each additional comparator can increase the need for direct or indirect comparative analyses, particularly where trial arms do not match national standards of care.
CONCLUSIONS: PICO multiplication is measurable and can range from single digits to dozens of PICOs per assessment. The burden is most pronounced in biomarker rich oncology, where subpopulation and comparator definitions interact. Early PICO anticipation, country level comparator surveillance and scenario based indirect comparison planning are essential to manage JCA evidence requirements.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR65
Topic
Health Policy & Regulatory, Health Technology Assessment, Methodological & Statistical Research
Topic Subcategory
Reimbursement & Access Policy