# European Joint Clinical Assessment PICO Scoping Process: Analysis of Current Approaches and Recommendations

## TL;DR

The paper analyzes the PICO scoping process for EU health technology assessments, highlighting the need for clearer guidelines to ensure consistent and transparent evaluations.

## Contribution

The paper provides insights into the PICO scoping process through a review and simulation, identifying gaps and suggesting improvements for the EU HTA Regulation.

## Key findings

- A review of 35 PICO exercises showed an average of 7 countries per exercise and 8 consolidated PICOs.
- A simulation for mNSCLC generated 67 PICOs, highlighting variability due to biomarker and histology sub-populations.
- Limited published examples and country participation hinder clear conclusions about PICO scoping outcomes.

## Abstract

The PICO framework determines the scope of the Joint Clinical Assessment (JCA) under the EU HTA Regulation (EU HTAR), with PICO consolidation being a critical final step of the scoping process. Due to limited clarity on how consolidation works in practice, Health Technology Developers (HTDs) may simulate PICO scoping as a strategic tool to guide the development of robust JCA submissions. A review of 14 publications, representing 35 individual PICO exercises across 20 indications (74% in oncology), showed an average of 7 countries participating per exercise and 8 consolidated PICOs per analysis. A separate PICO scoping simulation focused on a first-line immuno-oncology treatment for metastatic non-small cell lung cancer (mNSCLC) generated 67 PICOs, reflecting the anticipated perspectives of 25 countries, largely driven by biomarker and histology-based sub-populations. The limited number of published examples and country participation restricts the ability to draw clear conclusions or confidently predict the output of PICO scoping in a real life JCA processes. The simulation also raised questions about whether all sub-populations should be included or consolidated further. Overall, there is a need for greater clarity in the JCA PICO scoping process, in particular the consolidation step, to facilitate high-quality evidence generation and support the EU HTAR to meet its goals of efficiency, transparency, and equity in health technology evaluation across Europe, along with more consistent patient access.