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

Area of Science:

• Health Technology Assessment
• Regulatory Science
• Oncology

Background:

• The PICO framework is crucial for scoping Joint Clinical Assessments (JCA) under the EU HTA Regulation (EU HTAR).
• PICO consolidation is a critical, yet unclear, final step in the JCA scoping process.
• Health Technology Developers (HTDs) may use PICO scoping simulations to strategically guide JCA submissions.

Purpose of the Study:

• To review existing PICO scoping exercises in JCA.
• To simulate PICO scoping for a specific oncology indication to understand practical challenges.
• To identify areas needing greater clarity in the JCA PICO scoping and consolidation process.

Main Methods:

• A systematic review of 14 publications detailing 35 PICO exercises across 20 indications.
• A PICO scoping simulation for a first-line immuno-oncology treatment in metastatic non-small cell lung cancer (mNSCLC).
• Analysis of country participation and the number of consolidated PICOs.

Main Results:

• The review found an average of 7 countries and 8 consolidated PICOs per exercise.
• The mNSCLC simulation generated 67 PICOs, reflecting anticipated perspectives from 25 countries, driven by sub-populations.
• Limited published examples and simulation outcomes restrict definitive conclusions on JCA PICO scoping predictability.

Conclusions:

• Greater clarity is needed in the JCA PICO scoping process, especially consolidation, for effective evidence generation.
• Clearer processes will support the EU HTAR's goals of efficiency, transparency, equity, and consistent patient access.
• The study raises questions regarding the inclusion and consolidation of sub-populations in JCA.