The PICO Puzzle: Can Public Data Predict EU HTA Expectations for All EU Countries?

Area of Science:

• Health Economics and Outcomes Research (HEOR)
• Regulatory Science
• Pharmaceutical Policy

Background:

• The European Union (EU) Health Technology Assessment (HTA) regulation mandates Joint Clinical Assessments (JCA) for specific medicinal products.
• The PICO framework (Population, Intervention, Comparator, Outcome) defines the scope of JCAs, crucial for dossier preparation under tight timelines.
• Health Technology Developers (HTDs) need to anticipate PICO elements early for effective dossier development.

Purpose of the Study:

• To investigate the predictability of PICO elements for JCAs across EU member states using publicly available information.
• To assess the availability of public data relevant for anticipating PICO requirements for HTA submissions.

Main Methods:

• Systematic literature review to identify relevant peer-reviewed articles.
• Extensive search of publicly available HTA documents (reports, guidelines, templates, market access information) across 29 European countries.
• Extraction of relevant information pertaining to PICO elements for anticipation.

Main Results:

• Significant public accessibility of HTA-related information: 66% HTA reports, 79% methodological guidelines, 69% dossier templates, and 100% market access lists.
• Population and outcome requirements show alignment across countries, highlighting the comparator as the central element for PICO anticipation.
• PICO elements can be reliably anticipated based on publicly accessible information.

Conclusions:

• Publicly available data provides a reliable basis for anticipating PICO elements in Joint Clinical Assessments.
• Health Technology Developers should leverage this information for strategic dossier preparation while remaining adaptable to evolving national procedures.
• Proactive anticipation of PICO, particularly comparators, is essential for navigating the EU HTA landscape effectively.