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

ABSTRACT: With the European Union (EU) Health Technology Assessment (HTA) regulation, Joint Clinical Assessments (JCA) are now required for oncological and advanced therapy medicinal products. The JCA assessment scope is determined through the PICO framework (Population, Intervention, Comparator, Outcome). Given the tight JCA timelines, Health Technology Developers (HTD) must anticipate PICO elements early to prepare dossiers effectively. This study investigates whether PICO can be predicted across EU member states using publicly available information. A systematic literature review was conducted to identify relevant peer-reviewed articles. Additionally, an extensive search of publicly available HTA documents, including reports, methodological guidelines, submission templates, and market access info

SUBMITTER: Eberle K 

PROVIDER: S-EPMC12286018 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature