Presentation (CTI)

OBJECTIVES: The HTA Regulation requires integrating patient perspective and assessing the social impact of health technologies. Agencies acknowledge that they lack methodologies to do this rigorously. The aim of this study is to set down a structured method for introducing patient-based evidence in the HTA action.
METHODS: A narrative literature review was carried out to analyze the use of causal inference in the healthcare field. A comprehensive analysis was conducted in June 2026 using official sources, including regulatory documents, health technology assessment guidelines, and national health directories.
RESULTS: The causal inference applies Pearl’s methods quantitative data to evaluate the comparative effectiveness of treatments. Recent studies advocate integrating these methods into European HTA and explore synergies between causal inference and health decision science. The patient-based evidence is useful to integrate the patient perspective, and the EMA recognizes its value. IMPACTA HTA project used causal inference framework to qualitative data from semi-structured interviews. A combined methodology could be robust: interviews, to reconstruct the full patient journey and what happens, and a causal graph to formalize why it happens and what would change if interventions were made. What had not been attempted is using both simultaneously, feeding the second with data from the first. This means building a causal model where each absent arrow is an equally important statement: we assume that relationship does not exist. The result is a formal model that contains the patient voice within it, not alongside it.
CONCLUSIONS: A saturation-based registry combined with causal inference is a practical way to operative HTA patient participation, replacing single, unstructured input with representative, source traceable evidence mapped to PICO.