Presentation (CTI)

OBJECTIVES: Generative AI (GenAI) is increasingly used by manufacturers to prepare health technology assessment (HTA) submissions, including for evidence synthesis and economic modelling. Although some HTA bodies have issued preliminary guidance and position statements on GenAI use in HTA, mandatory requirements and rules governing acceptable use remain absent, leaving manufacturers without clear direction. This study aimed to characterise the current landscape of GenAI in HTA usage guidelines issued by EU4+UK HTA bodies and examine the impact of the bilateral AI literacy gap in lieu of mandatory criteria.
METHODS: The review included the EU4+UK HTA bodies: NICE, G-BA, HAS, AIFA, and CIPM. Websites of each organisation, along with those of the EMA and MHRA, national guidelines, and recent literature (2022 onward) were searched for publications, guidance, or policies related to GenAI use in HTA. Identified publications were extracted and catalogued to facilitate cross-sectional analysis of GenAI in HTA policy among the EU4+UK HTA bodies.
RESULTS: Of the EU4+UK HTA bodies reviewed, only NICE has issued a formal position statement regarding GenAI use in HTA, recommending that submissions are prepared with strict human-in-the-loop validation, disclosure and justification of GenAI use is included, and that data/input transparency checklists are utilised. In contrast, G-BA, HAS, AIFA, and CIPM lack independent, dedicated policies for GenAI-based submissions, deferring instead to EU-level regulatory frameworks, including the EU AI Act, and the Joint Clinical Assessment guidelines.
CONCLUSIONS: A lack of published, mandated policy by EU4+UK HTA bodies dictating how GenAI may - or may not - be used is resulting in uncertainty, hesitancy, and potentially non-compliance by manufacturers. To ensure responsible and transparent usage of GenAI in HTA, and to realise the potential for GenAI to speed up access to new medicines, there is an urgent need for clear policy from EU4+UK HTA bodies, co-developed with industry stakeholders.