Acceptance of Artificial Intelligence in Evidence and Dossier Development by Global HTA Agencies
Author(s)
Radoslaw Skowron, M.Sc.1, Cecile Remuzat, PharmD, MSc2, Sylvaine Barbier, MSc3, Clement Francois, MSc, PhD2.
1Putnam, Krakow, Poland, 2Putnam, Paris, France, 3Putnam, Lyon, France.
1Putnam, Krakow, Poland, 2Putnam, Paris, France, 3Putnam, Lyon, France.
OBJECTIVES: This study investigates the extent to which Health Technology Assessment (HTA) agencies have issued guidance related to the use of Artificial Intelligence (AI) in HTA submissions. The aim is to assess the current landscape and identify opportunities and challenges for broader adoption of AI-supported methodologies in evidence generation.
METHODS: A targeted search was conducted for publicly available documents—such as policy papers, position statements, or other materials—issued by HTA agencies that provide guidance on the use of AI in HTA submissions. The search covered ten countries: United Kingdom, Germany, France, Italy, Spain, Sweden, Netherlands, Canada, Australia, and the United States. Agency websites and official publications were reviewed as of June 2025 to determine the presence and nature of any such guidance.
RESULTS: Position statements addressing the use of AI in HTA submissions have been published by agencies such as NICE (UK) and the Canadian Drug Agency (CDA), with the latter’s 2025 statement adapted from NICE’s 2024 guidance. No AI-specific HTA guidance was identified for other countries reviewed, although some agencies were reporting to actively exploring AI applications internally. In parallel, regulatory bodies such as the EMA and FDA have released or drafted documents on the use of AI in the medicinal product lifecycle. Broader acceptance will require clear methodological frameworks, pilot projects, cross-stakeholder collaboration, hybrid AI-human approaches, and reviewer training.
CONCLUSIONS: Although AI has potential in systematic literature review, accelerated RWE data synthesis, and health economic modeling (e.g. PICOs), its actual use in HTA dossiers is not well documented and likely to be under reported. AI is gradually entering the HTA domain, with agencies such as NICE and CDA providing early direction. Continued development and harmonization of HTA-specific frameworks will be essential to support credible and consistent integration of AI into assessment processes.
METHODS: A targeted search was conducted for publicly available documents—such as policy papers, position statements, or other materials—issued by HTA agencies that provide guidance on the use of AI in HTA submissions. The search covered ten countries: United Kingdom, Germany, France, Italy, Spain, Sweden, Netherlands, Canada, Australia, and the United States. Agency websites and official publications were reviewed as of June 2025 to determine the presence and nature of any such guidance.
RESULTS: Position statements addressing the use of AI in HTA submissions have been published by agencies such as NICE (UK) and the Canadian Drug Agency (CDA), with the latter’s 2025 statement adapted from NICE’s 2024 guidance. No AI-specific HTA guidance was identified for other countries reviewed, although some agencies were reporting to actively exploring AI applications internally. In parallel, regulatory bodies such as the EMA and FDA have released or drafted documents on the use of AI in the medicinal product lifecycle. Broader acceptance will require clear methodological frameworks, pilot projects, cross-stakeholder collaboration, hybrid AI-human approaches, and reviewer training.
CONCLUSIONS: Although AI has potential in systematic literature review, accelerated RWE data synthesis, and health economic modeling (e.g. PICOs), its actual use in HTA dossiers is not well documented and likely to be under reported. AI is gradually entering the HTA domain, with agencies such as NICE and CDA providing early direction. Continued development and harmonization of HTA-specific frameworks will be essential to support credible and consistent integration of AI into assessment processes.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA18
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas