Decoding the Future: How Are HTA Agencies Evaluating AI in Healthcare?
Author(s)
Claire Rémy, MPH1, Heloisa Ricci Conesa, MSc2, Harshil Patel, BSc3, Sangeeta Budhia, BSc, MSc, PhD3.
1Parexel International s.r.l., Milan, Italy, 2Parexel, Copenhagen, Denmark, 3Parexel International, London, United Kingdom.
1Parexel International s.r.l., Milan, Italy, 2Parexel, Copenhagen, Denmark, 3Parexel International, London, United Kingdom.
OBJECTIVES: Artificial Intelligence (AI) is revolutionizing medical technology development, accelerating drug discovery, efficacy and safety analysis, and healthcare provision. This research aimed to understand the use of AI to generate evidence for HTA and HTA evaluations of AI-enabled technologies to gain learnings that may be applicable to trial designs, trial methodologies and evidence generation through an HTA perspective.
METHODS: Guidance documents on the use of AI for evidence generation and HTA evaluations of AI-enabled technologies in the United Kingdom (UK), France, Germany, Spain, Italy, Sweden, and Denmark between January 2020 and May 2025 were identified by searching on HTA bodies’ websites and reviewed.
RESULTS: Six guidance documents on the use of AI in the generation of evidence for HTA evaluations were identified from the UK, France, Spain and Sweden; none were identified in Denmark, Germany and Italy. Thirty-one assessments of AI-enabled technologies were identified; eighteen in the UK, six in France, five in Spain, one in Sweden, and one in Denmark. HTA evaluations were in oncology (23%), cardiology (23%), and radiology (20%). 63% of the evaluations gained conditional approval dependent on further evidence generation. HTA bodies raised uncertainties such as inequality in diagnostic accuracy across patient populations and risk of over-reliance on technology. In contrast, adoption of AI technologies improved triaging of information, and reduced time spent analyzing information.
CONCLUSIONS: This analysis clearly shows a fragmented but growing engagement with AI across EU markets. Approvals of AI-enabled technologies underscore that some HTA bodies are well-positioned to evaluate the use of AI in generation of evidence packages, with further development expected to align all HTA evaluations. Manufacturer engagement with adherence to a HTA framework on AI application in evidence generation, including clinical trials and RWE, can enhance optimisation of access and reimbursement strategy.
METHODS: Guidance documents on the use of AI for evidence generation and HTA evaluations of AI-enabled technologies in the United Kingdom (UK), France, Germany, Spain, Italy, Sweden, and Denmark between January 2020 and May 2025 were identified by searching on HTA bodies’ websites and reviewed.
RESULTS: Six guidance documents on the use of AI in the generation of evidence for HTA evaluations were identified from the UK, France, Spain and Sweden; none were identified in Denmark, Germany and Italy. Thirty-one assessments of AI-enabled technologies were identified; eighteen in the UK, six in France, five in Spain, one in Sweden, and one in Denmark. HTA evaluations were in oncology (23%), cardiology (23%), and radiology (20%). 63% of the evaluations gained conditional approval dependent on further evidence generation. HTA bodies raised uncertainties such as inequality in diagnostic accuracy across patient populations and risk of over-reliance on technology. In contrast, adoption of AI technologies improved triaging of information, and reduced time spent analyzing information.
CONCLUSIONS: This analysis clearly shows a fragmented but growing engagement with AI across EU markets. Approvals of AI-enabled technologies underscore that some HTA bodies are well-positioned to evaluate the use of AI in generation of evidence packages, with further development expected to align all HTA evaluations. Manufacturer engagement with adherence to a HTA framework on AI application in evidence generation, including clinical trials and RWE, can enhance optimisation of access and reimbursement strategy.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA102
Topic
Health Technology Assessment, Medical Technologies
Topic Subcategory
Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas