EU HTA Publication Digest: Health technology assessment in Europe: A comparison of organizations and introduction to the European regulation

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Sustainability Publications Digest. In a recent publication, Godard et al. assessed the carbon footprint of a French nuclear medicine department by comprehensively analyzing both direct and indirect greenhouse gas emissions from diagnostic and therapeutic activities. The study found that, in 2022, total emissions reached 772 tons of CO2 equivalent, with patient and staff transport accounting for the majority (67%) of emissions, followed by procurement and energy use. These findings highlight that indirect emissions constitute the primary environmental burden in tertiary healthcare settings.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Health Economic Publications Digest. In a recent publication, Fleurence et al. introduced a structured taxonomy of generative AI in health economics and outcomes research (HEOR). The authors explore foundational concepts and map emerging applications across domains such as economic modeling, real-world evidence, and dossier development. Key methodological tools - including prompt engineering, retrieval-augmented generation, domain-specific models, and model fine-tuning - are discussed as means to enhance performance and reliability. While the transformative potential of generative AI in HEOR is recognized, the study highlights ongoing challenges around bias, reproducibility, and practical implementation. The report calls for deeper integration of HEOR expertise into AI development to leverage these technologies in health decision-making responsibly.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Gehder et al. conducted a mixed methods study in Germany analyzing the use of the patient-relevant structural and procedural improvement (pSVV) pathway for Digital Health Applications (DiGAs). Their analysis showed that only 20% of DiGAs utilized the pSVV pathway, largely due to a preference for established medical benefit endpoints and challenging regulatory barriers. The study highlights the importance of clearer frameworks, secure processes, and proactive innovation management to support the effective implementation of patient-centered digital health solutions.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Sustainability Publications Digest. In a recent publication, Wang et al. evaluated the global warming potential of various greenhouse gases used in medical practice, analyzing both their clinical applications and environmental effects. The study identified anesthetic agents such as nitrous oxide, as well as fluorinated gases used in retinal surgery, as particularly problematic due to their exceptionally high global warming potential and prolonged atmospheric persistence. The authors advocate for targeted interventions to reduce the environmental footprint of medical gases while maintaining clinical effectiveness.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Hogervorst et al. conducted a systematic literature review to map analytical methods used for comparing uncontrolled trials with external controls derived from real-world data. The authors benchmarked these approaches against European regulatory and HTA practices. The review, encompassing European agency guidelines and assessment reports, revealed a lack of alignment between state-of-the-art methodological recommendations and their practical application in regulatory and HTA decision-making. The authors propose twelve actionable recommendations to bridge these methodological gaps and enhance transparency in the use of real-world data.