Publications Digest

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Gupte et al. conducted a review of accelerated approval pathways for medical devices in the United States and the European Union. The authors found that while the US Breakthrough Devices Program granted marketing authorization to just 12.3% of 1,041 designated devices between 2015 and 2024, approval was achieved substantially faster than through standard routes. In the EU, where no specific accelerated pathway exists, newly introduced Medical Device and Health Technology Assessment Regulations aim to harmonize approvals, with joint clinical assessments set to begin in 2026. The authors highlight that aligning regulatory, funding, and coverage policies is essential for device accessibility, and call for global convergence of standards and post-market surveillance to balance innovation with patient safety.

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, Dietrich examined the current and potential roles of artificial intelligence in pricing, reimbursement, and market access (PRMA) processes, focusing on Germany and broader EU implications. The study highlighted that AI could help forecast HTA agency decisions and streamline tasks like literature reviews and submissions. However, its use in HTA remains limited due to strict transparency demands, the need for explainability and human oversight, and the sensitive nature of PRMA documentation, especially in critical negotiations. The author concludes that while AI has transformative potential, its adoption should be gradual and supported by close collaboration among stakeholders. Broader use will depend on robust evidence of performance and cost-effectiveness compared to traditional methods.

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 EU HTA Publications Digest. In a recent publication, Fernandez et al. conducted a cross-European survey of Health Technology Assessment (HTA) bodies to map organizational diversity and assess progress toward harmonization. Their findings reveal substantial variation in agency structures and processes, but also a strong move toward collaboration, which is expected to accelerate with the implementation of the EU HTA Regulation in 2025. These developments are anticipated to drive mutual learning and more efficient technology adoption, ultimately benefiting patients across Europe.

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.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Wang et al. conducted a survey and multi-stakeholder workshop to assess the readiness and strategic approaches of pharmaceutical companies regarding the Joint Clinical Assessment (JCA) under the new European HTA Regulation. Thirteen companies took part, reporting moderate preparedness for the JCA process (with readiness scores of 6–7 out of 10), but expressing concerns about uncertain timelines and challenges in integrating JCA outcomes into national processes. To support effective JCA implementation in national HTA decisions, the authors recommend creating a product-based scorecard for submission quality, increasing member state training, and promoting ongoing dialogue among key stakeholders.

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, Mastronardi et al. evaluated the implementation of a recycling program in operating rooms at a single Italian center to reduce environmental impact and costs. Conducted from June 2023 to April 2024, the study demonstrated that recycling 21.8% of operating room waste led to an 11.6% reduction in CO2 emissions and 13.5% cost savings in waste disposal. These results highlight the feasibility and benefits of structured recycling initiatives in surgical settings.

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, Botwright et al. presented a comprehensive report by a multinational task force outlining good practices for developing health technology assessment (HTA) guidelines. The study aimed to enhance transparency and legitimacy in HTA decision-making across diverse country contexts. Key recommendations address the full guideline development cycle, emphasizing content development, stakeholder engagement, institutional arrangements, and monitoring guideline implementation success.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Merész et al. examined the implementation of the EU HTA Regulation from the perspective of public health decision-makers in Central European member states. Their study highlighted both opportunities for enhanced cooperation and challenges related to timelines and scope differences across member states. The authors concluded that while foundations for successful collaboration exist, policymakers and payers must share the responsibility of acting as drivers of change in health policy to reduce duplication of efforts by health technology developers.