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 Sustainability Publications Digest. In a recent publication, Amin et al. conducted an audit to quantify both contaminated and recyclable waste generated from invasive cardiac procedures in a single cardiac center, which performs approximately 350 cardiac surgeries and 2,900 interventional cases annually. The study found that the center produced an estimated 11,000 kg of recyclable and 30,000 kg of contaminated waste each year, with potential global extrapolation reaching 150 million kg of annual waste from such procedures. The authors highlight the need for sustainability initiatives within cardiology to address the environmental burden of medical waste.

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, Arcà et al. addressed the persistent challenge of integrating patient perspectives into PICO scoping for Health Technology Assessment (HTA) under the EU HTA Regulation. The authors proposed a structured framework based on the Delphi panel methodology to enhance the validity and transparency of patient contributions, facilitating structured engagement and consensus among patients and caregivers across Europe. This approach is designed to better align stakeholder expectations with HTA outcomes, and a study is currently underway to assess its practical feasibility.

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, Thokala et al. provided an overview of how resource constraints can be incorporated into health economic evaluations. Drawing on literature and expert input, the authors identified three distinct categories of resource constraints: single-use resources, reusable resources, and constraints related to patient throughput. They also developed a comprehensive framework to guide a more accurate and realistic assessment of health technologies under real-world limitations. Their findings underscore the importance of systematic consideration of resource constraints by HTA agencies to enhance the relevance of economic evaluations.

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, Basu et al. investigated whether health technology assessment (HTA) agencies systematically consider unique characteristics of medical devices in their guidelines and reports. Specifically, the study examined factors such as learning curve, incremental innovation, dynamic pricing, and organizational impact through a review of documents from 14 HTA agencies, five HTA networks, and the published literature. The authors identified inconsistent inclusion of device-specific attributes, with most agencies lacking comprehensive methodological guidance, underscoring the need for standardized frameworks in future HTA processes.

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, Qin et al. assessed the economic and environmental impact of single-use instruments (SUIs) versus reusable instruments (RUIs) in cataract surgery across six centers in Europe and the United States. The analysis found that annual costs for SUIs were lower or similar to those of RUIs in four out of six centers, with the greatest cost-effectiveness observed in facilities where sterilization costs were highest. Over a five-year period, however, the carbon footprint of SUIs was substantially greater: 5,478.2 kg CO₂ eq without recycling and 4,639.9 kg CO₂ eq with recycling, compared to just 20.6 kg CO₂ eq for RUIs. These findings suggest that while SUIs may offer financial advantages in some hospital settings, they pose a significant environmental impact.

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, Reason et al. introduced how generative artificial intelligence (GenAI), particularly large language models (LLMs) like ChatGPT, can support health economics and outcomes research (HEOR). The authors highlight that LLMs can streamline a range of HEOR activities, including literature summary, data extraction, report drafting, and statistical code generation. However, they also point out key limitations, such as the risk of hallucinated outputs, security vulnerabilities, reproducibility issues, and potential bias. Implementing LLMs in HEOR necessitates robust security measures to ensure compliance with the European Union’s General Data Protection Regulation (GDPR) and the United States’ Health Insurance Portability and Accountability Act (HIPAA) when handling sensitive 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, 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.