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Publications Digest

25
Jun 2025

Sustainability Publication Digest: Decarbonizing surgical care: a qualitative systematic review guided by the Congruence Model

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, Kloevekorn et al. conducted a qualitative systematic review to analyze direct sources of carbon emissions in hospital surgical care, using the Congruence Model as a framework. The authors found that major emission sources include anesthetic gases, sterilization practices, and ingrained workplace behaviors, while sustainability efforts are primarily linked to waste policies. The study highlights the value of the Congruence Model for uncovering challenges in decarbonizing surgical care.
24
Jun 2025

Publication Digest: Use of Real-World Evidence in Health Technology Reassessments Across 6 Health Technology Assessment Agencies

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, Jaksa et al. conducted a targeted review of health technology reassessments across six international HTA agencies to examine the use of real-world evidence (RWE). The analysis of 40 recent reassessments found that 55% incorporated RWE, primarily drawing on registry data to address clinical uncertainties. However, RWE use did not alter patient access outcomes, and no de novo comparative RWE studies were identified, highlighting the need for greater alignment between agencies and sponsors on evidence needs and study feasibility.
23
Jun 2025

EU HTA Publication Digest: The Art of Bridge Building: A Look at the European-Level Cooperation in HTA (EU-HTA)

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, Ivo et al. examined the evolution and future prospects of European-level cooperation in health technology assessment, focusing on the implementation of the EU HTA Regulation. The authors highlighted the critical role of harmonised methodologies and coordinated capacity building in overcoming national heterogeneity. The new regulation is expected to streamline assessments, improve efficiency, and accelerate equitable access to innovative health technologies across Europe.
19
Jun 2025

Sustainability Publication Digest: An Audit of Recyclable and Contaminated Waste From Invasive Cardiac Procedures

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.
18
Jun 2025

EU HTA Publication Digest: Enhancing Patient Engagement in HTA: Using Consensus Research to Overcome PICO Scoping Challenges Under the EU HTAR

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.
17
Jun 2025

Health Economic Publication Digest: Incorporating Resource Constraints in Health Economic Evaluations: Overview and Methodological Considerations

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.
16
Jun 2025

Publication Digest: Are Medical Device Characteristics Included in HTA Methods Guidelines and Reports? A Brief Review

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.
12
Jun 2025

Sustainability Publication Digest: Estimation of the Economic and Environmental Impact of Single-Use Instruments in Routine Cataract Surgery

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.
11
Jun 2025

Health Economic Publication Digest: Using Generative Artificial Intelligence in Health Economics and Outcomes Research: A Primer on Techniques and Breakthroughs

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.
10
Jun 2025

EU HTA Publication Digest: Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union

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.
09
Jun 2025

Publication Digest: Artificial intelligence in key pricing, reimbursement, and market access (PRMA) processes: better, faster, cheaper-can you really pick two?

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.
06
Jun 2025

Sustainability Publication Digest: Estimation of carbon footprint in nuclear medicine: illustration of a french department

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.