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 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.