On June 2, 2025, the submission period for Joint Scientific Consultations (JSCs) requests under the EU Health Technology Assessment Regulation (HTAR) framework opened. JSCs offer health technology developers the opportunity to seek scientific advice on the information and evidence required for a potential future Joint Clinical Assessment (JCA). Requests related to both medical devices and medicines can be submitted until June 30, 2025.

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.

In late May 2025, the Innovation Committee of the Federal Joint Committee (G-BA) published decisions recommending the transfer of several completed healthcare research and new forms of care projects into standard care. These projects addressed a range of topics, including a web-based self-help program for relatives of individuals with depressive disorders, strengthening crisis resilience in outpatient medical practices, and structured aftercare following bariatric surgery.

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.

The French National Authority for Health (HAS) released new recommendations regarding the registration of medical devices and medical aids in the List of Reimbursable Products and Services (LPPR) following the May 2025 meetings of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). One favourable opinion was issued concerning add-on reimbursement for medical device in the men’s health field.

On May 12, 2025, the updated version of the Finnish Laboratory Tests Nomenclature was published by the Finnish Institute for Health and Welfare (THL) to come into force on June 1, 2025. Twenty-one new codes were introduced.

Our goal at MTRC is to inform the decision-making of our clients and to support their market access activities. Below is a snapshot of our planned activities for the next two weeks. This can help our existing and prospective clients to understand the potential scope of our support better. From the week of June 2nd, we plan to work on 16 projects. Review the complete list of planned activities in this post.

In May 2025, the National Institute for Health and Care Excellence (NICE) published two new Early Value Assessments (Digital therapy for chronic tic disorders and Tourette syndrome, AI technologies for skin lesions) and one new Late Stage Assessment (Drug-eluting stents for coronary artery disease). Furthermore, three clinical guidelines were updated.

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.

On May 13, 2025, the Common Package of Benefits of the Spanish National Health System (NHS) was amended. The med tech-related updates mostly concerned in-vitro diagnostics, gastrointestinal, e-Health, cardiovascular, ENT, ophthalmology, oral health, and neurology fields.