In December 2024, MTRC reported that the first health app had entered Level 3+ of the mHealthBelgium validation pyramid, indicating eligibility for regular reimbursement. However, no health apps are currently listed at Level 3 on the validation pyramid. mHealthBelgium clarified to MTRC that the December 2024 listing was part of a visual test to demonstrate how an app would appear at Level 3 on their website. They anticipate that the first apps will officially reach Level 3 by the end of January 2025.

MTRC developed a White Paper featuring an analysis of five rapid HTAs and strategic recommendations for evidence generation strategy in Tuscany, Italy. In this White Paper, we reviewed five rapid HTA reports from the Tuscany region to highlight the evidence requirements of the HTA program.

In December 2024, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedures Guidance (Direct skeletal fixation of limb prostheses using an intraosseous transcutaneous implant, MRI-guided focused ultrasound subthalamotomy and thalamotomy for treating Parkinson’s), one new Diagnostic Guidance (Home-testing devices for diagnosing OSAHS) and one new Early Value Assessment (Digital technologies to support self-management of COPD).

MTRC announces the start of the new service – Med Tech Sustainability Center. MTRC delivers a comprehensive analysis of sustainability requirements for market access and procurement in Europe, along with evidence summaries to support tender submissions for the medical device industry.

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, d'Angela et al. conducted a literature review and analyzed global HTA resources to develop a methodological framework for assessing laboratory diagnostic technologies. The study identified seven methodological articles and 23 HTA reports, including EUnetHTA rapid assessments and NICE diagnostics guidance. The findings emphasized a strong focus on organizational and economic domains, which are critical elements for shaping an upcoming survey among laboratory professionals.

On December 20, 2024, the Belgian Health Care Knowledge Center (KCE) released the Health Services Research report on expenditure control measures in Diagnosis-Related Group (DRG)-based hospital payment systems. The report offers an overview of the current hospital financing model in Belgium, details proposed reforms toward case-based DRG payments, reviews expenditure control mechanisms in five European countries, and provides recommendations to stakeholders.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the December 2024 meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Three favorable opinions were published concerning the registration of new medical devices in the List of Reimbursable Products and Services (LPPR). They relate to breast reconstruction and medical aids.

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, Goeldner et al. analyzed the evolving ecosystem of digital health applications (DiGAs) in Germany, leveraging a data-driven approach based on public sources to assess market dynamics, pricing trends, and clinical evidence. The study highlighted the challenges of achieving permanent listing, driven by the rigorous requirements to demonstrate clinical efficacy, with a consistent reliance on randomized controlled trials. The authors emphasized the need for innovative study designs and a stronger focus on patient-relevant outcomes to facilitate the integration of DiGAs into Germany’s healthcare system.

MTRC, a Pan-European Med Tech market access consultancy, is opening a position of Evidence Synthesis Specialist to contribute to our evidence synthesis projects, including systematic reviews and value dossiers, in the evolving field of medical devices.

In December 2024, the Austrian Institute for HTA published a project report on the threshold values in health economic evaluations and decision-making. It concluded that, despite their complexity, implementing thresholds could enhance transparency and efficiency in health systems.

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 the 13th of January, we plan to work on 16 projects. Review the complete list of planned activities in this post.

On January 1, 2025, the revised EBM (German Uniform Evaluation Standard) catalog for the first quarter of 2025 came into force. The main changes introduced concern updates of the contents (services legends, preambles of several EBM subchapters), the introduction of new EBM codes related to dialysis services, CT coronary angiography, management of long COVID patients, different types of consultations and visits, and material costs flat rates related to shipping services.