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 April 2025 meetings of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Eleven favorable opinions were published concerning the registration of new devices or modifying conditions/indications for existing ones in the LPPR List. The recommendations relate to devices in the fields of endocrine, e-health, neuromodulation, peripheral vascular, and medical aids.

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 5th of May, we plan to work on 19 projects. Review the complete list of planned activities in this post.

On April 14, 2025, the National Board of Health and Welfare was tasked to allocate 80 million SEK from the government to support Genomic Medicine Sweden (GMS) project in 2025. Funding will be distributed to several projects, including the development and/or implementation of innovative technologies such as whole genome sequencing based on long DNA reads, gene panels for sensitive detection of residual disease, and precision diagnostics (liquid biopsies for solid tumors, detection of antibiotic resistance).

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, De Simone et al. evaluated the environmental impact of liver transplantation procedures performed in Italy by a retrospective bottom-up approach. The authors assessed energy use, waste, anesthetic consumption, and units of blood products transfused for each transplant. The study revealed that each transplant procedure generated about 310 kg of CO₂ emissions, with operating room energy consumption contributing the largest share. The findings highlight the importance of engaging transplant clinicians, hospital administrators, policymakers, and patients in efforts to promote more sustainable practices.

In April 2025, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedures Guidance (Balloon disimpaction of the baby’s head during the cesarean section) and two Early Value Assessments (Robot-assisted surgery for soft tissue and orthopedic procedures). Furthermore, one new clinical guideline was published, and one was updated.

On April 11, 2025, the Innovation Committee at the Federal Joint Committee (G-BA) announced the opening of the application period for the submission of topics for upcoming funding opportunities in the areas of healthcare research and new forms of care. The deadline for submitting topic proposals is June 20, 2025.

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, Kachapila et al. conducted a systematic review to investigate the integration of economic evaluations into multiarm, multistage, adaptive Randomized Controlled Trials. The review included 17 articles, with four reporting results of economic evaluations and 13 presenting economic evaluation protocols. Although costs and benefits could be estimated at interim stages in 14 studies, only five interim cost-effectiveness analyses were performed, and just three influenced decisions to drop or maintain trial arms. Overall, the use of economic evidence remains limited, despite its potential value in guiding adaptive decisions.

On March 19, 2025, the Ministry of Labor, Health, Solidarity and Families published the Decree establishing a regulatory framework for the restoration and traceability of medical devices for individual use. It mandates that only certified centers may perform refurbishment, introduces a national registry for tracking restored devices, and links LPPR reimbursement to compliance with restorability criteria (pending further specification of applicable device categories).

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, Al Sayah et al. conducted a systematic literature review to summarize and evaluate minimally important difference (MID) estimates for EQ-5D instruments. The review included 90 studies reporting 840 MID estimates and revealed a wide variability in MID values depending on the population, estimation method, and EQ-5D version. The findings emphasize the need for context-specific MID selection when interpreting EQ-5D outcomes.

MTRC, a leading boutique Med Tech market access consultancy in Europe, is looking for a Senior Market Access Consultant.

MTRC, a leading boutique Med Tech market access consultancy in Europe, is looking for a Senior Health Economist.

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, Sarri et al. investigated the methodological alignment between EU joint clinical assessments and national HTA requirements in France, Germany, The Netherlands, and Spain. While the study found strong consensus on the need for systematic evidence generation, national agencies diverged in their guidance on evidence derived from indirect treatment comparisons. These findings highlight the challenges health technology developers face in meeting both EU-wide and local evidentiary demands.