In a new White Paper, MTRC identified evidence requirement pitfalls that act as a barrier to listing in the LPPR based on analyzing five recent HAS reports with negative recommendations from different medical disciplines. The analysis was performed in January 2024.

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, Brönneke et al. examined the implications of Germany's 2019 Digital Healthcare Act on the reimbursement pathway for patient-centered digital health applications (DiGA).  The authors outlined the challenges facing DiGA manufacturers in generating evidence required for ongoing price negotiations and reimbursement, proposing adaptations to current health technology assessment methods to accommodate the dynamic nature of DiGA assessment, and emphasizing the role of continuous evaluation using real-world evidence (RWE) in this process.

On February 28, 2024, the Ministry of Labor, Health, and Solidarity published an Order in the Official Journal of the French Republic setting the tariffs for the medical telemonitoring activities for patients with defibrillators and cardiac pacemakers. The half-yearly tariff for the distributor of digital medical devices is set at €550 per patient for the first 4,999 patients.

In February 2024, Danish Regions announced the launch of the National board for digitization and data in health and elderly. The new National Board will have decision-making competence regarding digital solutions and infrastructure, welfare technology, new data-driven technologies, and the use of data for patient treatment, research, statistics, and quality improvement in the health and elderly areas.

On February 15, 2024, the new version of the Nomenclature of Medical Biology Acts was released in France. Various changes were implemented, including the introduction of five new codes and modification of the existing codes and titles. The newly introduced codes concern microbiological and biochemical tests.

On February 26, 2023, the InEK (Institute for the Hospital Remuneration System) published the updated DRG catalog (Fallpauschalen-Katalog) with the list of DRGs and additional reimbursement categories (ZEs) for 2024.

In February 2024, the Basque Office for Health Technology Assessment (OSTEBA) is working on several HTAs, including evaluations in the cardiovascular, e-health, ENT, IVD, and some other fields.

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, Steigenberger et al. investigated barriers and facilitators in health technology assessment (HTA), pricing, and funding policies pertaining to the utilization of rapid point-of-care diagnostics for patients with community-acquired acute respiratory tract infections. The authors conducted expert interviews with representatives from five European countries and identified key challenges, such as the lack of evidence and limited transferability of methods from drug-based HTA to diagnostics, alongside pricing barriers due to the absence of price regulation and weak purchasing power. They underscored the importance of optimized peri-launch policies to enhance the adoption of point-of-care tests.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in February 2024. Fourteen recommendations were published concerning the registration of medical devices or modification of registration conditions with the extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular, neurovascular, neuromodulation, endocrine, and endoscopy devices, as well as 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, Pearson et al. proposed a novel value assessment framework for digital health technologies (DHTs). Given the diversity of DHT modalities and the lack of standard regulatory and payer pathways, the authors aimed to establish evidence standards tailored specifically for DHTs, guiding technology developers in generating robust evidence. This framework can help organizations in adopting high-impact DHTs with the strongest evidence for delivering improved clinical outcomes and cost savings.

On February 08, 2024, the Austrian Institute for HTA (AIHTA) published the 2023 annual HTA report. The report contains AIHTA works, activities, and publications in 2023, including medical technologies belonging to technology groups such as robotic surgery, diagnostic imaging, and neurology.

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 2935 of February 13, 2024, Tuscany Regional Healthcare has published assessments of four medical devices in the cardiovascular and peripheral vascular, ICU/OR, pulmonary and airways, dermatology, and robotic surgery areas.