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, Di Bidino et al. conducted a Delphi survey among 46 experts to identify critical topics for developing a health technology assessment (HTA) framework tailored to AI-based health technologies (AIHTs). The study revealed 48 key topics, highlighting the most crucial: accuracy of the AI model, patient safety, ethical benefit-harm balance, and bias in data. The authors highlighted gaps in the EUnetHTA Core Model, proposing a comprehensive framework to guide the evaluation of AI tools like those being developed in the European AI-Mind project for early dementia diagnosis.

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

On November 6, 2024, the first meeting of the Board for Health Apps was held in Denmark. As soon as the Board determines the criteria according to which it will assess health apps, it will be possible to apply for assessment followed by recommendations

In November 2024, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedures Guidance concerning endoscopic bipolar radiofrequency ablation for malignant biliary obstruction. Furthermore, one new clinical guideline was published, and two were updated.

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 better understand the potential scope of our support. From the week of the 2nd of December, we are planning to work on 15 projects. Review the complete list of planned activities in this post.

In November 2024, the HTA body of the Tuscany Regional Healthcare published five rapid HTA reports (four new assessments and one reassessment) of medical devices in the cardiovascular, ophthalmology, ENT, and dermatology areas.

On November 12, 2024, the Danish Health Data Authority published the DRG tariffs for 2025. In accordance with the released documentation, four new DRGs in the fields of radiology, dermatology, and the treatment of functional disorders will be introduced in 2025.

In mid-November 2024, a new version of the classification of procedure codes (CCAM v.77), effective from January 1, 2025, was published. No new codes were introduced. The main changes concerned the tariff rules for procedures and their applications for doctors, as well as the modification of tariffs for 31 dental procedures.

In November 2024, the Galician Agency for Health Technology Assessment (AVALIA-T) is working on several HTAs, including in cardiovascular, e-health, ICU/OR, in-vitro diagnostics, neurology and neurosurgery, neuromodulation, orthopedics, pulmonary and airways, radiotherapy, surgical procedures, and some other fields.

In November 2024, the Dutch Healthcare Authority (NZa) published an updated regulation and policy framework for small-scale experiments to introduce innovations, which will enter into force on January 01, 2025. The small-scale experiments for introducing innovations apply to innovative medical procedures that improve the organization and provision of patient care (including online consultation, telemonitoring, home neuromodulation, school counseling, etc.) but do not have enough evidence to obtain coverage within basic health insurance.

On November 17, 2024, the French Ministry of Health and Access to Care published an Order in the Official Journal of the French Republic on the support and reimbursement of reinforced care pathways – a direct outcome of the experimental projects under Article 51 of the Social Security Financing Act of 2018, which aimed to innovate healthcare delivery and financing models. The new framework aims to enhance the coordination and quality of care for patients with complex health needs and provides financing for coordinated care projects.

On November 14, 2024, the State-Regions Conference approved the Decree with the new national LEA tariffs for outpatient specialist care and prosthetic care presented by the Italian Ministry of Health. The effective date of new tariffs is December 30, 2024.