On November 22, 2024, the Danish Health Authority announced that it would change its organizational structure. This restructuring is expected to prepare the Danish Health Authority for Health Care Reform work and set a new framework for the work with public health. The organizational changes will take effect on January 1, 2025.

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 16th of December, we plan to work on 20 projects. Review the complete list of planned activities in this post.

In late November – early December 2024, the application period for 2026 ICD-10-GM (German modification of ICD-10 diagnosis codes), OPS (procedure codes), and DRG changes was opened by the Federal Institute for Drugs and Medical Devices (BfArM) and the Institute for Hospital Remuneration Systems (INeK), respectively.

On November 28, 2024, NHS England published a report summarising the Innovation Ecosystem Programme’s (IEP) findings and recommendations for the next steps. The IEP aimed to foster collaboration between the NHS and key stakeholders (industry, academia, and regulators) to streamline healthcare innovation. Recommendations are summarised in four areas: a) setting the direction, b) structures and tools for delivery, c) people, skills, and capabilities, and d) acceleration.

In November 2024, the annual update of the Swedish NordDRG system was published to come into force on January 1, 2025. No new DRGs were introduced. In 2025, to obtain DRG tariffs, cost-weights must be multiplied by a base rate of 88,061 SEK.

On November 29, 2024, the Ministry of Health and Access to Care published an Order outlining the requirements for application files to request coverage of innovative biology or pathology procedures within the new RIHN 2.0 framework. The Order concerns the application file model and list of supporting documents for coverage requests

On November 21, 2024, the Innovation Committee at the Federal Joint Committee (G-BA) announced that a total of fifty applications for Innovation Funding for the new forms of care in one- and two-stage procedures were accepted.

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, Schramm et al. conducted a structured literature review to identify key success factors for the sustainability of digital health applications (DiGAs) under Germany’s Digital Supply Act. Their findings highlight the importance of patient-centered design, application effectiveness, user-friendliness, and robust data security measures in ensuring the long-term success of DiGAs and advancing digital transformation in European healthcare systems.

In December 2024, the Skåne University Hospital (HTA South) is working on health technology assessments in several areas, including men’s health and neurology.

On December 2, 2024, the Swiss Federal Office of Public Health published the changes that will occur to the Healthcare Benefit Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The updates will enter into force on January 1, 2025, and they relate to the list of explicitly evaluated services (Annex 1 of KLV/OPre), outpatient-before-hospital services (Annex 1a), List of Tools and Equipment (Annex 2), and the List of Analyses (Annex 3).

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.