In February 2024, the Skåne University Hospital is working on several HTAs, including evaluations in the cardiovascular, e-health, endocrine, men’s health, neurology and neurosurgery, orthopedics fields.

Between mid-January 2024 and mid-February 2024, three more health apps were introduced in the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM) and thus became reimbursable. These apps can be prescribed by physicians and psychotherapists and will be reimbursed by health insurers. In total, 56 health apps are currently available in the DiGA Directory, and six health apps were delisted from the Directory.

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, Eckhardt et al. investigated the evolution of clinical evidence and the utilization of 25 innovative technologies in German inpatient care. Through systematic searches and empirical analysis, the authors revealed that the body of clinical evidence per technology often consisted mainly of non-comparative studies, and its robustness increased over time for many but not all technologies. The results highlighted the need for strengthened market approval standards, HTA pathways, and approaches like coverage with evidence development to ensure informed reimbursement decisions.

On January 22, 2024, NHS England published a 5-year implementation strategy for Hybrid closed loop (HCL) technologies following the NICE technology appraisal (TA943) publication. As a rule, commissioners and providers must implement TA recommendations within three months. However, an agreed five-year implementation will allow NHS to build specialist competencies and cost-effective procurement. NHS England will fund integrated care boards to reimburse the use of HCL systems

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 January 2024. Twelve 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, peripheral vascular, interventional radiology, neurovascular, ophthalmology, men’s health, 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, Cangelosi et al. conducted a systematic review to assess how data from health technology assessments (HTAs) informs procurement decisions for medical devices. By synthesizing evidence from 11 relevant studies, the authors aimed to identify the criteria used in purchasing decisions, highlighting the minimal evidence of HTA influencing procurement. The authors emphasized the unmet need for enhanced transparency, incentivization for publishing procurement-related work, and further research to strengthen the connection between HTA and procurement, ultimately aiming to optimize resource allocation and expand access to innovative medical technologies within healthcare systems.

In January 2024, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (intravascular lithotripsy in peripheral arterial disease, temperature control after cardiac arrest, and pharyngeal electrical stimulation for neurogenic dysphagia) and one new Diagnostics Guidance (AI-derived software to help clinical decision making in stroke). Furthermore, one Diagnostics Guidance and five clinical guidelines were updated.

On January 30, 2024, the Institute for the Hospital Remuneration System (InEK) published the list of the requests for innovation funding (NUB) that were submitted by the hospitals in 2023. The medical technologies of cardiovascular, ENT, extracorporeal, gastrointestinal, neuromodulation, and other technology groups obtained positive status 1.

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, Groene et al. conducted a comprehensive evaluation of Germany's pioneering policy to include digital health applications in the statutory health insurance system, aiming to assess its impact, highlight challenges, and propose prospective policy options. Through analysis of publicly available data from the Federal Institute for Drugs and Medical Devices and empirical findings published by academic institutions and sickness funds, the authors delineated areas for improvement, such as low prescription rates and temporary reimbursement of applications that lack proven benefit. The authors advocated for value-based pricing and increased budget authority for insurance organizations to foster innovation while ensuring optimal resource allocation in healthcare.

In January 2024, the Ministry of Health and Prevention published the Order in the Official Journal of the French Republic updating the cancer screening programs. The new Order replaces the previous one from September 2006 and specifies the implementation conditions for the organized screening programs for breast, colorectal, and cervical cancers.

In a new White Paper, MTRC identified evidence requirements for national add-on reimbursement via the LPPR List process based on analysis of five recent HAS reports with positive recommendations. Cases included technologies with different levels of added clinical value (II, III, IV, and V). A review of five cases is followed by recommendations in relation to evidence generation for medical technologies in France, and factors influencing the decision-making of HAS. The analysis was performed in February 2024.

On February 5, 2024, NICE published proposed methods and processes to include technology appraisal recommendations in the clinical guidelines and launched a consultation. The deadline for submitting comments is March 15, 2024.