In June 2023, the Belgian Health Care Knowledge Center (KCE) published Health Services Research concerning the performance of the Belgian healthcare system. KCE regularly conducts such "check-ups" of the healthcare system in collaboration with Sciensano, the National Institute for Health and Disability Insurance (INAMI/RIZIV), and the FPS Public Health. The conceptual framework and the list of performance indicators were revised and updated.

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, Albuquerque de Almeida et al. studied the regulatory framework differences between medical devices and drugs in the European Union and their impact on clinical and HTA research. The authors identified varying approval standards for devices and drugs as well as fewer manufacturer-sponsored clinical studies and HTA-supported recommendations for medical devices compared to drugs. The study concludes that policy changes, such as the consensual classification of medical devices from an HTA perspective and the adoption of conditional coverage practices, could promote an integrated evidence-based assessment system and improve resource allocation in healthcare.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on July 1, 2023. The most significant changes concern introducing the new EBM codes for several IVD tests, as well as for the cryopreservation of the ovarian tissue.

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, Vandenberk et al. reviewed the topic of remote monitoring (RM) of cardiac implantable electronic devices (CIEDs). The publication discusses the clinical benefits of RM, which include improved survival, early detection of actionable events, and more efficient healthcare utilization. The authors emphasized the need for appropriate reimbursement for RM device clinics and the implementation of universal alert programming and data processing to optimize patient care and device clinic workflows. The study concluded that RM should be considered the standard of care for managing patients with CIEDs and implementing adapted healthcare policies to ensure its future manageability.

On June 8, 2023, Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) published an updated List of reimbursable devices and Nominative lists of brands to come into force on July 1, 2023. Three new material codes concerning cardiovascular and spinal procedures were introduced. Several new branded devices were registered on the Nominative Lists connected to new and already existing material codes.

In June 2023, NHS England published two new specialized service specifications for pediatric photon radiotherapy and gender incongruence in children and young people. These documents define national standards for the provision of specialized services, including aims, outcomes, model of provision, patient pathway, inclusion criteria, and requirements for the facilities and staff.

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, Farah et al. conducted a systematic literature review to investigate the acceptability of current studies assessing Artificial Intelligence-based Medical Devices (AI-based MDs) for health technology assessment (HTA) purposes. The authors found that AI-based MDs studies lack robust and complete evidence, with limited data on safety and economic issues. The study emphasizes the need for standardized evaluation models, reliable evidence generation, and adjustments in HTA processes for AI-based MDs. In addition, the study suggests a number of measures to improve the quality of evidence for AI-based MDs.

On June 19, 2023, the Swiss Federal Office of Public Health (FOPH) published the changes that will occur to the Healthcare Benefit Ordinance (KLV/OPre) and its Annexes, which determines coverage of medical services in Switzerland. Key changes relate to introduction of two codes for genetic tests, several extensions of Coverage with Evidence Development, and updates in reimbursement conditions for transcatheter aortic valve implantation. The changes entered into force on July 1, 2023.

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, Everhart investigated the availability of cost-effectiveness analyses (CEAs) for medical devices in the United States. By analyzing data from the Tufts University Cost-Effectiveness Analysis Registry, the author identified 218 CEAs published between 2002 and 2020. On average, these CEAs were published 4 to 6 years after FDA approval or clearance of the studied devices. The findings suggest that decision-makers often lack timely evidence of cost-effectiveness when making initial reimbursement decisions regarding newly available medical devices.

On June 27, 2023, the National Institute for Health and Care Excellence (NICE) launched a consultation on the updated health technology evaluation process manual, initially published in January 2022. Key changes concerned introducing a new faster approach to technology appraisal development. The deadline for comments submission is July 25, 2023.

On June 11, 2023, the Ministry of Health and Prevention published an Order in the Official Journal of the French Republic on the transitional coverage for the Insides System from Insides Company for the treatment of intestinal failure associated with temporary double enterostomy or enterocutaneous fistula by actively reinfusing chyme into the distal intestine.

The Danish Health Data Authority quarterly updates the Health Care Classification System (SKS), which includes coding for procedures, diagnoses, and other codes. The latest version was published in mid-June to come into force on July 1, 2023. Changes include the introduction of sixteen new surgical and 26 new medical procedure codes.