In April 2023, NHS England published an updated version of the National Genomic Test Directory for 2023/2024, which lists tests commissioned by NHS England via Genomic Laboratory Hubs. Sixteen new codes (test-indication combinations) were introduced in the Test Directory for cancer, and 25 new codes in the Test Directory for rare and inherited diseases.

On March 31, 2023, the Ministry of Health and Prevention published the Decree in the Official Journal of the French Republic that defines an application process for the early coverage of digital medical devices for therapeutic purposes and medical telemonitoring by health insurance.

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, Boriani et al. evaluated the expectations and opinions of healthcare professionals in Europe on reimbursement policies for the use of digital devices (including wearables) in atrial fibrillation and other arrhythmias. The study summarized information about the use of digital devices, trust in digital technologies, and availability of reimbursement of digital technologies in individual EU countries.

In April 2023, the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) published the updated 2023 version of the assessment framework of the "state of science and practice" criteria, including the assessment framework itself, modules with additional explanations for its application, and other information material.

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, Drummond et al. analyzed the actual alignment between the current practice of coverage with evidence development (CED) schemes for medical devices in Europe and the theoretical principles proposed by health economists. In addition, the authors provided a series of recommendations that should support decision-makers in developing and conducting CED schemes in the future, as these schemes can provide real-world evidence on the performance of medical devices.

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, Drummond et al. analyzed the actual alignment between the current practice of coverage with evidence development (CED) schemes for medical devices in Europe and the theoretical principles proposed by health economists. In addition, the authors provided a series of recommendations that should support decision-makers in developing and conducting CED schemes in the future, as these schemes can provide real-world evidence on the performance of medical devices.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2023. The most significant changes concern introducing the new EBM codes for follow-up and evaluation of the “Invirto” health app, high-frequency endometrium ablation, and reducing the tariff for COVID-19 PCR tests.

On March 16, 2023, the Reimbursement Commission of the Social Security Institution (SSI) released an updated version of the Healthcare Implementation Communique (SUT). The main change relates to the increase in reimbursement fees of services and medical devices. Furthermore, eight new cardiovascular procedure codes were introduced.

On March 24, 2023, the French National Authority for Health (HAS) announced a three-year experiment on the health economic evaluation of digital medical devices (DMD). This will allow manufacturers to voluntarily provide a budget impact analysis (indicating a cost-saving effect on the healthcare system) that can support the registration of their DMDs in the LPPR List and a pricing decision.

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, Ciani et al. analyzed international HTA practice of the actual considerations around using surrogate endpoint evidence for both pharmaceuticals and medical devices. Based on the analysis, the authors developed a web-based tool which helps health technology assessment agencies and payers assess the clinical and cost-effectiveness of healthcare technologies by considering surrogate endpoints and, thus, support the decision-making process.

In March 2023, the National Institute for Health and Care Research (NIHR) in England released two MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned total ankle replacement versus ankle arthrodesis in end-stage osteoarthritis, and techniques for managing an impacted fetal head during emergency cesarean section. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.

The Dental and Pharmaceutical Benefits Agency is currently conducting several health economic assessments of products for electrical spinal cord stimulation. The assessments were commissioned by the Medical Technology Product Council as the first step of the national Orderly Introduction process for new medical devices. The evaluations are planned to be accomplished during 2023.