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.

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.

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.

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, Messori et al. analyzed five HTA reports of high-risk medical devices (classes IIb and III, and active implantable devices) that included cost-effectiveness data, developed in the Tuscany region. The analysis demonstrated a high level of concordance between value-based prices and actual prices, which suggests a wider application of the value-based pricing framework for high-risk medical devices, which, however, requires an adequate level of cost-effectiveness data.

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.

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, Weir et al. reviewed the use of surrogate endpoints in health technology assessment (HTA) processes used to evaluate drugs and biologic therapies and developed an overview of statistical methods for surrogate evaluation. In addition, the authors described how regulatory authorities, payers, and HTA agencies use clinical trial evidence based on surrogate outcomes. Despite the focus on pharmaceuticals, the article can be of interest to the audience from the med tech space as well.

In March 2023, the Danish Health Technology Council (Behandlingsrådet) completed a major analysis (større analyser) on patient-centered diabetes technology. The Council recommended that sensor-based glucose monitoring devices with alarms be offered to all adult patients with type 1 diabetes.

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 March 2023. Fifteen recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, endocrine, endoscopy, gastrointestinal, surgical, and diagnostic imaging devices, as well as medical aids.