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.

OPCS-4 is the clinical coding classification of interventions and procedures undertaken within the NHS in England. It is updated every three years, reflecting current clinical practice to be used for statistical purposes and reimbursement. On April 1, 2023, a new version (OPCS-4.10) came into force. A total of 236 new four-character codes were introduced in multiple areas, including cardiovascular, endoscopy, ENT, gastrointestinal, urology, neurology, gynecology, breast reconstruction, and others.

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, Vogler et al. provided an overview of the current situation regarding HTA, pricing, and funding policies for point-of-care (POC) diagnostic tests for community-acquired acute respiratory tract infections (CA-ARTI) in 17 European countries by conducting a qualitative survey of healthcare authorities. In addition, the authors provided recommendations for improvement in decision-making processes.

On April 1, 2023, an updated version of the Health Care Classification System (SKS) came into force. The Danish Health Data Authority quarterly updates the SKS system, which includes coding for procedures, diagnoses, and other coding (e.g., administrative, pharmaceuticals). In the current version, eight new surgical procedure codes, one medical procedure code, multiple codes for regional anesthesia, one code for diagnostic imaging, one for nuclear medicine, and several additional codes were implemented.

In March 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) updated the List of reimbursable devices and Nominative lists to take effect on April 1, 2023. Eight new codes for intracardiac transcatheter pacing systems with the corresponding conditions of reimbursement were added to the List, and two devices (Micra VR and Micra AV) were registered on the list of brands connected to that new codes.

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, Hoogendoorn et al. presented a study, the goal of which was to develop a new framework for assessing the quality and reliability of health and wellness apps. While developing the framework, the authors obtained feedback from 83 experts, predominantly from Europe, using a two-round Delphi method. The final framework includes 81 questions that impact four overarching quality aspects, and it will help manufacturers enhance and demonstrate the quality of health apps.

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, Klein et al. evaluated the use of real-world evidence (RWE) by HTA agencies in Europe for assessing the cost-effectiveness of high-risk medical devices. In total, 25 HTA reports using RWE data were reviewed. Authors offered a critical review of the use of RWE in these reports and provided recommendations for improvement.

In March 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous transluminal renal sympathetic denervation for resistant hypertension, endoluminal gastroplication for gastro-oesophageal reflux disease), three new Health Technology Evaluations via piloted early value assessment approach (CaRi-Heart for predicting cardiac risk in suspected coronary artery disease, ProKnow cloud-based system for radiotherapy data storage, and Genedrive MT-RNR1 ID Kit for detecting a genetic variant), and two new MedTech Innovation Briefings (QBTest and BPMpathway). No new clinical guidelines were published.