On June 16, 2025, the Decision Forum for the "New Methods" framework made a favorable coverage decision for leadless pacemakers (Micra™) to treat patients with atrial fibrillation and bradycardia in specific clinical indications.

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, Jaksa et al. conducted a targeted review of health technology reassessments across six international HTA agencies to examine the use of real-world evidence (RWE). The analysis of 40 recent reassessments found that 55% incorporated RWE, primarily drawing on registry data to address clinical uncertainties. However, RWE use did not alter patient access outcomes, and no de novo comparative RWE studies were identified, highlighting the need for greater alignment between agencies and sponsors on evidence needs and study feasibility.

The Danish Health Data Authority quarterly updates the Health Care Classification System (SKS). The latest version was published in mid-June 2025 to come into force on July 1, 2025. Among other changes, seventy-eight new procedure codes were introduced concerning dermatology, endoscopy, ENT, interventional radiology, obstetrics and gynecology, orthopedics, spine, surgical procedures, and some other fields.

MTRC is pleased to announce the release of its latest White Paper: “Co-Funded Studies for Innovative Medical Devices in Germany (§137e SGB V)”, a coverage with evidence development program in hospital and ambulatory sectors. The Paper explains strategic rationale, legal framework, procedural steps required to launch a co-funded study and data about the utilization of the scheme.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Ivo et al. examined the evolution and future prospects of European-level cooperation in health technology assessment, focusing on the implementation of the EU HTA Regulation. The authors highlighted the critical role of harmonised methodologies and coordinated capacity building in overcoming national heterogeneity. The new regulation is expected to streamline assessments, improve efficiency, and accelerate equitable access to innovative health technologies across Europe.

On June 6, 2025, NHS England published an updated work plan for the development of Clinical Commissioning Policies for specialised services. Two new MedTech-related policies concerning interventional radiology were added to the work program, and none have been published since the previous update. The status of ongoing policies has also been updated.

On June 10, 2025, the Swiss Federal Office of Public Health published updates to the Healthcare Benefit Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The changes will take effect on July 1, 2025, and relate to colorectal cancer screening with the increase in the number of reimbursed colonoscopies, cancer treatment, men’s health, medical aids, and other medical services.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Sustainability Publications Digest. In a recent publication, Amin et al. conducted an audit to quantify both contaminated and recyclable waste generated from invasive cardiac procedures in a single cardiac center, which performs approximately 350 cardiac surgeries and 2,900 interventional cases annually. The study found that the center produced an estimated 11,000 kg of recyclable and 30,000 kg of contaminated waste each year, with potential global extrapolation reaching 150 million kg of annual waste from such procedures. The authors highlight the need for sustainability initiatives within cardiology to address the environmental burden of medical waste.

In May 2025, the Dutch Healthcare Institute (ZIN) published the Advice on considering staff deployment and sustainability criteria when assessing whether to reimburse medical procedures and technologies from basic health insurance. Since May 2025, ZIN has initiated a three-year trial to incorporate these criteria into the assessment process, with an interim evaluation after 1.5 years to be discussed with the Ministry of Health, Welfare, and Sport.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Arcà et al. addressed the persistent challenge of integrating patient perspectives into PICO scoping for Health Technology Assessment (HTA) under the EU HTA Regulation. The authors proposed a structured framework based on the Delphi panel methodology to enhance the validity and transparency of patient contributions, facilitating structured engagement and consensus among patients and caregivers across Europe. This approach is designed to better align stakeholder expectations with HTA outcomes, and a study is currently underway to assess its practical feasibility.

On June 5, 2025, the French National Authority for Health (HAS) published its favorable opinion on the coverage of AI-assisted digitalized urine cytology using VisioCyt Bladder, an in-vitro diagnostic medical device, under the renewed Repository of Innovative Procedures outside the Nomenclature of Biology and Anatomocytopathology (RIHN) 2.0.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Health Economic Publications Digest. In a recent publication, Thokala et al. provided an overview of how resource constraints can be incorporated into health economic evaluations. Drawing on literature and expert input, the authors identified three distinct categories of resource constraints: single-use resources, reusable resources, and constraints related to patient throughput. They also developed a comprehensive framework to guide a more accurate and realistic assessment of health technologies under real-world limitations. Their findings underscore the importance of systematic consideration of resource constraints by HTA agencies to enhance the relevance of economic evaluations.