On March 4, 2025, the Member State Coordination Group on Health Technology Assessment (HTACG) published submission (‘briefing’) templates for Joint Scientific Consultations (JSC) of medical devices and in-vitro diagnostics under the EU HTAR framework. Health Technology Developers submit completed briefing templates as part of the briefing package to be considered for JSC. The JSC Outcome Document template was published as well.
In March 2025, the Health Sciences Institute in Aragon released a document that provides guidance on incorporating real-world data into health technology assessment, focusing on the preadoption phase for evaluating new technologies in the Spanish Network of HTA Agencies (RedETS) framework. It outlines a workflow aligning with RedETS practices, identifying key milestones where RWD adds value and offering methods and tools to integrate RWD into decision models.
On February 21, 2025, the “New Method” framework published an annual summary of the Decision Forum and Ordering Forum work in 2024. Among 109 coverage decisions in 2024, only one was for Med Tech (Oncotype DX), while all others concerned pharmaceuticals.
On February 7, 2025, the National Institute for Health and Care Excellence (NICE) published a manual for a new HealthTech program and launched a consultation. The HealthTech program will produce two types of guidance: Interventional Procedures guidance and HealthTech guidance (replacing former Medical Technologies guidance and Diagnostics guidance). The deadline for comments submission is March 6, 2025.
On January 24, 2025, the European Commission adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices under the EU HTAR framework.
Starting January 12, 2025, Norway joined the EU Health Technology Assessment Regulation (HTAR) framework, a collaborative European initiative for method assessments. In 2024, a national working group assessed how to integrate HTAR into the "New Methods" framework. The Norwegian Medical Products Agency (NOMA) will be the key organization representing Norway and contributing to the development of Joint Clinical Assessments (JCAs) of medicines and medical devices.
In December 2024, the Austrian Institute for HTA published a project report on the threshold values in health economic evaluations and decision-making. It concluded that, despite their complexity, implementing thresholds could enhance transparency and efficiency in health systems.
Since January 1, 2025, the Danish Healthcare Quality Institute has been established, replacing the Health Technology Council and the Regions' Clinical Quality Development Program. The Institute comprises three overall focus areas that contribute to patients receiving high and uniform quality treatment across the country and the best possible health for the money.
On December 3, 2024, the Member State Coordination Group on HTA released the 2025 Annual Work Programme for the new joint EU-level HTA framework (Regulation on Health Technology Assessment, HTAR). The framework will be fully operational from January 12, 2025.
In December 2024, the Skåne University Hospital (HTA South) is working on health technology assessments in several areas, including men’s health and neurology.
In February 2024, the Skåne University Hospital is working on several HTAs, including evaluations in the cardiovascular, e-health, endocrine, men’s health, neurology and neurosurgery, orthopedics fields.
On February 5, 2024, NICE published proposed methods and processes to include technology appraisal recommendations in the clinical guidelines and launched a consultation. The deadline for submitting comments is March 15, 2024.