Norway

Since January 2025, three MedTech-related mini-HTAs were initiated in the areas of men’s health, in-vitro diagnostics, and diagnostic imaging as a part of a framework for the managed introduction of innovations "New Methods" in Norway. Furthermore, 11 mini-HTAs were published in this period, including cardiovascular, e-health, gastrointestinal, men’s health, and spine areas.

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.

On May 23, 2025, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system and associated tariffs to be implemented no later than September 1, 2025. A total of 55 new codes were added in the biochemistry, microbiology, clinical pharmacology, and immunology fields.

In May 2025, the evaluation phase of the “New Methods” framework was completed for three technologies: leadless pacemaker for cardiac arrhythmias, MR-guided focused ultrasound for essential tremor, and Electrical Field Therapy for glioblastoma treatment. As the recommendations from HTA are now available, the Decision Forum needs to make coverage decisions for these technologies.

In April 2025, the proposals to improve the New Methods framework processes were published by the Norwegian authorities. The key changes include revised enter pathways and selection criteria for assessment of medical devices within the framework. The proposals are open for public comment until May 18, 2025.

In March 2025, the Decision Forum for the "New Methods" framework made a favorable coverage decision for robotic-assisted prostatectomy, hysterectomy, and rectal resection in cancer indications.

On March 23, 2025, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system and associated tariffs to be implemented no later than May 1, 2025. A total of 143 new codes were added in the biochemistry, microbiology, clinical pharmacology, and immunology fields

In February 2025, the Ministry of Health and Care Services published a National Cancer Strategy for 2025-2030. The strategy outlines five key target areas with corresponding goals and actions. The target areas comprise pioneering cancer prevention and early detection, improving patient outcomes, enhancing user-oriented cancer care, increasing survival rates and longevity, and ensuring the best possible quality of life. The actions include the expansion of national screening initiatives, the accreditation of Comprehensive Cancer Centers, digital home monitoring, precision diagnostics, and the establishment of a national healthcare innovation hub.

In late January 2025, the Nordic Initiative for Environmental Labelling of Medical Supplies (NIELS) project was completed. The initiative was aimed to promote greener procurement of medical equipment by expanding the use of eco-labeling. Following its successful conclusion, the project is now considering opportunities to broaden the dialogue to a European level.

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.

In February 2025, the Decision Forum for the "New Methods" framework made a favorable coverage decision for transcutaneous vagus nerve stimulation (gammaCore) in the treatment of cluster headaches.

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.