Norway

On 25th of September, the Norwegian Decision Forum of “New Methods” had a meeting to review several medical technologies and IVD tests. Decisions were made in relation to the introduction of 2 new newborn screening tests, prehospital emergency thoracotomy, aortic valve replacement using sutureless stent Perceval, and digital breast tomosynthesis.

All significant innovations in Norway should undergo either national or hospital-based health technology assessment within “New Methods” framework. Guiding criteria for prioritization of topics for assessments were recently formulated by the administration of the program.

Researchers evaluated care process, access, administrative efficiency, equity and health care outcomes in 11 countries on the basis of published health care statistics for 72 indicators. The best overall performers among European countries were the UK (ranked 1st), the Netherlands (3rd), Norway (4th), Sweden and Switzerland (6th). Germany (8th) and France (10th) were low in the ranking.

The guideline is based on recently updated and summarized research-based knowledge of the effects and side effects associated with the treatment. Both user experiences and research-based knowledge are emphasized in the assessments of the adverse effects that have been associated with the treatment.

The Ministry of Health and Care Services has decided to transfer management tasks related to the medical device area from Norwegian Directorate of Health to the Norwegian Medicines Agency from 1 January 2018.

Currently there are 10 ongoing mini-health technology assessments of medical technologies in Norway. After completion of evaluation, decision will be made about funding of these technologies at hospital level.

Guidelines from Norwegian Directorate for Health have high impact and can be considered as commissioning guidelines. New criteria for screening for gestational diabetes and new fasting glucose threshold for diagnosis were determined.

The Forum of Norwegian payers made decision about introduction of three medical technologies: mechanical thrombectomy for stroke, baroreflex activation therapy for resistant hypertension and non-invasive prenatal testing for detection of trisomy 13, 18 and 21.

Three mini-HTAs were published since beginning of 2017: procalcitonin for diagnostic of bacterial infections, Per Oral Endoscopic Myotomy (POEM) for achalasia, and use of the Prosigna test (PAM50 ROR) for decisions on adjuvant treatment in breast cancer. These assessments can support introduction of methods at local hospital level in Norway.