Norwegian authorities have requested evidence submission from manufacturers for number of medical technologies and IVD tests in relation to assessment for funding

Norway established in 2013 a framework for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. This framework is called the “New Method”.

In this framework, all innovations should undergo HTA before being funded. Selection of methods is performed by the Ordering Forum (Bestillerforum). If the method is of national concern, it undergoes Single Technology Appraisal at national level followed by the funding decision by the group of payers (Decision Forum, Beslutningsforum). Decision Forum has regular meetings to review results of assessments to the make funding decisions.

Recently, administrators of the “New Method” program have initiated technology assessments of 10 technologies and now have requested manufacturers to make submission of clinical and economic evidence.  

The call for evidence submission concerns the following 10 technologies:

• Regional heat treatment (hyperthermia) for cancer treatment (Pyrexar Medical)
• Bronchial thermoplasty (Boston Scientific)
• Implantable mini-telescopic lens for age-related macular degeneration (VisionCare)
• Magnetic resonance thermometry-guided laser interstitial thermal therapy for intracranial neoplasms (Medtronic, Monteris Medical)
• The Nellix endovascular aneurysm sealing (EVAS) system (Endologic)
• Normotermic extracorporeal preservation of hearts for transplantation by donation after brain-dead (TransMedics)
• Rotor mapping and ablation for atrial fibrillation (Abbott)
• Blood Test Based Test (OncoBeam NRAS CRC) to determine KRAS mutation status (Sysmex)
• Vagus Nerve Blockade (neurostimulation) for obesity (Maestro RC2) (EnteroMedics)
• Lithoplasty balloon catheter for peripheral artery disease (Shockwave Medical)

See full text of request here.

If you need support with understanding of Norwegian process or development of evidence submission dossier, please, contact us.

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