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Market access for medical technologies in Norway

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in Norway

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Key topics

There are three key themes describing market access for medical technologies in Norway: 

  • Reimbursement: payment mechanism via the DRG system
  • Funding: national guidelines by the Directorate of Health, coverage decisions in the national “New Methods” framework
  • Health technology assessment: stand-alone HTAs by the Norwegian Institute of Public Health
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Reimbursement

Reimbursement for hospital and most outpatient specialist procedures is made via the Norwegian version of the NordDRG system, which is shared with other Nordic countries, including Finland and Sweden. The DRG system does plays a smaller role compared with other European countries (e.g. France or the Netherlands), as it accounts only for 40% of hospital revenue (the other 60% - via block grant payment mechanism), but plays a greater role comparted to other Nordic countries. 

The Norwegian reimbursement system (ISF) has the following components:

  • Diagnosis-related groups (DRGs), which are determined by the combination of a procedure code (NKPK coding system) and a diagnosis code (ICD-10). The NKPK coding system is maintained by the Directorate of Health and released annually;
  • Special Service Groups (STGs) cover specialist health services that take place in other than traditional inpatient and outpatient settings, as extended over a long period of time and so that the patient himself is more responsible for the administration of the treatment;
  • Service Progress Groups (TFG) "bundled payments", so it is an aggregated level above DRG and STG, providing financing of a patient treatment course with several stays and activities. The aim of TFG introduction was to provide incentives for cost-effective treatment choices through harmonization of pricing and payment for different methods (technology, organization, etc.).
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Funding

Norway has no nationally defined list of health benefits which are guaranteed to the Norwegian population. Decisions on which treatment methods to use and which new technologies to introduce are made by the hospitals.

However, all innovative medical technologies must undergo evaluation and obtain a coverage decision within the national “New Methods” framework. The framework has two levels:

  • National level, where decisions based on HTAs are made by the four Regional Health Authorities jointly. This is relevant mostly for highly specialized services, and highly innovative technologies;
  • Local level, where decisions are made based on the mini-HTAs performed locally in the hospital.
    The presence of methods in national guidelines developed by the Norwegian Directorate of Health can significantly support the adoption of novel technologies by healthcare providers and payers (Regional Health Authorities). 
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Health technology assessment

HTAs are performed by the Norwegian Institute of Public Health, including stand-alone assessments and evaluations within the “New Methods” framework. 
 

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Specifics for IVD tests

All laboratory tests in hospital settings and simple laboratory biochemistry tests that are performed as part of outpatient consultations are covered within the DRG system.

IVD tests performed in outpatient specialist settings are reimbursed on a fee-for-service basis using the Norwegian Laboratory Code (NLK) System. 

MTRC has experience with more than 149 projects in Norway

News and insights

Ongoing mini-HTAs in Norway in June 2024

In June 2024, the following ongoing mini-HTA assessments for cardiovascular, diagnostic imaging, e-health, endoscopy, gastrointestinal, in-vitro diagnostics, men’s health, neurology and neurosurgery, neuromodulation, peripheral vascular, pulmonary and airways, robotic surgery, and some other fields are evaluated as a part of a framework for the managed introduction of innovations "New Methods" in Norway.

Regular update of the Norwegian Laboratory Code System released

On May 23, 2024, 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 July 1, 2024. Twenty-two new codes were added, and 49 codes were changed.

Regular update of the Norwegian Laboratory Code System released

On March 23, 2024, 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, 2024. A total of 107 new codes were added, 92 codes were amended, and two codes were terminated.

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