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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 147 projects in Norway

News and insights

25 Jan 2024

2024 Norwegian Pathology Activity Codes (APAT) and reimbursement tariffs released

In December 2023, the reimbursement scheme for outpatient pathology services was updated for 2024. This scheme has been gradually introduced in Norway since 2022. It comprises fee-for-service reimbursement by the Norwegian Health Economics Administration (Helfo) using Pathology Activity Codes (APAT). Fourteen new reimbursement codes were introduced.
16 Jan 2024

Administrative reorganization in Norway came into force

On January 1, 2024, changes in the Norwegian central health administration announced by the government in May 2023 came into force. The Directorate of Health expanded its responsibility in digitalization, the development of health care services, and public health. The Directorate of e-Health discontinued to be an independent body and merged with the Directorate of Health.
04 Jan 2024

2024 Norwegian DRG system released

In December 2023, the Norwegian Directorate of Health published a final version of the DRG system (Innsatsstyrt finansiering, ISF) for 2024. In general, no significant changes were introduced. No new DRGs will be added. One new Special Service Group (STG) for light treatment and five new Service Progress Groups (TFGs) concerning maternity care pathways and rehabilitation will be introduced.

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