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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 play 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 compared 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 so that the patient himself is more responsible for the administration of the treatment;
  • Service Progress Groups (TFG) "bundled payments" are aggregated levels above DRG and STG, providing financing of a patient treatment course with several stays and activities. The aim of the 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 160 projects in Norway

News and insights

Regular update of the Norwegian Laboratory Code System released

On September 23, 2024, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system. Sixty-nine new codes were added, and 209 codes were changed.

Favorable coverage decision for molecular gene profile analysis (Oncotype DX) in Norway

Molecular gene profile analysis (Oncotype DX) was evaluated within the "New Methods" framework starting in 2021. On August 26, 2024, the Decision Forum for "New Methods" recommended Oncotype DX to be introduced to predict the benefit of chemotherapy in postmenopausal patients with lymph node-positive, estrogen receptor-positive (ER+), human epidermal growth factor receptor-2 negative (HER2-) early-stage invasive breast cancer.

Proposal for changes to the process of including new diseases in newborn screening in Norway

On June 26, 2024, the Norwegian Directorate of Health published its proposal to change the process of including new diseases in newborn screening. The key objective is making the process more dynamic, which requires regulatory and administrative amendments.

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