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Market access for medical technologies in Denmark

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

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Key topics

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

  • Reimbursement: payment mechanism via the DRG-adjusted budget system
  • Funding: national recommendations from the Health Technology Council
  • Health technology assessment: obtaining recommendations from the national and local HTA bodies
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Reimbursement

Denmark uses the Danish DRG system, but hospital revenue from the DRGs accounts for only about 20%. Hospital care is predominantly funded via a global budget mechanism, which is mostly calculated based on actual costs incurred by the hospitals (differences in calculation methodology among regions may exist). 

However, all inter-regional care is reimbursed on a case-by-case basis via the DRG system. Therefore, the role of DRG is higher for procedures, which are concentrated only in several hospitals across the country and which provide care for patients from other Danish regions. 

DRGs are determined by the combination of a procedure code (SKS) and a diagnosis code (ICD-10). The SKS nomenclature and the Danish DRG system are maintained by the Health Data Authority. 

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Funding

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

Danish regions have a system to collaborate on the introduction of medical technologies and to enable equal access, cost-effective and efficient use of medical technologies in the country. In this framework, technologies are evaluated on the national level by the Health Technology Council, which provides recommendations for the adoption of novel technologies to payers (Regions) and healthcare providers. 

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Health technology assessment

HTA is performed on the national level (as part of the evaluations by the Health Technology Council) or on the regional and local levels (two organizations have limited activity in the Med Tech space). 

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Specifics for IVD tests

There is no specific reimbursement framework for in-vitro diagnostic tests. IVD tests are funded using a global budget principle as part of the laboratory funding.

MTRC has experience with more than 143 projects in Denmark

News and insights

Recent publications by the Danish Health Technology Council

On May 27, 2024, the Danish Health Technology Council released two new publications: an evaluation of Optune® (Novocure) and a major analysis on the treatment of obstructive sleep apnea.

Expected reassessments of national clinical recommendations in Denmark

The Danish Health Authority has initiated a process of assessing the national clinical recommendations. Work is set to start in 2024. Recommendations in diagnostic imaging, endoscopy, endocrine, ENT, gastrointestinal, nephrology and urology, neurology and neurosurgery, neuromodulation, obstetrics and gynecology, ophthalmology, orthopedics, pulmonary and airways, radiotherapy, spine, and some other fields are considered for reassessment.

Preparations for the establishment of the Board for Health Apps in Denmark

The Ministry of the Interior and Health is currently working on the establishment of the Board for Health Apps (Nævnet for sundhedsapps). It is expected that the Board's purpose will be to assess whether the health apps can be recommended to citizens and healthcare professionals in Denmark. The Executive order on the rules of procedure of the Board for Health Apps is expected to enter into force on July 1, 2024, and the Board is foreseen to meet as soon as possible after this.

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