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Market access for medical technologies in Sweden

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

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Key topics

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

  • Reimbursement: payment mechanism via the DRG-adjusted budget system
  • Funding: recommendations in the national “Orderly Introduction of Medical Technologies” framework
  • Health technology assessment: obtaining recommendations from the national and regional HTA bodies
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Reimbursement

Hospital care is predominantly funded via a global budget adjusted for activity based on DRGs. 

Sweden shares the DRG system (NordDRG) with several other countries, including Finland and Norway. 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 Swedish regions. 

DRGs are determined by the combination of a procedure code (KVÅ) and a diagnosis code (ICD-10). KVÅ nomenclature is maintained by the National Board of Health and Welfare and released annually. The Swedish version of the NordDRG system is approved annually, and the base rate is determined at the national level.

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Funding

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

Swedish 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 (“Orderly Introduction of Medical Technologies” framework). In this framework, technologies are evaluated on the national level, and recommendations for the adoption of novel technologies are provided to payers (Regions) and healthcare providers. 

Two organizations play a key role in the framework: 

  • MTP Council initiates the HTAs and makes final recommendations for adoption
  • The Dental and Pharmaceutical Benefits Agency (TLV) performs horizon scanning activities to identify relevant topics for evaluation and full health technology assessments (with a heavy focus on the health economic evaluation) of the procedures selected for evaluation by the MTP Council. 
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Health technology assessment

HTA is performed on the national level (as part of the “Orderly Introduction of Medical Technologies” or as stand-alone evaluations) or on the regional level (which can inform regional/local decision-making).

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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 184 projects in Sweden

News and insights

Updates in coverage recommendations for CGM devices in type 2 diabetes in Sweden

On May 8, 2025, the Medical Technologies Product (MTP) Council revised its recommendations on continuous glucose monitoring (CGM) for patients with type 2 diabetes (T2D), initially issued in 2022 under the Orderly Introduction of Medical Technologies framework. The updated recommendations now allow the use of other CGM devices considered equivalent to FreeStyle Libre and FreeStyle Libre 2, which were the only recommended products in 2022. Simultaneously, the MTP Council initiated a reassessment of CGM devices for T2D and tasked the Dental and Pharmaceutical Benefits Agency (TLV) to carry out a new health economic evaluation.

Health technology assessments by Swedish TLV in Q1 of 2025

In the first quarter of 2025, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) published two health technology assessments in the robotic surgery field and proceeded with working on HTAs in the e-health, endocrine, and neurosurgery fields.

Funding of 80 million SEK in 2025 for the Genomic Medicine Sweden (GMS) project

On April 14, 2025, the National Board of Health and Welfare was tasked to allocate 80 million SEK from the government to support Genomic Medicine Sweden (GMS) project in 2025. Funding will be distributed to several projects, including the development and/or implementation of innovative technologies such as whole genome sequencing based on long DNA reads, gene panels for sensitive detection of residual disease, and precision diagnostics (liquid biopsies for solid tumors, detection of antibiotic resistance).

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