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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 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.

Sweden 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.

How can MTRC help?

MTRC has experience with more than 167 projects in Sweden

News and insights

MR-guided focused ultrasound to be evaluated within the Orderly introduction framework in Sweden

On May 6, 2024, the Swedish Medical Technologies Product (MTP) Council commissioned the Dental and Pharmaceutical Benefits Agency (TLV) to perform a health economic evaluation of MR-guided focused ultrasound (Exablate Neuro) for the treatment of patients with essential tremor and Parkinson's disease. This evaluation is a part of the Orderly introduction framework, a staged process aimed at managing the national introduction of novel technologies. Based on the TLV assessment, the MTP Council will make recommendations to regions regarding the implementation of the technology and the criteria for use.

Swedish MTP Council made positive recommendations for three spinal cord stimulation devices

On March 26, 2024, the Swedish Medical Technologies Product (MTP) Council recommended three spinal cord stimulation devices (Intellis, Proclaim, and WaveWriter) for patients with neuropathic pain and insufficient effect of conventional treatment. Devices have been evaluated as part of the Orderly introduction framework.

Ongoing HTAs by Skåne University Hospital in Sweden in February 2024

In February 2024, the Skåne University Hospital is working on several HTAs, including evaluations in the cardiovascular, e-health, endocrine, men’s health, neurology and neurosurgery, orthopedics fields.

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