Healthcare services in Sweden are financed and organized by 21 regional authorities, each making independent decisions on funding and adoption of medical technologies. While health technology assessment (HTA) is not formally required for market access of medical devices, evaluations conducted by the Dental and Pharmaceutical Benefits Agency (TLV) inform the recommendations of the national MTP Council about the orderly introduction of medical technologies.
The framework for the national joint introduction of new medical technologies ("Ordnat Införande") aims to ensure equal, evidence-based, and cost-effective access to innovative medical devices across Sweden’s regions. TLV identifies and prioritizes impactful technologies using sources such as manufacturer submissions, clinical associations, and healthcare providers. If a technology is considered promising, TLV may be requested by the MTP Council to conduct a formal HTA.
Based on clinical and economic evidence from manufacturers and expert input, TLV prepares an evaluation that serves as the basis for the MTP Council’s recommendation. These recommendations, while non-binding, aim to support consistent and cost-effective technology adoption across Sweden. Final decisions remain with each region.
This report provides an opportunity to learn about the evidence requirements of Sweden's Dental and Pharmaceutical Benefits Agency (TLV) and the Medical Technology Product (MTP) Council in relation to the national process of Orderly Introduction of medical technologies. White Paper outlines the key points and recommendations for the MedTech industry informed by three HTA reports with positive recommendations.
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Request this analytical White Paper to gain strategic insights into Sweden’s evidence requirements for the national Orderly Introduction process