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National evaluations commissioned to Swedish TLV in February 2025
In February 2025, the MTP Council announced national evaluations of two technologies within the Orderly introduction framework. This framework is a staged process, including horizon scanning, selection of the method for evaluation, the decision on national collaboration, health economic evaluation by the Dental and Pharmaceutical Benefits Agency (TLV), and recommendations by the Medical Technologies Product (MTP) Council to regions.
The first commissioned evaluation concerned rectal spacers (SpaceOAR Hydrogel and Barrigel), which are used to reduce the side effects of radiotherapy in prostate cancer. These products have already been evaluated within the Orderly introduction framework. In 2022, based on the TLV assessment, the MTP Council recommended a gradual introduction of the products in selected regions, while other regions were recommended to wait for the introduction. In February 2025, MTP Councils decided that enough follow-up data was collected so TLV could conduct a new health economic evaluation.
The second launched national evaluation concerned Stratipath Breast, a CE-marked, AI-based solution for breast cancer risk assessment. The product is used to perform image analyses of tissue samples from breast cancer tumors. Stratipath Breast can be an alternative to gene expression analysis (more expensive and time-consuming) to support decision-making about adjuvant chemotherapy.
Based on the TLV assessment, MTP will make recommendations to the regions regarding the introduction of the products.
See the full details in Swedish here and here.
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