TLV assessed Oncotype DX and ProSigna tests for early breast cancer detection in July 2021

The Orderly introduction framework became permanent in early 2020, and it aims to evaluate new medical technologies with a significant impact to the Swedish healthcare system, and to provide national recommendations, to reduce the inequality of adoption of innovative medical technologies among Swedish regions. This is a staged process, including horizon scanning, selection of the method for evaluation, the decision on national collaboration, health economic evaluation by the Swedish Dental and Pharmaceutical Benefits Agency (TLV), and recommendations by the Medical Technologies Product (MTP) Council to regions about the introduction of the technology and criteria for use.

In September 2020, the MTP Council commissioned Swedish Dental and Pharmaceutical Benefits Agency (TLV) to perform a health economic evaluation of gene diagnostics for breast cancer, including Oncotype DX and ProSigna. In July 2021, the final assessments were released by the TLV with the following conclusions:

• The cost per quality-adjusted life-year for ProSigna is estimated to be 207,000 SEK on average, compared to the stand-alone clinical pathology assessment (link);
• The analysis shows that the use of Oncotype DX, in addition to clinical pathology assessment, leads to 0.24 won quality-adjusted life years on average, and the treatment cost is reduced by approximately 50,500 SEK in comparison with the stand-alone clinical pathology assessment. The analysis in the health economic assessment indicates that the use of Oncotype DX provides greater benefit than the alternative, also at a lower cost (link).

As the next step, the MTP Council will make recommendations to regions about the introduction of the assessed tests and criteria for its use. After that, the regions will decide whether to proceed with the adoption of these technologies.

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