In September 2020, Swedish Medical Technologies Product (MTP) Council decided to evaluate gene diagnostics for breast cancer within the Orderly introduction framework. This framework aimed to manage the national introduction of novel technologies is working as permanent from the beginning of 2020. This is a staged process, including horizon scanning, selection of the method for evaluation, the decision on national collaboration, health economic evaluation, and recommendations by MTP Council to regions about the introduction of the method and criteria for use.
Gene diagnostics for breast cancer are the first technologies that are planned to go through all stages of this new framework. The examples of the products considered for evaluation are MammaPrint, Oncotype DX, ProSigna, and EndoPredict. These gene diagnostics are used to predict the risk of metastases in breast cancer before deciding on chemotherapy to avoid over- and under-treatment.
MTP Council commissioned Swedish Dental and Pharmaceutical Benefits Agency (TLV) to perform a health economic evaluation for these tests.
Based on the results, the MTP Council will then make recommendations to the regions on how the products should be used in healthcare.
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