On the request of the Medical Technology Council (MTP-rådet), representing the Swedish regions, TLV has performed a health economic evaluation of Prosigna. The evaluation is part of the decision basis in the upcoming national recommendation that the Medical Technology Council will issue concerning Prosigna.
Prosigna is a gene expression analysis of breast cancer tumor tissue that assesses the risk of developing distant metastases (prognostic performance). The test result is used in addition to conventional clinical-pathological assessment to decide whether the patient should be treated with chemotherapy or not.
In the Swedish guidelines for breast cancer, gene expression analysis is recommended for a specific subgroup of patients where it is difficult to estimate the risk of the development of distant metastases and whether the patient should be treated with chemotherapy or not. Prosigna is one of the tests that is mentioned in the Swedish guidelines. The patient group that is included in TLV’s main scenario is chosen to reflect the recommendations in the guidelines as close as possible.
The uncertainties in the results of TLV’s analysis is moderate and lies foremost in the distribution between different risk classes according to the test result, and on the proportion of patients within each risk class that is expected to receive chemotherapy. However, these uncertainties are not so large that they are expected to affect the conclusion concerning the product’s cost-effectiveness.
TLV estimates that the use of Prosigna in addition to clinical-pathological assessment costs around 207 000 Swedish kronor per gained quality adjusted life year (QALY), compared to only clinical-pathological assessment.