Published on 29 May 2024

Use of multigene-expression tests for breast cancer

Multigene-expression tests for patients with breast cancer are designed to help decide whether to proceed with chemotherapy following breast cancer surgery. This HTA report assessed the compulsory reimbursement of the multigene expression tests OncotypeDX, MammaPrint, EndoPredict and Prosigna for breast cancer. The HTA report reviewed the clinical efficacy, cost-effectiveness and budget impact, as well as the ethical, legal, social and organisational aspects.

A systematic literature review included a total of 25 clinical studies. Only on MammaPrint there was a comparable study on clinical effectiveness compared with conventional testing for guiding the decision on chemotherapy after breast cancer surgery. It showed that making treatment decisions based on MammaPrint may potentially result in fewer breast cancer patients receiving chemotherapy, alongside potentially small differences in metastasis-free survival. OncotypeDX, MammaPrint, Endopredict and Prosigna may predict the course of the disease, but the studies provided low to very low certainty of evidence. Studies on predicting the benefit of chemotherapy showed either no clear evidence or only low to very low certainty of evidence. Studies have shown that multigene-expression tests altered the decision regarding chemotherapy following breast cancer surgery, but those studies lack the effect on clinical outcomes.
To analyse the cost effectiveness and budget impact, a published health economic model was used that was adapted to Switzerland. The existing uncertainties in the model mean that it is impossible to deliver a sound assessment of the cost effectiveness of multigene-expression tests. In other words, it is unclear whether multigene-expression tests lead to higher or lower costs and better or worse health outcomes.
Ethical aspects studied were the insufficient consideration of ethnic minorities and men in the studies. Social problems included the emotional stress caused by the tests. Many organisational factors were mentioned, such as how the tests would be integrated and applied in clinical practice.

The report concludes that there is a lack of comparable clinical studies. Studies on predictive ability regarding the benefit of chemotherapy, prognostic ability and impact on treatment management showed low to very low certainty of evidence. Meanwhile, the effect of multigene expression tests on cost effectiveness and budget impact are unclear.