OBJECTIVES: The objective of this study was to estimate the economic costs from the introduction of a second generation gene expression test combining a molecular signature with the clinical factors tumor size and nodal status to a score predicting risk of distant recurrence and chemotherapy benefit (12-gene assay) for patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) early-stage breast cancer who are lymph node negative or positive for the largest public payer in Greece.

METHODS: A cost analysis of introduction of the 12-gene assay was performed compared to the current clinical practice in Greece for different patient subgroups, including Ν0 patients and Ν+ (1–3) patients. The primary outcome was the economic direct costs to the third payer for the 1^st year of diagnosis.

RESULTS: For a hypothetical cohort of 1,165 ER+, HER2-, Ν0 patients, the total costs of new practice after testing amounts to €4.3 million compared to an estimated total cost of €8.86 million of currently clinical practice, contributing cost-savings of approximately €4.5 million. In regards to the second scenario and for a hypothetical cohort of 537 Ν+ (1–3 positive lymph nodes) patients, the analysis showed slightly higher economic burden of gene assay testing to the third payer and particularly €4.11 million costs compared to €4.09 million of current clinical practice.

CONCLUSIONS: Our study highlighted the decreased direct costs of clinical practice after the introduction of the prognostic second generation 12-gene assay for the third-party payer, namely the Hellenic National Organization for the Provision of Healthcare Services, which is the only public payer in the Hellenic health market. In fact, savings for early-breast cancer N0 patients are higher compared to costs incurred using the current clinical practice of testing clinicopathologic indicators.