Background: The accurate identification of patients with early breast cancer (eBC) suitable for adjuvant chemotherapy is essential in order to avoid overtreatment or undertreatment. For eBC patients with luminal (HR+/HER2-) intermediate risk disease, multigene assays (MGAs) have been convincingly reported to be useful in guiding treatment decisions. The most recently published data and recommendations from main International Guidelines and Heath Technology Assessment reports confirmed the benefit of MGAs in guiding treatment decisions for clinically intermediate risk patients, and led several countries to test reimbursement.
Purpose: This article describes the process followed by the Lombardy region in Italy regarding the reimbursement of MGAs for patients with eBC, based on the results of a prospective clinical trial.
Results: The study shows that the use of Oncotype DX allowed avoiding the use of unnecessary adjuvant chemotherapy in 50% of patients for whom chemotherapy was initially recommended according to traditional clinical practice. On the basis of these data, a group of oncologists in collaboration with a pathologist regional board formally requested authorization for MGA reimbursement in Lombardy. Acknowledging the strategic importance of the proposal, the Lombardy region approved the reimbursement of MGAs for resident patients with luminal eBC at intermediate clinical risk. It can be assumed that about 1500 patients will be tested in Lombardy per year and this should allow the Regional Health Service to save more than 750 chemotherapies/year.
Conclusion: The introduction of MGAs in the clinical evaluation of patients with luminal eBC with intermediate risk is economically sustainable and contributes towards preserving quality of life of eligible women.
Keywords: Oncotype DX test; adjuvant chemotherapy; breast cancer; multigene assays; recurrence score results.