No more disparities among regions in Italy: recent approval of genomic test reimbursability for early breast cancer patients in the country

There are five BC gene-profiling tests commercially available namely Prosigna®(PAM50), Mammaprint®, Oncotype DX®, Breast Cancer Index®, and Endopredict®. The use of these tests emerge to be different among the various countries because of the disparity in clinical criterion of genomic test recommendation (e.g., presence of axillary lymph nodes involvement or not), and test reimbursement. This implies that the country where a patient lives can be a discriminant for him to be eligible for the molecular test execution. Several time ago, the Italian Ministry of Health signed the approval for genomic test reimbursability for breast cancer patients who need the evaluation of gene profile in order to establish the risk of disease recurrence within 10 years. This means less toxicities for patients and to save money avoiding inappropriate treatments. In Italy, the diagnostic workflow requires that the clinicians ask to perform the molecular test to the reference laboratory. Unfortunately, not all laboratories are equipped to perform this type of test given that specific instruments are necessary as well as specialized personnel. The establishment of criteria used to perform molecular tests in BC patients needs to be standardized, and the tests should be performed in specialized laboratories. Test centralization and reimbursement are fundamental to be able to compare the outcome of patients treated or not with chemotherapy in addition to hormone therapy to verify data from clinical randomized studies in a real-world setting.