The Ministry of Health published the implementing decree establishing the reimbursement of genomic tests. The provision, in particular, makes it possible to use the Fund of 20 million euros, established with the 2021 Budget Law, for the direct reimbursement of the expenses incurred by hospitals for the purchase of genomic tests for the benefit of women with hormone-responsive breast cancer in early stage. Thanks to the implementing decree that establishes reimbursement, approximately 10,000 women will be able to benefit from these tests every year in Italy.
He test Oncotype DX
“We welcome the adoption of the implementing decree with great appreciation. This important development brings Italy closer to other European countries where the use of the Oncotype DX test is already widespread – underlines Aldo Cervi, Country Manager Italy Exact Sciences – The introduction of genomic tests in the clinical path represents a virtuous example of synergy between institutions, patients, the scientific community and industry, creating an economically sustainable model of personalized therapy that is strongly integrated with traditional diagnostic-therapeutic paths. As a company we are committed to working alongside doctors and health institutions to ensure access for all suitable women ”. The Oncotype DX test – the company reports – is the only genomic test validated for its ability to predict both the probable advantages of chemotherapy and the risk of relapse of hormone-responsive breast cancer at an early stage. It accurately identifies patients who can benefit from adjuvant chemotherapy following surgery, as demonstrated by numerous international studies. The value of the test was also confirmed by experiments conducted in Italy. The Oncotype DX test was first made available to patients in 2004, and since then more than one million patients worldwide have benefited from it. The test is recommended by the main international guidelines on breast cancer and has been included in the guidelines on breast cancer of the Italian Association of Medical Oncology.
Genomic testing is requested by breast specialists and is performed on a small sample of tumor tissue. At the end of the test, doctors receive the Recurrence Score result, in the case of Oncotype DX: a number between 0 and 100 specific to the patient’s tumor. For postmenopausal patients, a Recurrence Score between 0-25 means that the cancer is less likely to recur when treated with hormone therapy alone and that chemotherapy does not change the chances of recurrence. A Recurrence Score between 26 and 100 indicates a higher risk of relapse and the addition of chemotherapy to hormone therapy can provide a substantial benefit in reducing the risk. In patients under the age of 50, or premenopausal, the study results show a benefit from chemotherapy with lower Recurrence Score results.