On 8 July, the Minister of Health signed the implementing decree that unlocks 20 million euros allocated for the application of genomic tests: tests that, in women with “hormonal” breast cancer (HR positive, HER2 negative) and at an early stage, they help predict the risk of recurrence and thus help doctors understand when chemotherapy is needed and when it can be avoided. Well, but there is still a step in our regional health care: in order for the examinations to be refundable, the regions must issue measures. In fact, the deadline for the transmission to the Ministry of Health of the regional resolutions which will have to report the methods of prescription, execution and use, monitoring, checks and controls of tests, is 60 days and expires on 7 September. In the following 60 days, the Coordination Committee assesses the compliance of the Resolutions with the implementing Decree. And November 7 is the deadline for the disbursement to the Regions of 50% of the funding for 2021. The remaining 50% will be disbursed by March 31, 2022, after the evaluation by the Ministry of Final Regional Relations which must contain the number , the type and costs of the tests carried out in 2021.
Breast cancer: every year 10,000 women in Italy will be able to access genomic tests
by Tiziana Moriconi
The voice of patient associations
The gratuitousness of genomic tests throughout the territory is the very important result of a battle for which the Italian Association of Medical Oncology (Aiom) and patient associations have spent these months. “The issue of free access to genomic tests to avoid unnecessary chemotherapy patients has been busy for years and we are aware that it cannot stop now,” he said. Rosanna D’Antona, President of Europa Donna Italia, during the online webinar for associations, created with the support of Exact Sciences: “We are in fact ready to continue, together with the 170 Associations that are part of our network, our monitoring and reminder action to the Regions so that, in turn, they immediately issue the measures required by the Ministry for the disbursement of the loan “.
A test for 10,000 women a year
About 20% of women affected by breast cancer, equal to more than 10 thousand patients every year in Italy, can be subjected to genomic tests because they have luminal disease, that is, it expresses estrogen receptors but not the HER2 protein, and is considered at intermediate risk of relapse. “So far there has been an understandable prevalence of prudential attitudes in these cases in which chemotherapy was generally recommended,” he says. Francesco Cognetti, President of the Together Against Cancer Foundation and FOCE (Confederation of Oncologists, Cardiologists, Hematologists): “In the PONDx study, carried out by Regina Elena of Rome on 1,738 patients, a 21-gene genomic test was performed, more than one avoided chemotherapy which, without this test, would have been practiced “.
Experience in numerous clinical trials and in some tens of thousands of patients shows that genomic testing helps define the appropriate therapy and allows many women to avoid chemotherapy, as he explains. Adriana Bonifacino, President of IncontraDonna onlus: “The sharp decrease in the improper use of chemotherapy can translate, on the one hand, into a clinical benefit for patients who are no longer exposed to excess treatment and the relative risk of immediate and late toxicity, on the other hand, in a favorable impact on healthcare spending, which represents a fundamental element for the sustainability of the system “. The exam costs 2 thousand euros, a course of chemotherapy ranges from 7 to 8 thousand euros.” The signing of the implementing decree in a few months is really an excellent result, obtained thanks to teamwork – he concludes Giordano Beretta, President Aiom: “The objective of our scientific society is to continue to collaborate with the institutions and with all the actors involved in the exclusive interest of patients”.