Breast cancer: because only 50% of genomic tests are prescribed
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There is the law that allows it, the necessary funding and scientific evidence, yet still today it is estimated that on average only 50% of diagnostic tests have actually been prescribed and in some regions of the South, the women who have benefited from them do not exceed 1 or 2% of those eligible. This is why Europa Donna Italia, which has been carrying out initiatives at various levels for some time, wonders if genomic tests are really a right for all women today. In reality, there are many patients who are waiting for concrete answers that will give them the possibility to face the tumor in the best way.
The reimbursement of tests
The ‘history’ of genomic tests in Italy begins with the decree of 18 May 2021 of the Minister of Health which made these tests reimbursable throughout Italy for patients with early stage breast cancer responsive to hormonal therapies and negative for HER2. Reimbursability recognized on the basis of positive results for this category of patients, demonstrated by numerous scientific studies. The decree explains in detail the methods and requirements needed to access the specific fund for the reimbursement of genomic tests, amounting to 20 million euros, allocated with the 2020 budget law. work that led to the drafting and approval of the Ministerial Decree in 2021, the bureaucratic issues, the problems and we are committed to developing various initiatives, towards places of care, towards patients and towards local administrations “, declares Rosanna D’ Antona, President of Europe Woman Italy.
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The advantages of genomic testing
Genomic testing can significantly improve the quality of life of many patients and their families. Depending on the result of the test, the patient could avoid chemotherapy without this changing her risk of the disease returning. Advantages for women who can benefit from a better quality of life with repercussions on the whole family and, from a health point of view, savings due to not buying chemotherapy drugs and hospitalizations avoided. “In the case of breast cancer – continues D’Antona – it is essential that all women are aware of these tests and that those who have the characteristics established in the DM can use them, which unfortunately does not happen today. But it is a reality that must change: no woman must be forced to give up the genomic test if she falls within the foreseen canons, because she lives in the wrong Region or because the bureaucracy hinders or slows down the assignment ”.
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The criticality of the extra-regional reimbursement
However, it is estimated that only half of the genomic tests were actually used in 2022. An underutilization that appears paradoxical. What can it be due to? “The hypotheses of this underutilization are different – underlines Corrado Tinterri, Professor at Humanitas University of Rozzano, Milan and Director of the Humanitas Breast Unit and Scientific Director of CTS Europa Donna Italia. “Probably originally it was expected to be used in more clinical cases, but I think the biggest cause was the delay in regional implementation. The extra-regional reimbursement for patients who migrated to other Regions to seek treatment remains critical, a reimbursement that was contemplated in the 2021 Decree but which often does not happen, all of which makes it very difficult to use it to the detriment of sick women who do not find in the regions of origin a Network of Breast Units that is effective and responsive to this need”.
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A matter of common sense
But the list of hypotheses that led to a 50% use of funds does not stop there. “The Ministerial Decree gives the possibility of proposing the genomic test to a very large population of women,” – explains Lucia Del Mastro, Full Professor and Clinical Director of Medical Oncology at the San Martino IRCCS Polyclinic Hospital, University of Genoa. “In clinical practice, however, we oncologists prescribe less because in some cases the anatomical-pathological characteristics of the tumor help us to understand in themselves without the help of the test whether or not to refer the woman to chemotherapy.
The burden of bureaucracy
Surely, then, the bureaucracy must be considered which, at least in the initial phase of application of the ministerial decree of 2021, made the prescription of tests more investigative. “In Liguria in 2022, as in many other Italian regions – notes Del Mastro – the percentage of women subjected to the test was lower than expected. However, data for the first 6 months of 2023 saw a doubling of usage compared to the previous year, confirming that bureaucratic hurdles have been overcome”.
How important is the awareness of specialists
The 21 regional and provincial health systems present in Italy have made the national law effective with other implementing decrees and the launch of procurement tenders. In 2022 bureaucratic obstacles arose in various areas of Italy that no longer exist today. But the numbers show that even now something is not going as it should, in some regions. “The national average in the first half of 2023 is 58%” – underlines Francesco Cognetti, President of the Confederation of Oncologists Cardiologists Hematologists (FOCE). “But there are Regions that have performed very well, such as Lombardy with 77% of genomic tests carried out, Lazio with 92% and on the other hand, others with depressing numbers, such as Calabria with 1%, Piedmont, 14%, Puglia with 33%. Therefore, I think that there is a problem of awareness also among specialist doctors, especially oncologists, and I think that scientific societies should launch information and educational initiatives for their members in order to improve this gap”.
A guarantee for doctors and patients
The greater use of genomic tests could also be encouraged in the field of defensive medicine. “We have solid data from validated randomizing studies, they are included in international guidelines and are paid for by the National Health Service – says Valentina Guarneri, full professor of Medical Oncology and Director of the School of Specialization in Medical Oncology, University of Padua. “Of course, they don’t replace the histological examination or even the correct diagnosis, but they represent additional information, essential for the woman because it can allow her to avoid chemotherapy, and protect the oncologist. Another important aspect is that discussion within the multidisciplinary team is necessary for the prescription of genomic tests and this is also a guarantee for the doctor and the patient”.
The good example of our country
Yet, despite these critical issues, in a survey conducted by the European Society of Medical Oncology (Esmo), the results of which have just been published in the journal Annals of Oncology, Italy is cited as a model to be taken as an example precisely because it was established an ad hoc fund managed by the Ministry of Health for the reimbursement of Ngs tests with a gradient determined by the EScat scale, which classifies the clinical impact of the individual molecular alterations of various tumors (not just breast cancer) on the basis of available evidence . This is an attempt to identify a priority scale of patients to be tested to understand who is actually a candidate for therapies that target specific DNA mutations for gastrointestinal stromal tumors and metastatic forms of breast, thyroid, colon- rectum, bile ducts, esophagus, stomach, salivary glands and lungs.
The next initiatives
But a good example sounds like something abstract for women who experience the discomforts of breast cancer on their own skin every day and who ask for concrete answers. Europa Donna Italia already has the next initiatives ready, including a region-by-region census to draw up an updated map of the Breast Centers where genomic tests are used; a communication aimed at the institutions of the less virtuous Regions and a call-to-action involving the Breast Units on the national territory, to stimulate greater awareness on genomic tests by oncologists. On the institutional front, however, the focus is on the Lea: “We ask for the inclusion of genomic tests in the Essential Levels of Assistance. FOCE’s positive opinion has been received and it is hoped that the final document will be approved by the end of the year”, states Cognetti. And Tinterri adds: “I believe that making the genomic test operational and accessible as LEA in the Breast Centers in all Italian Regions could guarantee equality of care for all Italian women who fall ill with breast cancer”.
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