Breast cancer, genomic test prescribed only to 50% of eligible patients

Only 50% of genomic tests have actually been prescribed to women who could benefit from them in 2022. An under-utilization that cannot be explained but which undoubtedly penalizes patients who, thanks to these tests, could receive personalized therapy for breast cancer otherwise. To pay the costs - not only in the literal sense - also the National Health System which bears the costs of sometimes unnecessary treatments. A theme that was discussed again at the international conference "The New Face of Breast Cancer Care, how to orient yourself in the galaxy of Genomic Tests" organized by the Federation of Oncologists, Cardiologists and Hematologists (Foce) with the patronage of the Italian Association of Medical Oncology (Aiom) and made possible by the unconditional contribution of Exact Sciences.

Being able to avoid unnecessary chemotherapy

The scarce use of this important diagnostic tool is certainly not due to the lack of studies that prove its usefulness. “All the scientific evidence produced in recent years has demonstrated unequivocally the absolute importance of tests – explained Francesco Cognetti, scientific director of the conference and President of Foce, Federation of Oncologists, Cardiologists and Hematologists. “I'm able to identify patients at high risk of disease recurrence at 10 years, for whom chemotherapy may be useful as an adjunct to hormone therapy. We can thus avoid the useless administration of chemotherapy drugs which have a significant physical, mental and relational impact on a woman. In Italy we are still paying for the significant delay with which we arrived at the use of these exams. The definitive data relating to 2022, which we presented at the conference, are not yet satisfactory for the purposes of using the tests in all the patients for which they are indicated".

Delays for the use of the Special Fund

At the end of 2020, Parliament, which was discussing the finance law, created an ad hoc fund of 20 million for the purchase of genomic tests to be used in around 10,000 patients operated on for breast cancer. But only in the following summer there was the implementing decree of the Ministry of Health. “It then took several months for all the regions to publish their Resolutions to make the provision effective,” he added Cognetti. “Currently, genomic tests are being provided throughout the national territory under a reimbursement regime and the Regions are already renewing the funding for 2023, in accordance with the 2021 Ministerial Decree”. In other words, there are no more bureaucratic and administrative impediments. “There is a need for greater awareness, also on the part of surgeons and medical oncologists, on the potential of tests that must actually be part of ordinary clinical practice. They make it possible to significantly improve the quality of life of many patients and their family members and caregivers”, reiterated the president of Foce.

What tests are currently available

There are five tests available on the market, they are based on different technologies and analyze different groups of genes. “Exams can be performed on paraffin-embedded, fixed breast cancer tissue,” he explained Richard Masetti, director of the Integrated Breast Center and Professor of General Surgery at the Catholic University of the Gemelli Polyclinic. “This is taken during a biopsy or surgery and is then stored in pathology. The non-invasive genomic tests for the patient and the prescription must be established by the multidisciplinary team operating within the Breast Unit”.

Genomic testing in Lea

During the event, Foce relaunched its proposal to include genomic tests for breast cancer in the new Essential Levels of Assistance (LEA). "It is the request that we have made in recent weeks to the Minister of Health, Orazio Schillaci and to the Lea Commission", underlined the Foca president. In our opinion, it is a good solution to the current problem of underutilization of exams which is particularly evident in some Regions. In recent years, scientific advances have facilitated the development and adoption of multigene expression tests capable of personalizing breast cancer therapeutic strategies. Although Italian oncology is at the forefront in the world, especially in the fight against breast cancer, we are late in adopting genomic tests that have been used regularly for over 10 years in many European countries. We have to make up for lost time and therefore we hope for the decree of the Minister of Health for the inclusion of tests in the Lea soon ".