Reimbursement by Social Security predictive tests for the risk of recurrence of a cancer breast detected early is "premature", according to the High Authority of Health (HAS). These tests are intended to distinguish women who need or not chemotherapy after the operation of the tumor.
"Indispensable to continue clinical research". However, in a report released Monday motivating this "negative opinion", the HAS recommends to extend "conditionally" funding support for innovation, which currently allows their support. She "recognizes the potential value of these tests as a tool for decision-making", but "considers it essential to continue clinical research".
About 4.500 tests done in 2017. She therefore calls for a comparative study of the four tests available, said Cédric Carbonneil, head of professional services at HAS. The HAS "may reconsider its opinion on reimbursement when it disposes of these data". The tests - Mammaprint, Oncolype Dx, Prosigna and Endopredict - evaluate the risk according to a group of genes involved in the development of the tumor from a sample of it. About 4.500 tests were performed in 2017 as part of the innovative acts. Breast cancer, with 55.000 new cases per year, is the most common cancer in women, recalls HAS.
The treatments are adapted to the multiple forms of the disease (surgery, radiotherapy, chemotherapy, hormonotherapy). Its stage, advanced (metastases) or not, and the characteristics of the tumor (for example sensitive to hormonal treatment) are taken into account. In the "vast majority of situations", the care teams have sufficient elements to decide whether or not to set up chemotherapy after the operation, without having recourse to these tests, judge HAS.
Decisions that vary depending on the test used. The HAS defines precisely the population of women (tumor of 1 5 cm, sensitive to hormone therapy, no ganglion invaded or with micro-invasion ...) for which these genetic tests would be useful. This equates to "5% 10% of some 40.000 localized infiltrating cancers," says Cédric Carbonneil. According to various studies, for a woman in five or one in four, the decision to do adjuvant chemotherapy differs according to the test used, notes the HAS among its critics.
"Near 10.000 women in France have benefited from these tests in the last three years," according to Professor Pascal Pujol, president of the French Society of Predictive and Personalized Medicine (SFMPP). This learned society, unlike the HAS experts, believes that recent international studies provide a sufficient level of evidence to justify reimbursement. Nevertheless, "SFMPP is pleased that HAS is allowing women access to these tests by advocating extending their funding in the context of innovation," he adds.
"Avoid unnecessary therapies". "We do too much chemotherapy in France," says Professor Roman Rouzier, of the Institut Curie, at the origin of the request which allowed to obtain derogatory funding for these tests which are used for "de-escalation". "Avoiding unnecessary therapies is obviously a major benefit." "All the better" if the funding of the tests is kept, adds the specialist, anyway, a supporter of the control of their use.