The reimbursement by social security of the predictive tests of the risk of recurrence of breast cancer detected in the initial phase, intended to distinguish women who need or not chemotherapy after the operation of the tumor, is "premature", according to the Haute Autorité de Santé (HAS).
However, in a report released Monday that motivates this "negative opinion" to reimbursement, HAS recommends extending support to "conditional" funding for innovation, which currently allows their support.
"Recognizes the potential value of these tests as a tool for decision making", but "considers it essential to continue clinical research".
Comparative study of the tests
It therefore requires a comparative study of the four available tests and that this clinical study concerns "the target population of patients with greater probabilities of benefit, or from 2,000 to 4,000 women in the year according to the figures we could do" said Cédric Carbonneil, head of the department of professional deeds at HAS.
L & # 39; HAS "can reconsider its opinion on reimbursement when it has these data".
The tests in question dubbed "genomic signatures" – Mammaprint, Oncotype 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.
During the course of 2017, about 4,500 tests were carried out in the context of innovative measures.
Breast cancer, with 55,000 new cases every year, is the most common cancer in women, recalls HAS.
The treatments are adapted to the many forms of the disease (surgery, radiotherapy, chemotherapy, hormone therapy). Its stage, advanced (metastasis) or not, and the characteristics of the tumor (for example sensitive to hormonal treatment) are taken into account.
New evidence to justify reimbursement
"Nearly 10,000 women in France have benefited from these tests over the past three years," according to Professor Pascal Pujol, president of the French Predictive and Predictive Medicine Society (SFMPP), which does not agree with HAS's position.
This learned society, unlike the HAS experts, believes that recent international studies provide sufficient evidence to justify reimbursement. However, "SFMPP is pleased that HAS is allowing women to access these tests by claiming to extend their funding in the context of innovation," he adds.
"We do too much chemotherapy in France," says Professor Roman Rouzier of the Curie Institute at the origin of the request that has obtained denigrating funding for these tests that are used for "de-escalation".
"Avoiding useless therapies is obviously a big advantage." "So much the better" if the funding of the tests is maintained, adds this specialist, however, a supporter of the control of their use wisely.
In the "vast majority of situations", the health care teams have sufficient elements to decide whether or not to set up adjuvant chemotherapy after the operation, without resorting to this type of test, Judge HAS.
The HAS defines precisely the female population (tumor from 1 to 5 cm, sensitive to hormone therapy, no invaded ganglion or with micro invasion …) for which these genetic tests would be useful. This is equivalent to "5% to 10% of the 40,000 localized infiltrating carcinomas," says Carbonneil.
According to various studies, for a woman in five or four, the decision to do adjuvant chemotherapy differs according to the test used, notes the HAS among its critics.