In a report published on Monday to motivate this "negative advice" for reimbursement, HAS recommends extending "conditional" financing support for innovation, which currently allows for support.
She "recognizes the potential value of these tests as a tool for decision making", but "finds it essential to continue with clinical research".
It therefore requires a comparative study of the four available tests and that this clinical study covers "the target population of patients most likely to benefit, or 2000 to 4000 women per year according to the figures that we could ", has indicated to AFP Cédric Carbonneil, department head professional acts at the HAS.
The HAS "can reconsider its opinion on reimbursement if it has this information".
The tests in question with the nickname "genome signatures" – Mammaprint, Oncolype Dx, Prosigna and Endopredict – evaluate the risk according to a group of genes that are involved in the development of the tumor from a sample. Approximately 4,500 tests were carried out 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 different forms of the disease (surgery, radiotherapy, chemotherapy, hormone therapy). The stage, advanced (metastases) or not, and the characteristics of the tumor (for example susceptible to hormonal treatment) are taken into account.
In the & # 39; vast majority of situations & # 39; the care teams have sufficient elements to set up adjuvant chemotherapy after the operation or not, without using this type of testing, judge HAS.
The HAS defines exactly the population of women (tumor 1 to 5 cm, susceptible to hormone therapy, no ganglion invaded or with micro-invasion …) for which these genetic tests would be useful. This corresponds to "5% to 10% of the estimated 40,000 localized infiltrative cancers," says Mr. Carbonneil.
According to several studies, for a woman aged five or one in four, the decision to do adjuvant chemotherapy differs depending on the test used, the HAS notes among its critics.
"Nearly 10,000 women in France have benefited from these tests in the last three years," said Professor Pascal Pujol, president of the French Association for Predictive and Personalized Medicine (SFMPP), who disagrees with the position of the HAS.
This learned society is of the opinion that, in contrast to the HAS experts, recent international studies provide sufficient evidence to justify reimbursement. Nevertheless, "SFMPP is pleased that HAS offers women access to these tests by advocating for expansion of their funding in the context of innovation," he adds.
"We are doing too much chemotherapy in France," says Professor Roman Rouzier of the Curie Institute at the origin of the request for denigrating funding for these tests used for "de-escalation".
"Avoiding unnecessary therapies is clearly a big advantage." "All the better", if the funding of the tests is kept up, this specialist adds in any sensible way a proponent of the control over their use.