Breast cancer: adverse opinion for the reimbursement of predictive tests

The reimbursement by the Social Security of the predictive tests of the risk of recurrence of breast cancer detected at the early stage, 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 published Monday motivating this "negative opinion" to the reimbursement, 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".

HAS expects additional data

It therefore calls for a comparative study of the four available tests and that this clinical study concerns "the target population of patients most likely to benefit, ie 2.000 4.000 women per year according to the figures that could be made", has indicated to AFP Cédric Carbonneil, head of department of professional acts at the HAS. The HAS "may reconsider its opinion on reimbursement when it disposes of these data".

The tests in question nicknamed "genomic signatures" - 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.

The test is not considered essential

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 health care teams have sufficient elements to decide whether or not to set up adjuvant chemotherapy after the operation, without having recourse to this kind of test, Judge HAS.

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 Mr. 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.

A decision criticized

"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), who disagrees with the position of the HAS. 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.

"We do too much chemotherapy in France" says Professor Roman Rouzier of the Curie Institute at the origin of the request that has obtained derogatory funding for these tests that are used for "de-escalation". "Avoiding unnecessary therapies is obviously a major benefit." "So much the better" if the funding of the tests is kept, adds this specialist, anyway partisan of the control of their use wisely.

This article appeared first on