This January 8, the High Authority of Health announces a big step in the diagnosis of endometriosis, by recognizing the usefulness of the Endotest®, a saliva test which distinguishes the biomarkers of the disease. If the solution is not yet eligible for reimbursement, it will now be included in an “innovation package”. Explanations.
One in 10 women suffer from endometriosis in Europe. And 2 million adult women are currently likely to wonder if this condition is the cause of their chronic pelvic pain. Despite everything, diagnosing this pathology still remains complicated and time-consuming. This is why, with the aim of moving the subject forward, the High Authority of Health (HAS) took action in order to evaluate the effectiveness and clinical usefulness of the Endotest® saliva diagnostic test, designed by the company Ziwig, in for a refund. A hope for many women.
The performance of the Endotest® recognized, in 3rd intention
Today, the diagnosis of endometriosis is based primarily on a clinical examination, and 2e intention on an imaging assessment (a pelvic ultrasound and a pelvic MRI). A laparoscopy can be considered, to confirm the diagnosis of endometriosis, if a surgical therapeutic project shared with the patient is associated with it. But like any surgical procedure, the laparoscopic examination is invasive and does not guarantee improvement.
The Endotest® stands out here as a welcome non-invasive solution. The saliva test does not fall into the category of rapid diagnostic orientation tests (TROD), but it can be collected by the patient herself, in order to be sequenced and read by artificial intelligence within a laboratory. specialized medical biology.
In its opinion of January 8, the HAS recognizes very good diagnostic performance for Endotest® (95% sensitivity and 94% specificity) and underlined the high expectations and the significant potential of this test in the management strategy of patients. She recognizes the usefulness of the third-line saliva test in diagnostic research:
- In patients aged 18 and over of childbearing age, for whom endometriosis is strongly suspected and presenting pelvic pain not controlled by empirical medical treatment or having a desire to become pregnant;
- To reduce the number of unnecessary laparoscopies performed in these patients, when the reference imaging findings are negative or uncertain.
Not yet reimbursed, but eligible for the innovation package
However, for the HAS, it is still too early to demonstrate the “clinical” usefulness of the Endotest®. For the moment, the data transmitted by the manufacturer do not make it possible to demonstrate whether the saliva test would have a real impact in patient care. In this context, long-term reimbursement cannot be offered.
On the other hand, the innovative nature of the solution allows it to be included in the innovation package. The last step before a pick-up?
What is the innovation package?
If the diagnostic test is not yet reimbursed, it can now be included in the innovation package, thanks to the innovative nature retained. This means that patients will be able to benefit from early, supervised and secure access to the test, with “exempt” care conditional on the completion of the clinical utility study. In this way, it would make it possible to obtain data that is still missing, such as the impact of the test on patient care, an estimate of the volume of test prescriptions in the target population, and patient acceptability. Before a possible long-term reimbursement.