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This October 18, the High Authority for Health issues a favorable opinion on the coverage of the Endotest saliva test as part of an innovation package. A promising step, as the Ministry of Health intended to make this test accessible as first intention from 2025.
Good news for patients suffering from endometriosis, one in 10 women! While the diagnosis of endometriosis today remains difficult and time-consuming, the Endotest, a non-invasive saliva test, could soon be reimbursed. The High Authority for Health (HAS) has just issued a favorable opinion on the coverage of the system as part of an innovation package.
A much less invasive solution to detect endometriosis
Today, the diagnosis of endometriosis is based primarily on a clinical examination, and 2e intention on an imaging assessment (a pelvic ultrasound and one 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 saliva test therefore presents encouraging first clinical results and is innovative in nature, due to its novelty in the indication, its non-invasive nature and its potential to cover an unmet medical need.
Already last year, the HAS recognized 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.
Last March 2024, the Minister of Health Catherine Vautrin stepped up the pace: she wanted Social Security to be able to fully cover the saliva test,“in January 2025″ and this, as a first intention.
A test that becomes covered when endometriosis is “strongly suspected”
As the deadline approaches, HAS has therefore put forward its opinion on the question. According to the press release published today, the clinical data available during its first evaluation by the HAS last January were insufficient to conclude in particular on a favorable impact on patient care. HAS therefore invited the manufacturer to submit an application for an innovation package for Endotest and thus allow a population of patients to access it as quickly as possible. She supported the manufacturer in developing a sufficiently robust clinical study protocol to meet the requirements for entry into the device.
Today, these conditions having been met, the HAS is in favor of exceptional financial support for Endotest as part of the innovation package.
Concretely, if the advice of the HAS is followed by the government, women over 18 years of age, for whom endometriosis is “strongly suspected”, will be able to carry out this test free of charge. Support “conditional” on participation in new studies, which will make it possible to decide whether or not in favor of long-term reimbursement.
The results of the clinical study will facilitate its subsequent evaluation with a view to broad and lasting reimbursement.
What is the innovation package?
An exceptional and temporary support system, the innovation package aims to facilitate patient access to innovative technologies (professional procedures, medical devices or in vitro diagnostic medical devices). In practice, it allows an industrialist or a national professional council to obtain financial support for its technology from the implementation of the clinical study which will establish proof of its effectiveness. The innovation package is granted by the ministers responsible for Health and Social Security after advice from the HAS on the eligibility of the request, that is to say the innovative nature of the technology concerned and the relevance of the protocol. the proposed clinical study.
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