At the beginning of August 2020, the French National Authority for Health (HAS) issued a favorable opinion on the inclusion of the genome detection of SARS-CoV-2 by gene amplification on saliva samples to the innovation package (forfait innovation) according to the article L. 165-1-1 of the social security code. The package is approved by the Ministry of Solidarity and Health, after consultation with HAS. This is one of the rare examples when forfait innovation was used to cover an IVD test.
The French Society of Microbiology associated with the Andrée Rosemon Hospital Center in Cayenne asked the HAS to assess the advisability of using the innovation package for SARS-CoV-2 tests on salivary samples.
Based on the systematic critical analysis of the scientific literature, it was concluded that this test could not be assessed as those with sufficient actual benefit (SA) because of a lack of evidence. However, the detection of the SARS-CoV-2 genome by gene amplification on saliva samples can be considered innovative with regard to the eligibility criteria provided in Article R.165-63 of the social security code.
The HAS issued a favorable opinion about the innovation package for this test, taking into account the importance of such tests for screening and outpatient diagnosis. The test will be performed as an alternative to the detection of the SARS-CoV-2 genome on nasopharyngeal samples.
The innovation package involves the performance of a clinical or medico-economic study, at the national or international level, aimed at providing missing data and confirming the value of innovation for patients.
See the full details in French here.
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