Published in the official journal of May 7th 2017, a decree signed on May 5th 2017 has just included NIPT in the list of authorized prenatal diagnosis tests, just a few days before the end of the presidential mandate. Requiring only a simple blood test, NIPT is a test which analyses the overrepresentation of abnormal foetal DNA sequences in the foetal DNA that runs through the mother’s blood. It is used to detect any embryos carrying Down Syndrome but also Patau’s Syndrome and Edward’s Syndrome. The Ministry of Health is expected to issue an order to set the conditions in which the test will be prescribed and carried out.
The decree was published even though the High authority of health has not yet given its full opinion on the matter. Last November, public authorities published a rushed technical document reporting on the subject. A second document on ethics and economic consequences has been announced and should be published shortly. Whether or not the social security reimburses these tests supposedly depends on these very documents.
However, the public hospital authorities of Paris have already announced that NIPT would be generalized throughout its hospitals and is offering free tests “thanks to the funding it received due to its participation in innovative acts outside nomenclature”.
It is most likely the test will be granted social security reimbursement and it will certainly not come as a surprise. Indeed, the dosage of serum markers for Down Syndrome testing was added to the classification of biological medical acts by a ruling from January 1997, thus insuring its reimbursement. A principal that the ruling from June 23rd 2009 did not question, when the combined testing for Down Syndrome, including the measurement of nuchal translucency, the dosage of serum markers in the blood and the age of the mother, was included in the list of prenatal diagnosis examinations. The various prenatal diagnosis examinations for Down Syndrome were de facto placed in existing lists of reimbursed medical acts, and were reimbursed on that basis. It is therefore quite probable that this new testing method will fall within the same rules and receive an almost systematic reimbursement.
Note from Gènéthique: 85% of pregnant women are tested for Down Syndrome[2]. 92% of babies with Down Syndrome are detected[3]. Due to “the testing strategy” 96% of babies with Down Syndrome are eliminated[4].
[2] Sources: BEH (Weekly epidemiological record) study published on May 12th 2015 Dominique Royère, Brigitte Simon-Bouy… and Conference from Romain Favre, obstetrician and specialist in prenatal diagnosis and foetal medicine, survey carried out among 450 patients, European bioethics conference in Strasbourg in 2012
[3] 2009 French State Council report “la révision des lois bioéthiques. Paris : la documentation française”, 2009, p.40.
[4] 2009 State Council report “la révision des lois bioéthiques. Paris: la documentation française”, 2009, p.40 and Boyd P. et al: Survey of prenatal screening policies in Europe for structural malformations and chromosome anomalies, and their impact on detection and termination rates for neural tube defects and Down’s syndrome, BJOG, 2008; 115: 689-696.