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Cost-effectiveness threshold of first-trimester Down syndrome maternal serum screening for the use of cell-free DNA as a second-tier screening test Volume 79, issue 4, Juillet-Août 2021

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Authors
1 Service de médecine, Centre hospitalier de Mauriac, France
2 Université Clermont-Auvergne, CNRS-UMR 6602, Institut Pascal, Axe TGI, Péprade, Clermont-Ferrand, France
3 Laboratoire de biochimie-hormonologie, Hôpital Robert-Debré, APHP, Paris, France
4 Laboratoire de mathématiques, UMR CNRS 6620, Université Blaise-Pascal ; CNRS, UMR 6620, Laboratoire de mathématiques, Aubière, France
5 Laboratoire Eurofins Biomnis, Lyon, France
6 Direction de la recherche clinique, Centre hospitalier universitaire de Clermont-Ferrand, France
7 Pôle Femme et Enfant, Centre hospitalier universitaire de Clermont-Ferrand, France
* Correspondance

Introduction: We aimed to identify the most relevant cost-effectiveness threshold of first-trimester Down syndrome (DS) maternal serum screening (T21T1) for the use of cell-free DNA (cfDNA) as a second-tier test in the French context. Method: A cost-effectiveness analysis was performed on 108,121 singleton pregnancies using a simulation model. The threshold of T21T1 screening was ranged from 1/51 to 1/1,000 in steps of 1/50. The most relevant threshold was based on cost-effectiveness ratio (CER; costs = direct medical costs after T21T1 screening/ effectiveness = number of DS cases identified). Results: In the sample, 161 cases of DS were identified. At the threshold of ≥ 1/50, 47.2% of total DS cases were diagnosed. In the simulation model, for a threshold ≥ 1/250, 73.9% of total DS cases were diagnosed, for ≥ 1/500, 78.8% and for ≥ 1/1,000, only two additional cases were diagnosed. The slope of the cost increase was slight from threshold ≥ 1/250 (978,634 €), then steep up to 1/500 (1,966,576 €) and increased exponentially to 1/1,000 (3,980,216 €). The CER was 38,560 for a threshold ≥ 1/500. Conclusion: The most cost-effective threshold for cfDNA as a second-tier test seems to be ≥ 1/500. For higher thresholds, costs increase dramatically for only a few additional cases of DS identified.