OBJECTIVES

: NIPT has been developed in order to introduce non-invasive genetic techniques in prenatal screening. They show high accuracy in the detection of common fetal autosomal trisomies (i.e. T21, T18, T13) in pregnant women. The aim of the study was to evaluate the financial and clinical impact on the Italian NHS of the contingent use of NIPT in comparison to current clinical practice.

METHODS

: A budget impact analysis was developed in the short-term period until child birth, and the target population was represented by Italian singleton-pregnant women (508,705). The analysis compared two scenarios: current clinical practice vs introduction of NIPT as a contingent screening for women with a risk ≥ 1:1,000 from the current clinical practice.

RESULTS

: NIPT reduced the number of invasive tests performed by 71%, with a consequent decrease in the number of invasive-related miscarriages (from 532 to 156). The overall trisomy detection rate increased by 3% compared to the standard clinical practice. Following NIPT introduction, total short term costs per year decreased by €19.4 million (from million €86.6 to €67.2), due to the decrease of testing costs (by €17 million) and ancillary-care costs (by €2.4 million), even with an increase of the number of genetic counseling visits. The cost savings was € 40.49 per screened woman.

CONCLUSIONS

: The adoption of NIPT test, as a contingent screening for women with a trisomy risk ≥ 1:1,000 after standard of care screening, represents a benefit for the mother and fetus with the possibility of avoiding invasive diagnostic testing. Therefore, for both clinical and economic reasons, the adoption of NIPT under a reimbursement setting would be a cost-saving choice.