Introducing the non-invasive prenatal test for trisomy 21 in Belgium: a cost-consequences analysis

Abstract

BackgroundThe first- and second-trimester screening for trisomy 21 (T21) are reimbursed for all pregnant women in Belgium. Using a cut-off risk of 1:300 for T21, about 5% of all pregnant women are referred for definitive prenatal diagnosis using an invasive test, at a sensitivity of (only) 72.5%. The sensitivity and specificity of the non-invasive prenatal test (NIPT) are over 99% but come at a cost of €460 (£373) per test. The objective is to estimate the consequences of introducing NIPT for the detection of T21.MethodsA cost-consequences analysis was performed presenting the impact on benefits, harms and costs. Context-specific real-world information was available to set up a model reflecting the current screening situation in Belgium. This model was used to construct the second and first line NIPT screening scenarios applying information from the literature on NIPT's test accuracy.ResultsIntroducing NIPT in the first or second line reduces harm by decreasing the number of procedure-related miscarriages after invasive testing. In contrast with NIPT in the second line, offering NIPT in the first line additionally will miss fewer cases of T21 due to less false-negative test results. The introduction of NIPT in the second line results in cost savings, which is not true for NIPT at the current price in the first line. If NIPT is offered to all pregnant women, the price should be lowered to about €150 to keep the screening cost per T21 diagnosis constant.ConclusionsIn Belgium, the introduction and reimbursement of NIPT as a second line triage test significantly reduces procedure-related miscarriages without increasing the short-term screening costs. Offering and reimbursing NIPT in the first line to all pregnant women is preferred in the long term, as it would, in addition, miss fewer cases of T21. However, taking into account the government's limited resources for universal reimbursement, the price of NIPT should first be lowered substantially before this can be realised.

Non-Invasive Prenatal Testing: Review of Ethical, Legal and Social Implications

“…However, implementing NIPT into public health programs would raise several challenges related to the availability of budgetary [77,78] and personnel resources [53]. For instance, if and when NIPT is validated for use by all pregnant women (high and average risk), challenges will be introduced regarding the coverage within the available limited budget in order to ensure equity of access [7].…”

Evaluation of preferences of women and healthcare professionals in Singapore for implementation of noninvasive prenatal testing for Down syndrome

“…Consequently, it is essential to remember that NIPT is only a screening method and a subsequent invasive test is recommended to confi rm a positive result. Some countries are beginning to implement the technology into their national health programmes, (14,15) and recent research highlights differences in how NIPT is being implemented throughout the world. (16) Unlike many countries, Singapore does not have a free healthcare system; all patients have to contribute to the costs of their care, either as private or subsidised patients.…”

Clinical and Economic Impact of Adopting Noninvasive Prenatal Testing as a Primary Screening Method for Fetal Aneuploidies in the General Pregnancy Population

“…The most frequently used approach is first-trimester screening (FTS), which combines nuchal translucency (NT) ultrasound measurement and maternal serum testing to assess the levels of human chorionic gonadotropin (hCG) and pregnancyassociated plasma protein A in combination with age and medical history [1,2]. The triple test (hCG, alpha-fetoprotein, and unconjugated estriol) is used to screen women presenting in the second trimester [3].…”