Dataset Information

Introducing the non-invasive prenatal testing for detection of Down syndrome in China: a cost-effectiveness analysis.

ABSTRACT:

Objective

This study aimed to compare the health economic value of a non-invasive prenatal testing (NIPT) strategy against a second-trimester triple screening (STS) strategy for the detection of Down syndrome based on real-world data from China.

Design

A decision-analytical model was developed to compare the cost-effectiveness of five strategies from a societal perspective. Cost and probability input data were obtained from the real-world surveys and published sources.

Setting

China.

Participants

Women with a singleton pregnancy.

Interventions

The five strategies for screening were: (A) maternal age with STS (no NIPT); (B) STS plus NIPT screening; (C) age-STS plus NIPT screening (the currently referral strategy in China); (D) maternal age with NIPT screening and (E) universal NIPT screening.

Main outcome measures

Incremental cost-effectiveness ratios (ICERs) per additional Down syndrome case terminated, univariate and probabilistic sensitivity analysis and cost-effectiveness acceptability curves were obtained.

Results

Strategy A detected the least number of Down syndrome cases. Compared with the cheapest Strategy B, Strategy D had the lowest ICER (incremental cost, US$98 944.85 per additional Down syndrome case detected). Strategy D had the highest probability of being cost-effective at the willingness-to-pay level between US$110 000.00 and US$535 000.00 per additional Down syndrome case averted. Strategy E would not be cost-effective unless the unit cost of the NIPT could be decreased to US$60.50.

Conclusion

Introducing NIPT screening strategies was beneficial over the use of STS strategy alone. Evaluating maternal age in combination with the NIPT screening strategy performs better than China's currently referral strategy in terms of cost-effectiveness and safety. Lowering the price of NIPT and optimising payment methods are effective measures to promote universal NIPT strategies in China.

SUBMITTER: Shang W

PROVIDER: S-EPMC8261875 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.