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Cost-Effectiveness Analysis of Non-invasive Prenatal Testing for Down Syndrome in China

Published online by Cambridge University Press:  27 May 2019

Yan Xu
Affiliation:
Key Lab of Health Technology Assessment, National Health Commission (Fudan University), School of Public Health, Fudan University, Shanghai, China
Yan Wei
Affiliation:
Key Lab of Health Technology Assessment, National Health Commission (Fudan University), School of Public Health, Fudan University, Shanghai, China
Jian Ming
Affiliation:
Key Lab of Health Technology Assessment, National Health Commission (Fudan University), School of Public Health, Fudan University, Shanghai, China
Na Li
Affiliation:
Key Lab of Health Technology Assessment, National Health Commission (Fudan University), School of Public Health, Fudan University, Shanghai, China
Ningze Xu
Affiliation:
Key Lab of Health Technology Assessment, National Health Commission (Fudan University), School of Public Health, Fudan University, Shanghai, China
Raymond W. Pong
Affiliation:
Centre for Rural and Northern Health Research, Laurentian University, Canada
Yingyao Chen*
Affiliation:
Key Lab of Health Technology Assessment, National Health Commission (Fudan University), School of Public Health, Fudan University, Shanghai, China
*
Author for correspondence: Yingyao Chen, E-mail: [email protected]

Abstract

Objectives

There is little evidence in China regarding the cost-effectiveness of non-invasive prenatal testing (NIPT) for Down syndrome (DS). This study aims to evaluate the cost-effectiveness of NIPT and provide evidence to inform decision-making.

Methods

To determine the cost-effectiveness of NIPT for DS, a decision-analytic model was developed using the TreeAge Pro software from a societal perspective in a simulated cohort of 10 000 pregnant women. Main indicators were based on field surveys from sampled hospitals in four locations in China and a literature review.

Results

The conventional maternal serum screening (CMSS) strategy, contingent screening strategy (NIPT delivered to high risk pregnant women after CMSS), and universal screening strategy could prevent 3.02, 7.53, and 9.97 DS births, respectively. NIPT would decrease unnecessary invasive procedures, resulting in fewer procedure-related miscarriages. The cost-effectiveness ratio of the contingent screening strategy was the lowest. When compared with the CMSS strategy, the incremental cost per DS birth averted by the contingent screening strategy and universal screening strategy were USD 20,160 and 352,388, respectively. One-way sensitivity analysis showed that, if the cost of NIPT could be decreased to USD 76.92, the cost-effectiveness ratio of the universal screening strategy would be lower than the CMSS strategy.

Conclusions

Although NIPT has the merits of greater effectiveness and safety, CMSS is unlikely to be replaced by NIPT at this time because of NIPT's higher cost. Contingent screening may be an appropriate strategy to balance the effectiveness and cost factors of the new genetic testing technology.

Type
Assessment
Copyright
Copyright © Cambridge University Press 2019 

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Footnotes

This study was funded by the National Health and Family Planning Commission of China and the China Medical Board Health Technology Assessment Collaborating Program in China(13-153 and 16-251). The main part of this article was presented orally at the Health Technology Assessment International (HTAi) annual meeting in 2017. We also appreciate the anonymous reviewers’ helpful comments and suggestions for improvement.

References

1.Patterson, D (2009) Molecular genetic analysis of Down syndrome. Hum Genet 126, 195214.Google Scholar
2.International Clearinghouse for Birth Defects Surveillance and Research Annual Report (2012) http://www.icbdsr.org/wp-content/annual_report/Report2012.pdf.Google Scholar
3.China Birth Defect Prevention Report (2012) National Health and Family Planning Commission of the People's Republic of China. Available at http://www.gov.cn/gzdt/att/att/site1/20120912/1c6f6506c7f811bacf9301.pdf.Google Scholar
4.Chen, YY, Qian, X, Zhang, J, Li, J, Chu, A, Schweitzer, SO (2008) Preliminary study into the economic burden of Down syndrome in China. Birth Defects Res A Clin Mol Teratol 82, 2533.Google Scholar
5.Wald, NJ, Kennard, A, Hackshaw, A, McGuire, A (1997) Antenatal screening for Down's syndrome. J Med Screen 4, 181246.Google Scholar
6.Alldred, SK, Deeks, JJ, Guo, B, Neilson, JP, Alfirevic, Z (2012) Second trimester serum tests for Down's Syndrome screening. Cochrane Database Syst Rev CD009925.Google Scholar
7.Wortelboer, EJ, Koster, MP, Stoutenbeek, P, Loeber, JG, Visser, GH, Schielen, PC (2008) Fifteen years of triple tests in The Netherlands; the life cycle of a screening test. Prenat Diagn 28, 950955.Google Scholar
8.Palomaki, GE, Deciu, C, Kloza, EM, et al. (2012) DNA sequencing of maternal plasma reliably identifies trisomy 18 and trisomy 13 as well as Down syndrome: an international collaborative study. Genet Med 13, 296305.Google Scholar
9.Norton, ME, Brar, H, Weiss, J, et al. (2012) Non-invasive chromosomal evaluation (NICE) study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol 207, 137.e1–8.Google Scholar
10.Benn, P, Borell, A, Chiu, R, et al. (2013) Position statement from the Aneuploidy Screening Committee on behalf of the Board of the International Society for Prenatal Diagnosis. Prenat Diagn 33, 622629.Google Scholar
11.American College of Obstetricians and Gynecologists Committee on Genetics (2012) Committee Opinion No. 545: noninvasive prenatal testing for fetal aneuploidy. Obstet Gynecol 120, 15321534.Google Scholar
12.Gregg, AR, Gross, SJ, Best, RG, et al. (2013) ACMG statement on noninvasive prenatal screening for fetal aneuploidy. Genet Med 15, 395398.Google Scholar
13.Zhang, R, Li, JM China's policies regarding next-generation sequencing diagnostic tests [EB/OL]. [cited December 23, 2016] Available at https://imirus.com/tmp/12426/17384/-1/pm12426.pdf.Google Scholar
14.Henan Provincial Health Bureau (2016) The Henan Provincial Health Bureau disseminates the NHFPC's notice regarding approval procedures for a pilot project involving clinical use of high-throughput genetic sequencing; c2016 [cited December 27, 2016]. http://www.henanyz.com/images/artpic/201403.Google Scholar
15.Wald, NJ, Kennard, A, Hackshaw, A, McGuire, A (1998) Antenatal screening for Down's syndrome. Health Technol Assess 2, 11124.Google Scholar
16.Yang, RF, Wang, MY, Ding, FH, et al. (2008) Screening analysis of Down syndromes in 10484 cases on middle period pregnancy. Chin J Birth Health Hered 16, 4648.Google Scholar
17.Ball, RH, Caughey, AB, Malone, FD, et al. (2007) First- and second-trimester evaluation of risk for Down syndrome. Obstet Gynecol 110, 1017.Google Scholar
18.Chou, CY, Hsieh, FJ, Cheong, ML, Lee, FK, She, BQ, Tsai, MS (2009) First-trimester Down syndrome screening in women younger than 35 years old and cost-effectiveness analysis in Taiwan population. J Eval Clin Pract 15, 789796.Google Scholar
19.Xu, HY, Liu, KB, Qi, QQ (2016) The analysis of screening situation for Down syndrome between 2010 to 2014 in Beijing. Chin J Birth Health Hered 24, 4849.Google Scholar
20.Cuckle, H, Benn, P, Pergament, E (2013) Maternal cfDNA screening for Down syndrome--a cost sensitivity analysis. Prenat Diagn 33, 636642.Google Scholar
21.Chen, YY, Qian, X, Li, J, Zhang, J, Chu, A, Schweitzer, SO (2007) Cost-effectiveness analysis of prenatal diagnosis intervention for Down's syndrome in China. Int J Technol Assess Health Care 23, 138145.Google Scholar
22.Tu, S, Rosenthal, M, Wang, D, Huang, J, Chen, Y (2016) Performance of prenatal screening using maternal serum and ultrasound markers for Down syndrome in Chinese women: a systematic review and meta-analysis. BJOG 123(Suppl 3), 1222.Google Scholar
23.Mei, L, Jin, JJ, Chen, YY, et al. (2016) Systematic review on safety and effectiveness of MPS technology screening for Down syndrome. China Health Resour 19, 180186.Google Scholar
24.Norton, ME, Jacobsson, B, Swamy, GK, et al. (2015) Cell-free DNA analysis for noninvasive examination of trisomy. N Engl J Med 372, 15891597.Google Scholar
25.Akolekar, R, Beta, J, Picciarelli, G, Ogilvie, C, D'Antonio, F (2015) Procedure-related risk of miscarriage following amniocentesis and chorionic villus sampling: a systematic review and meta-analysis. Ultrasound Obstet Gynecol 45, 1626.Google Scholar
26.Li, CL, Shi, LY, Huang, J, Qian, X, Chen, Y (2016) Factors associated with utilization of maternal serum screening for Down syndrome in mainland China: a cross sectional study. BMC Health Serv Res 16, 8.Google Scholar
27.Liu, XJ, Xue, M (2012) The management and result analysis of prenatal screening using 14099 cases in the second trimester. Chin Matern Child Health Care 27, 200202.Google Scholar
28.Ohno, M, Caughey, A (2013) The role of noninvasive prenatal testing as a diagnostic versus a screening tool-a cost-effectiveness analysis. Prenat Diagn 33, 630635.Google Scholar
29.Walker, BS, Nelson, RE, Jackson, BR, Grenache, DG, Ashwood, ER, Schmidt, RL (2015) A cost-effectiveness analysis of first trimester non-invasive prenatal screening for fetal trisomies in the United States. PLoS One 10, e0131402.Google Scholar
30.You, XY, Liu, YQ, Wu, M (2016) Analysis on prenatal screening results during the second trimester of pregnancy in Nanchang city from 2012 to 2014. Mod Prev Med 43, 646648.Google Scholar
31.Hu, CX, Tan, JQ, Wang, F (2016) Retrospective analysis on antenatal screening results of 44410 cases in the second trimester in Yuhang District of Hangzhou. Chin J Gen Pract 14, 423425.Google Scholar
32.Deng, CF, Ling, Y, Mu, Y, et al. (2015) Recent trends in the birth prevalence of Down syndrome in China: impact of prenatal diagnosis and subsequent terminations. Prenat Diagn 35, 311318.Google Scholar
33.Liu, B, Gao, ES (2002) Risk factors for spontaneous abortion of Chinese married women at reproductive age. China Public Health 18, 890892.Google Scholar
34.Xu, Y, Li, N, Ming, J, et al. (2017) Systematic review of economic evaluation of non-invasive prenatal screening strategies for Down's syndrome. China Health Resour 20, 137–42.Google Scholar
35.Walker, BS, Jackson, BR, La Grave, D, Ashwood, ER, Schmidt, RL (2015) A cost-effectiveness analysis of cell free DNA as a replacement for serum screening for Down syndrome. Prenat Diagn 35, 440446.Google Scholar
36.Fairbrother, G, Burigo, J, Sharon, T, Song, K (2016) Prenatal screening for fetal aneuploidies with cell-free DNA in the general pregnancy population: a cost-effectiveness analysis. J Matern Fetal Neonatal Med 29, 11601164.Google Scholar
37.Neyt, M, Hulstaert, F, Gyselaers, W (2014) Introducing the non-invasive prenatal test for trisomy 21 in Belgium: a cost-consequences analysis. BMJ Open 4, e005922.Google Scholar
38.Morris, S, Karlsen, S, Chung, N, Hill, M, Chitty, LS (2014) Model-based analysis of costs and outcomes of non-invasive prenatal testing for Down's syndrome using cell free fetal DNA in the UK National Health Service. PLoS One 9, e93559.Google Scholar
39.Ayres, AC, Whitty, JA, Ellwood, DA (2014) A cost-effectiveness analysis comparing different strategies to implement noninvasive prenatal testing into a Down syndrome screening program. Aust N Z J Obstet Gynaecol 54, 412–7.Google Scholar
40.Evans, MI, Sonek, JD, Hallahan, TW, Krantz, DA (2015) Cell-free fetal DNA screening in the USA: a cost analysis of screening strategies. Ultrasound Obstet Gynecol 45, 7483.Google Scholar
41.Song, K, Musci, TJ, Caughey, AB (2013) Clinical utility and cost of non-invasive prenatal testing with cfDNA analysis in high-risk women based on a US population. J Matern Fetal Neonatal Med 26, 11801185.Google Scholar
42.O'Leary, P, Maxwell, S, Murch, A, Hendrie, D (2013) Prenatal screening for Down syndrome in Australia: costs and benefits of current and novel screening strategies. Aust N Z J Obstet Gynaecol 53, 425433.Google Scholar
43.Beulen, L, Grutters, JP, Faas, BH, Feenstra, I, van Vugt, JM, Bekker, MN (2014) The consequences of implementing non-invasive prenatal testing in Dutch national health care: a cost-effectiveness analysis. Eur J Obstet Gynecol Reprod Biol 182, 5361.Google Scholar
44.Langlois, S, Brock, JA, GENETICS COMMITTEE (2013) Current status in non-invasive prenatal detection of Down syndrome, trisomy 18, and trisomy 13 using cell-free DNA in maternal plasma. J Obstet Gynaecol Can 35, 177183.Google Scholar
45.Jin, KQ, Wu, YQ, Jiang, QF, et al. (2015) Analysis of 20232 cases in the second trimester of pregnancy for Down's syndrome and part results of its prenatal diagnosis. Chin J Birth Health Hered 7, 3031.Google Scholar
46.Verweij, EJ, Oepkes, D, Vries, M, van den Akker, ME, van den Akker, ES, de Boer, MA (2013) Non-invasive prenatal screening for trisomy 21: what women want and are willing to pay. Patient Educ Couns 93, 641645.Google Scholar
47.Ming, J, Zhou, P, Xu, Y, et al. (2015) International experience of clinical practice of non-invasive prenatal testing. China Health Resour 18, 391394.Google Scholar
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