Ökem Zeynep Güldem, Örgül Gökçen, Kasnakoglu Berna Tari, Çakar Mehmet, Beksaç M Sinan
TOBB University of Economics and Technology, Department of International Entrepreneurship, Turkey.
Hacettepe University, Division of Perinatology, Department of Obstetrics and Gynecology, Turkey.
Eur J Obstet Gynecol Reprod Biol. 2017 Dec;219:40-44. doi: 10.1016/j.ejogrb.2017.09.025. Epub 2017 Oct 5.
To examine the costs and outcomes of different screening strategies for Down Syndrome (DS) in singleton pregnancies.
A decision-analytic model was developed to compare the costs and the outcomes of different prenatal screening strategies. Five strategies were compared for women under 35-year of age: 1A) triple test (TT), 2A); combined test (CT), 3A) Non-invasive Prenatal Screening Test by using cell free fetal DNA (NIPT), 4A) and 5A) NIPT as a second-step screening for high-risk patients detected by either TT, or CT respectively. For women ≥35-year of age, 1B) implementing invasive test (amniocentesis -AC) and 2B) NIPT for all women were compared. Data was analyzed to obtain the outcomes, total costs, the cost per women and the incremental cost-effectiveness ratios (ICERs) for screening strategies.
Among the current strategies for women under 35 years old, CT is clearly dominated to TT, as it is more effective and less costly. Although, the current routine practice (2A) is the least-costly strategy, implementing NIPT as a second step screening to high-risk women identified by CT (5A) would be more effective than 2A; leading to a 10.2% increase in the number of detected DS cases and a 96.3% reduction in procedural related losses (PRL). However, its cost to the Social Security Institution that is a public entity would be 17 times higher and increase screening costs by 1.5 times. Strategy 5A would result in an incremental cost effectiveness of 6,873,082 (PPP) US$ when compared to the current one (2A). Strategy 1B-for offering AC to all women ≥35-year of age is dominated over NIPT (2B), as it would detect more DS cases and would be less costly. On the other hand, there would be 206 PRL associated with AC, but NIPT provides clear clinical benefits as there would be no PRL with NIPT.
NIPT leads to very high costs despite its high effectiveness in terms of detecting DS cases and avoiding PRL. The cost of NIPT should be decreased, otherwise, only individuals who can afford to pay from out-of-pocket could benefit. We believe that reliable cost-effective prenatal screening policies are essential in countries with low and smiddle income and high birth rates as well.
研究单胎妊娠中不同唐氏综合征（DS）筛查策略的成本与结果。
构建一个决策分析模型，比较不同产前筛查策略的成本与结果。对35岁以下女性比较了五种策略：1A）三联筛查试验（TT），2A）联合筛查试验（CT），3A）使用游离胎儿DNA的无创产前筛查试验（NIPT），4A）和5A）分别将NIPT作为对TT或CT检测出的高危患者的第二步筛查。对35岁及以上女性，比较了1B）实施侵入性检测（羊膜穿刺术 -AC）和2B）对所有女性进行NIPT这两种策略。分析数据以获取筛查策略的结果、总成本、每位女性的成本以及增量成本效益比（ICER）。
在目前针对35岁以下女性的策略中，CT明显优于TT，因为它更有效且成本更低。尽管目前的常规做法（2A）是成本最低的策略，但将NIPT作为对CT检测出的高危女性的第二步筛查（5A）会比2A更有效；可使检测出的DS病例数增加10.2%，与操作相关的损失（PRL）减少96.3%。然而，对于作为公共实体的社会保障机构而言，其成本会高出17倍，筛查成本增加1.5倍。与当前策略（2A）相比，策略5A的增量成本效益为6,873,082（购买力平价）美元。对所有35岁及以上女性提供AC的策略1B被NIPT（2B）所主导，因为它能检测出更多DS病例且成本更低。另一方面，AC会有206例PRL，但NIPT具有明显的临床益处，因为NIPT不会出现PRL。
尽管NIPT在检测DS病例和避免PRL方面非常有效，但成本极高。NIPT的成本应降低，否则只有那些能够自掏腰包支付费用的个人才能受益。我们认为，在低收入、中等收入且出生率高的国家，可靠且具有成本效益的产前筛查政策也至关重要。
