Grabner Michael, Burchard Julja, Nguyen Chi, Chung Haechung, Gangan Nilesh, Boniface J Jay, Zupancic John A F, Stanek Eric
Scientific Affairs, HealthCore, Inc., Wilmington, DE, USA.
Research and Development, Sera Prognostics, Salt Lake City, UT, USA.
Clinicoecon Outcomes Res. 2021 Sep 14;13:809-820. doi: 10.2147/CEOR.S325094. eCollection 2021.
Preterm birth (PTB) carries increased risk of short- and long-term health problems as well as higher healthcare costs. Current strategies using clinically accepted maternal risk factors (prior PTB, short cervix) can only identify a minority of singleton PTBs.
We modeled the cost-effectiveness of a risk-screening-and-treat strategy versus usual care for commercially insured pregnant US women without clinically accepted PTB risk factors. The risk-screening-and-treat strategy included use of a novel PTB prognostic blood test (PreTRM) in the 19th-20th week of pregnancy, followed by treatment with a combined regimen of multi-component high-intensity-case-management and pharmacologic interventions for the remainder of the pregnancy for women assessed as higher-risk by the test, and usual care in women without higher risk.
We built a cost-effectiveness model using a combined decision-tree/Markov approach and a US payer perspective. We modeled 1-week cycles of pregnancy from week 19 to birth (preterm or term) and assessed costs throughout the pregnancy, and further to 12-months post-delivery in mothers and 30-months in infants. PTB rates and costs were based on >40,000 mothers and infants from the HealthCore Integrated Research Database with birth events in 2016. Estimates of test performance, treatment effectiveness, and other model inputs were derived from published literature.
In the base case, the risk-screening-and-treat strategy dominated usual care with an estimated 870 fewer PTBs (20% reduction) and $54 million less in total cost ($863 net savings per pregnant woman). Reductions were projected for neonatal intensive care admissions (10%), overall length-of-stay (7%), and births <32 weeks (33%). Treatment effectiveness had the strongest influence on cost-effectiveness estimates. The risk-screening-and-treat strategy remained dominant in the majority of probabilistic sensitivity analysis simulations and model scenarios.
Use of a novel prognostic test during pregnancy to identify women at risk of PTB combined with evidence-based treatment is estimated to reduce total costs while preventing PTBs and their consequences.
早产（PTB）会增加短期和长期健康问题的风险，同时医疗成本也更高。目前使用临床公认的母体风险因素（既往早产、宫颈短）的策略只能识别少数单胎早产病例。
我们对一种风险筛查与治疗策略与常规护理在美国商业保险的无临床公认早产风险因素的孕妇中的成本效益进行了建模。风险筛查与治疗策略包括在妊娠第19至20周使用一种新型早产预后血液检测（PreTRM），然后对检测评估为高风险的女性在妊娠剩余时间采用多组分高强度病例管理和药物干预的联合方案进行治疗，对无高风险的女性采用常规护理。
我们采用决策树/马尔可夫联合方法并从美国支付方的角度构建了一个成本效益模型。我们对从第19周妊娠到出生（早产或足月产）的1周周期进行建模，并评估整个孕期以及产后母亲12个月和婴儿30个月的成本。早产率和成本基于HealthCore综合研究数据库中2016年有出生事件的40,000多名母亲和婴儿。检测性能、治疗效果及其他模型输入的估计值均来自已发表的文献。
在基础病例中，风险筛查与治疗策略优于常规护理，预计早产病例减少870例（减少20%），总成本减少5400万美元（每位孕妇净节省863美元）。预计新生儿重症监护入院人数减少（10%）、总住院时间减少（7%）以及孕周<32周的分娩减少（33%）。治疗效果对成本效益估计的影响最大。在大多数概率敏感性分析模拟和模型情景中，风险筛查与治疗策略仍然占优。
孕期使用新型预后检测来识别有早产风险的女性并结合循证治疗，估计可降低总成本，同时预防早产及其后果。
