Gynecology and Obstetrics Clinical Medicine (Sep 2021)
Robust cost efficacy of a novel, validated screening test at 12–20 Weeks gestation for the prediction of preterm birth (PTB) at or before 32 Weeks in singletons
Abstract
Objective: Preterm birth (PTB) at or before 32 weeks complicates up to 2 % of United States (US) births and accounts for 80 % of perinatal expenditures in the first year of life. Existing screening tests for PTB performed from 12 weeks to 19 weeks 5 days have receiver operated area under the curve (AUC) indices of <80 % and at most <70 %. We evaluated FutureBIRTH™, a unique maternal screening test comprised of plasma cell-free RNA for the prediction of PTB ≦ 32 weeks due to spontaneous labor (sPTB) with or without preterm premature rupture of the membranes (PPROM) or early-onset pre-eclampsia before 34 weeks (EOP). FutureBIRTH™ is supported by multiple validation studies derived from 12 weeks to 19 weeks 5 days gestation achieving AUCs of 84.2 % for sPTB and 94.1 % for EOP. Methods: Using the US rates for EOP (0.5 %) and sPTB ≦ 32 weeks (1.8 %) and adjusting the US pregnancy/neonatal medical costs to US dollars (2017 value), we calculated the cost per 100,000 singletons with or without universal FutureBIRTH™ testing before 19 weeks and 6 days using three detection rates and assuming screen-positive women would be treated with and respond to aspirin (assumed 80 % efficacy for EOP) and vaginal progesterone (assumed 38 % efficacy for sPTB). We also assessed test performance at disease incidence rates below that of the US (down to 0.46 %). For considering screening costs, we assumed test costs of $750, and treatment costs of $1000 for patients over 20 weeks gestational age. Results: The identification and treatment of ‘at-risk’ pregnancies by FutureBIRTH™ with existing therapies would reduce direct healthcare costs by up to $95 million per 100,000 births. The projected savings were robust and achievable at each FutureBIRTH™ price despite the conservative costs, efficacy, and detection rate assumptions. The incidence of PTB ≦ 32 weeks would decline by 40 %–50 % with a test cost of $750 and an 80 % detection rate. Conclusion: The accurate risk assessment provided by universal FutureBIRTH™ screening coupled with existing preventative treatments could lead to a 40 %–50 % decrease in PTB ≦ 32 weeks due to sPTB and EOP among ‘at-risk’ pregnancies, covering the cost of screening and treatment while still saving $450-$950 per pregnancy.
