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Michael Grabner,1 Julja Burchard,2 Chi Nguyen,3 Haechung Chung,4 Nilesh Gangan,3 J Jay Boniface,2 John AF Zupancic,5 Eric Stanek1 1Scientific Affairs, HealthCore, Inc., Wilmington, DE, USA; 2Research and Development, Sera Prognostics, Salt Lake City, UT, USA; 3Health Economics and Outcomes Research, HealthCore, Inc., Wilmington, DE, USA; 4Research Operations, HealthCore, Inc., Wilmington, DE, USA; 5Department of Neonatology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USACorrespondence: Michael GrabnerScientific Affairs, HealthCore, Inc., 123 Justison St, Suite 200, Wilmington, DE, 19801, USATel +1 302-230-2000Email mgrabner@healthcore.comBackground: 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.Objective: 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.Methods: 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.Results: 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.Conclusion: 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.Keywords: preterm birth, cost effectiveness, progesterone, prognostic test |
