Abstract / Summary
Preeclampsia (PE) affects 8% of United States (US) pregnancies, driving substantial maternal and neonatal morbidity, costs, and mortality. Current United States Preventive Services Task Force (USPSTF) risk-based stratification has limited specificity, which may reduce the ability to effectively target preventive interventions and optimize PE prevention. We evaluated the budget impact of adopting a cell-free RNA (cfRNA) PE blood test compared with USPSTF screening in advanced maternal age (AMA; maternal age ≥ 35 years at delivery) pregnancies without pre-existing high-risk conditions. The evaluated intervention was a cfRNA-guided test-and-treat strategy in which high-risk pregnancies received targeted preventive management including low-dose aspirin. An observational claims analysis and deterministic budget impact model was developed from the US commercial payer perspective to simulate a 4.5-million–member health plan with 10,000 eligible AMA pregnancies annually. Costs were assessed at year 1 and year 5 timepoints at the maternal–infant dyad level, capturing both maternal and neonatal expenditures. Clinical performance inputs were derived from published data; cost inputs were drawn from commercial claims. The model compared USPSTF screening with cfRNA testing and targeted use of prophylactic low-dose aspirin. Economic endpoints included maternal and neonatal costs, budget impact, and return on investment (ROI). In the base case, the cfRNA test-and-treat strategy was projected to generate first-year net health plan savings (in 2024 US dollars) of $36.6 million per 10,000 eligible AMA pregnancies tested. On a total allowed-payment basis, projected first-year net budget savings after testing and intervention costs were $37.4 million, gross clinical-event savings (before testing and intervention costs) were $56.1 million, and ROI was 3.00:1. Projected annual net savings increased to $56.1 million using net plan payments and $57.2 million using total allowed payments in year 5. Cell-free RNA–based screening combined with targeted preventive interventions and changes in preventive management was projected to reduce severe PE cases and associated maternal and neonatal healthcare costs, resulting in substantial payer savings and favorable ROI in this modeled analysis. Results depend on assumptions regarding clinical recommendations, adherence, treatment effects, gestational-age shifts, test cost, and neonatal payments. Preeclampsia (PE) can cause serious complications for pregnant individuals and infants, particularly when it leads to preterm delivery. We developed a budget impact model to estimate the financial effect of replacing current United States Preventive Services Task Force risk-based screening with a cell-free RNA test-and-treat strategy. The model represented a hypothetical 4.5-million–member United States (US) commercial health plan with 10,000 eligible advanced maternal age pregnancies each year. Eligible pregnancies were singleton pregnancies without pre-existing high-risk conditions for PE. Under the model assumptions, high-risk results informed preventive management, including low-dose aspirin. Compared with current guideline-based screening, the strategy was projected to produce first-year net health plan savings (in 2024 US dollars) of approximately $36.6 million per 10,000 eligible pregnancies tested using net plan payments. Using total allowed payments, which include the health plan and patient cost-sharing portions of reimbursed care, projected first-year net budget savings were $37.4 million, gross clinical-event savings were $56.1 million, and return on investment was 3.00:1. The projected savings were driven mainly by fewer early preterm deliveries and lower neonatal costs. These are model-based estimates rather than results observed in a clinical implementation study and require prospective validation.