Budget Impact of a PreTRM-Guided Preventive Bundle for Preterm Birth in Low-Risk Pregnancies: A Microsimulation Study Using PRIME Trial Data
Author(s)
Paul E. Kearney, PhD1, Abdool F. Bhollah, MSc1, Eric Stanek, PhD2.
1Sera Prognostics, Inc., Salt Lake City, UT, USA, 2Carelon Research, Wilmington, DE, USA.
1Sera Prognostics, Inc., Salt Lake City, UT, USA, 2Carelon Research, Wilmington, DE, USA.
OBJECTIVES: To estimate the 3-year budget impact of a PreTRM® Test-guided preventive intervention bundle—including low-dose aspirin, vaginal progesterone, and care management—applied to low-risk singleton pregnancies stratified for preterm birth risk. The analysis focused on reducing neonatal intensive care unit (NICU) length of stay and first-year-of-life costs using an individual-level microsimulation model that accounts for patient heterogeneity in a low-risk population.
METHODS: We developed a microsimulation model from a mixed-payer perspective using individual-level data from the PRIME randomized controlled trial. The model simulated 1M commercial health plan members representative of the target population over a 3-year time horizon, incorporating variability in demographics, obstetric outcomes, treatment adherence, and clinical effectiveness. 2024 costs included standard pregnancy care, direct and indirect costs of the intervention bundle, NICU length of stay, and first-year-of-life healthcare utilization. NICU and postnatal costs were derived from a claims-based cohort of 62,093 pregnancies in the HealthCare Integrated Research Database (2016, Carelon Research). Key model inputs such as number needed to screen to reduce a NICU day and gestational age shifts were based on outcomes from the PRIME trial (ClinicalTrials.gov #NCT04301518).
RESULTS: Relative to standard care, the PreTRM-guided intervention bundle yielded a net savings of $2.1 per member per month by year 3 (95% CI, $2.1-2.2) achieved break-even at 52 weeks (95% CI, 52-53 weeks), and required a maximum investment of $6.5M (95% CI, $6.47-6.57M), which occurred by week 60. The total net savings at 3 years for 1M covered lives was $15M. Sensitivity analyses identified NICU day cost, first year of life healthcare cost and test adoption and intervention compliance rate (these were bundled together) as the most influential model parameters.
CONCLUSIONS: This microsimulation provides robust budget impact estimates for a PreTRM-guided strategy, demonstrating the potential for clinically targeted, cost-saving interventions in a low-risk pregnancy population.
METHODS: We developed a microsimulation model from a mixed-payer perspective using individual-level data from the PRIME randomized controlled trial. The model simulated 1M commercial health plan members representative of the target population over a 3-year time horizon, incorporating variability in demographics, obstetric outcomes, treatment adherence, and clinical effectiveness. 2024 costs included standard pregnancy care, direct and indirect costs of the intervention bundle, NICU length of stay, and first-year-of-life healthcare utilization. NICU and postnatal costs were derived from a claims-based cohort of 62,093 pregnancies in the HealthCare Integrated Research Database (2016, Carelon Research). Key model inputs such as number needed to screen to reduce a NICU day and gestational age shifts were based on outcomes from the PRIME trial (ClinicalTrials.gov #NCT04301518).
RESULTS: Relative to standard care, the PreTRM-guided intervention bundle yielded a net savings of $2.1 per member per month by year 3 (95% CI, $2.1-2.2) achieved break-even at 52 weeks (95% CI, 52-53 weeks), and required a maximum investment of $6.5M (95% CI, $6.47-6.57M), which occurred by week 60. The total net savings at 3 years for 1M covered lives was $15M. Sensitivity analyses identified NICU day cost, first year of life healthcare cost and test adoption and intervention compliance rate (these were bundled together) as the most influential model parameters.
CONCLUSIONS: This microsimulation provides robust budget impact estimates for a PreTRM-guided strategy, demonstrating the potential for clinically targeted, cost-saving interventions in a low-risk pregnancy population.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO34
Topic
Clinical Outcomes, Economic Evaluation, Health Technology Assessment
Disease
Reproductive & Sexual Health