Cost-Effectiveness of a Proteomic Test for Preterm Birth Prediction

Abstract

Background 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.

Clinical and economic evaluation of a proteomic biomarker preterm birth risk predictor: Cost-effectiveness modeling of prenatal interventions applied to predicted higher-risk pregnancies within a large and diverse cohort

“…This study builds upon a previously published modeling study [30], wherein the authors constructed a decision-analytic/Markov cost-effectiveness model evaluating a test-and-treat strategy that used the risk predictor to identify patients at higher risk of PTB, followed by multimodal intervention. These authors found that the test-and-treat strategy was dominant in most scenarios.…”

“…However, these traditional approaches are limited by the fact that risk factors only capture a small percentage (approximately 11%) [4,5] of patients who will deliver prematurely, whereas the proteomic biomarker captures the majority (75%) of sPTBs [9]. Benefit is therefore more likely, since this approach of risk identification holds promise if it identifies a much larger proportion of those destined to deliver prematurely, and intervention or combination of interventions appropriate for the group chosen are applied [30].…”

“…Outlier values were traced and explored. In partially dependent external validation, cost results were compared to the decision-analytic model used in a separate risk predictor cost-effectiveness study [30], and results for RP-MM were compared to direct observation of PREVENT-PTB outcomes [12]. Sources for predictive validity are currently unavailable.…”

Advances in mass spectrometry technologies to characterize cervicovaginal microbiome functions that impact spontaneous preterm birth

“…A recent cost effectiveness analysis showed that the use of a hypothetical proteomics prognostic test to identify women at risk of sPTB combined with appropriate treatment is cost-effective and may reduce total costs, while preventing sPTBs and their consequences. 74 These F I G U R E 2 Metaproteomics and metabolomics allow for the exploration of actual microbial and host function and predicted microbial taxonomy. Metataxonomic and metagenomics methods are gold standards for taxonomic analysis; however, these methods can only generate predicted functional profiles.…”

Systematic Reviews to Inform Practice, May/June 2022

“…For someone without a history of PTB but a short cervix at 18 weeks’ gestation, vaginal progesterone should be offered. New approaches to identify those at high risk for PTB without a history of PTB or short cervix using proteomics from a maternal blood test is a potentially promising avenue to identifying, treating, and preventing early PTB, an enduring public health issue 8,9 …”