| Summary: | Stacey J Ackerman,1 Tyler Knight,2 Peter M Wahl,2 Charles P Cartwright3 1Covance Market Access Services Inc., San Diego, CA, USA; 2Covance Market Access Services Inc., Gaithersburg, MD, USA; 3Center for Esoteric Testing, Laboratory Corporation of America Holdings, Burlington, NC, USA Background: Vulvovaginitis (VV) is a common reason women seek medical attention in the USA. Both the non-specific clinical presentation and risk of preterm labor or delivery necessitate accurate identification of the causative agents to guide appropriate therapy. The diagnostic accuracy of amplified molecular probe testing (AMP) has been shown to exceed that of non-amplified molecular probe (NAMP) by 20%–25%.Objective: To evaluate the impact of diagnosis with AMP testing on health care utilization, direct costs, and health outcomes, compared with NAMP, for symptomatic patients with suspected VV from a commercial payer perspective. Methods: Symptomatic women (aged 18–64 years) who underwent VV testing with AMP or NAMP from January 1, 2012–December 31, 2016 were identified using the Truven Health Analytics MarketScan Database; those with continuous medical and pharmacy benefit enrollment 6 months pre/post AMP or NAMP testing were included. Patients were propensity score (PS) matched and 6-month all-cause health care resource utilization, all-cause direct costs (2017 USD), risk of all-cause hospitalization, and risk of preterm labor or delivery were compared between cohorts. Results: After PS match (N=46,810 per group, mean age 34.2 years), AMP had significantly (all P<0.0001) fewer mean hospital outpatient visits (AMP 0.9 vs NAMP 1.0), primary care physician office visits (AMP 1.1 vs NAMP 1.2), and prescription medications (AMP 7.3 vs NAMP 8.0), and a 21% reduction in risk of hospitalization (risk ratio [RR]=0.79, 95% CI= 0.75–0.83, P<0.0001). Total medical expenditures per patient were lower for AMP than NAMP (mean AMP $3,287 vs NAMP $3,555, P<0.0001). Among pregnant women (N=2,175 per group), AMP had a 12% reduction in risk of preterm labor or delivery (RR =0.88, 95% CI=0.77–0.99, P=0.041). Conclusion: This real-world study offers evidence on the clinical utility for symptomatic patients with suspected VV diagnosed with AMP compared to NAMP – demonstrating an opportunity to improve the patient journey while delivering value-based care. Keywords: vulvovaginitis, preterm labor, preterm delivery, amplified molecular probe testing, propensity-score matching, health care utilization, costs, NuSwab, clinical utility
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