The Clinical Value and Cost-Effectiveness of DefenCath for Reducing Catheter-Related Bloodstream Infections in Adult Patients Receiving Hemodialysis Through a Central Venous Catheter

Author(s)

Elmar R. Alizadeh, PhD1, Devin Incerti, PhD1, Erin Mistry, MS2, Peter Sullivan, PharmD, BCOP2, Liz Hurlburt, MS2, Jared L. Crandon, PharmD2;
1EntityRisk Inc., Princeton, NJ, USA, 2CorMedix Inc., Berkeley Heights, NJ, USA

Presentation Documents

OBJECTIVES: DefenCath is an antimicrobial catheter lock solution (CLS) approved by the U.S. Food and Drug Administration to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients receiving chronic hemodialysis via a central venous catheter. CRBSIs are associated with increased morbidity, mortality, and health-care utilization. This analysis modeled the cost-effectiveness of DefenCath relative to heparin as a CLS.
METHODS: The model had a 10-year horizon, payer perspective, and 3% discount rate in the base case. A patient-level simulation was parametrized using real-world (Premier Healthcare Database) and DefenCath patient-level clinical trial data combined with literature estimates. Given a health state, the model simulated times to all competing states from parameterized time-to-event distributions, and patients transitioned to the state with the shortest time. Modeled clinical outcomes were CRBSIs, CRBSI-related hospitalizations and intensive care unit (ICU) stays, and CRBSI-related deaths. Model costs were dialysis, CLS acquisition, outpatient CRBSI treatment, hospitalization, ICU, and post-CRBSI secondary diagnoses. The model utilized a generalized cost-effectiveness analysis framework; stacked cohorts were included in conjunction with dynamic pricing for DefenCath acquisition. Hemodialysis patients experienced a 0.71 utility, with hospitalization due to CRBSI resulting in a 20% decline in quality of life (i.e., 0.568). Total costs and quality-adjusted life-years (QALYs) were outputted for each CLS and the incremental cost-effectiveness ratio (ICER) of DefenCath to heparin was calculated.
RESULTS: Per 1,000 patients, DefenCath prevents 139 CRBSIs, 117 hospitalizations, 61 ICU stays, and 11 deaths. DefenCath’s total costs are $1,535 less per patient and it yields an additional 0.07 QALYs. With more QALYs and lower costs, DefenCath’s ICER is negative (i.e., it dominates heparin).
CONCLUSIONS: Relative to heparin, DefenCath resulted in fewer serious negative clinical events, lower total costs, and more QALYs. Given the potential impacts of CRBSIs to an already vulnerable patient population, stakeholders should focus on reducing infection risk with cost-effective products.

Conference/Value in Health Info

2025-05, ISPOR 2025, Montréal, Quebec, CA

Value in Health, Volume 28, Issue S1

Code

EE346

Topic

Economic Evaluation

Disease

No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Infectious Disease (non-vaccine), SDC: Urinary/Kidney Disorders

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