Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial

Abstract

Background - In the WRAP-IT trial, adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device (CIED) infection without increased risk of complication in 6,983 patients undergoing CIED revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator (CRT-D) implant. There is limited information on the cost-effectiveness of this strategy. As a pre-specified objective, we evaluated antibacterial envelope cost-effectiveness compared to standard-of-care infection prevention strategies in the US healthcare system. Methods - A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention vs. standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years (QALYs) were discounted at 3%. An upper willingness-to-pay (WTP) threshold of $150,000 per QALY was used to determine cost-effectiveness, in alignment with American College of Cardiology and American Heart Association (ACC/AHA) practice guidelines and as supported by the World Health Organization (WHO) and contemporary literature. Results - The base-case incremental cost-effectiveness ratio (ICER) of the antibacterial envelope compared to standard-of-care was $112,603/QALY. The ICER remained lower than the WTP threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost. Conclusions - The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of CIED infection.

Cost-Effectiveness Analyses of an Absorbable Antibacterial Envelope for Use in Patients at Increased Risk of Cardiac Implantable Electronic Device Infection in Germany, Italy, and England

“…In line with these results, a recent study from the perspective of the US healthcare system found the envelope to be costeffective in the population formed by the WRAP-IT inclusion criteria, at an upper threshold of $150 000 per QALY when compared to SOC infection prevention among patients at increased risk of infection. 37 The study also used data from the WRAP-IT trial, although it did not include PADIT score subgroups as adopted in the current model.…”

Infections associated with cardiac electronic implantable devices: economic perspectives and impact of the TYRX™ antibacterial envelope

“…Two CEAs have been conducted by clinical study investigators involved in the WRAP-IT. 45 , 46 Both analyses were based on a prior model 47 and because CEA was pre-specified for the WRAP-IT study, both analyses used prospectively collected data for patients’ quality of life (EQ-5D) and healthcare resource use, in addition to clinical endpoints. 43 One study tailored the resource use and cost inputs for the US healthcare system 45 while the second analysis presented data for three European countries (UK, Germany, and Italy).…”

Gain in real-world cardiac resynchronization therapy efficacy with SyncAV dynamic optimization: Heart failure hospitalizations and costs

“…Thus, the observed 23% reduction in HFH-related expenditures with SyncAV™-enabled CRT is notable. Assuming 7.8-and 4.2-year life expectancy of patients with CRT-D and CRT-P devices, respectively 27 , lifetime savings amount to $4,031 per CRT patient when SyncAV™ is enabled.…”