Economic evaluation of expanded hemodialysis with the Theranova 400 dialyzer: A post hoc evaluation of a randomized clinical trial in the United States.

INTRODUCTION: The Theranova 400 is a medium cut-off dialyzer that allows for superior clearance of larger middle molecules than traditional high-flux dialyzers. This study evaluates the association of expanded hemodialysis (HDx) using the Theranova dialyzer versus conventional hemodialysis (HD) with a high-flux dialyzer on hospitalization rates and healthcare costs as compared to conventional HD in a post hoc analysis of a randomized controlled trial. METHODS: In a non-concealed, 24-week clinical trial, maintenance HD patients were randomized to receive treatment with either Theranova 400 or a similar size high-flux dialyzer. Hospitalization rate and average length of stay were calculated from trial data. Use of erythropoiesis-stimulating agents and iron were assumed to be equal and therefore excluded from the model. Average cost per inpatient day was obtained from a publicly available published source. Probabilistic sensitivity analyses were conducted to account for variability in model inputs. FINDINGS: There were 86 patients (389 patient-months) in the Theranova group and 85 patients (366 patient-months) in the high-flux HD group. All-cause hospitalization rate was 45% lower with Theranova compared to high-flux HD (IRR = 0.55; p = 0.05). Average annual estimated cost of hospitalization was $6098 lower with Theranova compared to high-flux HD. Compared to high-flux HD, average annual estimated cost associated with Theranova use was $4772 lower per patient. Hospitalization rate and hospital length of stay were the main drivers of cost. CONCLUSIONS: Use of the Theranova dialyzer is associated with lower estimated costs of care among maintenance HD patients, driven by fewer hospitalization events.

Cost-effectiveness of the TherMax blood warmer during continuous renal replacement therapy.

Hypothermia is a common adverse event during continuous renal replacement therapy (CRRT), affecting multiple organ systems and increasing risk of poor health outcomes among patients with acute kidney injury (AKI) undergoing CRRT. TheraMax blood warmers are the next generation of extracorporeal blood warmers which reduce risk of hypothermia during CRRT. The purpose of this study is to elucidate the potential health economic impacts of avoiding CRRT-induced hypothermia by using the novel TherMax blood warming device. This study compares health care costs associated with use of the new TherMax blood warmer unit integrated with the PrisMax system compared to CRRT with a standalone blood warming device to avoid hypothermia in continuous renal replacement therapy (CRRT). An economic model was developed in which relevant health states for each intervention were normothermia, hypothermia, discharge, and death. Clinical inputs and costs were obtained from a combination of retrospective chart review and publicly available summary estimates. The proportion of AKI patients treated with CRRT who became hypothermic (<36°C) during CRRT treatment was 34.5% in the TherMax group compared to 71.9% in the 'standalone warmer' group. Given the 78.7-year average life expectancy in the US and the assumed average patient age at discharge/death of 65.4 years, the total life-years gained by avoiding mortality related to hypothermia was 9.0 in the TherMax group compared to 8.0 in the 'standalone warmer' group. Cost per life-year gained was $8,615 in the TherMax group versus $10,115 in the 'standalone warmer' group for a difference of -$1,501 favoring TherMax. The incremental cost-effectiveness ratio was negative, indicating superior cost-effectiveness for TherMax versus 'standalone warmer'. The TherMax blood warming device used with the PrisMax system is associated with lower risk of hypothermia, which our model indicates leads to lower costs, lower risk of mortality due to hypothermia, and superior cost-effectiveness.