Economic evaluation of expanded hemodialysis with the Theranova 400 dialyzer: A <scp>post hoc</scp> evaluation of a randomized clinical trial in the <scp>United States</scp>
Michael Blackowicz, Luke Falzon, Werner Beck, Ha Le Bao Tran, Daniel E. Weiner
Abstract
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.