OBJECTIVES: IgA Nephropathy (IgAN) is a rare autoimmune disease that often leads to End-Stage Renal Disease (ESRD). The goal of treatment is to slow disease progression so that patients are less likely to develop kidney failure in their natural lifetime. Recent clinical trial results show that Nefecon slows eGFR loss, potentially prolonging the time to kidney failure. This study assesses the cost-effectiveness of Nefecon in conjunction with optimized Standard of Care (SoC), relative to optimized SoC alone, for US adult primary IgAN patients. This analysis is based on the full data set from the Phase 3 NefIgArd clinical trial.

METHODS: For this analysis, a semi-Markov model with a lifetime horizon was developed, encompassing both the U.S payer and societal perspectives. The model architecture incorporated nine health states, reflecting varying degrees of CKD severity, ESRD, and mortality. Transition probabilities between these health states were determined by a regression analysis of individual patient-level data obtained from the NefIgArd trial and supplemented with data from the literature. Costs such as treatment expenses, adverse event management, dialysis, transplantation, and mortality costs were considered.

RESULTS: The range of results reflects a dominant strategy, i.e., cost savings with concurrent QALY gains. In the US payer perspective, cost savings ranged from $55,805 to $321,164 and cost-effectiveness ratios (ICERs) ranged from -$58,173 to -$334,750 assuming up to 4 rounds of treatment. Nefecon resulted in 0.959 QALYs gained. Furthermore, modelling estimated that fewer patients would reach ESRD within ten years with Nefecon plus SoC (23.27%) versus SoC alone (55.70%). Sensitivity analyses supported the base case findings, further solidifying the economic case for Nefecon.

CONCLUSIONS: Model results suggest that adding Nefecon to SoC can help preserve kidney function by slowing eGFR loss in patients with IgAN while reducing overall net costs from the payer and societal perspective in the US.