OBJECTIVES: Primary IgA nephropathy in adults (IgAN) is a rare autoimmune disease that can lead to chronic kidney disease (CKD), end-stage renal disease, and early death. Until recently, there were no approved therapies available. Nefecon is the development project name for a novel oral formulation of budesonide which is or will be marketed under other trade names. Nefecon is being investigated for IgAN in a two-part pivotal study (NefIgArd). This analysis aims to assess the budget impact of introducing Nefecon as a novel oral treatment for adult patients with primary IgAN in the United States (US).

METHODS: Two cost scenarios over a 3-year horizon were developed from a hypothetical US commercial payer perspective of one million members. A scenario with Nefecon was compared to a scenario without Nefecon. The model was a prevalence-based analysis and evaluated results from a drug plan perspective (base case). Therefore, patient flow was based on disease prevalence with each additional model year incorporating the annual incidence of IgAN and expected mortality. Efficacy and safety data for Nefecon and SoC were based on Part A of the NefIgArd trial, while costs in the model came from various sources. Costs included treatment, routine medical care, adverse events, and mortality.

RESULTS: Over three years, the adoption of Nefecon was projected to increase overall costs by $3,265,769 with per member per month (PMPM) costs of $0.09 in the base case analysis. One-way sensitivity analyses showed results to be most sensitive to the uptake of Nefecon (for patients with CKD stage 3), with incremental results ranging from $3,146,512 to $3,402,396 in the optimistic and conservative scenarios, respectively.

CONCLUSIONS: Introducing Nefecon into the US market to treat patients with primary IgAN is estimated to lead to a modest increase in the drug plan budget.