Objectives: To assess the cost-effectiveness of targeted-release form (TRF)-budesonide added to standard of care (SoC) for the treatment of adults with biopsy-proven immunoglobulin A nephropathy (IgAN) with urine protein-creatinine ratio of ≥0.8g/g or proteinuria of ≥1.0 g/g over 24 hours, versus SoC alone in Greece.

Methods: The cost-effectiveness model (CEM) consists of a cohort Markov approach and is adapted to estimate the costs and health outcomes of a hypothetical cohort of patients with IgAN over a lifetime horizon, from the third-party payer perspective (EOPYY). Population and clinical data for the CEM are sourced from the NefIgArd clinical trial. Greek clinical experts provided local healthcare resource use data. Cost parameters consist of drug and health state costs, including dialysis and transplantation, adverse events and end-of-life care costs. Unit costs are derived from official sources and literature (€, 2024). Health outcomes are expressed in quality-adjusted life years (QALYs), as sourced from literature. All the future costs and outcomes are discounted at 3.5% per annum. Costs and effects of treatment with TRF-budesonide as an add-on to SoC are compared to SoC alone to assess the incremental cost-effectiveness ratio (ICER). One-way sensitivity analysis was undertaken to assess the parameters that mainly affect the analysis and a probabilistic sensitivity analysis (PSA) to account for uncertainty in the model.

Results: Compared to SoC, TRF-budesonide was estimated to result in incremental costs of €38,566 and additional effects of 0.473 QALYs, while the estimated ICER (€81,537) remains well below the published ICERs for orphan drugs. Drug costs, health state utilities and the utilities for hemodialysis are the parameters highly affecting the results. PSA confirms the robustness of the base case results.

Conclusions: The present analysis suggests that TRF-budesonide can be considered a cost-effective treatment option in adult patients with IgAN in Greece compared to SoC alone.