The Cost-Effectiveness of Targeted-Release Form (TRF)-Budesonide for the Treatment of Adult Population With Immunoglobulin A Nephropathy (IgAN) in Greece
Author(s)
Katerina Vellopoulou, MSc1, Stylianos Ravanidis, PhD1, Konstantinos Kipentzoglou, MSc2, Yanna Sotirakou, MSc3, Zhuro Olga, MSc3, Joachim Vöhringer, MSc3, Panagiotis Koukoulommatis, PhD4, Vassilios Liakopoulos, PhD5, Smaragdi Marinaki, PhD6, Maria Stangkou, PhD7, Georgia Kourlaba, PhD8.
1ECONCARE LP, Athens, Greece, 2Britannia Pharmaceuticals, Berkshire, United Kingdom, 3STADA Arzneimittel AG, Bad Vilbel, Germany, 4FARAN SA, Athens, Greece, 5Second Department of Nephrology, AHEPA University Hospital, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece, 6Clinic of Nephrology and Renal Transplantation, "Laiko" General Hospital, National & Kapodistrian University of Athens, Athens, Greece, 7Department of Nephrology Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece, 8Department of Nursing, School of Health Sciences, National and Kapodistrian University of Athens, Athens, Greece.
1ECONCARE LP, Athens, Greece, 2Britannia Pharmaceuticals, Berkshire, United Kingdom, 3STADA Arzneimittel AG, Bad Vilbel, Germany, 4FARAN SA, Athens, Greece, 5Second Department of Nephrology, AHEPA University Hospital, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece, 6Clinic of Nephrology and Renal Transplantation, "Laiko" General Hospital, National & Kapodistrian University of Athens, Athens, Greece, 7Department of Nephrology Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece, 8Department of Nursing, School of Health Sciences, National and Kapodistrian University of Athens, Athens, Greece.
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.
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.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE694
Topic
Economic Evaluation, Health Technology Assessment
Topic Subcategory
Trial-Based Economic Evaluation
Disease
Rare & Orphan Diseases, Urinary/Kidney Disorders