BUDGETARY IMPLICATIONS OF REPLACING PATENTED SEVELAMER IN THE MANAGEMENT OF CHRONIC KIDNEY DISEASE IN MEXICO
Author(s)
José Ángel Paladio-Hernández, MA, MS1, Pamela Sánchez-Rodríguez, MBA, MSc2, Carlos Dominguez, MBA2, Oscar Muñoz-Puga, MBA2.
1Head of Health Economics, PalaGod Health Supply, Cuautitlán Izcalli, Mexico, 2Synthon, Mexico City, Mexico.
1Head of Health Economics, PalaGod Health Supply, Cuautitlán Izcalli, Mexico, 2Synthon, Mexico City, Mexico.
OBJECTIVES: Chronic kidney disease (CKD) is a progressive condition frequently complicated by hyperphosphatemia, which contributes to cardiovascular morbidity and increased healthcare resource utilization in patients receiving dialysis. This study aimed to evaluate the budgetary implications of replacing patented sevelamer with a lower-cost alternative in the management of CKD within the Mexican Institute of Social Security (IMSS).
METHODS: A budget impact analysis was conducted from the institutional perspective of IMSS over a one-year time horizon. The analysis followed a cohort of 560 patients with CKD receiving phosphate binder therapy. A substitution scenario was modeled in which 70% of patients treated with patented sevelamer were switched to generic sevelamer (Synthon). Drug acquisition costs were compared between treatment alternatives. The annual per-patient cost of patented sevelamer was estimated at USD 82, while the annual per-patient cost of generic sevelamer was USD 51. Clinical outcomes were assumed to be equivalent between treatments, and the analysis focused exclusively on direct pharmaceutical expenditures.
RESULTS: In the modeled cohort of 560 patients, the scenario without generic availability—where all patients received patented sevelamer—resulted in a total annual pharmaceutical expenditure of USD 45,920. Under the substitution scenario, in which 70% of patients (n=392) were switched to generic sevelamer, total annual drug acquisition costs decreased to USD 33,768. This reduction was driven by the lower annual per-patient cost of generic sevelamer compared with patented sevelamer, generating a direct saving of USD 31 per patient switched to the generic alternative. At the cohort level, this translated into total annual savings of USD 12,152 for IMSS. Budget savings increased proportionally with the substitution rate.
CONCLUSIONS: Replacing patented sevelamer with a lower-cost generic alternative represents an effective cost-containment strategy for IMSS. Large-scale substitution can generate meaningful budget efficiencies without compromising access to essential therapy, supporting the financial sustainability of CKD management in the Mexican public healthcare system.
METHODS: A budget impact analysis was conducted from the institutional perspective of IMSS over a one-year time horizon. The analysis followed a cohort of 560 patients with CKD receiving phosphate binder therapy. A substitution scenario was modeled in which 70% of patients treated with patented sevelamer were switched to generic sevelamer (Synthon). Drug acquisition costs were compared between treatment alternatives. The annual per-patient cost of patented sevelamer was estimated at USD 82, while the annual per-patient cost of generic sevelamer was USD 51. Clinical outcomes were assumed to be equivalent between treatments, and the analysis focused exclusively on direct pharmaceutical expenditures.
RESULTS: In the modeled cohort of 560 patients, the scenario without generic availability—where all patients received patented sevelamer—resulted in a total annual pharmaceutical expenditure of USD 45,920. Under the substitution scenario, in which 70% of patients (n=392) were switched to generic sevelamer, total annual drug acquisition costs decreased to USD 33,768. This reduction was driven by the lower annual per-patient cost of generic sevelamer compared with patented sevelamer, generating a direct saving of USD 31 per patient switched to the generic alternative. At the cohort level, this translated into total annual savings of USD 12,152 for IMSS. Budget savings increased proportionally with the substitution rate.
CONCLUSIONS: Replacing patented sevelamer with a lower-cost generic alternative represents an effective cost-containment strategy for IMSS. Large-scale substitution can generate meaningful budget efficiencies without compromising access to essential therapy, supporting the financial sustainability of CKD management in the Mexican public healthcare system.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE433
Topic
Economic Evaluation
Topic Subcategory
Budget Impact Analysis, Cost/Cost of Illness/Resource Use Studies
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity), SDC: Urinary/Kidney Disorders