The Cost of Gastrointestinal Adverse Events and the Impact of Dose-Reductions/Discontinuations on Acute Rejection in Kidney Transplant Patients of Mycophenolate Mofetil-Related Compared to Enteric-Coated Mycophenolate Sodium: A Pharmacoeconomic Study.
BACKGROUND
Mycophenolate mofetil (MMF) is effective in decreasing rejection and graft loss in renal transplant patients. Enteric-coated mycophenolate sodium (EC-MPS) was designed to reduce MMF gastrointestinal (GI) effects. Dose manipulations in MMF/EC-MPS produce GI tolerability, increasing the risk of rejection. Significant differences in tolerance of MMF/EC-MPS may have economic influence in transplant efficacy outcomes. Herein, we performed a pharmacoeconomic evaluation of acute rejection incidence and interventions in GI-intolerant patients using MMF/EC-MPS.


METHODS
A cost-effectiveness analysis was performed through a decision tree model with a 1-year time horizon estimating costs and effectiveness of MMF and EC-MPS in renal transplant patients with GI intolerance. The costs and use of resources (US dollars; USD) were from payer perspective (Mexican Social Security). Primary health outcomes were mean cost of acute rejection and GI adverse events treatment. A probabilistic sensitivity analysis (PSA) was generated to test robustness of the model.


RESULTS
Calculated incidence of MMF GI intolerance was 44%, and calculated rejection incidence for MMF was 24.05%. Calculated incidence of EC-MPS GI intolerance was 29%, and calculated rejection incidence for EC-MPS was 20.1% Total cost of MMF with GI intolerance during 1-year period plus cost of treating one rejection sums $752,107.25 USD. Total cost of EC-MPS with GI intolerance plus cost of treating one rejection sums $638,018.97 USD.


CONCLUSIONS
EC-MPS-based treatment is a cost-saving alternative vs MMF in GI-intolerant kidney transplant patients. PSA supports the decision to utilize EC-MPS based on cost-effectiveness analysis.
Department of Organ Transplantation, Instituto Mexicano del Seguro Social, Unidades Medicas de Alta Especialidad, Veracruz, Mexico. Electronic address: gmtzmier@gmail.com.
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Martinez-Mier
Health Economics & Outcomes Research Manager, Novartis Mexico, Mexico D.F., Mexico.
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Salazar-Ramirez
D003362:Cost-Benefit Analysis; D004305:Dose-Response Relationship, Drug; D004361:Drug Tolerance; D017850:Economics, Pharmaceutical; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000191:economics / Q000493:pharmacokinetics; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000191:economics / Q000378:metabolism; D006084:Graft Rejection / Q000188:drug therapy* / Q000191:economics / Q000378:metabolism; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D015994:Incidence; D016030:Kidney Transplantation / Q000009:adverse effects* / Q000191:economics; D009173:Mycophenolic Acid / Q000008:administration & dosage* / Q000191:economics / Q000493:pharmacokinetics; D013608:Tablets, Enteric-Coated; D013997:Time Factors
D004791:Enzyme Inhibitors; D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D009173:Mycophenolic Acid