title: Cost-effectiveness and cost-utility analysis of OTC use of simvastatin 10 mg for the primary prevention of myocardial infarction in Iranian men.
abstract: BACKGROUND
  Several clinical trials and meta-analyses have shown the advantageous effects of statins in populations with different levels of cardiovascular disease (CVD) risk. Considering the increasing cardiovascular risk among the Iranian population, the cost-effectiveness of the use of simvastatin 10 mg, as an Over-The-Counter (OTC) drug, for the primary prevention of myocardial infarction (MI) was evaluated in this modeling study, from the payer's perspective. The target population is a hypothetical cohort of 45-year CVD healthy men with an average (15%) 10-year CVD risk.
  
  
  METHODS
  A semi-Markov model with a life-long time horizon was developed to evaluate the Cost-Utility-Analysis (CUA) and Cost-Effectiveness-Analysis (CEA) of the use of OTC simvastatin 10 mg compared to no-drug therapy. Two measures of benefits were used in the model; Quality-Adjusted-Life-Years (QALYs) for the CUA and Life-Years-Gained (LYG) for the CEA. To examine the robustness of the results, one-way sensitivity analysis and probabilistic sensitivity analysis were applied to the model.
  
  
  RESULTS
  For the base-case scenario with a discount rate of 0% the estimated ICERs were 1113 USD/QALY and 935USD/LYG per patient (using governmental tariffs). No threshold has been determined in Iran for the cost-effectiveness of health-related interventions. However, according to the recommendation of WHO, this intervention can be considered highly cost-effective as its ICER is far less than the reported GDP per capita for Iran by World bank in 2013 ($4763).
  
  
  CONCLUSIONS
  This modeling study showed that the use of an OTC low dose statin (simvastatin 10 mg) for the primary prevention of myocardial infarction (MI) in 45-year men with a 10-year CVD risk of 15% could be considered highly cost-effective in Iran, as it meets the WHO threshold of the annual GDP per capita ($4763).
authors.affiliation: Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran. amirsadri@pharm.mui.ac.ir.
authors.forename: Mohammadreza
authors.initials: M
authors.lastname: Amirsadri
authors.affiliation: Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.
authors.forename: Abbas
authors.initials: A
authors.lastname: Hassani
mesh_terms: D003362:Cost-Benefit Analysis / Q000379:methods*; D006801:Humans; D007492:Iran; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D018803:Models, Economic; D009203:Myocardial Infarction / Q000517:prevention & control*; D004366:Nonprescription Drugs / Q000008:administration & dosage / Q000191:economics; D019057:Quality-Adjusted Life Years; D019821:Simvastatin / Q000008:administration & dosage* / Q000191:economics*
chemical_list: D004366:Nonprescription Drugs; D019821:Simvastatin