title: Cost-effectiveness of 10-Year Risk Thresholds for Initiation of Statin Therapy for Primary Prevention of Cardiovascular Disease.
abstract: OBJECTIVE
  The American College of Cardiology and the American Heart Association (ACC/AHA) cholesterol treatment guidelines have wide-scale implications for treating adults without history of atherosclerotic cardiovascular disease (ASCVD) with statins.
  
  
  OBJECTIVE
  To estimate the cost-effectiveness of various 10-year ASCVD risk thresholds that could be used in the ACC/AHA cholesterol treatment guidelines.
  
  
  METHODS
  Microsimulation model, including lifetime time horizon, US societal perspective, 3% discount rate for costs, and health outcomes. In the model, hypothetical individuals from a representative US population aged 40 to 75 years received statin treatment, experienced ASCVD events, and died from ASCVD-related or non-ASCVD-related causes based on ASCVD natural history and statin treatment parameters. Data sources for model parameters included National Health and Nutrition Examination Surveys, large clinical trials and meta-analyses for statin benefits and treatment, and other published sources.
  
  
  METHODS
  Estimated ASCVD events prevented and incremental costs per quality-adjusted life-year (QALY) gained.
  
  
  RESULTS
  In the base-case scenario, the current ASCVD threshold of 7.5% or higher, which was estimated to be associated with 48% of adults treated with statins, had an incremental cost-effectiveness ratio (ICER) of $37,000/QALY compared with a 10% or higher threshold. More lenient ASCVD thresholds of 4.0% or higher (61% of adults treated) and 3.0% or higher (67% of adults treated) had ICERs of $81,000/QALY and $140,000/QALY, respectively. Shifting from a 7.5% or higher ASCVD risk threshold to a 3.0% or higher ASCVD risk threshold was estimated to be associated with an additional 161,560 cardiovascular disease events averted. Cost-effectiveness results were sensitive to changes in the disutility associated with taking a pill daily, statin price, and the risk of statin-induced diabetes. In probabilistic sensitivity analysis, there was a higher than 93% chance that the optimal ASCVD threshold was 5.0% or lower using a cost-effectiveness threshold of $100,000/QALY.
  
  
  CONCLUSIONS
  In this microsimulation model of US adults aged 45 to 75 years [corrected], the current 10-year ASCVD risk threshold (≥7.5% risk threshold) used in the ACC/AHA cholesterol treatment guidelines has an acceptable cost-effectiveness profile (ICER, $37,000/QALY), but more lenient ASCVD thresholds would be optimal using cost-effectiveness thresholds of $100,000/QALY (≥4.0% risk threshold) or $150,000/QALY (≥3.0% risk threshold). The optimal ASCVD threshold was sensitive to patient preferences for taking a pill daily, changes to statin price, and the risk of statin-induced diabetes.
authors.affiliation: Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts.
authors.forename: Ankur
authors.initials: A
authors.lastname: Pandya
authors.affiliation: Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts.
authors.forename: Stephen
authors.initials: S
authors.lastname: Sy
authors.affiliation: Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Cho
authors.affiliation: Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts.
authors.forename: Milton C
authors.initials: MC
authors.lastname: Weinstein
authors.affiliation: Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts2Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Gaziano
mesh_terms: D000328:Adult; D000368:Aged; D050197:Atherosclerosis / Q000188:drug therapy*; D002318:Cardiovascular Diseases / Q000191:economics / Q000517:prevention & control*; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000191:economics* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D012306:Risk
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors