title: The value of atorvastatin over the product life cycle in the United States.
abstract: BACKGROUND
  US health care reform mandates the reduction of wasteful health care spending while maintaining quality of care. Introducing new drugs into crowded therapeutic classes may be viewed as offering "me-too" (new drugs with a similar mechanism of action compared to existing drugs) drugs without incremental benefit. This article presents an analysis of the incremental costs and benefits of atorvastatin, a lipid-lowering agent.
  
  
  OBJECTIVE
  This analysis models the cost-effectiveness of atorvastatin over the product life cycle.
  
  
  METHODS
  The yearly cost-effectiveness of atorvastatin compared to simvastatin was modeled from 1997 to 2030 from the point of view of a US third-party payer. Estimates for incremental costs (in US $) and effects (in quality-adjusted life-years [QALYs]) for the primary and secondary prevention of cardiovascular events were taken from previously published literature and adjusted for changes in drug prices over time. Estimates of total statin use were derived using the National Health and Nutrition Examination Survey. Sensitivity analyses were conducted to examine variations in study parameters, including drug prices, indications, and discount rates.
  
  
  RESULTS
  Assuming increasing statin use over time (with a mean of 1.07 million new users per year) and a 3% discount rate, the cumulative incremental cost-effectiveness ratio (ICER) of atorvastatin versus simvastatin ranged from cost-savings at release to a maximum of $45,066/QALY after 6 years of generic simvastatin use in 2012. Over the full modeled life cycle (1997-2030), the cumulative ICER of atorvastatin was $20,331/QALY. The incremental value of atorvastatin to US payers (after subtracting costs) was estimated at $44.57 to $194.78 billion, depending on willingness to pay. Findings from the sensitivity analyses were similar. A hypothetical situation in which atorvastatin did not exist was associated with a reduction in total expenditures but also a loss of QALYs gained.
  
  
  CONCLUSIONS
  The cumulative ICER of atorvastatin varied across the product life cycle, increasing during the period between generic simvastatin entry and generic atorvastatin entry, and decreasing thereafter.
authors.affiliation: University of Maryland School of Pharmacy; Baltimore, Maryland, USA. mjgrabner@gmail.com
authors.forename: Michael
authors.initials: M
authors.lastname: Grabner
authors.forename: Wallace
authors.initials: W
authors.lastname: Johnson
authors.forename: Abdulla M
authors.initials: AM
authors.lastname: Abdulhalim
authors.forename: Andreas
authors.initials: A
authors.lastname: Kuznik
authors.forename: C Daniel
authors.initials: CD
authors.lastname: Mullins
mesh_terms: D000069059:Atorvastatin; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D003362:Cost-Benefit Analysis; D017723:Drug Utilization Review; D006538:Heptanoic Acids / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D018803:Models, Economic; D011758:Pyrroles / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D019057:Quality-Adjusted Life Years; D019821:Simvastatin / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D013997:Time Factors; D014481:United States
chemical_list: D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011758:Pyrroles; D000069059:Atorvastatin; D019821:Simvastatin