title: Cost-effectiveness of statins revisited: lessons learned about the value of innovation.
abstract: BACKGROUND
  The economic evaluation of statins has undergone a development from risk-factor-based models to modeling of hard end points in clinical trials with a shift back to risk-factor models after increased confidence in their predictive power has now been established. At this point, we can look back on the historical economic data on simvastatin to see what lesson regarding reimbursement we can learn.
  
  
  METHODS
  Historical data on the usage and sales of simvastatin in Sweden were combined with published epidemiological and clinical data to calculate the social value of simvastatin to the present day and to make projection until projected until 2018. The distribution of the social surplus was calculated by taking the costs born by society and the producer of the drug into consideration.
  
  
  RESULTS
  The cost of simvastatin fell drastically following patent expiration, although the number of treated patients has continued to grow. Presently, the use of simvastatin is close to cost neutrality taking direct and indirect cost savings from reduced morbidity into account. However, the major part of the social surplus generated comes from the value of improved quality-adjusted survival. Of the social surplus generated, the producer appropriated 20-43% of the value during the on-patent period, a figure dropping to 1% following loss of exclusivity. The total producer surplus between 1987 and 2018 is 2-5% of the total social surplus.
  
  
  CONCLUSIONS
  Only a small part of the surplus value generated was appropriated by the producer. A regulatory and reimbursement approach that favors early market access and coverage with evidence development as opposed to long-term trials as a pre-requisite for launch is more attractive from both a company and social perspective.
authors.affiliation: Innovus, Stockholm, Sweden and Division of Cardiovascular Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Klarabergsviadukten 90 D, Stockholm, Sweden. peter.lindgren@innovus.com
authors.forename: Peter
authors.initials: P
authors.lastname: Lindgren
authors.forename: Bengt
authors.initials: B
authors.lastname: Jönsson
mesh_terms: D002318:Cardiovascular Diseases / Q000517:prevention & control; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D017048:Health Care Costs / Q000706:statistics & numerical data; D006291:Health Policy; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000191:economics* / Q000627:therapeutic use; D006949:Hyperlipidemias / Q000188:drug therapy* / Q000191:economics / Q000401:mortality; D019057:Quality-Adjusted Life Years; D012307:Risk Factors; D019821:Simvastatin / Q000191:economics* / Q000627:therapeutic use; D013548:Sweden
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D019821:Simvastatin