A cost-effectiveness analysis of over-the-counter statins.
To estimate the costs and benefits of over-the-counter (OTC) statins under the 2013 American College of Cardiology/American Heart Association guidelines.



A 10-year cost-effectiveness model using a health system perspective was developed to analyze the impact of making an OTC statin drug available.



We calibrated the model by using nationally representative survey data on statin use and cardiovascular risk, data from clinical studies on the safety and efficacy of statins, and data from a study on consumer decisions to use an OTC statin.



We estimated that OTC statins would result in 252,359 fewer major coronary events, 41,133 fewer strokes, and 135,299 fewer coronary revascularization procedures over 10 years, as well as reduce coronary heart disease- and stroke-related deaths by 68,534 over the same time frame. These averted events would save more than $10.8 billion in healthcare costs while the costs of drug therapy would increase by $28.3 billion. Increased statin utilization is estimated to cause 3864 more cases of rhabdomyolysis-a very rare but severe side effect of statins. The estimated incremental cost-effectiveness ratio (ICER) of OTC statins was $5667 per quality-adjusted life-year, and the 95% CI of the ICER was $1384 to $12,701.



With proper labeling and consumer education, it is highly likely that OTC statins would be cost-effective, as they significantly improve population health without large increases in healthcare costs.
Christopher
C
Stomberg
Margaret
M
Albaugh
Saul
S
Shiffman
University of Southern California, Sol Price School of Public Policy and Schaeffer Center for Health Policy and Economics, University Park Campus, Los Angeles, CA, USA 90089. E-mail: nsood@healthpolicy.usc.edu.
Neeraj
N
Sood
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000188:drug therapy* / Q000191:economics*; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000191:economics* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D004366:Nonprescription Drugs / Q000191:economics* / Q000627:therapeutic use*; D014481:United States
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D004366:Nonprescription Drugs