A cost-effectiveness analysis of over-the-counter statins.

OBJECTIVES

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

STUDY DESIGN

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

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.