The American Journal of Managed Care May 2016
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.
Am J Manag Care. 2016;22(5):e294-e303
- Statins are one of the most successful classes of prescription drugs, but regulators in the United States have not yet approved them for OTC use.
- This paper adds to the economic literature by estimating the impact of the introduction of an OTC statin on statin use, healthcare costs, population health, and mortality.
- This paper shows that, 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.
Despite this evidence, prior research shows that some people who would benefit from statins are not currently taking them. Based on the 2013 guidelines for the management of cholesterol jointly issued by the American College of Cardiology (ACC) and the American Heart Association (AHA), only 45% of adults meeting today’s statin treatment criteria are currently using statins.4 Moreover, despite the availability of relatively inexpensive generic statins, total low-density lipoprotein cholesterol (LDL-C) levels in the United States—which were in constant decline prior to 2008—have stopped declining.5 Increasing access to statins among the statin-eligible population not currently taking them could improve population health.
One way to increase access is to make drugs available over the counter (OTC). OTC drugs do not require a physician prescription and are available through more outlets, thereby promoting greater use. A recent study examining OTC conversions in several therapeutic drug classes in the United States found that classwide utilization increases by 27% on average.6 The idea of making statins available without a prescription is not new, however. The United Kingdom introduced OTC simvastatin in 2004, and a study examining this experience found that simvastatin use increased significantly following the introduction of the OTC version.7 Nevertheless, past attempts to introduce OTC statins in the United States have not received regulatory approval.8
The main arguments against OTC statins are: 1) consumers who do not meet guidelines for statin therapy might use statins, thereby exposing them to very rare but serious AEs, such as rhabdomyolysis, possibly without a countervailing benefit; 2) some high-risk patients for whom high-dose statin therapy is recommended might switch to a lower-dose OTC version, resulting in less-than-optimal risk reduction; and 3) consumers with contraindications (eg, other medications, pregnancy) might use statins inappropriately.9,10 The primary argument for OTC statins is improved access to statin treatment, leading to improved population health and healthcare cost savings from reduced cardiovascular events.11 The key question is whether the net benefits of broader access to statins outweigh the risk of inappropriate use.
One prior study based on data from the Consumer Use Study of Over-the-Counter Lovastatin (CUSTOM) trial predicted that OTC statins could avert 23,000 to 33,000 coronary heart disease (CHD) events per 1 million users over 10 years.12,13 However, no prior studies have evaluated both the benefit-cost tradeoff of OTC statins and their public health effects in the United States. This paper addresses these questions and adds to the literature by evaluating costs and benefits of OTC statins versus the status quo with no OTC statins under the 2013 ACC/AHA guidelines.14
The model divides the US noninstitutionalized population over the age of 20 into 3 groups: 1) Group 1—Individuals not currently taking prescription statins who are in Class I or Class IIA, for whom the benefits of treatment exceed the risks and for whom statins are recommended or may be reasonable, according to the 2013 ACC/AHA statin guidelines13; 2) Group 2—Individuals not currently taking prescription statins who are not in Class I or Class IIA according to the 2013 ACC/AHA statin guidelines13; and 3) Group 3—Individuals currently taking prescription statins.
Data from the 2007 to 2008 National Health and Nutrition Examination Survey (NHANES) were used to identify statin users and to determine which nonstatin users would benefit from statins based on ACC/AHA guidelines and the related risk-scoring algorithm.15-23 We assumed that individuals would benefit from statins if the guidelines state that treatment “should” be initiated or “it is reasonable” to initiate treatment. The population was further divided into low-, moderate-, and high-risk groups based on the 10-year risk of major coronary events (MCEs) by using the Framingham score (MCE combines myocardial infarctions and CHD deaths). These 3 groups had a 10-year risk of less than 10%, between 10% and 20%, and greater than 20%, respectively. eAppendix Table 1 [eAppendices available at www.ajmc.com] shows estimates of the population in each of these groups. The Framingham score was not used to determine eligibility for benefit from statins, but rather to enable the use of the wide range of literature that uses Framingham scores.
A recent study found that classwide utilization increases by 27%, on average, when an OTC therapy is introduced.6 This figure was used to estimate the rate at which previously untreated individuals would initiate OTC statin therapy, because class-level growth is likely due to new adoption. Because statins treat an asymptomatic disease and uptake may differ from previous OTC conversions, we included a range of utilization increases in our sensitivity analysis, described below.
The percentage of OTC users who substituted OTC for prescription treatment was derived from publicly available data from a self-selection study estimating consumer use of OTC statins (SELECT).24,25 In particular, the SELECT study found that approximately 13% of potential OTC adopters were using prescription cholesterol-lowering medication. We assumed that these individuals would experience reduced health benefits if they switched from high-dose prescription to low-dose OTC statin therapy. We estimated this population by using the fraction of statin users taking high-dose statins (41%) based on the 2011 Medical Expenditure Panel Survey (MEPS).26 Therefore, we estimated that 5% of OTC statin users switch from high-dose prescription statins.
The percentage of OTC users who would not benefit from statin treatment was derived in a similar manner. In particular, approximately 15% of potential OTC adopters in the SELECT study had LDL-C concentrations below 130. We use this as a proxy for the group that would not experience benefits but would experience the cost and the risks associated with statin use.
Costs are measured at the overall healthcare system level, regardless of the party ultimately responsible for bearing the cost. Future costs are discounted by 1% per year (the 10-year real discount rate published by the Office of Management and Budget). However, this is offset by the medical care inflation rate, which exceeds the general inflation rate used by OMB by approximately 1%.27 All cost estimates have been converted to 2014 dollars by using the real discount rate, adjusted for the medical care inflation rate.
The model uses IMS data (IMS Health, Danbury, CT) and the CMS’ National Average Retail Prices (NARP) data to estimate the cost of OTC statins ($25.42/30 days).28,29 We first used IMS data to estimate the relationship between the price of a branded prescription drug and its OTC counterpart at OTC launch by using the example of OTC Prilosec (15%). Because brand prices change after generic entry, this ratio is applied to the average branded statin prescription cost reported in the NARP data prior to the generic launch ($5.65 per pill based on the average of Lipitor  and Crestor ). The model also uses the NARP data to estimate the average cost of prescription statins. A range of OTC statin costs are used in the sensitivity analysis described below.
The model assumes that OTC statin users also initiate cholesterol monitoring, as might be directed by OTC labeling. We used 2011 MEPS data to estimate the share of the population currently receiving cholesterol tests. The cost of a cholesterol test was estimated by using public information from CVS and Walgreens ($60 per year).30,31 The model assumes no change in monitoring costs for those switching from prescription to OTC statins because cholesterol testing is expected for both prescription and OTC patients. Additionally, because the 2013 ACC/AHA statin guidelines13 do not have a cholesterol target that would be monitored via testing, we include a sensitivity that does not incorporate changes in monitoring costs.
The number of physician visits associated with certain conditions has been found to fall when OTC treatments are made available.32 We estimated that prescription statin users have an average of 3.5 statin-related physician visits per year based on National Medical Ambulatory Care Survey (NAMCS) data and NHANES data14,33; prescription statin users who switch to OTC therapy are assumed to drop to just 1 annual visit. Previously untreated patients are assumed to increase physician office visits to monitor statin therapy based on the CUSTOM study, which notes that 57% of users interacted with a physician during the course of the study.11 The cost for each physician visit in the current study was estimated by using MEPS data.17 Additionally, we estimated the time costs resulting from the changes in physician visits using employment and wage data from the Bureau of Labor Statistics.34,35
The 1-year cost of MCEs and associated complications ($36,700) is based on a retrospective claims analysis of the costs of acute coronary syndrome and is corroborated by 2 other studies that estimate MCE costs.36-38 The 1-year cost of stroke and associated complications ($37,500) is based on a literature review of studies measuring the cost of stroke in the United States and is also corroborated by 2 other studies.38-40 The model does not separately consider the costs of coronary revascularization because the MCE cost estimate includes them for some patients. Because the model predicts a decline in revascularization events, this choice is conservative. Finally, the cost of AEs is derived from a study that used the cost of hospitalization for rhabdomyolysis to estimate a per-subject per-year cost of AEs caused by statin treatment (an average of $5.95 per statin user).37
Health and Mortality Outcomes