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The American Journal of Managed Care May 2016
Greater Potential Cost Savings With Biosimilar Use
Benjamin Yu, PharmD
Implementing a Hybrid Approach to Select Patients for Care Management: Variations Across Practices
Christine Vogeli, PhD; Jenna Spirt, MPH; Richard Brand, PhD; John Hsu, MD, MPH; Namita Mohta, MD; Clemens Hong, MD, MPH; Eric Weil, MD; and Timothy G. Ferris, MD, MPH
Medicaid Managed Care Penetration and Drug Utilization for Patients With Serious Mental Illness
Aaron L. Schwartz, PhD; Jacqueline Pesa, PhD, MPH; Dilesh Doshi, PharmD; John Fastenau, PhD, MPH; Seth A. Seabury, PhD; Eric T. Roberts, PhD; and David C. Grabowski, PhD
Clinical Interventions Addressing Nonmedical Health Determinants in Medicaid Managed Care
Laura M. Gottlieb, MD, MPH; Kim Garcia, MPH; Holly Wing, MA; and Rishi Manchanda, MD, MPH
Physician Perceptions of Choosing Wisely and Drivers of Overuse
Carrie H. Colla, PhD; Elizabeth A. Kinsella, BA; Nancy E. Morden, MD, MPH; David J. Meyers, MPH; Meredith B. Rosenthal, PhD; and Thomas D. Sequist, MD, MPH
Potential of Risk-Based Population Guidelines to Reduce Cardiovascular Risk in a Large Integrated Health System
Galina Inzhakova, MPH; Hui Zhou, PhD, MS; Macdonald Morris, PhD; Megan I. Early, MD, MPH; Anny H. Xiang, PhD; Steven J. Jacobsen, MD, PhD; and Stephen F. Derose, MD, MSHS
Enhanced Primary Care and Impact on Quality of Care in Massachusetts
Asaf Bitton, MD, MPH; Amy W. Baughman, MD, MPH; Sara Carlini, BA; Joel S. Weissman, PhD; and David W. Bates, MD, MSc
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G. Thomas Ray, MBA; Jeanne Mandelblatt, MD; Laurel A. Habel, PhD; Scott Ramsey, MD, PhD; Lawrence H. Kushi, ScD; Yan Li, MD; and Tracy A. Lieu, MD, MPH
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A Cost-Effectiveness Analysis of Over-the-Counter Statins
Christopher Stomberg, PhD; Margaret Albaugh, MA; Saul Shiffman, PhD; and Neeraj Sood, PhD

A Cost-Effectiveness Analysis of Over-the-Counter Statins

Christopher Stomberg, PhD; Margaret Albaugh, MA; Saul Shiffman, PhD; and Neeraj Sood, PhD
This paper estimates the costs and benefits of over-the-counter (OTC) statins using data on statin use and cardiovascular risk, clinical studies of statin safety and efficacy, and an OTC statin use trial.
A 2010 meta-analysis of statin trials is used to estimate the reduction in risk—dependent on initial risk category—of MCE, stroke, coronary revascularization, and CHD death associated with statin treatment.2 These estimates were reduced to account for suboptimal adherence outside of the clinical trial setting and then applied to the group of previously untreated individuals that initiate OTC statin therapy and are assumed to benefit from statins. The model conservatively assumes that individuals who initiate OTC statin therapy but do not meet the guidelines receive no benefit from statin therapy. To the extent that these individuals receive any benefits, the model understates the overall cost-effectiveness of the introduction of OTC statins. The same meta-analysis also provides estimates of the differences in risk associated with low- versus high-dose statin treatment. We applied these estimates to the individuals who substitute low-dose OTC statin therapy for high-dose prescription statin treatment. The findings of this meta-analysis are corroborated by other studies and meta-analyses.41-47

Adverse Events

The rate of AEs for OTC statin users was derived from a published estimate of the increase in rhabdomyolysis under statin therapy48— a very rare but severe side effect of statins—and the rate of rhabdomyolysis mortality was derived from a separate study that investigated the effects of statin therapy.49 The model applies these rates to all previously untreated statin users and it conservatively assumes that individuals who switch to OTC statins from high-dose prescription statins experience no reduction in AEs.

A recent FDA bulletin suggested that statin use may be associated with cognitive impairment and an increased risk of raised blood sugars and the development of type 2 diabetes.50 However, the published literature provides no definitive evidence that statin users have an increased risk of these conditions relative to the general population.51 Therefore, the model does not incorporate these potential AEs.

Additionally, some prior research has found an increased risk of hemorrhagic stroke with statin use.52 The impact of this AE is a component of our measure of risk reduction for stroke overall. Other potential AEs, such as muscle pain, are accounted for through quality-adjusted life-year (QALY) measures, discussed below.


The estimated change in QALYs due to adopting OTC statin therapy is derived from a study by the Heart Protection Study Collaborative Group, which applied results from a large UK clinical trial to determine the cost-effectiveness of prescription statin therapy for patients in the United States at different vascular risk levels.53 The lifetime QALY change reported in that study is converted to a 10-year figure, then applied to the previously untreated individuals who meet the guidelines for statin benefit and adopt OTC statin treatment.54 No QALY benefits were assumed for individuals who initiate statin therapy but do not meet the guidelines. The estimated QALY loss for individuals switching from high-dose prescription statins to low-dose OTC treatment was derived from a study comparing the cost-effectiveness of high- versus low-dose prescription statin treatment for high-risk individuals.51

Sensitivity Analysis

Monte Carlo simulation was used (100,000 draws) to measure the sensitivity of the results to adjustments in model parameters. Table 1 lists the standard deviation or range used to vary each parameter in the simulation.

OTC Statin Users

We estimate that of the 46.1 million patients who meet statin guidelines and are not taking prescription statins, about 7.3 million patients (15.8%) will initiate treatment with OTC statins (see eAppendix Table 2, which also breaks out these data by MCE risk group). Additionally, we estimate that of the 136.4 million individuals who do not meet statin guidelines and are not taking prescription statins, about 1.5 million (1.1%) will initiate treatment with OTC statins. Finally, we estimate that of the 32.5 million patients taking prescription statins, approximately 1.3 million (4.0%) will switch to OTC statins. Overall, these estimates imply that availability of OTC statins will increase the number of individuals using statins by 10.1 million (a 27.0% increase), and 85% of new OTC statin users will benefit from statin treatment.

Benefits and Costs

Table 2 summarizes the results of the model. Overall, we estimate that OTC statin conversion would result in 293,492 fewer MVEs (252,359 MCEs; 41,133 strokes), and 135,299 fewer coronary revascularization procedures over 10 years. These averted events would save more than $10.8 billion in healthcare costs. Moreover, OTC statin conversion would reduce CHD- and stroke-related deaths by 68,534 over the same time frame. Increased statin utilization is estimated to cause 3864 more cases of rhabdomyolysis, of which, 479 are estimated to result in death. Overall, OTC statin conversion would avert 68,055 deaths. The eAppendix Figure illustrates the range of this estimate based on Monte Carlo simulation (see eAppendix Table 3 for detailed results). Total costs to the health system would increase by approximately $12.6 billion—less than $200,000 per death averted.


Group 1: Previously Untreated Patients Who Meet Statin Guidelines.
We estimate that OTC statin use by the 7.3 million patients who were previously untreated but meet statin benefit guidelines will result in 451,700 fewer MVEs and 70,291 fewer deaths over a 10-year horizon. However, initiation of OTC statin use by these patients may also result in 3198 cases of rhabdomyolysis. Overall, we estimate that OTC statins will increase healthcare costs by $14.5 billion over a 10-year period ($12.2 billion assuming no change in monitoring costs), due largely to the cost of the OTC drug.

Group 2: Previously Untreated Patients Who Do Not Meet Statin Guidelines. We assume that OTC statin use by the 1.5 million patients who were previously untreated and do not meet statin guidelines yields no health benefits but we estimate it may result in 666 additional cases of rhabdomyolysis. OTC statin use by this group also results in increased expenditures on statins and associated monitoring and physician visit costs (including time costs) totaling $5.4 billion over a 10-year period, or $4.9 billion, assuming no change in monitoring costs.

Group 3: Previous Prescription Statin Users Who Take Up OTC Statin Treatment. We estimate that OTC statin use by the 538,016 patients who switch from high-dose prescription statins to low-dose OTC statins will result in 22,909 more MVEs and 2154 more deaths over a 10-year horizon. The added MVEs increase costs by $499.6 million. We also estimate that the switch from prescription to OTC statins (for all patients who switch) will result in a $1.2-billion increase in expenditures on statins, as we believe that OTC statins would be more expensive than (generally generic) prescription statins. However, the switch from prescription to OTC statins would reduce physician office visit costs by $9.0 billion (including time costs) over a 10-year horizon. Thus, switching from prescription to OTC statins will result in overall cost savings of $7.8 billion over a 10-year horizon.


Cost-Effectiveness Analysis

Overall, we estimate that the introduction of OTC statins would result in an additional 2,216,157 QALYs at a net cost of $12.6 billion, resulting in an incremental cost-effectiveness ratio (ICER) of $5667 per QALY (or an ICER of $4421 per QALY, assuming no change in cholesterol monitoring costs). In our Monte Carlo simulations, 95% of the calculated ICERs were either cost-saving or less than $23,012, and never above the $50,000 threshold (Figure 1). An important driver of cost-effectiveness is the fraction of OTC statin users who do not meet benefit guidelines. Figure 2 shows that the ICER increases as this fraction increases, but does not rise above $50,000 until this percentage is approximately 72%. In addition, because cheaper options of prescription statins are becoming available, we examined the impact of the prescription statin costs on the cost-effectiveness of OTC conversion. As shown in Figure 3, the estimated ICER does not increase beyond approximately $7000, even as the estimate of prescription statin costs are reduced toward $0.


This study used nationally representative data and evidence from clinical studies to estimate the benefits and costs of OTC statins. We found that the benefits of OTC availability of statins well exceed the costs and are a highly cost-effective option for improving population health. These results are robust to alternative assumptions about model parameters.


One inherent limitation of this analysis is our understanding of the extent to which consumers will use statins appropriately in an OTC setting. Based on past studies, we estimated that 15% of OTC statin users would not meet guidelines for statin use. The results of this study are sensitive to this estimate. We nevertheless demonstrated that even if this rate was as high as 72%, the ICER for OTC statins remains below the $50,000 threshold.

In addition, we did not separate changes in costs by payer. Changes in total cost experienced by patients or insurers could vary substantially depending on insurance cost-sharing provisions for prescription drugs, office visits, and major medical events. Understanding who bears those costs (and when) would require modeling insurance coverage, but it would also improve our understanding of the incentives of various parties and how they might alter behavior.

Another limitation is that we did not model differences in compliance rates between OTC and prescription settings, and so it is not clear whether OTC access would increase or decrease compliance. This would require more explicit modeling of the time dimension than can be incorporated in the current model; a Markov Chain simulation framework would be one potential approach for modeling these differences.

Finally, we also did not consider the impact of OTC statin availability on statin treatment alternatives. For example, the availability of OTC statins may encourage some consumers to avoid lifestyle changes such as diet and exercise. The extent to which taking statins induces changes in lifestyle is, however, not well understood, although the CUSTOM study found a slight increase in healthy diet and physical activity in an OTC setting.55 The OTC availability of statins could also result in fewer opportunities for doctors to manage their patients’ cardiovascular health, which is likely to adversely affect patient health—particularly for high-risk consumers—but this is also not well understood. These questions underscore the importance of educating consumers at risk for heart disease about adopting a healthy lifestyle and seeking medical advice.

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