The proportions of patients projected to achieve the target cholesterol level were also reported. Direct costs The analysis of the costs was carried out from the perspective of the NHS. It included the costs of statins and the costs associated with the management of CHD and CVD events angina, acute coronary syndromes, stroke, transient ischaemic attack, chronic heart failure, peripheral vascular disease and CHD death.
The unit costs were not presented separately from the quantities of resources used as most costs were presented as macro-categories. Most of the costs and resource use data were derived from published studies, the majority of which used NHS reference costs. Given the long-term time horizon of the analysis, an annual discount rate of 3. Statistical analysis of costs The costs were assigned a gamma probabilistic distribution. Indirect Costs The indirect costs were not included in the economic analysis.
Currency UK pounds sterling. Sensitivity analysis A probabilistic sensitivity analysis was carried out to address the issue of uncertainty by assigning stochastic distributions to all model inputs.
Cost-effectiveness acceptability curves were generated to show the probability of each statin being cost-effective at different levels of society's willingness to pay for an additional QALY. A univariate sensitivity analysis was also performed to assess the impact on the cost-utility ratios of individual model inputs such as event costs, all-cause mortality, risk of events, proportion of lipid benefit, time horizon, starting age and discounting.
Estimated benefits used in the economic analysis The QALYs were incremental in comparison with no treatment. In men, the expected QALYs were 0. In women, the expected QALYs were 0.
Cost results The costs were incremental in comparison with no treatment. Synthesis of costs and benefits Incremental cost-utility ratios were calculated to combine the costs and benefits of the alternative strategies. The univariate sensitivity analysis showed that the model inputs with the greatest impact on cost-utility ratios were the baseline risk, time horizon and treatment efficacy.
However, the ranking among the alternative statins did not change. Authors' conclusions All statins represented cost-effective treatments in the primary prevention of coronary heart disease CHD in comparison with no treatment, but ROS was the most cost-effective from the perspective of the National Health Service NHS.
Our results may help to clarify some of these uncertainties and inform the ongoing evolution of lipid-lowering treatment guidelines. Others contend that clinical trials with principled monitoring plans yield valid estimates of treatment effects Because of the uncertainly surrounding this influential model parameter, we repeated our analyses using more conservative assumptions of treatment effects and found incremental cost-effectiveness ratios that remain below typical willingness-to-pay thresholds.
Only 1 prior estimate of the cost-effectiveness of statin treatment for patients with elevated hs-CRP has been published The study relied on statin treatment effects derived from post hoc analyses, which found smaller reductions in the risk of stroke from statins than was observed in JUPITER and did not consider other important pre-specified outcomes, such as venous thromboembolism or diabetes. Sensitivity analyses altering the model assumptions to be more similar to those that we used yielded results that are very consistent with ours.
As expected, rosuvastatin treatment for patients with an elevated hs-CRP level becomes more cost-effective as the price of rosuvastatin is lowered. This price is similar to that of simvastatin and is more than those of pravastatin and lovastatin, which are both widely available in the U. Even if other statins were less effective than rosuvastatin, our analysis suggests their use could still be cost-effective, if not cost-saving, because of their much lower cost.
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.
Statins are some of the most studied prescription drugs due to their widespread use. The evidence from both clinical trials and observational studies suggests that appropriate use of statins can avert heart disease and stroke, and, if one already has these ailments, can reduce the risk of premature mortality from these conditions. 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. The United Kingdom introduced OTC simvastatin in , and a study examining this experience found that simvastatin use increased significantly following the introduction of the OTC version. Model inputs are described in Table 1. Below, we outline the source for each input parameter.
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