Are Statins Cost-Effective for Primary Prevention?

There has been no shortage of headlines about the cost-effectiveness of statins in recent weeks, and another study was reported today in Journal of the American College of Cardiology. In a pharmacoeconomic model developed by Choudry and other researchers at Brigham and Women’s Hospital/Harvard Medical School using the JUPITER (Justification for the Use of statins in Prevention: An Intervention Trial Evaluating Rosuvastatin) trial, the authors project that the average JUPITER patient treated with rosuvastastin will have $7,900 higher life costs and an additional 0.31 quality-adjusted life years (QALYs), providing a cost-effectiveness ratio of $25,000/QALY. Against the widely used benchmark of $50,000/QALY, the authors conclude that statins appear to be cost-effective for primary prevention.

These results are somewhat contradictory to the recent Cochrane Collaboration review of statins in primary prevention, which recommended that statins be prescribed with caution to those at low risk of cardiovascular disease. The researchers reviewed data from 14 trials and nearly 35,000 patients. Although clinical benefits were found, the authors concluded that “ there was evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease. Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life.” The authors pointed out that all but one of the trials they reviewed were industry-sponsored and that you cannot simply extrapolate results from studies of people with history of heart disease to those without.

So why the differing conclusions about statin cost-effectiveness? In a commentary accompanying the latest study, Mark Hlatky, a physician and researcher at Stanford, provides some insights on the study. Hlatky points out that the model was only based on JUPITER and not the full breadth of evidence, which has NOT found large reductions in risk from the use of statins in primary prevention. Furthermore, the longer term risk reduction is simply unknown because clinical trials rarely last longer than 5 years. Choudhry assumed that rosuvastatin would reduce the risk of cardiac events by more than 50% for 15 years. If the same effect does not extend beyond 5 years, the cost-effectiveness grows to $62,100/QALY. The assumption of proportional risk reductions across levels of severity has been a limitation of many of the more recent cost-effectiveness analyses of statins.

There are additional questions about this and other recent studies of statins for primary prevention. Choudhry did not have data on long-term adverse effects, to which their model was quite sensitive. As Hlatky pointed out, if patients taking rosuvastatin had a 2% decrease in their well-being, the cost-effectiveness ratio grew to more than $62,000 per QALY. Also unclear is whether the model adjusted for medication persistency rates over the longer-term. Studies have shown that even after the first year of therapy, 50% of patients discontinue their statin medication, leading to increased short-term costs with little or no clinical benefit.

In hearing this latest information, many providers and plan sponsors are likely to point to diet and exercise changes as the solution to reducing the long-term risk of cardiovascular disease. Unfortunately, a recent Cochrane Collaboration review also found that education and counseling to encourage people to change their diets and stop smoking had little or no impact on deaths or disease caused by cardiovascular disease. An accompanying editorial pointed out that “Although various multiple prevention strategies exist, the most effective and cost-effective intervention for primary prevention in adults at low risk currently remains unclear.”

Do you know what percent of your current statin use is for primary prevention? Depending on the population, it could be as high as 50% of your statin users and may be growing.  If you are funding a wellness program to reduce the risk of cardiovascular disease, do you have any rigorous evidence that the program is leading to sustained changes in behavior?

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