Statins Not Cost-Effective for Many Newly Eligible Patients

Marlene Busko

June 15, 2014

Prescribing statins for primary prevention of cardiovascular disease (CVD) according to the new American College of Cardiology (ACC)/American Heart Association (AHA) guidelines would provide a limited benefit for additional cost, especially in low-risk individuals who would be newly eligible for statins, among them some diabetes patients, researchers predict.

The estimate is that with the new guidelines, "18 to 19 million Americans who were not eligible for statin use now are considered eligible," lead author Xiaohui Zhuo, PhD, from the Centers for Disease Control and Prevention, in Atlanta, Georgia, told the American Diabetes Association (ADA) 2014 Scientific Sessions.

The main take-away message is that "statin use is not cost-effective in a significant proportion of the target populations, as recommended in the new guidelines," including people with a cardiovascular disease risk of 7.5% to 10%, regardless of diabetes status, he said.

"We're at the ADA. Should we listen to the ADA goals, or should we go with the AHA/ACC recommendations?" a member of the audience asked. "What should we do starting tomorrow?"

Dr. Zhuo replied that as a health economist and not a clinician, he could not answer this question.

Session moderator Elbert S. Huang, MD, from the University of Chicago, told Medscape Medical News that many unanswered questions remain.

Drastic Change, Uncertain Risks to Benefits

In his introduction, Dr. Zhuo said the guidelines are a "drastic change from the previous ATP3 guidelines [and] stirred up quite a controversy."

However, "the health benefits of statin use among a low-risk population without diabetes [in particular] still carries a lot of uncertainty," especially since these patients have poor medication adherence, and statin use is linked with increased risk for type 2 diabetes and complications such as myopathies.

To investigate the cost-effectiveness of statin therapy with the new guidelines, the researchers looked at 2 of the 4 groups of patients who were singled out in the recommendations:

  • Group 3: Individuals with diabetes aged 40 to 75 years old with LDL-cholesterol levels between 70 and 189 mg/dL and no evidence of atherosclerotic CVD.

  • Group 4: Individuals with no evidence of atherosclerotic CVD or diabetes but with LDL-cholesterol levels between 70 and 189 mg/dL and a 10-year risk for atherosclerotic CVD >7.5%.

They developed a simulation model that took a nationally representative sample of Americans from the 2005–2010 National Health and Nutrition Examination Survey (NHANES) and estimated the lifetime risk for atherosclerotic CVD and diabetes as well as cost per quality-adjusted life-year (QALY) that would be gained by following the AHA/ACC lipid-lowering treatment recommendations.

Using the $50,000-per-QALY benchmark, intensive statin use was cost-effective in diabetic patients if their CVD risk was greater than 10%, while moderate statin use was not cost-effective if CVD risk was between 7.5% and 10%.

In nondiabetic adults, moderate statin use was cost-effective if their CVD risk was above10%, but was not cost-effective otherwise, particularly in people with prediabetes.

Questions Remain, Lower-Risk Group Has Least Benefit

Following the session, Dr. Huang told Medscape Medical News that the talk revealed that of the 4 groups identified as candidates for preventive statin therapy, treating patients in group 3 (who were 40 to 75 years old, with diabetes but no evidence of CVD) would be the least cost-effective.

"This shouldn't be that surprising," he observed. "The risk of cardiovascular events in this group is by definition lower, so the benefits of statin use are smaller and the costs/benefits are going to be higher."

Questions remain, nevertheless, he said. "Prior guidelines used different LDL-cholesterol cut points to make decisions about statin use, which were also controversial," he said. For example, it was previously unclear whether the cut point should be less than 100 mg/dL or less than 70 mg/dL, and the recommendations were not really based on solid evidence.

"I think that the use of baseline cardiovascular risk to determine when to treat makes more sense, but we are still going to have to make decisions about what risk cut points to use," he said.

Dr. Zhuo has reported no relevant financial relationships.

American Diabetes Association 2014 Scientific Sessions; June 13, 2014. Abstract 17-OR

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