Study Looks at Coverage of Non-Statins Following Publication of Cholesterol Guidelines

Analysis exploring Medicare formulary changes following the publication of the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults found that, although the cholesterol guideline was originally associated with more restrictive formulary coverage of non-statin lipid-lowering medications, many formularies continue to provide unrestrictive coverage. The research letter was published Jan. 9 in the Journal of the American College of Cardiology.

The analysis, led by Sanket S. Dhruva, MD, FACC, used Prescription Drug Plan Formulary Files from the U.S. Centers for Medicare and Medicaid Services to compare coverage in the second quarters of 2013 (pre-guideline) and 2015 (post-guideline) for the lowest guideline-recommended dose supported by randomized controlled trial data of each available moderate- and high-intensity statin, niacin, niacin/statin combinations, fibrates, ezetimibe, ezetimibe/simvastatin combination and bile acid sequestrants.

Results showed that more than 98 percent of Medicare formularies provided unrestrictive coverage of at least one moderate-intensity statin and at least one high-intensity statin, before and after publication of the cholesterol guideline. Atorvastatin, available as both moderate- and high-intensity formulations, was widely covered pre- and post-guideline; statins available only as moderate-intensity, but not high-intensity, were more often restricted.

The authors explain that although there was an association with increased restrictiveness for non-statin lipid-lowering medications after publication of the guideline, the changes were inconsistent, and many formularies continued to provide high rates of unrestrictive coverage without first requiring use of a statin. Furthermore, formularies that restricted access to non-statin lipid-lowering medications did so by discontinuing coverage or increasing the cost-sharing tier, which imposes greater out-of-pocket costs on patients prescribed second-line drugs for dyslipidemia.

According to authors, the analysis faced some limitations. “We only examined Medicare formularies; our results may not be generalizable to private plan formularies. In addition, we did not examine actual prescribing, only formulary coverage,” they said. “Finally, our study cannot establish causation; other factors, such as results from landmark trials published after the guideline, may also have influenced formulary coverage.” 


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