January 22, 2017
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Some Medicare formularies changed coverage for lipid-lowering therapies after ACC/AHA cholesterol guideline

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After publication of the 2013 American College of Cardiology/American Heart Association cholesterol guideline, some Medicare formularies made coverage for statin and nonstatin lipid-lowering medications more restrictive, according to a research letter published in the Journal of American College of Cardiology.

The guideline encouraged statin use for four high-risk groups and did not recommend nonstatin therapies as strongly. Sanket S. Dhruva, MD, from the Robert Wood Johnson Foundation Clinical Scholars Program, Yale University School of Medicine, and colleagues assessed Medicare formulary coverages for statin and nonstatin lipid-lowering therapies before and after publication of the guideline.

They compared coverage in the second quarters of 2013, before the guideline was published, and 2015, after it had been published for more than a year, for the lowest guideline-recommended dose supported by randomized controlled trial data of each available moderate- and high-intensity statin, niacin, combinations of niacin and statin therapies, fibrates, ezetimibe (Zetia, Merck), combined ezetimibe/simvastatin therapy (Vytorin, Merck) and bile acid sequestrants.

The researchers first determined if a formulary provided coverage, and then determined restrictiveness among those providing coverage. Restrictiveness was assessed by assignment to cost-sharing level tier 3 or higher, prior authorization requirement and step therapy requirement.

In the second quarter of 2013, 100% of 314 formularies had unrestrictive coverage of at least one moderate-intensity statin, while in the second quarter of 2015, 98.2% of 389 formularies did (P = .02), according to the researchers. The rate of unrestrictive coverage of at least one high-intensity statin was 98.1% in 2013 and 97.2% in 2015 (P = .47).

Among nonstatin medications, Medicare formulary coverage became more restrictive for brand-name niacin (Niaspan, AbbVie; P < .001), niacin/simvastatin (Simcor, AbbVie, P < .001), extended-release niacin/lovastatin (Advicor, AbbVie; P < .001), fenofibrate (P < .001), gemfibrozil (P = .046), cholestyramine light packet (P = .008) and colestipol (P < .001), according to the researchers.

“Although there was an association with increased restrictiveness for nonstatin lipid-lowering medications after publication of the guideline, the changes were inconsistent, and many formularies continued to provide high rates of unrestrictive coverage without requiring step therapy,” the researchers wrote. “Furthermore, formularies that restricted access to nonstatin 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.” – by Dave Quaile

Disclosure: Two researchers report financial ties with the Blue Cross Blue Shield Association, Johnson & Johnson and Medtronic.