Many U.S. patients prescribed PCSK9 inhibitors to lower their low-density lipoprotein cholesterol (LDL-C) levels are being denied coverage by their insurance providers, according to new research published in Circulation: Cardiovascular Quality and Outcomes.[1]
While PCSK9 inhibitors were originally approved to lower LDL-C in patients with atherosclerotic cardiovascular disease (ASCVD) or familiar hypercholesterolemia, that indication expanded in 2017 to cover primary hypercholesterolemia as well. Also, while these cholesterol-lowering drugs were associated with high healthcare costs at first, vendors started reducing those costs by as much as 60% in 2018 and 2019.
To track the potential impact of these changes on utilization, the study’s authors explored data from more than 700,000 patients prescribed evolocumab or alirocumab from 2015 to 2021.
The study’s authors were all representatives of the Family Heart Foundation (FHF), a nonprofit group focused on using “research, advocacy and education” to improve patient access to high-quality cardiovascular care. A prior FHF study from 2019 underlined the fact that rejected claims for these medications are directly associated with a greater risk of experiencing an adverse cardiovascular outcome.[2]
Overall, 45.86% of insurance claims for new evolocumab or alirocumab prescriptions were rejected from 2015 to 2018. That number dropped to 30.95% from 2019 to 2021, though the researchers argued that this is still much too high.
“The results from this new FHF study suggest that patients still experience substantial challenges getting the PCSK9 that have been prescribed for them by their medical team, despite guidelines recommending their use and extensive evidence documenting their role in LDL-C reduction and the prevention of heart attack or stroke,” co-author Diane E. MacDougall, MS, vice president of science and research for the FHF, said in a statement. “As a result, eligible patients remain at higher risk of heart attacks and other major cardiovascular events as demonstrated by the 2019 study.”
The group also found that the proportion of prescriptions being abandoned remained unchanged from 2015-2018 to 2019-2021. In addition, the rates of both rejected prescriptions and abandoned prescriptions were consistently much higher for PCSK9 inhibitors than they are for apixaban, sacubitril/valsartan, dapagliflozin, empagliflozin and liraglutide.
“This real-world evidence demonstrates persistent barriers to guideline-recommended LDL-C management, perpetuating the societal burden of ASCVD,” the authors concluded.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.