Patients who need PCSK9 inhibitors cant get them


Study: PCSK9 inhibitors are being rejected by insurers at very high rates even in high-risk patients like those with familial hypercholesterolemia.

Patients who need cholesterol-lowering therapy-PCSK9 inhibitors- are not being granted access to it, according to a novel data analysis published in the April 26th issue of Circulation. 

In a study sponsored by the Familial Hypercholesterolemia (FH) Foundation, 63% of patients with presumed FH and 58% with established atherosclerotic cardiovascular disease (ASCVD) had rejected insurance claims for FDA approved PCSK9 inhibitor therapies, effectively barring them from access to the new class of drugs shown to lower LDL cholesterol and reduce the risk of heart attacks. 


Lead investigator Joshua Knowles, MD, PhD, chief medical advisor to the FH Foundation, and colleagues examined clinical characteristics of patients prescribed PCSK9 inhibitors or another cholesterol-lowering medication (ezetimibe) and determined using claims adjudication data whether these were approved, rejected or abandoned. 

“PCSK9 inhibitors are being rejected at very high rates even in high-risk patients like those with familial hypercholesterolemia [genetically high cholesterol levels] or with prior ASCVD,” says Knowles, who is also attending physician in the Stanford Center for Inherited Cardiovascular Disease where he treats patients with FH.


According to Knowles, there were anecdotal reports from patients with FH and their providers that getting approval for these FDA-approved medications was very challenging. “We wanted to assess that more systematically,” he says.  

“This study demonstrates that patients who meet criteria for PCSK9 inhibitor treatment are having their claims rejected and that many of those that are approved take a long time-which may involve reviewing several appeals,” says Knowles. “These are patients at high risk for a cardiac event due to a genetic disorder, being prescribed a treatment that is FDA approved for their use and on the health plan formularies.”

The study suggests room for improvement in recognizing these patients in the prior authorization process in order to optimize their access to appropriate treatment for heart disease prevention, according to Knowles.

The drugs remain expensive and targeting them to the right patient at the right time is critical, says Knowles. 

“Education is important so that executives can understand which patients are at highest risk and therefore may benefit the most from these new therapies,” he says. “Putting ‘data to work’ within their own system to monitor not only that FH patients and ASCVD patients are being managed optimally. The FH Foundation would like to work with health plans to improve access to appropriate therapies for the high-risk FH population. We have already begun working with Express Scripts and United Healthcare and look forward to working with others in the interest of better patient outcomes.”



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