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Rejections for PCSK9 inhibitors, ezetimibe common in high-risk patients
Patients with familial hypercholesterolemia or atherosclerotic CVD whose LDL has not been controlled with statin therapies had high rejection rates for prescriptions, according to a research letter in Circulation.
Joshua W. Knowles, MD, PhD, an assistant professor of cardiovascular medicine at Stanford University Medical Center and a Cardiology Today Next Gen Innovator, and colleagues analyzed data from 1,112,876 patients who filed a claim for a PSCK9 inhibitor or ezetimibe (Zetia, Merck) from March 2012 to June 2016 to evaluate the treatment patterns of patients with familial hypercholesterolemia. Rejection rates of patients with atherosclerotic CVD or familial hypercholesterolemia who were prescribed PSCK9 inhibitors — alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen) were also reviewed.
The researchers assigned patients to two cohorts: presumed familial hypercholesterolemia (n = 5,795) and atherosclerotic CVD (n = 415,133).
In the familial hypercholesterolemia group, 515 patients were prescribed PCSK9 inhibitors, 237 of whom had LDL > 190 mg/dL despite lipid-lowering therapies. More than half of claims for patients with high LDL on other lipid-lowering therapy (63.3%) were rejected.
Also in this group, 5,442 patients were prescribed ezetimibe, and of those, 2,573 had LDL > 190 mg/dL while on lipid-lowering therapies. Nine percent of prescription claims were rejected in patients with high LDL.
Those with atherosclerotic CVD were either prescribed PCSK9 inhibitors (n = 25,349) or ezetimibe (n = 399,603), of whom a small percentage had LDL > 100 mg/dL with lipid-lowering therapy (1,622 prescribed PCSK9 inhibitors; 27,246 prescribed ezetimibe). Prescription rejection rates were 57.5% in patients with high LDL who were recommended PSCK9 inhibitors and 8.2% in patients with high LDL who were recommended ezetimibe.
Of the PCSK9 inhibitor prescriptions that were ultimately approved, approval for 34% came within 30 days, while approval for 40% took more than 2 months, according to the researchers.
“These data highlight potential challenges in operationalizing the results of the FOURIER trial showing a significant reduction in [atherosclerotic] CVD outcomes with PCSK9 inhibition,” Knowles and colleagues wrote. – by Darlene Dobkowski
Disclosure: Knowles reports receiving research grants from the American Heart Association and Amgen. Please see the full study for a list of the other researchers’ relevant financial disclosures.