More than half of patients are denied approval for proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i), according to research published in the journal Circulation. And that’s true even though many appear to meet labeled indicators, the data shows.
“Although a combination of clinical characteristics increases the likelihood of approval, payer type is the most significant factor,” write Gregory Hess, of University of Pennsylvania and of Symphony Health, and colleagues.
PCSK9i are a “novel class of medications,” which help certain patients who need to lower lipid levels beyond that achieved by diet and statin drug use alone, the authors write. Those patients may have familial hypercholesterolemia, a genetic disorder which causes elevated levels of “bad” cholesterol called low-density lipoprotein (LDL) and which can lead to heart attacks at early age, or clinical atherosclerotic cardiovascular disease, which builds plaque in the arteries.
“Because of the drugs’ high cost, rates of prescription approval by payers may be low,” Hess and colleagues write. “We aimed to identify payer approval and rejection rates for PCSK9i prescriptions and the potential factors influencing these rates.”
The national study, to date the largest of which the authors are aware which studies payer approvals, draws upon data from 220 million patients in all 50 states from within 5,140 health plans. Prescriptions for PCSK9i were submitted for 51,422 of those patients, 9,357 of whom were studied. Just 47 percent of the more than 51,000 patients was approved by the payer.
Among the variables that tended to be associated with coverage approval were age (over 65 years), history of atherosclerotic cardiovascular disease, intolerance to statins, longer duration of statins, and non-commercial (nonprofit) payers.
Patients who had higher levels of LDL didn’t tend to necessarily be approved at higher rates, and commercial third-party payers were approved just 24.4 percent of the time, the lowest, compared to 60.9 percent for Medicare, the highest rate.
The PCSK9i drugs alirocumab and evolocumab have been shown to decrease low-density lipoprotein levels by up to 60 percent, and can lower risks for major cardiovascular threats, but they are “significantly” pricier than other therapies that lower lipids, with PCSK9i costing an average of $14,300 per year, the researchers write.
Those costs present a “significant challenge” to healthcare providers, who typically have to authorize the drugs prior to use, they add. “This process may raise additional barriers in the care of patients who would most benefit from additional LDL-C lowering with new therapies.”