A study in JAMA Cardiology points out that fewer than a third of adults prescribed the drugs actually were able to get them due to high out-of-pocket costs and/or lack of insurance approval.
Alirocumab and evolocumab have been approved since 2015 for adults who have persistently elevated low-density lipoprotein cholesterol (LDL-C) levels despite maximally tolerated statin therapy, and for those with familial high cholesterol.
The problem has been high costs of PCSK9 inhibitors (PCSK9i). On the retail market, the price can reach $14,000 per year, leading to requirements for prior authorization and patient therapy copays.
Researchers from Duke Clinical Research Institute and colleagues sought to determine how those limitations affected drug access in community practice.
“While these strategies have contained costs, our analysis suggests that these practices may be a blunt instrument to identify those at highest risk or those who may benefit the most,” the researchers write.
To determine the effect, pharmacy transaction data was used to evaluate 45,029 patients who were newly prescribed PCSK9i in the United States between August 2015 and July 2016.
Of those patients, slightly more than half were female, and the majority were aged more than 65 years, so that government insurance was often involved.
Results indicate that, of the patients provided a prescription, 20.8% received approval on the first day, and 47.2% eventually received approval. Of those approved, 65.3% filled the prescription—which meant that only 30.9% of those initially prescribed PCSK9i ever actually received the therapy.
Approval rates were higher for patients who were older, male, and had atherosclerotic cardiovascular disease, but they did not appear to be affected by patient LDL-C level or statin use, study authors note.
Having government insurance instead of a commercial payor also improved approval rates, for an odds ratio of 3.3, as did using a specialty versus a retail pharmacy, for an odds ratio of 1.96. Yet rates of approval varied nearly three-fold among the top 10 largest pharmacy-benefit managers, the study finds.
Copay costs were the greatest determinant in failing to fill a prescription, with abandonment rates ranging from 7.5% for those with $0 copay to more than 75% for copays greater than $350.
“In the first year of availability, only half of patients prescribed a PCSK9i received approval, and one-third of approved prescriptions were never filled owing to copay,” study authors conclude.
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