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PCSK9 inhibitor approval rates, copays affect treatment of CVD
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Nearly half of patients with atherosclerotic CVD who were prescribed PCSK9 inhibitors received approval, and one-third of those did not fill the prescription due to the copay, according to an analysis published in JAMA Cardiology.
“This study highlights the extent to which insurance denials and high copays limit patient access to new PCSK9 inhibitor therapies,” Ann Marie Navar, MD, PhD, assistant professor of medicine at Duke University School of Medicine, member of the Duke Clinical Research Institute and a Cardiology Today Next Gen Innovator, said in an interview. “Also, we show that whether or not someone received approval after being prescribed therapy appeared to be more driven by their insurer or pharmacy benefit manager than clinical factors.”
Pharmacy data
Researchers analyzed pharmacy claims transactional data from 45,029 patients who had a diagnosis of prior atherosclerotic CVD and were newly prescribed a PCSK9 inhibitor — evolocumab (Repatha, Amgen) or alirocumab (Praluent, Sanofi/Regeneron) — from August 2015 to July 2016. Some results were previously presented at the American College of Cardiology Scientific Session in March.
The outcome of interest was the proportion of PCSK9 inhibitor prescriptions that were approved and abandoned.
More than half of patients prescribed PCSK9 inhibitors were women (51.2%), 52.5% had governmental insurance and 56.6% were aged at least 65 years. Approval occurred on the first day for 20.8% of patients, and the ultimate approval rate was 47.2%. The prescription was filled by 65.3% of patients, and 30.9% received therapy. The time between initial submission and approval was a median of 3.9 days (interquartile range, 0-20).
Patients who were more likely to be approved were older and men after adjustment. Those diagnosed with prior atherosclerotic CVD were also more likely to receive approval vs. those without a diagnosis (OR = 1.18; 95% CI, 1.04-1.35). Approval rates did not differ by high-intensity statin use (OR = 1; 95% CI, 0.9-1.2) or low- to moderate-intensity statin use (OR = 1.1; 95% CI, 0.9-1.4) compared with those who did not take a statin. There was also no difference in LDL levels.
Variance by plan, pharmacy
Higher odds of approval were seen in those with government insurance plans vs. commercial insurance (OR = 3.27; 95% CI, 2.79-3.83) and for prescriptions filled at specialty pharmacies vs. retail pharmacies (OR = 1.96; 95% CI, 1.66-2.33).
Approval rates among the 10 largest pharmacy benefit managers varied by nearly threefold.
Copay costs were linked to patients who abandoned their prescription of PCSK9 inhibitors (C statistic, 0.86). Abandonment rates were 7.5% for patients with $0 copay and more than 75% for those with copays that were at least $350.
“We can’t afford to treat everybody in the U.S. with heart disease with a PCSK9 inhibitor at current prices,” Navar told Cardiology Today. “Our current system is at best a blunt instrument to identify those adults who are the best candidates for therapy, and at worst is a form of rationing by roadblocks, where only those patients with persistent enough doctors can get on therapy. We need better ways to identify those who are at highest risk of heart attacks or strokes and who are therefore most likely to benefit from therapy so we can manage costs while maximizing the impact of new discoveries.” – by Darlene Dobkowski
Disclosures: The study was supported by Amgen. Navar reports she receives research funding from Amgen, Regeneron and Sanofi, and honoraria for research consulting for Amgen and Sanofi. Please see the study for all other authors’ relevant financial disclosures.
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