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Rate of Approval for PCSK9i Therapy 47 Percent

Rate of Approval for PCSK9i Therapy 47 Percent
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MONDAY, Oct. 30, 2017 (HealthDay News) — A combination of clinical factors and payer type increase the likelihood of approval for proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) treatment, and rates of approval are low overall, according to a study published online Oct. 30 in Circulation.

Gregory P. Hess, M.D., from the University of Pennsylvania in Philadelphia, and colleagues conducted a retrospective cohort study using nationwide pharmacy claims linked to electronic medical records. The data set included more than 220 million patients from all 50 states and all payer types, with 5,140 distinct health plans. In the pharmacy data set, PCSK9i prescriptions were submitted for 51,466 patients. Approval or rejection of PCSK9i prescription claims was the main outcome.

The researchers found that 47 percent of patients who were prescribed a PCSK9i were approved for coverage by the payer. Age >65 years, history of atherosclerotic cardiovascular disease, prescription by a cardiologist or nonprimary care provider, statin intolerance, longer statin duration, and noncommercial payers were variables associated with approval of PCSK9i. There was no correlation between higher low-density lipoprotein cholesterol levels and higher approval rates. The lowest and highest approval rates were seen for commercial third-party payers (24.4 percent) and Medicare (60.9 percent), respectively.

“Rates of approval for PCSK9i therapy are low, even for patients who appear to meet labeled indications,” the authors write. “Although a combination of clinical characteristics increases the likelihood of approval, payer type is the most significant factor.”

One author disclosed ties to Amarin Corp. The data were supplied by Symphony Health.

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