The number of U.S. adults eligible for PCSK9 inhibitors could range from 700,000 to approximately 10 million, according to a study published in American Heart Journal.

Paul L. Hess, MD, MHS, et al., used ACC's PINNACLE Registry to assess the impact of LDL-C and statin intensities on the proportion of patients who might be eligible for PCSK9 inhibitor therapy. The researchers defined eligibility using a range of LDL-C thresholds of 70 mg/dL or greater and 160 mg/dL and greater and statin dosing at high intensity, moderate intensity or any intensity. The study population comprised 252,956 patients ages 18 to 75 with available LDL-C data who had prior acute coronary syndrome, coronary or other arterial revascularization, cerebrovascular accident, transient ischemic attack or peripheral arterial disease.

According to the results, 23.3 percent of patients were taking a high-intensity statin, 27.7 percent were taking a moderate-intensity statin, and 60.6 percent were taking any statin. Among patients on a high-intensity statin, the proportion of patients potentially eligible for PCSK9 inhibitor therapy increased from 1.9 percent with the threshold of 160 mg/dL or greater to 23.3 percent with the threshold of 70 mg/dL or higher. For those receiving moderate-intensity statins, PCSK9 inhibitor eligibility went up from 1.7 percent with the higher LDL-C threshold to 27.7 percent with the lower threshold. Similarly, for patients receiving any statin, PCSK9 inhibitor eligibility increased from 4.3 percent to 60.6 percent.

With the number of patients eligible for PCSK9 inhibitor therapy ranging from approximately 700,000 to 10 million, the researchers conclude there are substantial cost implications associated with PCSK9 inhibitor therapy and suggest a reduction in PCSK9 inhibitor prices to meet cost-effectiveness thresholds.

In addition, the researchers suggest that encouraging lifestyle changes, titrating statin therapy, increasing statin compliance, and targeting a subset of high-risk patients based on clinical factors that include high LDL-C could reduce the need for PCSK9 inhibitor therapy.

This research was conducted as part of ACC's Research to Practice initiative, which identifies impactful cardiovascular research and analyzes its implications for contemporary clinical practice using ACC's NCDR clinical registries.

Keywords: Ischemic Attack, Transient, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Peripheral Arterial Disease, Acute Coronary Syndrome, Cost-Benefit Analysis, Registries, National Cardiovascular Data Registries

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