Estimation of Eligibility for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors and Associated Costs Based on the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk)

• cardiovascular disease
• cholesterol
• lipids

In the FOURIER trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk),¹ treatment with evolocumab resulted in a 15% relative (1.5% absolute) risk reduction of major cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD) at a median follow-up of 2.2 years. This trial included patients with low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL or non–high-density lipoprotein cholesterol ≥100 mg/dL on at least moderate-intensity statins. It is not known what proportion of patients with ASCVD would qualify for evolocumab on the basis of FOURIER entry criteria and how eligibility would change if maximal doses of evidence-based lipid-lowering therapies were required. We assessed the number and proportion of US veterans with ASCVD who would qualify for evolocumab on the basis of FOURIER trial entry criteria and how these figures would change if high-intensity statins, ezetimibe, or the combination of both agents were used.

Using a cohort of veterans with ASCVD (myocardial infarction, ischemic stroke, or peripheral arterial disease) receiving care in the Veterans Affairs (VA) system between October 2013 and September 2014, we identified all patients with ASCVD 40 to 85 years of age (n=631 855) using previously described algorithms with a positive predictive value of 88% in correctly identifying patients with ASCVD.² We identified patients meeting 1 major or 2 minor FOURIER protocol criteria and excluded patients with LDL-C <70 mg/dL or non–high-density lipoprotein cholesterol <100 mg/dL, those not receiving at least moderate-intensity statins, those with triglycerides >400 mg/dL, and those meeting other FOURIER exclusions.¹

Among patients meeting FOURIER inclusion and exclusion criteria, we determined proportions receiving moderate-intensity statins (30%–<50% LDL-C reduction), high-intensity statins (≥50% LDL-C reduction),³ or a …