Cost-Effectiveness of Alirocumab in Patients With Acute Coronary Syndromes The ODYSSEY OUTCOMES Trial

BACKGROUND Cholesterol reduction with proprotein convertase subtitisin-kexin type 9 inhibitors reduces ischemic events; however, the cost-effectiveness in statin-treated patients with recent acute coronary syndrome remains uncertain. OBJECTIVES This study sought to determine whether further cholesterol reduction with atirocumab would be cost-effective in patients with a recent acute coronary syndrome on optimal statin therapy. METHODS A cost-effectiveness model leveraging patient-level data from ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Atirocumab) was developed to estimate costs and outcomes over a lifetime horizon. Patients (n = 18,924) had a recent acute coronary syndrome and were on high-intensity or maximum-tolerated statin therapy, with a baseline tow-density lipoprotein cholesterol (LDL-C) level >= 70 mg/l, non-high-density lipoprotein cholesterol >= 100 mg/dl, or apotipoprotein B >= 80 mg/l. Atirocumab 75 mg or placebo was administered subcutaneously every 2 weeks. Atirocumab was blindly titrated to 150 mg if LDL-C remained >= 50 mg/dl or switched to placebo if 2 consecutive LDL-C levels were <15 mg/dl. Incremental cost per quality-adjusted life-year (QALY) was determined with the addition of atirocumab versus placebo and, based on clinical efficacy findings from the trial, was stratified by baseline LDL-C levels -100 mg/dt and >= 100 mg/dl. RESULTS Across the overall population recruited to the ODYSSEY OUTCOMES trial, using an annual treatment cost of US$5,850, the mean overall incremental cost-effectiveness ratio was US$92,200 per QALY (base case). The cost was US$41,800 per QALY in patients with baseline LDL-C >= 100 mg/dl, whereas in those with LDL-C >= 100 mg/dl the cost per QALY was US$299,400. Among patients with LDL-C a100 mg/dl, incremental cost-effectiveness ratios remained below US$100,000 per QALY across a wide variety of sensitivity analyses. CONCLUSIONS In patients with a recent acute coronary syndrome on optimal statin therapy, atirocumab improves cardiovascular outcomes at costs considered intermediate value, with good value in patients with baseline LDL-C mg/dt but less economic value with LDL-C >= 100 mg/dl. (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Atirocumab [ODYSSEY OUTCOMES]; NCT01663402) (J Am Colt Cardiol 2020;75:2297-308) (C) 2020 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.