Clinical and Economic Impact of Early Rreatment Initiation with Evolocumab in Patients with a Recent Myocardial Infarction in the United States

Abstract

<h3>Lead Author's Financial Disclosures</h3> Employee and stockholder of Amgen Inc. <h3>Study Funding</h3> Amgen Inc. <h3>Background/Synopsis</h3> Current ACC/AHA dyslipidemia guidelines recommend initiating non-statin therapies such as PCSK9 inhibitors in very high risk (VHR) patients with atherosclerotic cardiovascular disease (ASCVD) who do not reach the threshold of 70 mg/dL with statins alone. Patients with a recent myocardial infarction (MI) (in the past 12 months) constitute a subset of VHR patients who have a significantly higher risk of subsequent cardiovascular (CV) events (CVE) in the months and years following the event. <h3>Objective/Purpose</h3> This study aimed to estimate the clinical and economic impact of early initiation of evolocumab after an MI from a US perspective. <h3>Methods</h3> A published evolocumab partitioned survival model was used to simulate a cohort of 100,000 ASCVD patients with a recent MI and LDL-C above 100 mg/dL. CVE rates for non-fatal events (MI and stroke) and CV death were estimated using the US Prognos LDL-C database and NHANES with National Vital Statistics data, respectively. Treatment effect was modelled using the LDL-C percentage reduction and CVE rate ratios per mmol/L observed in the FOURIER trial. CVE costs were estimated from a US database representing healthcare claims from 2018 through 2020. We modelled the impact, over a 2-year time horizon, of early initiation of evolocumab (<10 days after the MI) compared to standard of care (SoC) of statins ± ezetimibe alone and compared to initiating evolocumab between 3 to 9 months after the MI. <h3>Results</h3> Early initiation of evolocumab in the simulated cohort of patients with a recent MI avoided a total of 5,356 CVE, corresponding to CVE cost savings of $310 million over the following 2 years, compared to treating patients with SoC alone. Treating patients with evolocumab early after the MI, in comparison to starting treatment at 3, 6 and 9 months after the MI, led to the avoidance of 1,150; 2,013; and 2,876 CVE with associated CVE cost savings of $67, $116,and $166 million, respectively. <h3>Conclusions</h3> Our model shows that the earliest initiation of evolocumab after an MI has the highest potential to decrease the predicted number of CVE substantially, resulting in significant CVE cost savings compared to a later initiation of evolocumab or treatment with SoC alone. These results underscore the value of early initiation of intensive lipid-lowering therapy in VHR ASCVD patients, especially in patients with a recent MI.