PCV1 Modeling the Clinical Consequences of Delayed Initiation of Evolocumab Due to Payer Restrictions in Patients with a Recent Myocardial Infarction

Abstract

The European Society of Cardiology (ESC) dyslipidemias guidelines recommend treatment initiation with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors early after a myocardial infarction (MI) in patients not achieving LDL-C target with standard-of-care (SoC) of statins and ezetimibe. Patients with an MI in the past two years show higher cardiovascular (CV) event rates than patients with a more distant MI. We modeled the clinical consequences of delayed initiation of evolocumab due to payer restrictions in patients with a recent MI. A model published elsewhere was used to simulate a cohort of 100 patients with a recent MI and LDL-C above 100 mg/dl (commonly reimbursed population in Europe). Annual major CV event (MACE) rates published elsewhere were used. Treatment effect was modeled based on FOURIER clinical trial. Addition of evolocumab to SoC was compared to SoC. Several scenarios were considered, with early and delayed (3, 6, 9 months) initiation of evolocumab, assuming varying proportions of patient uptake (25%, 50%, 100%). Delayed initiation of evolocumab increased the number of predicted MACE. If all patients were treated early after the MI, the number of MACE predicted would decrease from 37 to 28 (24% decrease) in the first two years. If 50% of patients initiated evolocumab treatment after 3, 6 and 9 months, as opposed to treating all patients immediately after the MI, the number of MACE predicted would increase from 28 to 33, 34 and 34 (18%-23% increase) in the first two years. If 25% of patients were treated, the number of MACE predicted would increase from 28 to 35, 35 and 36 (24%-27% increase) in the first two years. Early initiation of evolocumab after an MI lowers predicted CV risk. This study emphasizes the clinical benefit of early intensive lipid-lowering therapy after an MI, and the importance of reducing existing payer restrictions.