PCSK9 inhibitors patterns of use in France from nationwide repeated cross-sectional and cohort studies

PCSK9 inhibitors (PCSK9i) are indicated in combination with statins and/or ezetimibe to intensify LDL-cholesterol lowering and reduce the risks of atherosclerotic cardiovascular disease. We aimed at investigating PCSK9i (alirocumab and evolocumab) patterns of use in France by characterizing PCSK9i new-users and describing lipid-lowering agents (LLA) use before and after PCSK9i initiation. A cross-sectional study of PCSK9i users and a cohort study including PCSK9i new-users between 2018 and 2021 were conducted using the nationwide French healthcare insurance system database (SNDS). PCSK9i use increased greatly after the indication extension rapidly slowed by introduction of agreement prior to reimbursement in Dec-20. Among the 6891 PCSK9i new-users, 65.7% were men, 63.7% were at very-high cardiovascular risk, median age was 64 years (IQR: 56-71). Trajectories of cholesterol-lowering treatment prior to PCSK9i initiation showed high intensity treatment for 50.5% of patients, low/moderate treatment for 37.3% and no prior treatment for 12.2%. LLA discontinuation after PCSK9i initiation was most frequent in patients with no prior treatment (17.3%) than in those with prior low/moderate or high-intensity treatment (4.9 and 1.3% respectively). Agreement prior to reimbursement seemed effective in contributing to control the appropriate use of PCSK9i with almost two-thirds of patients at very-high cardiovascular risk, and high treatment persistence.