PCSK9 inhibitors usage in South China: A Multi-Center Real-World Study

Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are effective for lipid management in high-risk patients with atherosclerotic cardiovascular disease. Their inclusion in China's National Reimbursement Drug List and the Hong Kong Hospital Authority Drug Formulary in 2021 improved accessibility. The Guangdong-Hong Kong-Macau Greater Bay Area is a unique integrated economic zone in Southern China where divergent healthcare systems coexist. How these disparate policies create inequities in drug access remains unexplored for regional health integration. This study aimed to compare real-world PCSK9i utilization and effect across the Greater Bay Area.

This multi-center cohort study analyzed electronic health records from five centers: Hong Kong Hospital Authority (HKHA) [Hong Kong], Macau Health Bureau (SSM) [Macau public], Macau University of Science and Technology Hospital - University Hospital (MUST-UH) [Macau private], Hong Kong-Shenzhen Hospital (HKU-SZH) [Shenzhen], and First Affiliated Hospital of Jinan University (JNUH) [Guangzhou], between August 2016 and December 2024, with center-specific start dates reflecting local PCSK9i availability. Adult (aged ≥18 years) new users of alirocumab or evolocumab were included. We investigated prescribing trends and evaluated the low-density lipoprotein cholesterol (LDL-C) goal attainment post-initiation.

There were total of 9828 new users (HKHA = 3296, HKU-SZH = 2529, SSM = 148, MUST-UH = 87, JNUH = 3768), agent choice varied with evolocumab most commonly prescribed in HKHA, MUST-UH, and JNUH, while alirocumab was most common in HKU-SZH and SSM. Patients were predominantly older male individuals with a high burden of atherosclerotic cardiovascular disease. Prescribing trends showed a divergent uptake, with the highest uptake in mainland centers (JNUH and HKU-SZH) post-National Reimbursement Drug List inclusion. Substantial LDL-C reductions were observed after PCSK9i initiation (median reductions of 38-56%). Approximately 60-70% of patients achieved an LDL-C <1.8 mmol/L in most centers, though attainment was slightly lower in JNUH.

In the largest real-world study of PCSK9i in Asia, therapy was primarily used in high-risk patients, and substantial LDL-C reductions with high goal attainment were observed following its initiation. The observed regional variations in prescribing patterns highlight the impact of local healthcare policies. The findings provide a robust model for multi-jurisdictional evidence generation and highlight the need for further research on whether harmonized access policies could improve lipid management and reduce the cardiovascular burden across East Asia.