Medical and Financial Consequences of Using PCSK9 Inhibitors for Managing Hypercholesterolemia in Saudi Arabia: A Historical Cohort Study.

Background: Managing hypercholesterolemia is essential for reducing health risks and costs. Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors are recommended for patients with high low-density lipoprotein cholesterol (LDL-C) levels at risk for cardiovascular disease, especially those on maximum doses of statins and ezetimibe. However, their cost-effectiveness is unclear, particularly in Saudi Arabia, where cardiovascular disease is prevalent. The main objective of this study was to evaluate the costs and outcomes of PCSK9 inhibitors versus statins and ezetimibe. Methods: A multicenter retrospective study reviewed charts of adults (≥18 years) with hypercholesterolemia treated with PCSK9 inhibitors (evolocumab or alirocumab) for at least 12 months. Outcomes included LDL-C reduction and cardiovascular-related hospitalizations, with direct medical costs estimated via micro-costing and adjusted for confounders. Results: The analysis included 118 patients on PCSK9 inhibitors and 304 on statins plus ezetimibe. Mean LDL-C reductions were 1.432 mmol/L [95% CI: 0.964 to 1.899] for PCSK9 inhibitors and 0.644 mmol/L [95% CI: 0.464 to 0.823] for the other group. Cardiovascular-related hospitalizations averaged 0.645 for PCSK9 inhibitors compared to 0.808 for statins plus ezetimibe. The annual cost for PCSK9 inhibitors ranged from USD 4024 [95% CI: 3786.80 to 7947.91] to USD 7559 [95% CI: 7331.35 to 11,509.66]. In 99.13% and 98.78% of bootstrap distributions, PCSK9 inhibitors led to greater LDL-C reductions and fewer hospitalizations. Conclusions: The use of PCSK9 inhibitors for managing hypercholesterolemia was associated with a greater reduction in LDL-C levels and fewer cardiovascular-related hospitalizations. However, the more modest LDL-C reduction compared to clinical trials, combined with the high acquisition cost of PCSK9 inhibitors, underscores the need to provide significant price reductions to improve patient access to these lipid-lowering agents.