Cost-effectiveness and budget impact of ezetimibe-atorvastatin single-pill combination versus free combination in Chinese adults with hypercholesterolemia

BACKGROUND: Hypercholesterolemia imposes a growing cardiovascular burden in China, yet low-density lipoprotein cholesterol (LDL-C) target attainment remains low. The single-pill combination (SPC) of ezetimibe and atorvastatin (E/A SPC) was approved in China in 2023 and added to the National Reimbursement Drug List (NRDL) in 2024. Compared with free combination therapy (E/A FCT), E/A SPC may improve adherence and LDL-C reduction, but its economic value has not been assessed in the Chinese context. OBJECTIVE: To evaluate the cost-effectiveness of E/A SPC versus E/A FCT in Chinese adults with hypercholesterolemia inadequately controlled on statin monotherapy, and to estimate the 5-year budget impact of E/A SPC adoption. METHODS: = 311,242). Subgroup analyses were conducted by age, sex, and cardiovascular risk. A 5-year budget impact analysis estimated the financial consequences of increasing E/A SPC uptake. Costs and outcomes were discounted at 5% annually. RESULTS: E/A SPC generated 0.06 additional quality-adjusted life years (QALYs) at an incremental cost of USD 250.12, yielding an incremental cost effectiveness ratio (ICER) of USD 4,070/QALY, well below the willingness-to-pay threshold of USD 14,423. The probability of cost-effectiveness was 91%. Subgroup analyses consistently favored E/A SPC, with the most favorable ICERs observed in very high-risk patients and middle-aged patients. Over 5 years, E/A SPC was associated with incremental drug spending of USD 372.5 million, partly offset by USD 292.0 million in avoided cardiovascular event costs. CONCLUSION: E/A SPC is a cost-effective strategy for Chinese adults with hypercholesterolemia inadequately controlled on statin monotherapy, supporting its NRDL inclusion. The study findings should be further validated using larger-scale real-world data from China.