Cost-effectiveness of inclisiran in patients with atherosclerotic cardiovascular disease from Chinese healthcare perspective.

摘要

BACKGROUND: Atherosclerotic cardiovascular disease (ASCVD) imposes a substantial clinical and economic burden in China. Despite maximally tolerated statin therapy, many patients fail to achieve recommended low-density lipoprotein cholesterol (LDL-C) targets. Inclisiran, a novel small interfering ribonucleic acid (siRNA) therapy, provides sustained LDL-C reduction, but its economic value under the Chinese healthcare system remains uncertain. OBJECTIVE: To evaluate the cost-effectiveness of inclisiran when added to standard lipid-lowering therapy for patients with ASCVD in China. METHODS: A Markov cohort multistate-transition model was developed from the perspective of the Chinese healthcare system, using a one-year cycle length and a lifetime horizon. Clinical inputs, costs, and utilities were derived from published literature and clinical trials. Both costs and outcomes were discounted at 4.5% annually. The primary result of the economic evaluation was the incremental cost-effectiveness ratio (ICER), with inclisiran considered cost-effective if the ICER was below the willingness-to-pay (WTP) threshold of CNY 191,498 per quality-adjusted life year (QALY), equivalent to two times China's per capita gross domestic product in 2024. One-way and probabilistic sensitivity analyses were conducted to assess model uncertainty. RESULTS: Compared with statin therapy alone, inclisiran added to statin therapy yielded an additional 0.41 QALYs and incurred incremental costs of CNY 58,321.35, resulting in an ICER of CNY 143,044.57/QALY, which is well below the WTP threshold. One-way sensitivity analyses showed that the mortality reduction effect, discount rate, and inclisiran price were the main drivers of model outcomes; however, inclisiran remained cost-effective across all tested scenarios. Probabilistic sensitivity analysis showed a 95.1% probability that inclisiran is cost-effective at the current price. CONCLUSIONS: At its current negotiated price of CNY 2,790 per dose, inclisiran added to standard therapy is cost-effective for patients with ASCVD in China.