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Abstract
Tafolecimab is a novel PCSK9 inhibitor developed in China. In recently published phase III clinical trials, tafolecimab demonstrated long-term safety and efficacy in Chinese patients with hypercholesterolemia despite statin therapy. However, pharmacoeconomic studies of tafolecimab have yet to be published. This study aimed to explore the maximum cost-effective price of tafolecimab compared with statins alone for Chinese patients with hypercholesterolemia at various willingness-to-pay (WTP) thresholds. A Markov cohort state-transition model was employed to assess the cost-effectiveness of tafolecimab from the perspective of the Chinese healthcare system. The low-density lipoprotein cholesterol (LDL-C) lowering effect of tafolecimab was observed in the CREDIT-4 trial. The baseline and subsequent incidence and transfer probability of cardiovascular events were based on prospective observational data in China and meta-analyses from the Cholesterol Treatment Trialists Study. Cost and utility values were obtained from the China Health Statistics Yearbook, health insurance, and published articles in China. The study also performed subgroup, sensitivity, and scenario analyses. The annual price thresholds for tafolecimab as an adjunctive therapy to statins were Chinese yuan (CNY) 3304 and CNY 7022 at WTP thresholds of CNY 89,358 and CNY 268,074 per quality-adjusted life year (QALY), respectively. The corresponding annual price thresholds for patients with hypercholesterolemia with acute myocardial infarction were CNY 10,355 and CNY 21,793 per year. Sensitivity analyses showed that the time horizon significantly impacted price thresholds, with a several-fold difference. From the perspective of the Chinese healthcare system, the cost-effective annual price threshold for tafolecimab for patients with hypercholesterolemia was CNY 7022, at a threshold of CNY 268,074 per QALY.
Published Version
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