Yuansheng Wan, Jinyu Liu, Xiaolian Zhan, Yu Zhang, Ruxu You
{"title":"他伐昔单抗治疗低密度脂蛋白胆固醇升高患者的成本-效果和价格阈值分析。","authors":"Yuansheng Wan, Jinyu Liu, Xiaolian Zhan, Yu Zhang, Ruxu You","doi":"10.1007/s40256-025-00733-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":" ","pages":""},"PeriodicalIF":2.8000,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Cost-Effectiveness and Price Threshold Analysis of Tafolecimab in Chinese Patients with Elevated LDL Cholesterol Despite Statin Therapy.\",\"authors\":\"Yuansheng Wan, Jinyu Liu, Xiaolian Zhan, Yu Zhang, Ruxu You\",\"doi\":\"10.1007/s40256-025-00733-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":7652,\"journal\":{\"name\":\"American Journal of Cardiovascular Drugs\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-04-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American Journal of Cardiovascular Drugs\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40256-025-00733-0\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Cardiovascular Drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40256-025-00733-0","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Cost-Effectiveness and Price Threshold Analysis of Tafolecimab in Chinese Patients with Elevated LDL Cholesterol Despite Statin Therapy.
Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
期刊介绍：
Promoting rational therapy within the discipline of cardiology, the American Journal of Cardiovascular Drugs covers all aspects of the treatment of cardiovascular disorders, particularly the place in therapy of newer and established agents.
Via a program of reviews and original clinical research articles, the journal addresses major issues relating to treatment of these disorders, including the pharmacology, efficacy and adverse effects of the major classes of drugs; information on newly developed drugs and drug classes; the therapeutic implications of latest research into the aetiology of cardiovascular disorders; and the practical management of specific clinical situations.
The American Journal of Cardiovascular Drugs offers a range of additional enhanced features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist patients, caregivers and others in understanding important medical advances. The journal also provides the option to include various other types of enhanced features including slide sets, videos and animations. All enhanced features are peer reviewed to the same high standard as the article itself. Peer review is conducted using Editorial Manager®, supported by a database of international experts. This database is shared with other Adis journals.
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