Cost-Effectiveness Analysis of Evolocumab or Inclisiran in Combination with Statins Versus Statin Monotherapy Among Patients with ASCVD in China.

IF 3.1 4区 医学 Q1 ECONOMICS
Pengpeng Wang, Le Liang, Yamei Li
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引用次数: 0

Abstract

Background and objective: Several innovative proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been approved for combination lipid-lowering therapy in China. Compared with their high initial launch prices, some PCSK9 inhibitors have been subjected to the National Drug Price Negotiation (NDPN) policy with substantial price reductions, such as a 78.14% reduction for evolocumab (EVO). Others, such as inclisiran (INC), have not been included in this policy and maintain high prices. This study aimed to: (1) assess the cost-effectiveness of representative PCSK9 inhibitors (EVO and INC) in combination with statins versus statin monotherapy for Chinese patients with atherosclerotic cardiovascular disease (ASCVD), and (2) evaluate the influence of the NDPN policy on cost-effectiveness.

Methods: A Markov model was developed from the Chinese healthcare system perspective. Atorvastatin monotherapy was used as the standard of care (SOC), and the combinations of EVO or INC with SOC were employed as the intervention regimens. The transition probabilities and treatment effects were based on the Asian subgroup of the FOURIER trial and pooled analysis of the ORION-8, -9, and -10 trials, or calculated with results from a meta-analysis. Costs and utilities were derived from published literature or calculated with methods from literature and assumptions. Sensitivity and scenario analyses were conducted to evaluate the robustness of the model and the influence of the NDPN policy. Finally, the cost threshold analyses were conducted to estimate the annual costs required for EVO and INC to achieve a 75% probability of cost-effectiveness.

Results: The base-case incremental cost-effectiveness ratios (ICERs) of EVO + SOC and INC + SOC were 168,066 Chinese yuan (CNY) [23,652 US dollars (USD)] and 586,119 CNY (82,485 USD) per quality-adjusted life year (QALY), respectively. At WTP thresholds of three and one times GDP per capita (268,200 CNY [37,744 USD] and 89,400 CNY [12,581 USD]) per QALY gained, the probabilities that the intervention regimens were cost-effective would be 89.86% and 0.30% for EVO + SOC and 0.54% and 0% for INC + SOC, respectively. To achieve a 75% probability of cost-effectiveness, the required annual costs would be 9851 CNY (1386 USD) and 3434 CNY (483 USD) for EVO and 6554 CNY (922 USD) and 2096 CNY (295 USD) for INC, respectively. When the price reduction caused by the NDPN policy was removed from EVO and added to INC (assuming that the price of INC also reduces by 78.14%), the ICERs were 782,954 CNY (110,185 USD) and 130,877 CNY (18,418 USD) per QALY, respectively.

Conclusions: With the intervention of the NDPN policy, EVO + SOC has been a cost-effective option for Chinese patients with ASCVD at the WTP threshold of three times GDP per capita. However, INC + SOC is not a cost-effective regimen at the current price, and the NDPN policy may be an appropriate intervention measure.

中国ASCVD患者Evolocumab或Inclisiran联合他汀类药物与他汀类药物单药的成本-效果分析
背景与目的:几种新型蛋白转化酶subtilisin/kexin type 9 (PCSK9)抑制剂已在中国被批准用于联合降脂治疗。与最初的高价格相比,一些PCSK9抑制剂已经受到国家药品价格谈判(NDPN)政策的大幅降价,例如evolocumab (EVO)的降价幅度为78.14%。其他的,如inclisiran (INC),没有包括在这一政策中,并保持高价。本研究旨在:(1)评估具有代表性的PCSK9抑制剂(EVO和INC)联合他汀类药物与他汀类药物单药治疗中国动脉粥样硬化性心血管疾病(ASCVD)患者的成本-效果;(2)评估NDPN政策对成本-效果的影响。方法:从中国医疗卫生系统角度建立马尔可夫模型。采用阿托伐他汀单药治疗作为标准护理方案(SOC), EVO或INC联合SOC作为干预方案。转移概率和治疗效果基于FOURIER试验的亚洲亚组和ORION-8、-9和-10试验的汇总分析,或根据荟萃分析的结果计算。成本和效用是从已发表的文献中得出的,或者用文献和假设中的方法计算出来的。通过敏感性和情景分析来评估模型的稳健性和NDPN政策的影响。最后,进行成本阈值分析,以估计EVO和INC达到75%成本效益概率所需的年成本。结果:EVO + SOC和INC + SOC的基本情况增量成本-效果比(ICERs)分别为每质量调整生命年(QALY) 168,066元(23,652美元)和586,119元(82,485美元)。在WTP阈值为人均GDP的3倍和1倍时(每个QALY分别为268,200元人民币(37,744美元)和89,400元人民币(12,581美元)),EVO + SOC的干预方案具有成本效益的概率分别为89.86%和0.30%,INC + SOC的干预方案为0.54%和0%。为了达到75%的成本效益,EVO的年成本分别为9851元人民币(1386美元)和3434元人民币(483美元),INC的年成本分别为6554元人民币(922美元)和2096元人民币(295美元)。当从EVO中去除NDPN政策导致的价格下降并加入INC(假设INC的价格也下降了78.14%)时,ICERs分别为782,954 CNY (110,185 USD)和130,877 CNY (18,418 USD) / QALY。结论:在NDPN政策的干预下,EVO + SOC已成为中国ASCVD患者在人均GDP三倍的WTP阈值下的成本效益选择。然而,在目前的价格下,INC + SOC并不是一个具有成本效益的方案,NDPN政策可能是一个合适的干预措施。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Applied Health Economics and Health Policy
Applied Health Economics and Health Policy Economics, Econometrics and Finance-Economics and Econometrics
CiteScore
6.10
自引率
2.80%
发文量
64
期刊介绍: Applied Health Economics and Health Policy provides timely publication of cutting-edge research and expert opinion from this increasingly important field, making it a vital resource for payers, providers and researchers alike. The journal includes high quality economic research and reviews of all aspects of healthcare from various perspectives and countries, designed to communicate the latest applied information in health economics and health policy. While emphasis is placed on information with practical applications, a strong basis of underlying scientific rigor is maintained.
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