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整合药代动力学和药物经济学以量化提高依从性宽容度的价值:以新型黄嘌呤氧化酶抑制剂治疗痛风为例。

Integration of Pharmacometrics and Pharmacoeconomics to Quantify the Value of Improved Forgiveness to Nonadherence: A Case Study of Novel Xanthine Oxidase Inhibitors for Gout.

机构信息

Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.

Pharmacometrics, Pfizer Ltd, Sandwich, UK.

出版信息

Clin Pharmacol Ther. 2019 Sep;106(3):652-660. doi: 10.1002/cpt.1454. Epub 2019 May 31.

DOI:10.1002/cpt.1454
PMID:30993686
Abstract

Linked pharmacometric and pharmacoeconomic models provide a structured approach for assessing the value of candidate drugs in development. The aim of this study was to assess the utility of such an approach for identifying the properties of xanthine oxidase inhibitors (XOi) providing improved forgiveness to nonadherence and estimate the maximum reimbursement price. The pharmacometric and pharmacoeconomic models were used to simulate the time course of serum uric acid concentrations and estimate quality-adjusted life years and costs for the XOi febuxostat and a range of hypothetical analogues. Compounds with reduced clearance or increased potency were more forgiving to missed doses, however, even following relatively large changes in these properties the predicted maximum reimbursement prices represented an increase of only 19% above febuxostat 80 mg. Linked pharmacometric and pharmacoeconomic modeling methods have the potential to inform early drug development by providing an indication of pricing options that may permit reimbursement.

摘要

关联的药效学和药物经济学模型为评估候选药物在开发中的价值提供了一种结构化的方法。本研究的目的是评估这种方法在确定具有改善依从性的黄嘌呤氧化酶抑制剂 (XOi) 的特性方面的效用,并估算最大报销价格。使用药效学和药物经济学模型来模拟血清尿酸浓度的时间过程,并估算 XOi 非布索坦和一系列假设类似物的质量调整生命年和成本。清除率降低或效力增加的化合物对漏服更宽容,然而,即使这些特性发生了相对较大的变化,预测的最高报销价格仅比非布索坦 80mg 增加了 19%。关联的药效学和药物经济学建模方法有可能通过提供可能允许报销的定价选择的指示来为早期药物开发提供信息。

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引用本文的文献

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Clin Pharmacokinet. 2025 Jan;64(1):93-105. doi: 10.1007/s40262-024-01467-z. Epub 2024 Dec 18.
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Patient-Led Urate Self-Monitoring to Improve Clinical Outcomes in People With Gout: A Feasibility Study.患者主导的尿酸自我监测以改善痛风患者的临床结局:一项可行性研究。
ACR Open Rheumatol. 2024 Jul;6(7):403-411. doi: 10.1002/acr2.11666. Epub 2024 Apr 9.
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Incorporating Pharmacometrics into Pharmacoeconomic Models: Applications from Drug Development.
将临床药代动力学模型整合到药物经济学模型中:药物研发中的应用。
Pharmacoeconomics. 2020 Oct;38(10):1031-1042. doi: 10.1007/s40273-020-00944-0.