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帕替罗默治疗爱尔兰慢性肾脏病伴或不伴心力衰竭患者高钾血症的成本效益

The Cost Effectiveness of Patiromer for the Treatment of Hyperkalaemia in Patients with Chronic Kidney Disease with and without Heart Failure in Ireland.

作者信息

Ward Thomas, Brown Tray, Lewis Ruth D, Kliess Melodi Kosaner, de Arellano Antonio Ramirez, Quinn Carol M

机构信息

Health Economics and Outcomes Research Ltd., Rhymney House, Unit A, Copse Walk, Cardiff Gate Business Park, Cardiff, CF23 8RB, UK.

Health Economics Group, College of Medicine and Health, University of Exeter, Exeter, UK.

出版信息

Pharmacoecon Open. 2022 Sep;6(5):757-771. doi: 10.1007/s41669-022-00357-z. Epub 2022 Aug 4.

DOI:10.1007/s41669-022-00357-z
PMID:35925491
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9440184/
Abstract

BACKGROUND AND OBJECTIVE

Hyperkalaemia can be a life-threatening condition, particularly in patients with advanced chronic kidney disease with and without heart failure. Renin-angiotensin-aldosterone system inhibitor therapy offers cardiorenal protection in chronic kidney disease and heart failure; however, it may also cause hyperkalaemia subsequently resulting in down-titration or discontinuation of treatment. Hence, there is an unmet need for hyperkalaemia treatment in patients with chronic kidney disease with and without heart failure to enable renin-angiotensin-aldosterone system inhibitor use in this patient population. In this study, we develop a de novo disease progression and cost-effectiveness model to evaluate the clinical and economic outcomes associated with the use of patiromer for the treatment of hyperkalaemia in patients with chronic kidney disease with and without heart failure.

METHODS

A Markov model was developed using data from the OPAL-HK trial to assess the health economic impact of patiromer therapy in comparison to standard of care in controlling hyperkalaemia in patients with advanced chronic kidney disease with and without heart failure in the Irish setting. The model was designed to predict the natural history of chronic kidney disease and heart failure and quantify the costs and benefits associated with the use of patiromer for hyperkalaemia management over a lifetime horizon from a payer perspective.

RESULTS

Treatment with patiromer was associated with an increase in discounted life-years (8.62 vs 8.37) and an increase in discounted quality-adjusted life-years (6.15 vs 5.95). Incremental discounted costs were predicted at €4979 per patient, with an incremental cost-effectiveness ratio of €25,719 per quality-adjusted life-year gained. Patients remained taking patiromer treatment for an average of 7.7 months, with treatment associated with reductions in the overall clinical event incidence and a delay in chronic kidney disease progression. Furthermore, patiromer was associated with lower overall rates of hospitalisation, major adverse cardiovascular events, dialysis, renin-angiotensin-aldosterone system inhibitor discontinuation episodes and renin-angiotensin-aldosterone system inhibitor down-titration episodes. At a willingness-to-pay threshold of €45,000 per quality-adjusted life-year in Ireland, treatment with patiromer was estimated to have a 100% chance of cost effectiveness compared with standard of care.

CONCLUSIONS

This study has demonstrated an economic case for the reimbursement of patiromer for the treatment of hyperkalaemia in patients with chronic kidney disease with and without heart failure in Ireland. Patiromer was estimated to improve life expectancy and quality-adjusted life expectancy, whilst incurring marginal additional costs when compared with current standard of care. Results are predominantly attributed to the ability of patiromer to enable the continuation of renin-angiotensin-aldosterone system inhibitor treatment whilst also reducing potassium levels.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b67/9440184/30286b2790ea/41669_2022_357_Fig6_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b67/9440184/c96059569b61/41669_2022_357_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b67/9440184/17a97b6393e4/41669_2022_357_Fig2_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b67/9440184/1a7c9f3a4394/41669_2022_357_Fig4_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b67/9440184/30286b2790ea/41669_2022_357_Fig6_HTML.jpg
摘要

背景与目的

高钾血症可能是一种危及生命的病症,尤其是在伴有或不伴有心力衰竭的晚期慢性肾脏病患者中。肾素 - 血管紧张素 - 醛固酮系统抑制剂疗法可为慢性肾脏病和心力衰竭患者提供心肾保护作用;然而,它也可能导致高钾血症,进而致使治疗剂量下调或停药。因此,对于伴有或不伴有心力衰竭的慢性肾脏病患者的高钾血症治疗存在未被满足的需求,以便在这一患者群体中使用肾素 - 血管紧张素 - 醛固酮系统抑制剂。在本研究中,我们开发了一个全新的疾病进展和成本效益模型,以评估使用帕替罗姆治疗伴有或不伴有心力衰竭的慢性肾脏病患者高钾血症所带来的临床和经济结果。

方法

利用OPAL - HK试验的数据开发了一个马尔可夫模型,以评估在爱尔兰环境下,与标准治疗相比,帕替罗姆疗法在控制伴有或不伴有心力衰竭的晚期慢性肾脏病患者高钾血症方面的健康经济影响。该模型旨在预测慢性肾脏病和心力衰竭的自然病程,并从支付方的角度量化在一生时间范围内使用帕替罗姆管理高钾血症相关的成本和效益。

结果

使用帕替罗姆治疗与贴现生命年增加(8.62对8.37)以及贴现质量调整生命年增加(6.15对5.95)相关。预计每位患者的增量贴现成本为4979欧元,每获得一个质量调整生命年的增量成本效益比为25719欧元。患者平均持续接受帕替罗姆治疗7.7个月,该治疗与总体临床事件发生率降低以及慢性肾脏病进展延迟相关。此外,帕替罗姆与较低的总体住院率、主要不良心血管事件、透析、肾素 - 血管紧张素 - 醛固酮系统抑制剂停药事件以及肾素 - 血管紧张素 - 醛固酮系统抑制剂剂量下调事件发生率相关。在爱尔兰,每质量调整生命年支付意愿阈值为45000欧元的情况下,与标准治疗相比,使用帕替罗姆治疗估计具有100%的成本效益可能性。

结论

本研究证明了在爱尔兰,为伴有或不伴有心力衰竭的慢性肾脏病患者治疗高钾血症的帕替罗姆报销具有经济合理性。与当前标准治疗相比,帕替罗姆估计可提高预期寿命和质量调整预期寿命,同时产生边际额外成本。结果主要归因于帕替罗姆能够使肾素 - 血管紧张素 - 醛固酮系统抑制剂治疗得以持续,同时还能降低血钾水平。

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Hyperkalemia and its Association With Mortality, Cardiovascular Events, Hospitalizations, and Intensive Care Unit Admissions in a Population-Based Retrospective Cohort.基于人群的回顾性队列研究中高钾血症及其与死亡率、心血管事件、住院和重症监护病房入院的关联
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Pharmacological strategies to manage hyperkalaemia: out with the old, in with the new? Not so fast….管理高钾血症的药理学策略:弃旧迎新?没那么快……
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