西班牙高危患者中贝洛妥珠单抗联合标准治疗与标准治疗单用预防复发性艰难梭菌感染的成本-效果分析

Cost-Effectiveness Analysis of Bezlotoxumab Added to Standard of Care Versus Standard of Care Alone for the Prevention of Recurrent Clostridium difficile Infection in High-Risk Patients in Spain.

机构信息

Infectious Diseases Unit, Hospital Universitario La Fe, Valencia, Spain.

Infectious Diseases Department, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain.

出版信息

Adv Ther. 2018 Nov;35(11):1920-1934. doi: 10.1007/s12325-018-0813-y. Epub 2018 Oct 16.

DOI:10.1007/s12325-018-0813-y

PMID:30328061

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6223985/

Abstract

INTRODUCTION

Clostridium difficile infection (CDI) is the major cause of infectious nosocomial diarrhoea and is associated with considerable morbidity, mortality and economic impact. Bezlotoxumab administered in combination with standard of care (SoC) antibiotic therapy prevents recurrent CDI. This study assessed the cost-effectiveness of bezlotoxumab added to SoC, compared to SoC alone, to prevent the recurrence of CDI in high-risk patients from the Spanish National Health System perspective.

METHODS

A Markov model was used to simulate the natural history of CDI over a lifetime horizon in five populations of patients at high risk of CDI recurrence according to MODIFY trials: (1) ≥ 65 years old; (2) severe CDI; (3) immunocompromised; (4) ≥ 1 CDI episode in the previous 6 months; and (5) ≥ 65 years old and with ≥ 1 CDI episode in the previous 6 months. The incremental cost-effectiveness ratio (ICER) expressed as cost per quality-adjusted life-year (QALY) gained was calculated. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were performed.

RESULTS

In all patient populations (from 1 to 5), bezlotoxumab added to SoC reduced CDI recurrence compared to SoC alone by 26.4, 19.5, 21.2, 26.6 and 39.7%, respectively. The resulting ICERs for the respective subgroups were €12,724, €17,495, €9545, €7386, and €4378. The model parameters with highest impact on the ICER were recurrence rate (first), mortality, and utility values. The probability that bezlotoxumab was cost-effective at a willingness-to-pay threshold of €21,000/QALY was 85.5%, 54.1%, 86.0%, 94.5%, 99.6%, respectively.

CONCLUSION

The results suggest that bezlotoxumab added to SoC compared to SoC alone is a cost-effective treatment to prevent the recurrence of CDI in high-risk patients. The influence of changes in model parameters on DSA results was higher in patients ≥ 65 years old, with severe CDI and immunocompromised. Additionally, PSA estimated that the probability of cost-effectiveness exceeded 85% in most subgroups.

FUNDING

Merck Sharp & Dohme Corp.

摘要

介绍

艰难梭菌感染（CDI）是医院获得性感染性腹泻的主要原因，与相当大的发病率、死亡率和经济影响有关。贝洛妥珠单抗与标准治疗（SoC）抗生素联合使用可预防复发性 CDI。本研究从西班牙国家卫生系统的角度评估了贝洛妥珠单抗联合 SoC 预防高危患者 CDI 复发的成本效益，与单独 SoC 相比。

方法

使用马尔可夫模型在根据 MODIFY 试验确定的五个高危 CDI 复发患者人群中模拟 CDI 的自然史：（1）≥65 岁；（2）严重 CDI；（3）免疫功能低下；（4）过去 6 个月内发生过≥1 次 CDI 发作；和（5）≥65 岁且过去 6 个月内发生过≥1 次 CDI 发作。以增量成本效益比（ICER）表示，每获得一个质量调整生命年（QALY）的成本进行计算。进行了确定性（DSA）和概率敏感性分析（PSA）。

结果

在所有患者人群（从 1 到 5）中，与单独 SoC 相比，贝洛妥珠单抗联合 SoC 可分别降低 26.4%、19.5%、21.2%、26.6%和 39.7%的 CDI 复发率。各自亚组的相应 ICER 分别为 12724 欧元、17495 欧元、9545 欧元、7386 欧元和 4378 欧元。对 ICER 影响最大的模型参数是复发率（第一）、死亡率和效用值。在愿意支付 21000 欧元/QALY 的意愿支付阈值下，贝洛妥珠单抗具有成本效益的概率分别为 85.5%、54.1%、86.0%、94.5%和 99.6%。