Sacristán José A, Prieto Luis, Huete Teresa, Artigas Antonio, Badia Xavier, Chinn Christopher, Hudson Peter
Departamento de Investigación Clínica, Lilly España.
Gac Sanit. 2004 Jan-Feb;18(1):50-7. doi: 10.1016/s0213-9111(04)71999-8.
The PROWESS clinical trial has shown that treatment with drotrecogin alpha (activated) in patients with severe sepsis is associated with a reduction in the absolute risk of death compared with standard treatment. The aim of the present study was to assess the cost-effectiveness of drotrecogin alpha (activated) versus that of standard care in the treatment of severe sepsis in Spain.
A decision analysis model was drawn up to compare costs to hospital discharge and the long-term efficacy of drotrecogin alpha (activated) versus those of standard care in the treatment of severe sepsis in Spain from the perspective of the health care payer. Most of the information for creating the model was obtained from the PROWESS clinical trial. A two-fold baseline analysis was performed: a) for all patients included in the PROWESS clinical trial and b) for the patients with two or more organ failures. The major variables for clinical assessment were the reduction in mortality and years of life gained (YLG). Cost-effectiveness was expressed as cost per YLG. A sensitivity analysis was applied using 3% and 5% discount rates for YLG and by modifying the patterns of health care, intensive care unit costs, and life expectancy by initial co-morbidity and therapeutic efficacy of drotrecogin alpha (activated).
Treatment with drotrecogin alfa (activated) was associated with a 6.0% drop in the absolute risk of death (p = 0.005) when all of the patients from the PROWESS trial were included and with a 7.3% reduction (p = 0.005) when the analysis was restricted to patients with two or more organ failures. The cost-effectiveness of drotrecogin alfa (activated) was 13,550 euros per YLG with respect to standard care after analysing all of the patients and 9,800 euros per YLG in the group of patients with two or more organ failures. In the sensitivity analysis, the results ranged from 7,322 to 16,493 euros per YLG. The factors with the greatest impact on the results were the change in the efficacy of drotrecogin alfa (activated), adjustment of survival by initial co-morbidity and the application of discount rates to YLG.
Treatment with drotrecogin alfa (activated) presents a favorable cost-effectiveness ratio compared with other health care interventions commonly used in Spain.
PROWESS临床试验表明,与标准治疗相比,严重脓毒症患者接受活化蛋白C治疗可降低绝对死亡风险。本研究旨在评估在西班牙治疗严重脓毒症时,活化蛋白C与标准治疗相比的成本效益。
构建了一个决策分析模型,从医疗保健支付方的角度比较活化蛋白C与标准治疗在西班牙治疗严重脓毒症时的住院费用及长期疗效。创建该模型的大部分信息来自PROWESS临床试验。进行了双重基线分析:a)针对PROWESS临床试验纳入的所有患者;b)针对有两个或更多器官功能衰竭的患者。临床评估的主要变量是死亡率降低和获得的生命年数(YLG)。成本效益以每YLG成本表示。采用敏感性分析,对YLG使用3%和5%的贴现率,并通过改变医疗模式、重症监护病房成本以及根据初始合并症和活化蛋白C的治疗效果调整预期寿命。
当纳入PROWESS试验的所有患者时,活化蛋白C治疗使绝对死亡风险降低6.0%(p = 0.005);当分析限于有两个或更多器官功能衰竭的患者时,死亡风险降低7.3%(p = 0.005)。分析所有患者后,与标准治疗相比,活化蛋白C的成本效益为每YLG 13,550欧元,在有两个或更多器官功能衰竭的患者组中为每YLG 9,800欧元。在敏感性分析中,结果为每YLG 7,322至16,493欧元。对结果影响最大的因素是活化蛋白C疗效的变化、根据初始合并症调整生存率以及对YLG应用贴现率。
与西班牙常用的其他医疗保健干预措施相比,活化蛋白C治疗具有良好的成本效益比。