Willan Andrew R, Goeree Ron, Pullenayegum Eleanor M, McBurney Christopher, Blackhouse Gordon
SickKids Research Institute and Department of Public Health Sciences, Programme in Public Health Sciences, University of Toronto, Toronto, Ontario, Canada.
Pharmacoeconomics. 2006;24(1):93-106. doi: 10.2165/00019053-200624010-00008.
The positive results of a randomised clinical trial of rivastigmine in patients with dementia associated with Parkinson's disease have been published recently. Patient-level healthcare utilisation data were also collected, and this report is the economic evaluation based on these data.
To determine the cost effectiveness of rivastigmine 3-12 mg/day in patients in whom mild to moderate dementia developed at least 2 years after they received a clinical diagnosis of Parkinson's disease.
A cost-effectiveness analysis was performed by applying Canadian and UK cost weights (year 2004 values) to healthcare utilisation data collected prospectively during a randomised, double-blind, multinational, 24-week trial of rivastigmine 3-12 mg/day (n = 362) versus placebo (n = 179). Patients were > or =50 years of age, had a Mini-Mental State Examination (MMSE) score of between 20 and 24 and had contact with a responsible caregiver at least 3 days a week.Quality-adjusted survival time, transformed from MMSE scores, was the measure of effectiveness. Caregiver costs included paid and unpaid time, and direct costs included concomitant medications, outpatient care, hospitalisations, long-term care and study medications. Analysis was conducted from a societal perspective with a time horizon of 24 weeks.
Consistent with the improvement in clinical outcomes, there was an observed increase in quality-adjusted survival time in the rivastigmine arm of 2.81 quality-adjusted life-days (two-sided p-value 0.13 [90% CI -0.243, 5.86]). Using Canadian price weights, there was an observed increase in cost in the rivastigmine arm of Can 55.76 dollars(two-sided p-value 0.98 [90% CI -3431, 3543]), with a resulting incremental cost-effectiveness ratio of Can 7429 dollars per QALY. Using UK price weights, there was an observed decrease in cost in the rivastigmine arm of pound 26.18 (two-sided p-value 0.99 [90% CI -2407, 2355]).
Although no between-treatment differences in cost were seen, the small sample size, highly variable cost distributions and short time horizon prevent us from making strong conclusions with regard to the effect of rivastigmine on total costs and, by inference, on cost effectiveness.
最近已发表了一项关于卡巴拉汀治疗帕金森病所致痴呆患者的随机临床试验的阳性结果。还收集了患者层面的医疗保健利用数据，本报告就是基于这些数据进行的经济学评价。
确定卡巴拉汀3 - 12毫克/天对在临床诊断帕金森病至少2年后出现轻至中度痴呆的患者的成本效益。
通过将加拿大和英国的成本权重（2004年数值）应用于在一项随机、双盲、多国、为期24周的卡巴拉汀3 - 12毫克/天（n = 362）对比安慰剂（n = 179）试验中前瞻性收集的医疗保健利用数据，进行成本效益分析。患者年龄≥50岁，简易精神状态检查表（MMSE）评分在20至24分之间，且每周至少有3天与责任照护者有接触。从MMSE评分转换而来的质量调整生存时间是疗效的衡量指标。照护者成本包括有偿和无偿时间，直接成本包括伴随用药、门诊护理、住院、长期护理和研究用药。分析从社会角度进行，时间跨度为24周。
与临床结局的改善一致，卡巴拉汀组的质量调整生存时间观察到增加了2.81个质量调整生命日（双侧p值0.13 [90%可信区间 - 0.243, 5.86]）。使用加拿大价格权重，卡巴拉汀组的成本观察到增加了55.76加元（双侧p值0.98 [90%可信区间 - 3431, 3543]），由此得出的增量成本效益比为每质量调整生命年7429加元。使用英国价格权重，卡巴拉汀组的成本观察到减少了26.18英镑（双侧p值0.99 [90%可信区间 - 2407, 2355]）。
尽管未观察到治疗组之间的成本差异，但样本量小、成本分布高度可变以及时间跨度短，使我们无法就卡巴拉汀对总成本的影响以及由此推断的成本效益得出有力结论。
