An economic evaluation of donepezil in mild to moderate Alzheimer’s disease: results of a 1-year, double-blind, randomized trial.
Wimo A, Winblad B, Engedal K, Soininen H, Verhey F, Waldemar G, Wetterhorn AL, et al.;
Commented by , 21 Nov 2003
Aim of the study
To assess the cost-benefit of treatment with donepezil versus placebo over one year in a multinational randomized clinical trial.
Method
Planned analysis of the effects of the selective acetylcholinesterase inhibitor donepezil versus placebo over one year, in patients enrolled in the Nordic study (initial publication of study methods and results published by Winblad et al, Neurology 2001; 57: 489-495).
The results on the activities of daily living scales (ADL) are described using the intent-to-treat population. The impact of treatment on the caregiver and on the direct and indirect costs of care was measured using the Resource Utilization in Dementia questionnaire. Various sensitivity analyses were used to account for patients withdrawing through the year.
Results
142 patients with Alzheimer’s disease (AD) in mild to moderate stages were randomized to donepezil and 144 patients to placebo. Ninety-five (66.9%) of donepezil patients and 97 (67.4%) of placebo patients completed the study. At week 52, there was a statistically significant difference in favor of donepezil using two scales measuring ADL, the Progressive Deterioration Scale (p=0.042) and the Instrumental ADL Scale (p=0.025).
Caregivers of patients on donepezil spent an average of 400 hours less annually providing care compared to caregivers of placebo-treated patients. Mean annual healthcare costs were USD 16,438 per patient on donepezil (including the cost of drug) and USD 16, 147 per patient on placebo. When caregiver time and healthcare costs were combined, the mean annual costs were USD 24,969 on donepezil and USD 26, 066 on placebo, an annual saving of USD 1,097 per patient on donepezil.
Discussion
The Nordic study is remarkable in many ways, including the duration of the placebo treatment over one year, which will not be possible in the future for ethical reasons, since cholinesterase inhibitors are recognized as ‘standard treatment’ for AD in mild to moderate stages.
Once the safety and efficacy on standard outcomes for cognition, ADL, behavior and global assessment of change are established in phase III studies, third party payers and patients/families want to know if the drugs are worth their money. This report is a model in this regard, comparing all aspects of costs for caregiving and healthcare over one year between treatment groups.
As was found in shorter studies with donepezil and other cholinestersase inhibitors, not only the drugs pay for themselves but there is a net saving. Hopefully this analysis will add evidence for clinicians and government officials who do not believe that symptomatic treatment for AD is available and worth the costs.