Wade Alan G, Fernández José-Luis, François Clément, Hansen Karina, Danchenko Natalya, Despiegel Nicolas
CPS Research, Glasgow, UK.
Pharmacoeconomics. 2008;26(11):969-81. doi: 10.2165/00019053-200826110-00008.
Selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs) are approved for the treatment of major depressive disorder (MDD). The allosteric SSRI escitalopram has been shown to be at least as clinically effective as the SNRIs venlafaxine and duloxetine in MDD, with a better tolerability profile. In addition, escitalopram has been shown to be cost saving compared with venlafaxine.
To evaluate the cost effectiveness of escitalopram versus duloxetine in the treatment of MDD, and to identify key cost drivers.
The pharmacoeconomic evaluation was conducted alongside a 24-week, double-blind, multinational randomized study (escitalopram 20 mg/day and duloxetine 60 mg/day) in outpatients with MDD, aged 18-65 years, with Montgomery-Asberg Depression Rating Scale (MADRS) score >or=26 and Clinical Global Impression Severity (CGI-S) score >or=4, and baseline duration of the current depressive episode of 12 weeks to 1 year.The analysis was conducted on the full analysis set (FAS), which included all patients with >or=1 valid post-baseline health economic assessment. Effectiveness outcomes of the cost-effectiveness analyses (CEA) included the change in Sheehan Disability Scale (SDS) score (primary CEA), treatment response (MADRS score decrease >or=50%) and remission (MADRS score <or=12) rates at week 24. Cost outcomes were assessed from the societal perspective. Healthcare resource use and sick leave were evaluated using a health economic assessment questionnaire. Unit costs of healthcare services were obtained from standard UK sources ( pound, year 2006 values).
Over the total 24-week study period, escitalopram was associated with significant cost savings compared with duloxetine (total per-patient monthly cost pound 188 vs pound 334, respectively). In the primary CEA, escitalopram dominated duloxetine (i.e. was more effective on the disability scale and less costly). Treatment with escitalopram resulted in significantly lower mean sick leave duration per patient over 24 weeks than duloxetine (30.7 days vs 62.2 days).In multivariate analyses, escitalopram as a treatment choice was associated with a 54% reduction in sick leave duration (p < 0.001). Treatment with escitalopram also resulted in 49% lower total costs than treatment with duloxetine (p = 0.002). Absenteeism accounted for about two-thirds of the overall cost. Early clinical improvement (mean change in MADRS total score, response and remission) had an independent significant impact on the sick leave duration, after controlling for key co-variates.
Escitalopram was associated with significantly lower duration of sick leave and significant savings in the total cost compared with duloxetine; it dominated duloxetine when effectiveness was assessed on the SDS scale. Indirect costs due to sick leave accounted for the most substantial portion of the total cost and should, therefore, be an important consideration when pharmacoeconomic comparisons between treatments are made from the societal perspective. The link between decrease in absenteeism and early (8-week) clinical improvement suggested in the additional analyses may explain the reduced sick leave observed with escitalopram, given its superior short-term efficacy compared with duloxetine (demonstrated in the underlying clinical trial).
选择性5-羟色胺再摄取抑制剂(SSRIs)和5-羟色胺-去甲肾上腺素再摄取抑制剂(SNRIs)已被批准用于治疗重度抑郁症(MDD)。变构性SSRI艾司西酞普兰已被证明在治疗MDD方面临床疗效至少与SNRIs文拉法辛和度洛西汀相当,且耐受性更佳。此外,与文拉法辛相比,艾司西酞普兰已被证明具有成本效益。
评估艾司西酞普兰与度洛西汀治疗MDD的成本效益,并确定关键成本驱动因素。
药物经济学评估与一项为期24周的双盲、多国随机研究(艾司西酞普兰20mg/天和度洛西汀60mg/天)同时进行,该研究针对年龄在18 - 65岁、蒙哥马利-阿斯伯格抑郁评定量表(MADRS)评分≥26且临床总体印象严重程度(CGI-S)评分≥4、当前抑郁发作的基线持续时间为12周至1年的MDD门诊患者。分析在全分析集(FAS)上进行,该全分析集包括所有具有≥1次有效基线后健康经济评估的患者。成本效益分析(CEA)的有效性结果包括希恩残疾量表(SDS)评分的变化(主要CEA)、治疗反应(MADRS评分降低≥50%)以及第24周时的缓解率(MADRS评分≤12)。成本结果从社会角度进行评估。使用健康经济评估问卷评估医疗资源使用和病假情况。医疗服务的单位成本从英国标准来源获取(英镑,2006年价值)。
在整个24周的研究期间,与度洛西汀相比,艾司西酞普兰可显著节省成本(每位患者每月总成本分别为188英镑和334英镑)。在主要CEA中,艾司西酞普兰优于度洛西汀(即在残疾量表上更有效且成本更低)。与度洛西汀相比,使用艾司西酞普兰治疗导致每位患者在24周内的平均病假持续时间显著缩短(30.7天对62.2天)。在多变量分析中,选择艾司西酞普兰作为治疗方法与病假持续时间减少54%相关(p < 0.001)。与度洛西汀治疗相比,使用艾司西酞普兰治疗的总成本也降低了49%(p = 0.002)。旷工占总体成本的约三分之二。在控制关键协变量后,早期临床改善(MADRS总分的平均变化、反应和缓解)对病假持续时间有独立的显著影响。
与度洛西汀相比,艾司西酞普兰可显著缩短病假持续时间并大幅节省总成本;在SDS量表上评估有效性时,艾司西酞普兰优于度洛西汀。病假导致的间接成本占总成本的最大部分,因此,从社会角度进行治疗之间的药物经济学比较时应予以重要考虑。额外分析中提示的旷工减少与早期(8周)临床改善之间的联系可能解释了观察到的艾司西酞普兰病假减少的情况,因为其与度洛西汀相比具有更优的短期疗效(在基础临床试验中已证明)。