Adis, Auckland, New Zealand.
Pharmacoeconomics. 2012 Jul 1;30(7):611-31. doi: 10.2165/11208500-000000000-00000.
This article briefly summarizes the burden of bipolar disorder and the clinical profile of quetiapine (Seroquel®) in the management of bipolar disorder, followed by a detailed review of pharmacoeconomic analyses. Quetiapine is an atypical antipsychotic that is available in numerous countries as immediate-release and extended-release tablets for the treatment of major psychiatric disorders, including bipolar disorder. Randomized, double-blind, placebo-controlled trials with quetiapine have demonstrated its efficacy in bipolar I and II disorders, and the drug has been generally well tolerated in clinical trials. Three cost-effectiveness analyses of maintenance therapy in bipolar I disorder, which used similar Markov models and incorporated data from key clinical trials and a number of other sources, showed that quetiapine, as adjunctive therapy with mood stabilizers (lithium or divalproex), was a cost-effective treatment option from the healthcare payer perspective in the UK and the US. Quetiapine either dominated comparators (typically mood stabilizers alone) or was associated with incremental cost-effectiveness ratios that were usually well below widely accepted thresholds of cost effectiveness. One of the studies evaluated extended-release quetiapine, although clinical efficacy data used in the Markov model were for the immediate-release formulation. In another analysis, which used a discrete-event simulation model and was conducted from the perspective of the UK healthcare payer, quetiapine monotherapy was cost effective compared with olanzapine monotherapy as maintenance treatment for all phases of bipolar I or II disorder. In this model, favourable results were also shown for quetiapine (with or without mood stabilizers) compared with a wide range of maintenance therapy regimens. Another modelled analysis conducted from the UK healthcare payer perspective showed that quetiapine was dominated by haloperidol in the short-term treatment of a manic episode in patients with bipolar I disorder. Both favourable and unfavourable results have been reported in cost analyses of quetiapine in bipolar disorder (type I or type not specified). Possible explanations for some of the variability in results of the pharmacoeconomic analyses include heterogeneity among the models in terms of input parameters or assumptions in the base-case analyses, country- or region-specific differences in estimates of healthcare resource use and associated costs, variability in treatment alternatives, and differences in the year of costing and discounting used in the analyses. In addition, some of the studies had short time horizons and focused on acute manic episodes only, whereas others were longer-term analyses that considered the full spectrum of health states in patients with bipolar disorder. Various limitations of the studies have been recognized, and results from one country may not be applicable to other countries. In conclusion, results of available pharmacoeconomic analyses provide evidence of the cost effectiveness of quetiapine as an adjunct to mood stabilizers for maintenance therapy in (primarily type I) bipolar disorder from a healthcare payer perspective in the UK and the US. Some evidence is available to support the cost effectiveness of quetiapine monotherapy or the use of extended-release quetiapine as adjunctive therapy with mood stabilizers in this setting, although further analyses appear to be warranted. Whether these findings apply to other geographical regions requires further study. Evidence for the long-term (>2-year) cost effectiveness of quetiapine in bipolar disorder is currently limited and further studies are also needed to address the cost effectiveness of quetiapine from a societal perspective and in bipolar II disorder.
本文简要总结了双相情感障碍的负担和喹硫平(思瑞康)在双相情感障碍管理中的临床特征,随后详细回顾了药物经济学分析。喹硫平是一种非典型抗精神病药物,在许多国家都有上市,有速释和缓释片剂,用于治疗主要精神疾病,包括双相情感障碍。喹硫平的随机、双盲、安慰剂对照试验表明其在双相 I 型和 II 型障碍中的疗效,并且在临床试验中通常具有良好的耐受性。三项关于双相 I 型障碍维持治疗的成本效益分析使用了相似的 Markov 模型,并纳入了关键临床试验和其他一些来源的数据,表明从医疗保健支付者的角度来看,喹硫平作为心境稳定剂(锂或丙戊酸钠)的辅助治疗是一种具有成本效益的治疗选择,在英国和美国。喹硫平要么优于对照药物(通常是单独使用心境稳定剂),要么与增量成本效益比相关,通常远低于广泛接受的成本效益阈值。其中一项研究评估了缓释喹硫平,尽管 Markov 模型中使用的临床疗效数据是针对速释制剂的。在另一项分析中,使用离散事件模拟模型,从英国医疗保健支付者的角度出发,喹硫平单药治疗与奥氮平单药治疗相比,作为所有双相 I 或 II 型障碍阶段的维持治疗具有成本效益。在该模型中,喹硫平(联合或不联合心境稳定剂)与广泛的维持治疗方案相比,也显示出有利的结果。另一项从英国医疗保健支付者角度进行的建模分析表明,在治疗双相 I 型障碍患者的躁狂发作的短期治疗中,喹硫平优于氟哌啶醇。在双相情感障碍(I 型或未指定类型)的喹硫平成本分析中,报告了有利和不利的结果。药物经济学分析结果的一些差异可能归因于基础分析中模型输入参数或假设的异质性、不同国家或地区的医疗资源使用和相关成本估计值的差异、治疗选择的变异性以及分析中使用的定价和贴现的年度差异。此外,一些研究的时间范围较短,仅关注急性躁狂发作,而其他研究则是长期分析,考虑了双相情感障碍患者的所有健康状况。已经认识到各种研究的局限性,并且一项研究的结果可能不适用于其他国家。总之,现有药物经济学分析的结果提供了证据,证明从英国和美国医疗保健支付者的角度来看,喹硫平作为心境稳定剂的辅助治疗在(主要是 I 型)双相情感障碍中的成本效益。有一些证据支持喹硫平单药治疗或缓释喹硫平作为辅助治疗的成本效益,尽管似乎需要进一步的分析。这些发现是否适用于其他地理区域需要进一步研究。目前,双相情感障碍中喹硫平长期(>2 年)成本效益的证据有限,还需要进一步研究从社会角度和双相 II 型障碍来评估喹硫平的成本效益。