Medical Decision Modeling Inc., 8909 Purdue Road, Suite #550, Indianapolis, IN 46268, USA.
Appl Health Econ Health Policy. 2013 Jun;11(3):219-36. doi: 10.1007/s40258-013-0031-3.
Duloxetine has recently been approved in the USA for chronic musculoskeletal pain, including osteoarthritis and chronic low back pain. The cost effectiveness of duloxetine in osteoarthritis has not previously been assessed. Duloxetine is targeted as post first-line (after acetaminophen) treatment of moderate to severe pain.
The objective of this study was to estimate the cost effectiveness of duloxetine in the treatment of osteoarthritis from a US private payer perspective compared with other post first-line oral treatments, including nonsteroidal anti-inflammatory drugs (NSAIDs), and both strong and weak opioids.
A cost-utility analysis was performed using a discrete-state, time-dependent semi-Markov model based on the National Institute for Health and Clinical Excellence (NICE) model documented in its 2008 osteoarthritis guidelines. The model was extended for opioids by adding titration, discontinuation and additional adverse events (AEs). A life-long time horizon was adopted to capture the full consequences of NSAID-induced AEs. Fourteen health states comprised the structure of the model: treatment without persistent AE, six during-AE states, six post-AE states and death. Treatment-specific utilities were calculated using the transfer-to-utility method and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total scores from a meta-analysis of osteoarthritis clinical trials of 12 weeks and longer. Costs for 2011 were estimated using Red Book, The Agency for Healthcare Research and Quality's Healthcare Cost and Utilization Project database, the literature and, sparingly, expert opinion. One-way and probabilistic sensitivity analyses were undertaken, as well as subgroup analyses of patients over 65 years old and a population at greater risk of NSAID-related AEs.
In the base case the model estimated naproxen to be the lowest total-cost treatment, tapentadol the highest cost, and duloxetine the most effective after considering AEs. Duloxetine accumulated 0.027 discounted quality-adjusted life-years (QALYs) more than naproxen and 0.013 more than oxycodone. Celecoxib was dominated by naproxen, tramadol was subject to extended dominance, and strong opioids were dominated by duloxetine. The model estimated an incremental cost-effectiveness ratio (ICER) of US$47,678 per QALY for duloxetine versus naproxen. One-way sensitivity analysis identified the probabilities of NSAID-related cardiovascular AEs as the inputs to which the ICER was most sensitive when duloxetine was compared with an NSAID. When compared with a strong opioid, duloxetine dominated the opioid under nearly all sensitivity analysis scenarios. When compared with tramadol, the ICER was most sensitive to the costs of duloxetine and tramadol. In subgroup analysis, the cost per QALY for duloxetine versus naproxen fell to US$24,125 for patients over 65 years and to US$18,472 for a population at high risk of cardiovascular and gastrointestinal AEs.
The model estimated that duloxetine was potentially cost effective in the base-case population and more cost effective for subgroups over 65 years or at high risk of NSAID-related AEs. In sensitivity analysis, duloxetine dominated all strong opioids in nearly all scenarios.
度洛西汀最近已在美国获准用于治疗慢性肌肉骨骼疼痛,包括骨关节炎和慢性腰痛。度洛西汀治疗骨关节炎的成本效益尚未进行评估。度洛西汀被定位为一线治疗后(在使用对乙酰氨基酚后)治疗中重度疼痛的药物。
本研究旨在从美国私人支付者的角度评估度洛西汀治疗骨关节炎的成本效益,与其他一线治疗后(在使用对乙酰氨基酚后)的口服药物相比,包括非甾体抗炎药(NSAIDs)、强阿片类药物和弱阿片类药物。
使用基于英国国家卫生与临床优化研究所(NICE)2008 年骨关节炎指南中记录的模型的离散状态、时变半马尔可夫模型进行成本效用分析。通过添加滴定、停药和其他不良反应(AE),将该模型扩展到阿片类药物。采用终生时间范围来捕捉 NSAID 相关 AE 的全部后果。模型的结构由 14 个健康状态组成:无持续性 AE 的治疗、6 个 AE 期间状态、6 个 AE 后状态和死亡。使用转移到效用法和 Western Ontario 和 McMaster 大学骨关节炎指数(WOMAC)总评分来计算特定治疗的效用,该评分来自长达 12 周的骨关节炎临床试验的荟萃分析。2011 年的成本使用 Red Book、美国医疗保健研究与质量局的医疗保健成本和利用项目数据库、文献以及专家意见进行估计。进行了单因素敏感性分析和概率敏感性分析,以及对 65 岁以上患者和 NSAID 相关 AE 风险较高的人群进行亚组分析。
在基准情况下,该模型估计萘普生是总成本最低的治疗药物,他喷他多是成本最高的药物,而度洛西汀在考虑 AE 后是最有效的药物。与萘普生相比,度洛西汀累积了 0.027 个贴现质量调整生命年(QALY),与羟考酮相比,累积了 0.013 个 QALY。塞来昔布被萘普生所取代,曲马多受到延长性的支配,强阿片类药物则被度洛西汀所取代。该模型估计,与萘普生相比,度洛西汀的增量成本效益比(ICER)为 47678 美元/QALY。单因素敏感性分析确定 NSAID 相关心血管 AE 的概率是度洛西汀与 NSAID 相比时对 ICER 最敏感的输入。与强阿片类药物相比,度洛西汀在几乎所有敏感性分析场景下都优于阿片类药物。与曲马多相比,度洛西汀和曲马多的成本对 ICER 最敏感。在亚组分析中,度洛西汀与萘普生相比,65 岁以上患者的 QALY 成本降至 24125 美元,心血管和胃肠道 AE 风险较高的人群的 QALY 成本降至 18472 美元。
该模型估计,在基准人群中,度洛西汀可能具有成本效益,并且对于 65 岁以上或 NSAID 相关 AE 风险较高的亚组,其成本效益更高。在敏感性分析中,度洛西汀在几乎所有情况下都优于所有强阿片类药物。