Igarashi Ataru, Akazawa Manabu, Murata Tatsunori, Taguchi Toshihiko, Sadosky Alesia, Ebata Nozomi, Willke Richard, Fujii Koichi, Doherty Jim, Kobayashi Makoto
Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan.
Department of Public Health and Epidemiology, Meiji Pharmaceutical University, Tokyo, Japan.
Clinicoecon Outcomes Res. 2015 Oct 7;7:505-20. doi: 10.2147/CEOR.S89833. eCollection 2015.
To assess the cost-effectiveness of pregabalin for the treatment of chronic low back pain with accompanying neuropathic pain (CLBP-NeP) from the health care payer and societal perspectives.
The cost-effectiveness of pregabalin versus usual care for treatment of CLBP-NeP was evaluated over a 12-month time horizon using the incremental cost-effectiveness ratio (ICER). Quality-adjusted life years (QALYs), derived from the five-dimension, five-level EuroQol (EQ-5D-5L) questionnaire, was the measure of effectiveness. Medical costs and productivity losses were both calculated. Expected costs and outcomes were estimated via cohort simulation using a state-transition model, which mimics pain state transitions among mild, moderate, and severe pain. Distributions of pain severity were obtained from an 8-week noninterventional study. Health care resource consumption for estimation of direct medical costs for pain severity levels was derived from a physician survey. The ICER per additional QALY gained was calculated and sensitivity analyses were performed to evaluate the robustness of the assumptions across a range of values.
Direct medical costs and hospitalization costs were both lower in the pregabalin arm compared with usual care. The estimated ICERs in the base case scenarios were approximately ¥2,025,000 and ¥1,435,000 per QALY gained with pregabalin from the payer and societal perspectives, respectively; the latter included indirect costs related to lost productivity. Sensitivity analyses using alternate values for postsurgical pain scores (0 and 5), initial pain severity levels (either all moderate or all severe), and the actual EQ-5D-5L scores from the noninterventional study showed robustness of results, with ICERs that were similar to the base case. Development of a cost-effectiveness acceptability curve showed high probability (≥75%) of pregabalin being cost-effective.
Using data and assumptions from routine clinical practice, pregabalin is cost-effective for the treatment of CLBP-NeP in Japan.
从医疗保健支付方和社会角度评估普瑞巴林治疗伴有神经性疼痛的慢性下腰痛（CLBP-NeP）的成本效益。
采用增量成本效益比（ICER），在12个月的时间范围内评估普瑞巴林与常规治疗相比治疗CLBP-NeP的成本效益。从五维度、五级欧洲五维度健康量表（EQ-5D-5L）问卷得出的质量调整生命年（QALYs）作为疗效衡量指标。计算医疗成本和生产力损失。通过使用状态转换模型的队列模拟估算预期成本和结果，该模型模拟轻度、中度和重度疼痛之间的疼痛状态转换。疼痛严重程度分布来自一项为期8周的非干预性研究。通过医生调查得出用于估算不同疼痛严重程度水平直接医疗成本的医疗资源消耗情况。计算每增加一个获得的QALY的ICER，并进行敏感性分析以评估一系列值假设的稳健性。
与常规治疗相比，普瑞巴林组的直接医疗成本和住院成本均较低。在基础病例情景中，从支付方和社会角度来看，使用普瑞巴林每获得一个QALY的估计ICER分别约为202.5万日元和143.5万日元；后者包括与生产力损失相关的间接成本。使用手术疼痛评分的替代值（0和5）、初始疼痛严重程度水平（全部为中度或全部为重度）以及非干预性研究的实际EQ-5D-5L评分进行的敏感性分析表明结果具有稳健性，ICER与基础病例相似。成本效益可接受性曲线的绘制显示普瑞巴林具有成本效益的概率很高（≥75%）。
根据常规临床实践的数据和假设，在日本，普瑞巴林治疗CLBP-NeP具有成本效益。
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