Carter John A, Dammerman Ryan, Frost Michael
a EPI-Q Inc. , Oak Brook , IL , USA.
b Formerly of Braeburn Pharmaceuticals , Princeton , NJ , USA.
J Med Econ. 2017 Aug;20(8):893-901. doi: 10.1080/13696998.2017.1341416. Epub 2017 Jun 22.
Subdermal implantable buprenorphine (BSI) was recently approved to treat opioid use disorder (OUD) in clinically-stable adults. In the pivotal clinical trial, BSI was associated with a higher proportion of completely-abstinent patients (85.7% vs 71.9%; p = .03) vs sublingual buprenorphine (SL-BPN). Elsewhere, relapse to illicit drug use is associated with diminished treatment outcomes and increased costs. This study evaluated the cost-effectiveness of BSI vs SL-BPN from a US societal perspective.
A Markov model simulated BSI and SL-BPN cohorts (clinically-stable adults) transiting through four mutually-exclusive health states for 12 months. Cohorts accumulated direct medical costs from drug acquisition/administration; treatment-diversion/abuse; newly-acquired hepatitis-C; emergency room, hospital, and rehabilitation services; and pediatric poisonings. Non-medical costs of criminality, lost wages/work-productivity, and out-of-pocket expenses were also included. Transition probabilities to a relapsed state were derived from the aforementioned trial. Other transition probabilities, costs, and health-state utilities were derived from observational studies and adjusted for trial characteristics. Outcomes included incremental cost per quality-adjusted-life-year (QALY) gained and incremental net-monetary-benefit (INMB). Uncertainty was assessed by univariate and probabilistic sensitivity analysis (PSA).
BSI was associated with lower total costs (-$4,386), more QALYs (+0.031), and favorable INMB at all willingness-to-pay (WTP) thresholds considered. Higher drug acquisition costs for BSI (+$6,492) were outpaced, primarily by reductions in emergency room/hospital utilization (-$8,040) and criminality (-$1,212). BSI was cost-effective in 89% of PSA model replicates, and had a significantly higher NMB at $50,000/QALY ($20,783 vs $15,007; p < .05).
BSI was preferred over SL-BPN from a health-economic perspective for treatment of OUD in clinically-stable adults. These findings should be interpreted carefully, due to some relationships having been modeled from inputs derived from multiple sources, and would benefit from comparison with outcomes from studies that employ administrative claims data or a naturalistic comparative design.
皮下植入式丁丙诺啡（BSI）最近被批准用于治疗临床状况稳定的成年阿片类药物使用障碍（OUD）患者。在关键临床试验中，与舌下含服丁丙诺啡（SL - BPN）相比，接受BSI治疗的完全戒断患者比例更高（85.7%对71.9%；p = 0.03）。在其他地方，复吸非法药物与治疗效果降低和成本增加相关。本研究从美国社会角度评估了BSI与SL - BPN的成本效益。
一个马尔可夫模型模拟了BSI和SL - BPN队列（临床状况稳定的成年人）在12个月内经历的四种相互排斥的健康状态。队列积累了药物获取/给药、治疗转移/滥用、新感染丙型肝炎、急诊室、医院和康复服务以及儿童中毒方面的直接医疗成本。还包括犯罪、工资/工作生产力损失和自付费用等非医疗成本。向复发状态的转移概率来自上述试验。其他转移概率、成本和健康状态效用来自观察性研究，并根据试验特征进行了调整。结果包括每获得一个质量调整生命年（QALY）的增量成本和增量净货币效益（INMB）。通过单变量和概率敏感性分析（PSA）评估不确定性。
在所有考虑的支付意愿（WTP）阈值下，BSI与更低的总成本（-4386美元）、更多的QALY（+0.031）以及有利的INMB相关。BSI较高的药物获取成本（+6492美元）主要被急诊室/医院利用率的降低（-8040美元）和犯罪成本的降低（-1212美元）所抵消。在PSA模型重复中，89%的情况下BSI具有成本效益，并且在50000美元/QALY时具有显著更高的净货币效益（20783美元对15007美元；p < 0.05）。
从健康经济学角度来看，对于临床状况稳定的成年OUD患者的治疗，BSI优于SL - BPN。由于一些关系是根据来自多个来源的输入进行建模的，这些发现应谨慎解释，并且与采用行政索赔数据或自然主义比较设计的研究结果进行比较将有所助益。
