Economic Evaluation of Medication-Assisted Substance Abuse Treatment

描述(申请人提供)：戒毒是治疗阿片类药物依赖的主要方法，但以这种方式治疗的大多数患者会再次滥用阿片类药物，导致重复戒毒的昂贵和无效的再入院周期。NIDA的全国药物滥用治疗临床试验网络(CTN)启动了一项随机试验(CTN-0051)，将评估缓释注射纳曲酮(XR-NTX)和丁丙诺啡-纳洛酮(BUP-NX)预防阿片依赖戒断后复发的比较效果。这两种FDA批准的药物辅助门诊阿片依赖治疗方法为办公室医疗环境中的阿片依赖治疗提供了有希望的替代方案，避免了与美沙酮维持治疗相关的不便和耻辱，但这些药物相对昂贵，而且它们对患者和社会的好处尚未严格与其成本进行比较。我们建议使用CTN-0051试验期间收集的特定患者和部位水平的数据对XR-NTX和BUP-NX进行经济学评估。在同一试验中同时收集关于成本和结果的数据，提高了经济分析的内部有效性。我们还将探索CTN-0051试验中进行的遗传数据分析结果的潜在经济影响。我们已经组建了一支由经济和卫生政策研究人员组成的具有独特资质的协作团队来完成这些分析。我们的具体目标是：1)从治疗提供者、付款人和患者的角度估计和比较XR-NTX和BUP-NX治疗阿片依赖的成本；2)估计和比较XR-NTX和BUP-NX治疗阿片依赖的质量调整生命年(QALY)结果；3)从社会角度，评估XR-NTX和BUP-NX治疗阿片依赖的增量成本效益和成本效益(以及个性化治疗选择策略的增量成本效益)；以及4)对基因治疗前检测的潜在成本-效果进行探索性评估 与XR-NTX或BUP-NX阿片依赖治疗反应相关的变异体(如OPRM1、OPRK1、PDYN)。这项经济评估研究将有效地利用目前在CTN-0051临床试验中进行的投资，并将向各种利益相关者提供关于提供阿片类药物依赖的循证药物辅助门诊治疗的成本、成本效益和成本效益的严格和政策相关的发现。它还将推动这一领域的发展，包括考虑个性化治疗选择战略的创新方法，以及探索在药物滥用治疗之前进行基因筛查的成本效益，以确定最有可能从药物辅助治疗中受益的患者。

DESCRIPTION (provided by applicant): Detoxification is a mainstay of treatment for opioid dependence, but the majority of patients treated in this way relapse to opioid misuse leading to a costly and ineffectual cycle of readmission for repeated detoxification. NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN) has initiated a randomized trial (CTN- 0051) that will assess the comparative effectiveness of preventing opioid dependence relapse after detoxification with extended-release injectable naltrexone (XR-NTX) and buprenorphine-naloxone (BUP-NX). These two FDA-approved medication-assisted outpatient opioid dependence treatments offer promising alternatives for opioid dependence treatment in office-based medical settings, avoiding the inconvenience and stigma associated with methadone maintenance treatment, but the medications are relatively expensive and their benefits to patients and society have not been rigorously compared to their costs. We propose to conduct an economic evaluation of XR-NTX and BUP-NX using patient-specific and site-level data collected during the CTN-0051 trial. Collecting data simultaneously on both costs and outcomes in the same trial improves the internal validity of economic analyses. We will also explore potential economic implications of findings from genetic data analyses being conducted in the CTN-0051 trial. We have assembled a uniquely qualified collaborative team of economic and health policy researchers to complete these analyses. Our specific aims are to: 1) estimate and compare costs of opioid dependence treatment with XR-NTX and BUP-NX from the perspectives of the treatment provider, the payer, and the patient; 2) estimate and compare quality-adjusted life year (QALY) outcomes for opioid dependence treatment with XR-NTX and BUP-NX; 3) from a societal perspective, evaluate the incremental cost-effectiveness and cost-benefit of opioid dependence treatment with XR-NTX compared to BUP-NX (as well as the incremental cost-effectiveness of a personalized treatment selection strategy); and 4) conduct an exploratory evaluation of the potential cost-effectiveness of pre- treatment testing for genetic variants (e.g. OPRM1, OPRK1, PDYN) associated with responses to opioid dependence treatment with XR-NTX or BUP-NX. This economic evaluation study will efficiently leverage the investment currently being made in the CTN-0051 clinical trial, and will provide rigorous and policy-relevant findings to a variety of stakeholders about the cost, cost-effectiveness, and cost-benefit of delivering evidence- based medication-assisted outpatient treatment for opioid dependence. It will also advance the field by including innovative methods to consider a personalized treatment selection strategy and by exploring the cost- effectiveness of genetic screening prior to substance abuse treatment to identify patients most likely to benefit from medication-assisted treatments.