Economic Evaluation of Medication-Assisted Substance Abuse Treatment

描述（由申请人提供）：戒毒是阿片类药物依赖治疗的主要手段，但以这种方式治疗的大多数患者复发阿片类药物滥用，导致昂贵且无效的重复戒毒再入院周期。NIDA的国家药物滥用治疗临床试验网络（CTN）已经启动了一项随机试验（CTN- 0051），该试验将评估使用缓释注射纳洛酮（XR-NTX）和丁丙诺啡-纳洛酮（BUP-NX）脱毒后预防阿片类药物依赖复发的比较有效性。这两种FDA批准的药物辅助门诊阿片类药物依赖治疗为办公室医疗环境中的阿片类药物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，但药物相对昂贵，其对患者和社会的益处尚未严格比较其成本。我们建议使用CTN-0051试验期间收集的患者特异性和研究中心水平数据对XR-NTX和BUP-NX进行经济学评价。在同一试验中同时收集成本和结果的数据，可以提高经济分析的内部有效性。我们还将探讨CTN-0051试验中进行的遗传数据分析结果的潜在经济影响。我们组建了一个由经济和卫生政策研究人员组成的独特合格的合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、支付者和患者的角度估计和比较使用XR-NTX和BUP-NX的阿片类药物依赖治疗的成本; 2）估计和比较使用XR-NTX和BUP-NX的阿片类药物依赖治疗的质量调整生命年（QALY）结果;（3）从社会角度看，评价与BUP-NX相比，使用XR-NTX治疗阿片类药物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）对治疗前基因检测的潜在成本效益进行探索性评估 与对使用XR-NTX或BUP-NX的阿片样物质依赖治疗的反应相关的变体（例如OPRM 1、OPRK 1、PDYN）。这项经济评价研究将有效利用目前在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基于证据的药物辅助阿片类药物依赖门诊治疗的成本、成本效益和成本效益的严格和政策相关结果。它还将通过包括考虑个性化治疗选择策略的创新方法以及通过探索药物滥用治疗前遗传筛查的成本效益来确定最有可能从药物辅助治疗中受益的患者来推进该领域。

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.