Medical Affairs, Research and Development, Pear Therapeutics, Inc, Boston, MA, United States.
Formerly with Xcenda, LLC., Palm Harbor, FL, United States.
Postgrad Med. 2021 May;133(4):421-427. doi: 10.1080/00325481.2021.1884471. Epub 2021 Feb 22.
The opioid epidemic continues to generate a significant mental and physical health burden on patients, and claims the life of almost 150 Americans daily. Making matters worse, an increase in relapses and/or opioid-related deaths has been reported in more than 40 U.S. states since the start of the COVID-19 pandemic. Opioid use disorder (OUD) is one of the single most expensive disorders in the United States, generating average medical costs of $60B from just 2 million Americans diagnosed with the disorder. In commercial use since 2019, reSET-O is a non-drug, prescription digital therapeutic (PDT) that delivers evidence-based neurobehavioral treatment for OUD and helps overcome the barriers associated with access to care, stigma, and social distancing. Although shown to be cost effective and efficacious in clinical trials and real-world evidence studies, respectively, information on its value for money from a health utilities and cost per quality-adjusted life-year is needed to inform policy discussions. To evaluate the impact of reSET-O on health utilities and assess its overall cost per quality-adjusted life year (QALY) gained vs. treatment-as-usual (TAU). Decision analytic model comparing reSET-O plus TAU to TAU alone (i.e. buprenorphine, face-to-face counseling, and contingency management) over 12 weeks. Clinical effectiveness data (abstinence and health utility) were obtained from a clinical trial, and resource utilization and cost data were adapted from a recent claims data analysis to reflect less frequent face-to-face counseling with the therapeutic. The addition of reSET-O to TAU decreases total health care costs by -$131 and resulted in post-treatment utility values within population norms, with a corresponding gain of 0.003 QALYs. reSET-O when used adjunctively to TAU was economically dominant (less costly, more effective) vs. TAU alone. reSET-O is an economically-dominant adjunctive treatment for OUD and is associated with an overall reduction in total incremental cost vs TAU.
阿片类药物泛滥继续给患者带来严重的身心健康负担，几乎每天有 150 名美国人因此丧生。更糟糕的是，自 COVID-19 大流行开始以来，美国 40 多个州报告称复发和/或阿片类药物相关死亡人数有所增加。阿片类药物使用障碍（OUD）是美国最昂贵的疾病之一，仅 200 万被诊断患有该疾病的美国人就产生了 600 亿美元的平均医疗费用。自 2019 年以来，reSET-O 一直被用于商业用途，它是一种非药物、处方数字疗法（PDT），可提供针对 OUD 的循证神经行为治疗，并有助于克服获得治疗、污名化和社交距离的障碍。尽管在临床试验和真实世界证据研究中分别显示出具有成本效益和疗效，但需要了解其健康效用和每质量调整生命年成本的信息，以告知政策讨论。评估 reSET-O 对健康效用的影响，并评估其与常规治疗相比的每质量调整生命年（QALY）总成本。比较 reSET-O 加常规治疗与单独常规治疗（即丁丙诺啡、面对面咨询和应急管理）的 12 周决策分析模型。临床疗效数据（戒断和健康效用）来自临床试验，资源利用和成本数据来自最近的一项索赔数据分析，以反映治疗中面对面咨询频率降低。将 reSET-O 添加到常规治疗中可降低总医疗保健成本 131 美元，并使治疗后人群内的效用值达到正常值，相应地获得 0.003 的 QALY。与单独常规治疗相比，reSET-O 联合常规治疗具有经济学优势（成本更低、效果更好）。reSET-O 是一种经济优势的 OUD 辅助治疗方法，与常规治疗相比，总成本总增量降低。
