Health Economics and Real World Evidence, Pear Therapeutics, Inc ., Boston, MA, USA.
Consulting, Covance Market Access , Gaithersburg, MD, USA.
Expert Rev Pharmacoecon Outcomes Res. 2021 Feb;21(1):69-76. doi: 10.1080/14737167.2021.1840357. Epub 2020 Nov 4.
Buprenorphine medication assisted treatment (B-MAT) adherence for opioid use disorder (OUD) is suboptimal. reSET-O, an FDA-cleared prescription digital therapeutic, delivers neurobehavioral therapy (community-reinforcement approach+fluency training+contingency management) to B-MAT-treated OUD patients.
This retrospective claims study (10/01/2018-10/31/2019) evaluated healthcare resource utilization up to 6 months before/after reSET-O initiation. Repeated-measures negative binomial models compared incidences of encounters/procedures. Net change in costs was assessed.
Among 351 patients (mean age 37; 59.5% female; 82.6% Medicaid), 334 had pharmacy claims and 240 (71.9%) received buprenorphine pre-/post-index (medication possession ratio 0.73 and 0.82, respectively; 0.004). Facility encounters decreased, with 45 fewer inpatient (0.024) and 27 fewer emergency department (ED) visits (0.247). Clinical encounters with largest changes were drug testing (638 fewer; 0.001), psychiatry (349 fewer; 0.036), case management (176 additional; 0.588), other pathology/laboratory (166 fewer; 0.039), office/other outpatient (154 fewer; 0.302), behavioral rehabilitation (111 additional; 0.124), alcohol/substance rehabilitation (96 fewer; 0.348), other rehabilitation (66 fewer; 0.387), mental health rehabilitation (61 additional; 0.097), and surgery (60 fewer; 0.070). Changes in facility/clinical encounters saved $2,150/patient.
reSET-O initiation was associated with fewer inpatient, ED, and other clinical encounters, increased case management/rehabilitative services, and lower net costs over six months.
Real-world evidence is helpful in evaluating the effectiveness of interventions in usual-care conditions, outside of controlled research environments. Large observational studies based on health care claims are important to understand the actual pharmacoeconomic and outcomes impact of interventions at the health care system and population level.
阿片类药物使用障碍(OUD)的丁丙诺啡药物辅助治疗(B-MAT)的依从性并不理想。reSET-O 是一种获得美国食品药品监督管理局批准的处方数字治疗方法,为接受 B-MAT 治疗的 OUD 患者提供神经行为治疗(社区强化方法+流畅性训练+依情况处理)。
这项回顾性索赔研究(2018 年 10 月 1 日至 2019 年 10 月 31 日)评估了 reSET-O 启动前/后 6 个月内的医疗资源利用情况。重复测量负二项式模型比较了就诊/程序的发生率。评估了成本的净变化。
在 351 名患者(平均年龄 37 岁;59.5%为女性;82.6%为医疗补助)中,334 名有药房理赔记录,240 名(71.9%)在指数前/后接受丁丙诺啡治疗(药物持有率分别为 0.73 和 0.82;0.004)。就诊次数减少,住院人数减少 45 人(0.024),急诊就诊人数减少 27 人(0.247)。变化最大的临床就诊是药物检测(减少 638 次;0.001)、精神病学(减少 349 次;0.036)、个案管理(增加 176 次;0.588)、其他病理学/实验室(减少 166 次;0.039)、门诊/其他门诊(减少 154 次;0.302)、行为康复(增加 111 次;0.124)、酒精/药物康复(减少 96 次;0.348)、其他康复(减少 66 次;0.387)、心理健康康复(增加 61 次;0.097)和手术(减少 60 次;0.070)。设施/临床就诊次数的减少使每位患者节省了 2150 美元。
reSET-O 的启动与住院、急诊和其他临床就诊次数的减少,个案管理/康复服务的增加以及六个月内净成本的降低有关。
真实世界的证据有助于在非受控研究环境之外,在常规护理条件下评估干预措施的有效性。基于医疗保健索赔的大型观察性研究对于了解干预措施在医疗保健系统和人群层面的实际药物经济学和结果影响非常重要。