Wing Tech Inc., Menlo Park, CA, USA.
Ohio Sleep Medicine Institute, Dublin, OH, USA.
J Med Econ. 2024 Jan-Dec;27(1):1320-1327. doi: 10.1080/13696998.2024.2410595. Epub 2024 Oct 9.
Patients with medication-refractory restless legs syndrome (RLS) have limited therapeutic options available for symptom relief. Tonic motor activation (TOMAC) presents a novel, non-invasive therapy for this patient population. The aim of this study was to conduct an updated cost-effectiveness analysis of TOMAC therapy based on recently available longer-term follow-up data.
A previously published decision-analytic Markov model was utilized to project strategy-specific costs and outcomes over three-years and lifetime for TOMAC compared to status quo treatment (control). Cohort characteristics were based on 24-week clinical data from the extension cohort of the RESTFUL study, which included longer-term follow-up of RESTFUL completers who were assigned to continue or discontinue TOMAC use (TOMAC and control, respectively). The primary analysis outcome was the incremental cost-effectiveness ratio (ICER) in $ per quality-adjusted life year (QALY) gained, calculated using change in International RLS Study Group Rating Scale (IRLS) score as the effect measure. Extensive sensitivity analyses were performed.
TOMAC treatment improved IRLS by 5.9 versus control, resulting in estimated utility improvement of +0.05. Over three-years and lifetime, TOMAC added 0.14 and 0.73 QALYs, at incremental costs of $6,751 and $27,440, resulting in projected ICERs of $47,609 and $37,823 per QALY gained, respectively. TOMAC was found to be cost-effective across all tested sensitivity analyses.
The inclusion of longer follow-up data in the current analysis confirms earlier exploratory cost-effectiveness findings and suggest TOMAC therapy may provide a high-value treatment option for patients with medication-refractory RLS.
对于药物难治性不宁腿综合征（RLS）患者，缓解症状的治疗选择有限。紧张性运动激活（TOMAC）为这一患者群体提供了一种新颖的、非侵入性的治疗方法。本研究旨在根据最近获得的更长随访数据，对 TOMAC 治疗进行更新的成本效益分析。
使用先前发表的决策分析马尔可夫模型，在三年和终生的时间范围内，对 TOMAC 与现状治疗（对照组）相比的策略特异性成本和结果进行预测。队列特征基于 RESTFUL 研究扩展队列的 24 周临床数据，该队列包括对被分配继续或停止使用 TOMAC（TOMAC 和对照组）的 RESTFUL 完成者的更长时间随访。主要分析结果是增量成本效益比（ICER），即每获得一个质量调整生命年（QALY）的增量成本，使用国际 RLS 研究组评分（IRLS）评分的变化作为效果测量。进行了广泛的敏感性分析。
TOMAC 治疗使 IRLS 改善了 5.9 分，而对照组为 5.9 分，导致估计的效用改善为+0.05。在三年和终生时间内，TOMAC 分别增加了 0.14 和 0.73 QALYs，增量成本分别为 6751 美元和 27440 美元，导致预计的每获得一个 QALY 的增量成本分别为 47609 美元和 37823 美元。在所有测试的敏感性分析中，TOMAC 均被认为具有成本效益。
当前分析中纳入了更长的随访数据，证实了早期探索性成本效益发现，并表明 TOMAC 治疗可能为药物难治性 RLS 患者提供一种高价值的治疗选择。
