The Moran Company, Arlington, VA, USA.
J Med Econ. 2013;16(1):62-74. doi: 10.3111/13696998.2012.724745. Epub 2012 Sep 17.
Major depressive disease (MDD) represents a cost burden to the US healthcare system: approximately one-third of MDD patients fail conventional treatment: multiple failures define treatment-resistant depression (TRD). Vagus nerve stimulation (VNS) therapy is an approved adjunctive treatment for TRD.
To study the healthcare utilization experience of Medicare beneficiaries implanted with VNS (VNSBs) during Medicare coverage, compared with beneficiaries with TRD (TRDBs) and managed depression (Mdeps).
A retrospective analysis of 100% standard analytic file (SAF) Medicare claims from 2006-2009 using specific criteria to identify a VNSB dataset, compared to TRDs and Mdeps datasets (extract of 5% sample SAF from 2001-2009) and 2009 general Medicare beneficiaries (GMBs). Comparative analysis included demographics, mortality, healthcare utilization, and costs.
Among patients meeting study criteria for VNSBs (n = 690), TRDBs (n = 4639), Mdeps (n = 7524), and GMBs (n > 36 million), VNSBs were on average: younger, more likely to be female, and white, with Medicare eligibility due to disability. Of the VNSBs in the 2-year post-implantation period: 5% died; 22% experienced no negative events (defined as hospitalizations for psychoses or poisoning, emergency room use, electroconvulsive therapy, or poisoning, suicidal ideation, or self-harm diagnoses); 29% experienced multiple negative events; and 41% had either a single hospitalization or only all-cause ER visits. VNSBs experiencing negative events had more complex co-occurring psychiatric diagnoses. The annual mortality rate for VNSBs post-implant was 19.9 deaths per 1000 patient years, compared with 46.2 (CI: 41.9-51.6) and 46.8 (CI: 43.4-50.4) deaths for TRDBs and Mdeps, respectively. The medical costs per patient-year post-VNS implantation for VNSBs ($8749) was similar to the Mdeps ($8960; CI $8555-$9381) and was substantially lower than TRDBs ($13,618; CI $12,937-$14,342).
VNSBs achieving positive health outcomes (measured by lack of negative events post-implantation) tend to have fewer psychiatric co-occurring conditions. Lowered costs post-implantation with evidence of response to VNS suggest the therapy represents an option for carefully screened TRDBs who have failed other therapies.
Administrative data are missing pharmaceuticals and clinical measures. Data for the VNS population were not available pre-implantation for comparison to post-implantation experience. Cost comparisons are adjusted for missing costs in the VNS dataset.
重度抑郁症（MDD）给美国医疗保健系统带来了巨大的经济负担：约三分之一的 MDD 患者无法通过常规治疗缓解，多次治疗失败即定义为治疗抵抗性抑郁症（TRD）。迷走神经刺激（VNS）疗法是一种经过批准的 TRD 辅助治疗方法。
研究医疗保险受益人的医疗保健利用经验植入迷走神经刺激器（VNSBs）在医疗保险覆盖期间，与 TRD（TRDBs）和管理性抑郁症（Mdeps）的受益人的比较。
对 2006-2009 年 100%标准分析文件（SAF）医疗保险索赔进行回顾性分析，使用特定标准确定 VNSB 数据集，与 TRD 和 Mdeps 数据集（2001-2009 年 5%样本 SAF 的提取）和 2009 年普通医疗保险受益人（GMB）进行比较。比较分析包括人口统计学、死亡率、医疗保健利用和成本。
在符合 VNSB 研究标准的患者中（n=690），TRDB（n=4639）、Mdeps（n=7524）和 GMB（n>3600 万），VNSB 患者平均年龄更小，更有可能是女性，并且是白人，因残疾而有资格享受医疗保险。在植入后的 2 年期间：5%的患者死亡；22%的患者没有出现负面事件（定义为精神病或中毒、急诊室使用、电惊厥治疗或中毒、自杀意念或自伤诊断的住院治疗）；29%的患者出现多次负面事件；41%的患者只有单次住院或仅全因急诊室就诊。经历负面事件的 VNSB 患者有更多复杂的共发精神诊断。VNSB 患者植入后的年死亡率为每 1000 患者年 19.9 例死亡，而 TRDB 和 Mdeps 分别为每 1000 患者年 46.2（CI：41.9-51.6）和 46.8（CI：43.4-50.4）例死亡。VNS 植入后每位患者每年的医疗费用（VNSB 为 8749 美元）与 Mdeps（8960 美元；CI：8555-9381 美元）相似，明显低于 TRDB（13618 美元；CI：12937-14342 美元）。
在植入后缺乏负面事件的情况下，VNSB 患者获得积极健康结果的倾向更有可能有较少的共发精神疾病。植入后降低成本和对 VNS 反应的证据表明，该疗法是一种可供经过仔细筛选的 TRD 患者选择的治疗方法，这些患者已经对其他治疗方法无效。
行政数据中缺少药品和临床指标。VNS 人群的数据在植入前不可用，无法与植入后经验进行比较。对 VNS 数据集缺失成本进行了调整以进行成本比较。
