BACKGROUND Medication-refractory gastroesophageal reflux disease (GERD) is sometimes treated with laparoscopic Nissen fundoplication (LNF); however, this is a non-reversible procedure associated with important side effects and the need for repeat surgery. Removable magnetic sphincter augmentation (MSA) devices are an alternative, effective, and safe treatment option for such patients who have some lower esophageal sphincter function. The objective of this study was to assess the economic impact of introducing MSA technology (i.e., LINX Reflux Management System) into current practice from a US-payer perspective. METHODS An economic budget impact model was developed over a 1-year time horizon that compared current treatment of GERD patients who are medically managed (but refractory) or receiving LNF to future treatment of GERD patients that included a mix of patients treated with medical management only, LNF, or MSA. Resources included within the analyses were index procedures (inpatient and outpatient use), reoperations (revisions and removals), readmissions, healthcare visits, diagnostic tests, procedures, and medications. Medicare payment rates were typically used to inform unit costs. RESULTS Assuming a hypothetical commercial insurance population of 1 million members, the base-case analysis estimated a net cost savings of $111,367 with introduction of the MSA. This translates to a savings of $0.01 per member per month. Results were largely driven by avoided inpatient procedures with use of the MSA device. Alternative analyses exploring the potential impact of increasing surgical volumes predicted that results would remain cost saving if the proportion of MSA market share taken from LNF was ≥ 90%. CONCLUSIONS This study predicts that the introduction of the MSA device would lead to favorable budget impact results for the treatment of medication-refractory mechanical GERD for commercial payers. Future analyses will benefit from inclusion of middle-ground treatments as well as longer time horizons.

中文翻译：

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用于治疗药物难治性机械性胃食管反流病的磁性括约肌增强装置的预算影响分析：美国付款人的观点。

背景 药物难治性胃食管反流病 (GERD) 有时采用腹腔镜尼森胃底折叠术 (LNF) 治疗。然而，这是一个不可逆的过程，与重要的副作用和需要重复手术有关。对于此类食管括约肌功能较低的患者，可拆卸磁性括约肌增强 (MSA) 装置是一种替代、有效且安全的治疗选择。本研究的目的是从美国付款人的角度评估将 MSA 技术（即 LINX 回流管理系统）引入当前实践的经济影响。方法 在 1 年的时间范围内开发了一个经济预算影响模型，该模型将目前对接受药物管理（但难治）或接受 LNF 的 GERD 患者的治疗与未来对 GERD 患者的治疗进行比较，其中包括仅接受药物治疗的患者组合、LNF 或 MSA。分析中包括的资源是指数程序（住院和门诊使用）、再手术（修订和移除）、再入院、医疗访问、诊断测试、程序和药物。医疗保险支付率通常用于告知单位成本。结果 假设有 100 万成员的假设商业保险人口，基本案例分析估计引入 MSA 后可节省 111,367 美元的净成本。这意味着每位会员每月可节省 0.01 美元。结果很大程度上是由于使用 MSA 设备避免了住院手术。探索增加手术量的潜在影响的替代分析预测，如果从 LNF 获得的 MSA 市场份额的比例≥ 90%，结果将保持成本节约。结论 本研究预测，MSA 设备的引入将为商业支付者治疗药物难治性机械 GERD 带来有利的预算影响结果。未来的分析将受益于包含中间处理方法以及更长的时间范围。结论 本研究预测，MSA 设备的引入将为商业支付者治疗药物难治性机械 GERD 带来有利的预算影响结果。未来的分析将受益于包含中间处理方法以及更长的时间范围。结论 本研究预测，MSA 设备的引入将为商业支付者治疗药物难治性机械 GERD 带来有利的预算影响结果。未来的分析将受益于包含中间处理方法以及更长的时间范围。