Division of Headache Medicine, Stanford University, Palo Alto, CA, USA.
Theranica Ltd., Netanya, Israel.
J Med Econ. 2023 Jan-Dec;26(1):656-664. doi: 10.1080/13696998.2023.2205751.
Assess the clinical benefits and associated direct and indirect cost-savings from Remote Electrical Neuromodulation (REN) for migraine prevention.
REN, a prescribed, wearable, FDA-cleared neuromodulation-device for acute and/or preventive treatment of migraine, recently demonstrated efficacy for migraine prevention when used every-other-day, in a prospective, randomized, double-blind, placebo-controlled, multi-center study. Following baseline (4-weeks), subjects underwent treatment with REN or placebo (8-weeks), and electronically reported migraine symptoms and acute treatments daily. was the between-groups difference (REN minus placebo) in change from baseline to the second month of intervention. was derived as cost-savings associated with REN's clinical benefits.
Out of 248 subjects randomized (128 active, 120 placebo), 179 (95:84) qualified for modified intention-to-treat (mITT) analysis. Significant therapeutic gains favoring REN vs. placebo were found (Tepper et al. 2023), including mean (±SD) reduction in number of acute medication days (3.5 ± 0.4 vs. 1.2 ± 0.5; gain = 2.2; = .001) and presenteeism days (2.7 ± 0.3 vs. 1.1 ± 0.4; gain = 1.6, = .001). Mean changes of provider visits (reduction of 0.09 ± 0.1 vs. increase of 0.08 ± 0.2; = .297), and reduction of absenteeism days (0.07 ± 0.1 vs. 0.07 ± 0.2; = .997) were not significant. Mean annual cost-saving for one patient using REN for migraine prevention estimated $10,000 (±$1,777) from reductions in these four clinical outcomes relative to baseline without REN treatment. Extrapolated to a hypothetical US commercial health-plan of one-million covered lives, assuming the national prevalence of migraine patients on preventive treatment, annual mean (±SE) cost-saving from using REN migraine prevention estimated $560.0 million (±$99.5 million) from reduction in direct (∼$330 millionm) and indirect costs (∼$230 millionm) measured.
Clinical and cost-savings benefits presented are conservative, assessed only from endpoints measured in the clinical trial. Moreover, some of the endpoints had only scarce or no occurrences during the study period.
Coverage of the REN-device for migraine prevention may significantly reduce disease-burden and save a one-million-member payer plan at least $560 million per year.
评估远程电神经调节（REN）在偏头痛预防方面的临床获益和相关的直接和间接成本节约。
REN 是一种经过美国食品和药物管理局（FDA）批准的、可穿戴的、用于治疗偏头痛急性发作和/或预防的神经调节设备，最近在一项前瞻性、随机、双盲、安慰剂对照、多中心研究中，证明了其对偏头痛预防的有效性，每两天使用一次。在基线（4 周）后，受试者接受 REN 或安慰剂（8 周）治疗，并每天通过电子方式报告偏头痛症状和急性治疗情况。从基线到干预第二个月的变化，是 REN 与安慰剂之间的组间差异（REN 减去安慰剂）。是与 REN 的临床获益相关的成本节约。
在 248 名随机分组的受试者中（128 名活性组，120 名安慰剂组），179 名（95:84）符合改良意向治疗（mITT）分析的条件。与安慰剂相比，REN 具有显著的治疗获益（Tepper 等人，2023 年），包括急性药物治疗天数（3.5 ± 0.4 天对 1.2 ± 0.5 天；减少 2.2 天； = 0.001）和误工天数（2.7 ± 0.3 天对 1.1 ± 0.4 天；减少 1.6 天； = 0.001）的平均（±SD）减少。就诊次数的平均变化（减少 0.09 ± 0.1 次对增加 0.08 ± 0.2 次； = 0.297）和缺勤天数的减少（减少 0.07 ± 0.1 天对减少 0.07 ± 0.2 天； = 0.997）没有统计学意义。假设全国偏头痛预防性治疗患者的患病率，假设采用 REN 预防偏头痛的一名患者的年度成本节约估计为 10000 美元（±$1777），与未采用 REN 治疗时的基线相比，这四个临床结局的减少。从直接成本（约 3.3 亿美元）和间接成本（约 2.3 亿美元）来看，从假设的拥有 100 万参保人数的美国商业健康计划中，估计每年从使用 REN 预防偏头痛中可节省 5.60 亿美元（±$9950 万美元）。
本文介绍的临床和成本节约效益是保守的，仅从临床试验中测量的终点评估。此外，在研究期间，有些终点的发生次数很少或没有。
覆盖 REN 设备预防偏头痛可能会显著减轻疾病负担，并为拥有 100 万参保人数的支付方计划每年节省至少 5.6 亿美元。
