■评估远程电神经调节(REN)预防偏头痛的临床益处以及相关的直接和间接成本节约。
■REN,规定的,可穿戴,FDA批准的神经调节装置,用于急性和/或治疗偏头痛,最近证明了每隔一天使用偏头痛预防的功效,在一个潜在的,随机化,双盲,安慰剂对照,多中心研究。基线后(4周),受试者接受REN(或安慰剂;8周)治疗,每天以电子方式报告偏头痛症状和急性治疗。治疗增益是从基线到干预第二个月的组间差异(REN减去安慰剂)。健康经济学影响是由于与REN的临床益处相关的成本节约而得出的。
■在248名随机分组的受试者中(128名活跃,120安慰剂),179(95:84)符合修改意向治疗(mITT)分析的资格。发现了有利于REN与安慰剂的显着治疗收益(Tepper等人。,2023),包括急性用药天数的平均(±SD)减少(3.4±0.4vs1.2±0.5;增加=2.2;p=0.001)和出院前天数(2.7±0.3vs1.1±0.4;p=0.001)。提供者就诊的平均变化(减少0.09±0.1,增加0.08±0.2;p=0.297),旷工天数的减少(0.07±0.1vs0.07±0.2;p=0.997)没有显着。使用REN预防偏头痛的一名患者的平均年成本节省估计为$10,000(±$1,777),这四个临床结果相对于未使用REN治疗的基线减少。推断为一个假想的美国商业健康计划,涵盖了一百万人的生命,假设偏头痛患者接受预防性治疗的全国患病率,使用REN偏头痛预防的年平均(±SE)成本节省估计为5.60亿美元(±9950万美元),来自测量的直接和间接指标的减少。
■所提供的临床和成本节约优势是保守的,仅从临床试验中测量的终点进行评估。此外,在研究期间,一些终点事件仅很少发生或没有发生.
■显示出显著和有意义的临床,以及为患者节省成本的好处,医疗保险制度,和雇主,利用REN预防偏头痛。
UNASSIGNED: Assess the clinical benefits and associated direct and indirect cost-savings from Remote Electrical Neuromodulation (
REN) for migraine prevention.
UNASSIGNED: 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. Therapeutic-gain was the between-groups difference (REN minus placebo) in change from baseline to the second month of intervention. Health-economics impact was derived as cost-savings associated with
REN\'s clinical benefits.
UNASSIGNED: 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; p = .001) and presenteeism days (2.7 ± 0.3 vs. 1.1 ± 0.4; gain = 1.6, p = .001). Mean changes of provider visits (reduction of 0.09 ± 0.1 vs. increase of 0.08 ± 0.2; p = .297), and reduction of absenteeism days (0.07 ± 0.1 vs. 0.07 ± 0.2; p = .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.
UNASSIGNED: 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.
UNASSIGNED: 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.
Migraine affects more than 1 billion people worldwide, causing significant disability and substantial clinical economic burden. Remote Electrical Neuromodulation (REN) is a prescribed, wearable, non-pharmacological, non-invasive device (Nerivio), indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years and older. Efficacy of REN for migraine prevention was recently demonstrated in a randomized, blinded, placebo-controlled clinical-trial. This study further analyzes clinical benefits from endpoints measured in the clinical-trial as well as their associated direct and indirect costs. 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 over placebo were found, including an average reduction of 3.4 acute medication days/month, and an average reduction of 2.7 presenteeism days/month. A reduction in the number of provider visits and absenteeism days was also reported, though not significantly differed from changes in the control group. Mean annual cost-saving from reductions in these four clinical outcomes relative to baseline without REN treatment for a patient using
REN for migraine prevention estimated $10,000. Extrapolated to a hypothetical US commercial health-plan of one million covered lives, annual mean cost-saving from using REN for migraine prevention is estimated to be $560.0 million, composed of $327.8 million direct costs and $232.2 million indirect costs. Thus, REN preventive treatment for migraine reduces disease burden and leads to meaningful cost-saving, both direct and indirect, proposing clinical and financial incentives for patients, health insurance systems, and employers to utilize REN for migraine prevention.