From UCB Pharma (L.K.), Raleigh, NC; Department of Neurology (E.F., D.J.T.), Emory University School of Medicine, Atlanta, GA; Department of Neurology (H.K.), Stanford University School of Medicine, Palo Alto, CA; IQVIA (C.B., A.S.), Fairfax, VA; UCB Pharma (S.L.), Smyrna, GA; UCB Pharma (D.F.), Ascot, Berkshire, UK; UCB Pharma (K.H.), Monheim am Rhein, Germany; and FV & JK Consulting Ltd. (V.K.), Guildford, Surrey, UK. S.L. is currently employed by Aerie Pharmaceuticals, Durham, NC.
Neurology. 2019 May 7;92(19):e2197-e2208. doi: 10.1212/WNL.0000000000007448. Epub 2019 Apr 10.
To estimate the treatment gap between a new epilepsy diagnosis and antiepileptic drug (AED) initiation in the United States.
Retrospective claims-based cohort study using Truven Health MarketScan databases (commercial and supplemental Medicare, calendar years 2010-2015; Medicaid, 2010-2014) and a validation study using PharMetrics Plus Database linked to LRx claims database (2009-2014). Persons met epilepsy diagnostic criteria, had an index date (first epilepsy diagnosis) with a preceding 2-year baseline (1 year for persons aged 1 to <2 years; none for persons <1 year), and continuous medical and pharmacy enrollment without epilepsy/seizure diagnosis or AED prescription during baseline. Outcomes included percentage of untreated persons (no AED prescription) up to 3 years' follow-up and comparative outcomes (incidence rate ratio: untreated persons/treated persons), including medical events and health care resource utilization.
In the primary study, 59,970 persons met selection (or inclusion) criteria; 36.7% of persons with newly diagnosed epilepsy remained untreated up to 3 years after diagnosis. In the validation study (N = 30,890), 31.8% of persons remained untreated up to 3 years after diagnosis. Lack of AED treatment was associated with an adjusted incidence rate ratio (95% confidence interval) of 1.2 (1.2-1.3) for medical events, 2.3 (2.2-2.3) for hospitalizations, and 2.8 (2.7-2.9) for emergency department visits.
One-third of newly diagnosed persons remain untreated up to 3 years after epilepsy diagnosis. The increased risk of medical events and health care utilization highlights the consequences of delayed treatment after epilepsy diagnosis, which might be preventable.
评估美国新诊断癫痫与抗癫痫药物(AED)起始治疗之间的治疗差距。
使用 Truven Health MarketScan 数据库(商业和补充医疗保险,2010-2015 年;医疗补助,2010-2014 年)进行回顾性基于索赔的队列研究,并使用 PharMetrics Plus 数据库与 LRx 索赔数据库进行验证研究(2009-2014 年)。符合癫痫诊断标准的患者,有索引日期(首次癫痫诊断),并在前 2 年的基线期(1 年对于年龄为 1 至<2 岁的患者;对于年龄<1 岁的患者无基线期),且在基线期内持续进行医疗和药物治疗,没有癫痫/癫痫发作诊断或 AED 处方。结局包括 3 年随访期间未治疗患者(无 AED 处方)的比例,以及比较结局(未治疗患者/治疗患者的发病率比),包括医疗事件和医疗资源利用。
在主要研究中,59970 名患者符合选择(或纳入)标准;新诊断为癫痫的患者中有 36.7%在诊断后 3 年内未得到治疗。在验证研究(N=30890)中,31.8%的患者在诊断后 3 年内未得到治疗。缺乏 AED 治疗与调整后的发病率比(95%置信区间)为 1.2(1.2-1.3)的医疗事件、2.3(2.2-2.3)的住院治疗和 2.8(2.7-2.9)的急诊就诊相关。
新诊断的患者中有三分之一在癫痫诊断后 3 年内未得到治疗。医疗事件和医疗保健利用率增加突出了癫痫诊断后延迟治疗的后果,这可能是可以预防的。