Schein Jeff, Catillon Maryaline, Lemyre Anaïs, Qu Alice, Kinkead Frederic, Gauthier-Loiselle Marjolaine, Cloutier Martin, Childress Ann
Global Value & Real World Evidence, Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center, Princeton, NJ, 08540, USA.
Health Economics and Outcomes Research, Analysis Group, Inc., 151 West 42nd Street, 23rd Floor, New York, NY, 10036, USA.
Adv Ther. 2025 Sep 11. doi: 10.1007/s12325-025-03345-x.
Adverse events (AEs) are common in pediatric patients receiving attention-deficit/hyperactivity disorder (ADHD) treatment; however, real-world studies on their costs from a payer's perspective are lacking. Therefore, this study investigated the healthcare costs associated with selected AEs among pediatric patients receiving ADHD treatment in the United States.
Using a retrospective cohort design, patients aged 6-17 years who received pharmacologic treatment for ADHD were identified from US claims data (October 1, 2015-September 30, 2023) and were categorized into AE and AE-free cohorts, separately for each studied AE. The eight selected AEs had statistically significant risk differences in a matching-adjusted indirect comparison of ADHD treatments and were identifiable from claims with ICD-10-CM codes. Entropy balancing was used to create cohorts with similar characteristics. Total excess healthcare costs and costs associated with AE-specific claims per patient per month (PPPM) were compared across balanced cohorts with vs. without a given AE.
Overall, 393,919 patients (mean age: 12.5 years; male: 65.4%; stimulant monotherapy: 71.8%) were included, among whom 13.6% had ≥ 1 studied AE that resulted in a medical encounter during their treatment episode. The most prevalent AEs were upper abdominal pain (5.2%), vomiting (3.4%), and insomnia (3.2%). All AEs were associated with substantial AE-specific costs PPPM (asthenia: $196; somnolence: $171; insomnia: $169; vomiting: $106; dizziness: $92; upper abdominal pain: $91; irritability: $75; decreased weight: $46) and total excess healthcare costs PPPM (asthenia: $1178; somnolence: $821; vomiting: $427; insomnia: $404; dizziness: $380; upper abdominal pain: $336; irritability: $231; decreased weight: $219; all p < 0.01).
AEs were common during ADHD treatment episodes in pediatric patients and were associated with significant healthcare costs. ADHD treatments with a favorable safety profile could help alleviate the economic burden of AEs.
不良事件(AE)在接受注意力缺陷多动障碍(ADHD)治疗的儿科患者中很常见;然而,从支付方角度对其成本进行的真实世界研究却很缺乏。因此,本研究调查了美国接受ADHD治疗的儿科患者中特定不良事件相关的医疗保健成本。
采用回顾性队列设计,从美国医保理赔数据(2015年10月1日至2023年9月30日)中识别出6至17岁接受ADHD药物治疗的患者,并针对每项研究的不良事件分别将其分为发生不良事件组和未发生不良事件组。所选择的8种不良事件在ADHD治疗的匹配调整间接比较中具有统计学显著的风险差异,并且可通过ICD-10-CM编码从理赔数据中识别出来。使用熵平衡法创建具有相似特征的队列。比较了有或无特定不良事件的平衡队列中每位患者每月的总额外医疗保健成本以及与特定不良事件理赔相关的成本(PPPM)。
总体而言,共纳入393,919名患者(平均年龄:12.5岁;男性:65.4%;兴奋剂单一疗法:71.8%),其中13.6%的患者在治疗期间发生了≥1种研究中的不良事件并导致了医疗就诊。最常见的不良事件为上腹部疼痛(5.2%)、呕吐(3.4%)和失眠(3.2%)。所有不良事件均与较高的特定不良事件PPPM成本相关(乏力:196美元;嗜睡:171美元;失眠:169美元;呕吐:106美元;头晕:92美元;上腹部疼痛:91美元;易怒:75美元;体重减轻:46美元)以及总额外医疗保健PPPM成本相关(乏力:1178美元;嗜睡:821美元;呕吐:427美元;失眠:404美元;头晕:380美元;上腹部疼痛:336美元;易怒:231美元;体重减轻:219美元;所有p<0.01)。
不良事件在儿科患者ADHD治疗期间很常见,并且与显著的医疗保健成本相关。具有良好安全性的ADHD治疗方法可能有助于减轻不良事件的经济负担。