UCB Pharma, Smyrna, GA, USA.
UCB Pharma, Smyrna, GA, USA.
Epilepsy Behav. 2019 Oct;99:106331. doi: 10.1016/j.yebeh.2019.05.027. Epub 2019 Aug 6.
The objective of this study was to evaluate all-cause and epilepsy-specific healthcare resource utilization and costs following lacosamide (LCM) initiation as adjunctive therapy for the treatment of epilepsy.
A noninterventional retrospective database analysis was conducted that examined patients diagnosed as having epilepsy who added LCM to existing antiepileptic drug (AED) therapy between 2009 and 2016 (the first LCM prescription was the index event). This study used a single-case design whereby patients served as their own controls. Patients were further required to have a minimum of 12 months of continuous eligibility before (preindex period) and after (postindex period) their index event. In the 12-month postindex period, the only allowed AED regimen change was the addition of LCM. Demographic and clinical characteristics were measured at index and during the preindex period, respectively. All-cause and epilepsy-specific healthcare resource utilization and costs were measured and compared in the pre- and postindex periods. Paired t- and McNemar's tests were conducted to assess the significant differences between pre- and postindex. Univariate analyses were used to analyze the impact of LCM on specific subpopulations.
The study sample comprised of 2171 patients: mean (standard deviation [SD]) age: 38.9 (19.3) years; 52.6% female. Just over half (56%) of these patients were on monotherapy before adding LCM. Prior to adding LCM, 28.8% of patients had an epilepsy-specific inpatient (IP) admission, and 35.7% of patients had an all-cause IP admission, compared with 18.2% and 26.1% of patients in the post-LCM period, respectively (both p < 0.0001). Likewise, 35.6% of patients had an epilepsy-specific emergency room (ER) visit, and 50.0% had an all-cause ER visit prior to adding LCM, compared with 23.8% and 42.1% in post-LCM, respectively (both p < 0.0001). After adding LCM, one-year mean [SD] epilepsy-specific IP admission costs decreased by 42.9% ($13,647 [$52,290] to $7788 [$32,321]), and all-cause IP admission costs decreased by 38.6% ($20,654 [$72,716] to $12,688 [$46,120]) (both p < 0.0001). One-year epilepsy-specific mean [SD] ER costs decreased by 35.2% ($691 [$1756] to $448 [$1909]; p < 0.0001), and all-cause ER cost decreased by 17.8% ($1217 [$3014] to $1000 [$2970]; p < 0.01).
Epilepsy-related IP hospitalizations and ER visits (indicators of seizures) were significantly reduced in patients with epilepsy 12 months after adding LCM as an adjunctive therapy to existing AED treatment in a real-world setting, leading to reduced healthcare resource utilization and epilepsy costs.
本研究旨在评估拉考酰胺（LCM）作为附加疗法治疗癫痫时，所有病因和癫痫特定的医疗资源利用和成本。
进行了一项非干预性回顾性数据库分析，研究了 2009 年至 2016 年间添加 LCM 作为现有抗癫痫药物（AED）治疗的附加疗法的癫痫患者（首次 LCM 处方为索引事件）。本研究采用单病例设计，即患者自身作为对照。患者还必须在索引事件之前（预索引期）和之后（索引后期）至少有 12 个月的连续资格。在索引后 12 个月期间，唯一允许的 AED 方案变更为添加 LCM。在索引时和预索引期分别测量人口统计学和临床特征。测量了预索引期和索引后期的所有病因和癫痫特定的医疗资源利用和成本，并进行了比较。采用配对 t 检验和 McNemar 检验评估预索引期和索引后期之间的显著差异。采用单变量分析评估 LCM 对特定亚人群的影响。
研究样本包括 2171 名患者：平均（标准差 [SD]）年龄：38.9（19.3）岁；女性占 52.6%。在添加 LCM 之前，这些患者中有一半以上（56%）接受单药治疗。在添加 LCM 之前，28.8%的患者有癫痫特定的住院（IP）入院，35.7%的患者有全病因 IP 入院，而在添加 LCM 后，分别为 18.2%和 26.1%的患者（均 p<0.0001）。同样，35.6%的患者有癫痫特定的急诊室（ER）就诊，50.0%的患者有全病因 ER 就诊，而在添加 LCM 后，分别为 23.8%和 42.1%的患者（均 p<0.0001）。添加 LCM 后，癫痫特定 IP 入院的一年平均（SD）费用降低了 42.9%（$13647 [52290]至$7788 [32321]），全病因 IP 入院费用降低了 38.6%（$20654 [72716]至$12688 [46120]）（均 p<0.0001）。癫痫特定的一年平均（SD）急诊室费用降低了 35.2%（$691 [1756]至$448 [1909]；p<0.0001），全病因急诊室费用降低了 17.8%（$1217 [3014]至$1000 [2970]；p<0.01）。
在现实环境中，将 LCM 作为附加疗法添加到现有的 AED 治疗中，12 个月后，癫痫患者的癫痫相关 IP 住院和 ER 就诊（癫痫发作的指标）显著减少，导致医疗资源利用和癫痫相关成本降低。
