Sánchez Fernández Iván, Torres Alcy, Khan Taha Fathima, Sheikh Tahir, Romeu Amanda, Jonas Rinat, Douglass Laurie
Division of Pediatric Neurology, Department of Pediatrics, Boston Medical Center, The Boston University Chobanian and Avedisian School of Medicine, Boston, MA, USA.
Division of Pediatric Neurology, Department of Pediatrics, Boston Medical Center, The Boston University Chobanian and Avedisian School of Medicine, Boston, MA, USA.
Epilepsy Behav. 2024 Dec;161:110038. doi: 10.1016/j.yebeh.2024.110038. Epub 2024 Sep 20.
To describe the changes in Food and Drug Administration (FDA)-approved non-intravenous rescue benzodiazepine (non-IV-rBZD) use and cost after the introduction of intranasal midazolam and intranasal diazepam.
Retrospective descriptive study using the MarketScan Database between the years 2016 and 2022. We considered patients who had at least one non-IV-rBZD prescription before the introduction of intranasal rescue medications and at least one non-IV-rBZD prescription after the introduction of intranasal rescue medications.
There were 4,444 patients (45.8 % female, median (p-p) age of 10.0 (5.0-15.0) years). 2,255 of 4,444 (50.7 %) patients switched from rectal diazepam to either intranasal midazolam (1,110 (25.0 %)) or intranasal diazepam (1,145 (25.8 %)) as their last non-IV-rBZD. The change from rectal to intranasal non-IV-rBZDs has been increasing over the years from 2019 to 2022. On multivariable analysis, having a non-IV-rBZD for epilepsy (rather than for other reasons including febrile seizures), the year of the last rescue medication, urban (non-rural) patient's residence, and certain regions of the United States were the factors most strongly associated with a change from rectal diazepam to intranasal non-IV-rBZDs. After adjusting for inflation, the median (p-p) average wholesale price (AWP) of the last non-IV-rBZD was higher than that of the first non-IV-rBZD [702 (406-748) versus 417 (406-426), Wilcoxon signed rank test p < 0.0001)]. This difference was mainly driven by the patients who changed from rectal diazepam to intranasal non-IV-rBZD [748 (714-755) versus 417 (406-426), Wilcoxon signed rank test p < 0.0001)]. After adjusting for inflation, the median (p-p) patient cost of the last non-IV-rBZD was higher than that of the first non-IV-rBZD [16 (3-55) versus 12 (6-31), Wilcoxon signed rank test p < 0.0001)]. This difference was mainly driven by the patients who changed from rectal diazepam to intranasal non-IV-rBZD [41 (6-83) versus 12 (6-30), Wilcoxon signed rank test p < 0.0001)].
Approximately half of patients changed from rectal diazepam to intranasal midazolam or intranasal diazepam and that transition has been progressively increasing from the year 2019 to the year 2022. The inflation-adjusted AWP and patient cost increased, especially among those patients who changed from rectal to intranasal rescue medication.
描述在引入鼻内咪达唑仑和鼻内地西泮后，美国食品药品监督管理局（FDA）批准的非静脉注射急救苯二氮䓬类药物（非静脉注射 - rBZD）的使用情况及成本变化。
利用2016年至2022年期间的MarketScan数据库进行回顾性描述性研究。我们纳入了在引入鼻内急救药物之前至少有一张非静脉注射 - rBZD处方，且在引入鼻内急救药物之后至少有一张非静脉注射 - rBZD处方的患者。
共有4444例患者（45.8%为女性，年龄中位数（第25 - 75百分位数）为10.0（5.0 - 15.0）岁）。4444例患者中有2255例（50.7%）从直肠用地西泮转为鼻内咪达唑仑（1110例（25.0%））或鼻内地西泮（1145例（25.8%））作为其最后使用的非静脉注射 - rBZD。从2019年到2022年，从直肠用药转为鼻内用药的非静脉注射 - rBZD的情况逐年增加。在多变量分析中，因癫痫（而非包括热性惊厥在内的其他原因）使用非静脉注射 - rBZD、最后一次急救药物的年份、城市（非农村）患者居住地以及美国的某些地区是与从直肠用地西泮转为鼻内非静脉注射 - rBZD最密切相关的因素。在调整通货膨胀因素后，最后一次非静脉注射 - rBZD的平均批发价中位数（第25 - 75百分位数）高于首次使用的非静脉注射 - rBZD [702（406 - 748）对417（406 - 426），Wilcoxon符号秩检验p < 0.0001]。这种差异主要由从直肠用地西泮转为鼻内非静脉注射 - rBZD的患者驱动 [748（714 - 755）对417（406 - 426），Wilcoxon符号秩检验p < 0.0001]。在调整通货膨胀因素后，最后一次非静脉注射 - rBZD的患者成本中位数（第25 - 75百分位数）高于首次使用的非静脉注射 - rBZD [16（3 - 55）对12（6 - 31），Wilcoxon符号秩检验p < 0.0001]。这种差异主要由从直肠用地西泮转为鼻内非静脉注射 - rBZD的患者驱动 [41（6 - 83）对12（6 - 30），Wilcoxon符号秩检验p < 0.0001]。
约一半患者从直肠用地西泮转为鼻内咪达唑仑或鼻内地西泮，且从2019年到2-2年这种转变呈逐渐增加趋势。经通货膨胀调整后的平均批发价和患者成本增加，尤其是在那些从直肠用药转为鼻内急救药物的患者中。
