关键词: ABM, The Andersen Behavioral Model AHRQ, Agency for Healthcare Research and Quality AOR, Adjusted Odds Ratio AV, Atrioventricular CCS, Clinical Classification System CDHP, Consumer Directed Health Plan CLD, Chronic Lung Disease DMA, Disease-modifying agent DME, Durable Medical Equipment Disease modifying agent (DMA) ED, Emergency Department EDSS, Expanded Disability Status Score EPO, Exclusive Provider Organization FDA, Food and Drug Administration FIN, Fingolimod Fingolimod HCPCS, The Healthcare Common Procedure Coding System HDHP, High Deductible Health Plan HMO, Health Maintenance Organization ICD-9-CM, International Classification of Diseases, Ninth Revision, Clinical Modification INJ, Injectable DMAs Injectable DMA MRI, Magnetic Resonance Imaging MS, Multiple Sclerosis Multiple sclerosis NDC, National Drug Code Oral DMA POS, Point-of-service PPO, Preferred Provider Organization SD, Standard Deviation Treatment selection

来  源:   DOI:10.1016/j.rcsop.2021.100021   PDF(Sci-hub)   PDF(Pubmed)

Abstract:
UNASSIGNED: Fingolimod is the first approved oral disease-modifying agent (DMA) in 2010 to treat Multiple Sclerosis (MS). There is limited real-world evidence regarding the determinants associated with fingolimod use in the early years.
UNASSIGNED: The objective of this study was to examine the factors associated with fingolimod prescribing in the initial years after the market approval.
UNASSIGNED: A retrospective, longitudinal study was conducted involving adults (≥18 years) with MS from the 2010-2012 IBM MarketScan. Individuals with MS were selected based on ICD-9-CM: 340 and a newly initiated DMA prescription. Based on the index/first DMA prescription, patients were classified as fingolimod or injectable users. All covariates were measured during the six months baseline period prior to the index date. Multivariable logistic regression was performed to determine the predisposing, enabling, and need factors, conceptualized as per the Andersen Behavioral Model (ABM), associated with prescribing of fingolimod versus injectable DMA for MS.
UNASSIGNED: The study cohort consisted of 3118 MS patients receiving DMA treatment. Of which, 14.4% of patients with MS initiated treatment with fingolimod within two years after the market entry, while the remaining 85.6% initiated with injectable DMAs. Multivariable regression revealed that the likelihood of prescribing oral DMA increased by 2-3 fold during 2011 and 2012 compared to 2010. Patients with ophthalmic (adjusted odds ratio [aOR]-2.60), heart (aOR-2.21) and urinary diseases (aOR-1.37) were more likely to receive fingolimod. Patients with other neurological disorders (aOR-0.50) were less likely to receive fingolimod than those without neurological disorders. Use of symptomatic medication (for impaired walking (aOR-2.60), bladder dysfunction (aOR-1.54), antispasmodics (aOR-1.48), and neurologist consultation (aOR-1.81) were associated with higher odds of receiving fingolimod. However, patients with non-MS associated emergency visits (aOR-0.64) had lower odds of receiving fingolimod than those without emergency visits.
UNASSIGNED: During the initial years after market approval, patients with highly active MS were more likely to receive oral fingolimod than injectable DMAs. More research is needed to understand the determinants of newer oral DMAs.
摘要:
UNASSIGNED:芬戈莫德是2010年第一个批准的口腔疾病改善剂(DMA),用于治疗多发性硬化症(MS)。关于早期使用芬戈莫德的决定因素的现实证据有限。
UNASSIGNED:本研究的目的是研究在市场批准后的最初几年中与芬戈莫德处方相关的因素。
未经评估:回顾,纵向研究纳入2010-2012年IBMMarketScan的MS成人(≥18岁).基于ICD-9-CM:340和新开始的DMA处方选择患有MS的个体。根据索引/第一个DMA处方,患者被分类为芬戈莫德或可注射使用者.所有协变量均在索引日期之前的六个月基线期间测量。进行多变量逻辑回归以确定易感,启用,需要因素,按照安徒生行为模型(ABM)概念化,与芬戈莫德的处方与MS的可注射DMA有关。
UNASSIGNED:研究队列包括3118名接受DMA治疗的MS患者。其中,14.4%的MS患者在进入市场后两年内开始使用芬戈莫德治疗,而其余85.6%的人开始使用可注射DMA。多变量回归显示,与2010年相比,2011年和2012年口服DMA的可能性增加了2-3倍。眼科患者(调整后的比值比[aOR]-2.60),心脏(aOR-2.21)和泌尿系疾病(aOR-1.37)更有可能接受芬戈莫德。患有其他神经系统疾病(aOR-0.50)的患者接受芬戈莫德的可能性低于没有神经系统疾病的患者。使用对症药物(对于行走受损(aOR-2.60),膀胱功能障碍(aOR-1.54),抗痉挛药(aOR-1.48),和神经科医生会诊(aOR-1.81)与接受芬戈莫德的几率较高相关.然而,有非MS相关急诊就诊(aOR-0.64)的患者接受芬戈莫德的几率低于没有急诊就诊的患者.
未经评估:在市场批准后的最初几年,与可注射的DMA相比,高度活跃的MS患者更有可能接受口服芬戈莫德.需要更多的研究来了解新型口腔DMA的决定因素。
公众号