Factors associated with oral fingolimod use over injectable disease- modifying agent use in multiple sclerosis

Jagadeswara Rao Earla; George J Hutton; J Douglas Thornton; Hua Chen; Michael L Johnson; Rajender R Aparasu

doi:10.1016/j.rcsop.2021.100021

Factors associated with oral fingolimod use over injectable disease- modifying agent use in multiple sclerosis

Explor Res Clin Soc Pharm. 2021 May 5:2:100021. doi: 10.1016/j.rcsop.2021.100021. eCollection 2021 Jun.

Authors

Jagadeswara Rao Earla¹, George J Hutton², J Douglas Thornton¹, Hua Chen¹, Michael L Johnson¹, Rajender R Aparasu¹

Affiliations

¹ Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University of Houston, TX, USA.
² Baylor College of Medicine, Houston, TX, USA.

Abstract

Background: 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.

Objective: The objective of this study was to examine the factors associated with fingolimod prescribing in the initial years after the market approval.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: 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.