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- Title
Impact of Formulary Restrictions on Antiepileptic Drug Dispensation Outcomes.
- Authors
Mehta, Darshan; Davis, Matthew; Epstein, Andrew J.; Lee, Andrew
- Abstract
Introduction: The aim of this analysis was to assess the relationship between formulary restrictions and antiepileptic drug (AED) dispensation in patients with focal seizure (FS). Study Design: A retrospective cohort analysis was conducted using data from Symphony Health's Integrated Dataverse® (1 April 2015–30 June 2018). Methods: This study included two patient populations: the overall patient population (N = 54,097) and a pediatric population (< 18 years) (N = 12,610). Cohorts were defined based on approval or rejection of the index AED claim. Study outcomes were prescription life cycle analysis, proportion of patients with dispensation, time to dispensation, and likelihood of successful dispensation. A multivariable Cox proportional hazards model was estimated to study the association between formulary restriction and likelihood of successful AED dispensation. Results: Among patients in the overall population with a rejected claim (n = 9133), 8.0% did not receive any AED and 77.6% received approval for the index AED following an appeal. Among the pediatric patients with a rejected claim (n = 3081), 6.0% did not receive any AED and 81.7% received approval for the index AED after an appeal. In both populations, formulary restrictions were associated with significant delays in index AED dispensation (6.9 and 5.3 days, respectively; P < 0.0001 for each population), compared to approved AED claims. In the overall and pediatric populations, formulary-related rejections of AEDs were associated with a 35% (hazard ratio [HR] 0.65; 95% confidence interval [CI] 0.64–0.66; P < 0.0001) and 27% (HR 0.73; 95% CI 0.69–0.76; P < 0.0001) lower likelihood of successful dispensation of the index AED, respectively. Conclusions: Formulary restrictions of AEDs were associated with significant delays in treatment and significantly lower likelihood of successful AED dispensation in patients with FS. Plain Language Summary: Formulary restrictions on antiepileptic drugs (AEDs) are adopted by payers in the USA to guide the use of therapies and contain the costs of care. However, formulary restrictions on AEDs are inconsistent with the American Epilepsy Society position statement that indicates patients with epilepsy must have unrestricted access to all AEDs. This retrospective cohort analysis of open-source claims data assessed the effects of formulary restrictions on AED dispensation in patients with focal seizure (FS). Findings showed that formulary-related rejections of AED claims were associated with significant delays in treatment initiation and a significantly lower likelihood of successful AED dispensation. The treatment delays associated with formulary restrictions on AEDs may have a negative clinical and economic impact on patients with epilepsy and the healthcare system. Approximately 80% of rejected initial claims were reversed after an appeal. Claim denials and appeals represent an unnecessary administrative burden on physicians' practices. Further studies are required to identify the patient, physician, or payer factors that drive the delay in access to AEDs among patients with FS.
- Subjects
CHILD patients; ANTICONVULSANTS; TREATMENT delay (Medicine); PROPORTIONAL hazards models
- Publication
Neurology & Therapy, 2020, Vol 9, Issue 2, p505
- ISSN
2193-8253
- Publication type
Article
- DOI
10.1007/s40120-020-00195-3