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. 2020 Dec;9(2):505-519.
doi: 10.1007/s40120-020-00195-3. Epub 2020 May 30.

Impact of Formulary Restrictions on Antiepileptic Drug Dispensation Outcomes

Darshan Mehta  1 , Matthew Davis  2 , Andrew J Epstein  2 , Andrew Lee  3
Affiliations

Impact of Formulary Restrictions on Antiepileptic Drug Dispensation Outcomes

Darshan Mehta et al. Neurol Ther. 2020 Dec.

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.

Keywords: Antiepileptic drug; Dispensation; Focal seizure; Formulary restriction; Treatment delay.

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.

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Conflict of interest statement

Darshan Mehta is an employee of Sunovion Pharmaceuticals Inc. Andrew Lee was an employee of Sunovion Pharmaceuticals Inc. at the time of conducting the study; he is currently an employee of Vertex Pharmaceuticals. Matthew Davis is an employee of Medicus Economics, LLC, which received funding from the study sponsor to participate in this research. Andrew J Epstein is an employee of Medicus Economics, LLC, which received funding from the study sponsor to participate in this research.

Figures

Fig. 1
Fig. 1
Flow diagram of study design. AED Antiepileptic drug
Fig. 2
Fig. 2
Prescription life cycle for patient in rejected cohort during 6-month follow-up period. a Overall patient population. b Pediatric patient population. AED antiepileptic drug
Fig. 3
Fig. 3
Distribution by time to first dispensation of index AED. a Overall patient population. b Pediatric patient population. Asterisk indicates significant difference at P  < 0.0001. AED antiepileptic drug
Fig. 4
Fig. 4
Hazard ratios of successful dispensation of prescribed index AED. a Overall patient population. b Pediatric patient population. Horizontal lines indicate 95% confidence intervals plotted on a logarithmic scale. Dollar values of charges were inflated to 2018 United States (US) dollars using the US gross domestic product price index [22]. AED antiepileptic drug, CCI Charlson Comorbidity Index, ref reference
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