Abstracts

Rationale:
Individuals with epilepsy who do not respond adequately to two different regimens of anti-seizure medications (ASMs) are considered to have DRE. Among patients with DRE, the likelihood of attaining adequate seizure control decreases with each successive ASM regimen; therefore, alternative treatments with proven efficacy, such as neuromodulation, should be considered for use in this population. DRE has several deleterious impacts, including increased likelihood of comorbid mental health disorders and behavioral disturbances, lower quality of life, and higher risk of mortality (all vs. those without DRE). We sought to characterize how DRE manifests among pediatric patients during the two year period prior to neuromodulator implantation.

Methods:
We used a large US healthcare claims database to identify patients aged less than 18 years with DRE who underwent neurostimulator implantation between 2012 and 2019. The earliest date on which implantation was noted was deemed the index date, and patients aged over 18 years on this date were excluded, as were those without: (1) an epilepsy diagnosis on index date; (2) any ASM claims in the prior year; and (3) continuous enrollment during the prior two-year period (pre-index). We used all available information during pre-index to assess demographic and clinical characteristics of the study sample, as well as their patterns of use and cost of healthcare services and pharmacotherapy. Care was assessed alternatively as all-cause and epilepsy-related; the latter was defined as all medical care resulting in diagnoses of epilepsy and all ASM dispenses.

Results:
A total of 300 children with DRE met all study selection criteria. Mean (SD) age was 10.8 (4.4) years; 54% were male. Forty-nine percent had diagnosed learning disabilities, 19% had anxiety, and 12% had depression. A total of 76% of patients received ≥ 4 unique ASMs during the two-year pre-index period; 28% had at least six ASMs. Nearly two-thirds (62%) of patients had ≥ 1 hospitalizations during pre-index, and 70% had ≥ 1 emergency department (ED) visits. Most (97%) hospitalizations and ED visits (83%) were epilepsy-related. The proportion of patients visiting a physician monthly increased from 48% 24 months prior to implantation to 56% in the month prior to index. Median (IQR) healthcare costs over the pre-index period were $92,614 ($138,626); median (IQR) epilepsy-related healthcare costs were $64,886 ($103,087). Mean monthly all-cause healthcare costs increased from $6,082 (month 24) to $7,311 (month prior to index); epilepsy-related costs increased from $4,394 to $5,335, respectively (Figure 1).

Conclusions:
In the two year period prior to neuromodulator implantation, pediatric patients with DRE experience high levels of use and cost of healthcare services and prescription pharmacotherapy, most of which is epilepsy-related. They also carry a relatively high comorbidity burden, including mental health disorders. Further research is needed to determine whether earlier use of non-ASM interventions such as neuromodulation can reduce the burden of DRE to these patients and their families.

Funding: Project was funded by LivaNova, PLC.