Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
Antiepileptic drugs (AEDs) are the main therapeutic option for patients with epilepsy;
however, complete seizure control remains elusive for many patients. Uncontrolled or
refractory epilepsy is associated with a higher risk of mortality, physical injuries, and
depression or anxiety compared with patients with controlled epilepsy. Higher resource
utilization for patients with poor control is likely to be associated with higher economic
costs. While diagnostic criteria for uncontrolled epilepsy are debated by neurologists,
recent studies suggest that a diagnosis of uncontrolled epilepsy requires 1.) at least one
seizure per month and 2.) a history of drug failures.
The objective of this study is to identify patients with uncontrolled epilepsy in both a
Medicaid database and a private health plan database, to describe patient characteristics and
AED treatment patterns between cohorts of patients with uncontrolled versus well-controlled
epilepsy, and to evaluate the economic burden of uncontrolled versus well-controlled
epilepsy.
For this evaluation, the data sources are medical and pharmacy claims in Medicaid databases
from Florida (Third quarter 1997 to second quarter 2008), Iowa (First quarter 1998 to second
quarter 2006), Kansas (First quarter 2001 to second quarter 2009), Missouri (First quarter
1997 to second quarter 2008) and New Jersey (First quarter 1997 to fourth quarter 2008) and
medical and pharmacy claims in an private health plan database.
The study design is a retrospective, longitudinal, matched-cohort study. Eligible patient
records will be assigned to one of three mutually-exclusive cohorts: uncontrolled epilepsy
(at least 2 consecutive changes in AED therapy in at least 30 days, and at least 1
epilepsy-related inpatient or emergency department (ED) visit within 365 days),
well-controlled epilepsy (no AED changes and no epilepsy-related inpatient or ED visits), and
intermediate epilepsy (not classified as uncontrolled or well-controlled).