Burden of illness in patients with possible Lennox-Gastaut syndrome: A retrospective claims-based study.

OBJECTIVE: Lennox-Gastaut syndrome (LGS) is a severe and treatment-resistant epilepsy syndrome characterized by multiple subtypes of intractable seizures, moderate to severe cognitive impairment, and slow spike-wave complexes on electroencephalographic (EEG) recordings. Lennox-Gastaut syndrome is also associated with increased risk for injury, reduced quality of life, long-term disability, and early mortality. By evaluating private and public US medical insurance claims, we quantified healthcare utilization and direct costs in patients with possible LGS. METHODS: Commercial and Medicaid insurance claims (Truven Health Analytics) from October 2010 to September 2015 were queried to identify patients with intractable epilepsy, intellectual disability, ≥1 prescription for selected antiepileptic drugs (AEDs), and ≥2 years of continuous enrollment. To identify patients with LGS in the absence of a specific International Classification of Diseases ICD-9 diagnosis code, current or prior rufinamide use was selected as a disease indicator of LGS per previously published methodology. Characteristics significantly predictive of rufinamide use were identified with multivariate regression by comparing groups with and without LGS, then assessed in non-rufinamide users fulfilling all other inclusion criteria. Controls without epilepsy, seizures, or prescriptions for selected AEDs were matched to patients with possible LGS by age, gender, US region, and dates of insurance coverage. Average healthcare utilization and costs per patient per year (PPPY) were evaluated for a 2-year postindex period and compared between the cohort with LGS and controls by insurance type. Costs were normalized to 2017 dollars at 3% per annum. RESULTS: In the study, 6019 patients with possible LGS (53% male, mean age of 13 years, in both insurance groups) were identified: 2270 with commercial insurance and 3749 with Medicaid. The cohort with LGS used >8 times more services and >7 times more drugs than controls (all p < 0.001) in both insurance groups. The biggest contributors to service use PPPY were outpatient physician visits and home health services in the commercial-insured cohort with LGS and other outpatient visits and home health services in the Medicaid-insured cohort with LGS. Average total costs PPPY (services + drugs) were significantly higher for the cohort with LGS vs. controls: $65,026 (SD $34,324) vs. $2442 (SD $10,670) for commercial-insured and $63,930 (SD $45,761) vs. $3849 (SD $13849) for Medicaid-insured patients. The biggest cost contributors PPPY were inpatient care in the commercial-insured cohort with LGS and home health services in the Medicaid-insured cohort with LGS. CONCLUSIONS: Patients with possible LGS have significantly higher healthcare utilization and costs than patients without epilepsy or seizures. Our results suggest that direct costs associated with LGS are substantial and highlight the need for new and effective treatments.

Assessment of treatment patterns and healthcare costs associated with probable Lennox-Gastaut syndrome.

Lennox-Gastaut syndrome (LGS) is a chronic and severe form of epilepsy characterized by intractable seizures, cognitive impairment, and abnormal electroencephalogram findings with slow spike-wave complexes. It typically presents before age 8, but symptoms continue into adulthood and require lifelong treatment associated with significant clinical burden. Data on LGS-associated healthcare utilization and costs are limited. In this study we use a claims-based LGS classifier based on random forest methodology to identify patients with probable LGS from the a Medicaid multi-state database and assess its prevalence across the age spectrum, healthcare utilization, treatment patterns, costs, and comorbid conditions. The classifier identified patients with probable LGS across all ages, with up to 8% of 10-year-old patients with epilepsy identified as having probable LGS. The prevalence of probable LGS was lower in older age cohorts, indicating that it may be under-recognized in older patients. Our analysis showed that probable LGS is associated with considerably higher total healthcare and medical costs than non-LGS patients. The costs were generally consistent between age cohorts, suggesting that the cost burden extends beyond childhood and has a lifelong impact. Analysis of treatment patterns suggest that while the majority of probable LGS patients in this study received widest-spectrum AEDs, a considerable proportion did not and therefore may have been inadequately treated. Further, usage of clobazam and rufinamide was decreased in older compared to younger patient cohorts, indicating that older patient cohorts are less likely to be receiving optimum treatment for LGS. These findings indicate the need for increased clinical attention to LGS beyond pediatric years, with a focus on optimization of treatment for LGS patients of all ages with widest-spectrum AEDs. Timely recognition and adequate treatment of LGS are likely to result in improved outcomes and less costly management of this condition.

Budget impact analysis of antiepileptic drugs for Lennox-Gastaut syndrome.

BACKGROUND: In October 2011, clobazam was FDA-approved for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a debilitating childhood epilepsy characterized by drop attacks, for patients 2 years and older. OBJECTIVE: To assess the budget impact of adding clobazam to an antiepileptic drug (AED) portfolio containing topiramate, lamotrigine, and rufinamide in a hypothetical, 100,000-member commercially insured health plan. METHODS: Patient characteristics and AED efficacy (decrease in drop-seizure frequency) were modeled with clinical data. Medical costs were derived from administrative claims data from a large U.S. managed health plan, with the assumption that 2.3% of drop seizures required medical care. Two-year budget impact was measured. Results were expressed as the overall difference in costs (medical and pharmacy) to a health plan and cost per member per month (PMPM) after addition of clobazam. Analyses of alternative scenarios were performed. RESULTS: With the assumption that 0.04% of the plan population had LGS, adding clobazam to the formulary resulted in cost savings of $98,059 in year 1 and $131,690 in year 2 (savings of $0.08 and $0.11 PMPM, respectively). Analyses of alternative scenarios with lower seizure rates upon discontinuation or greater long-term efficacy for lamotrigine and topiramate did not substantially alter conclusions. The assumption that fewer drop seizures required medical care resulted in a savings of approximately $5,000 per year with clobazam, which suggested that medically attended drop seizures drive costs. CONCLUSIONS: Medically attended drop seizures are a major cost driver for LGS patients. Adding clobazam to a health plan formulary can have a positive overall budget impact through decreased medical costs associated with drop seizures.