Generic Step Therapy Program for Epilepsy Patients

San Francisco—A step therapy program found that patients with epilepsy who switched to generic formulations had a numerically and statistically significant reduction in costs compared with patients who stayed on brand formulations, based on study results presented during a poster session at the AMCP meeting. The poster was titled Impact of Generic Step Therapy of Divalproex ER, Levetiracetam, Lamotrigine, and Topiramate on Healthcare Utilization in Epilepsy Patients.

On January 1, 2011, UnitedHealthcare Employer & Individual (UHC E&I) implemented a step therapy program requiring a trial of A-rated generic formulations for 4 multisource brand anti-epilepsy drugs (AEDs): divalproex ER, levetiracetam, lamotrigine, and topiramate. Although overrides to continue receiving brand AEDs were available for epilepsy patients, some patients opted to switch to generic formulations.

In a retrospective analysis of UHC E&I commercial and pharmacy medical claims from 2010 to 2011, the researchers sought to identify differences in healthcare utilization and costs between 2385 patients (85%) who stayed on brand products and 421 (15%) patients who switched to generics. A total of 2806 patients met the inclusion criteria. Patients needed both continuous enrollment and at least 1 medical claim with a diagnosis of epilepsy and/or convulsions from 180 days before the index claim (baseline period) for inclusion. To ensure consistent therapy with a brand AED, patients had to have at least a 90-day supply of the index drug during the baseline period.

Baseline characteristics were analyzed to identify potential differences in age, sex, region of residence, hospital inpatient (IP) or emergency department (ED) utilization and costs, outpatient (OP) utilization and costs, and pharmacy utilization and costs between study populations.

The results found that 3 baseline characteristics were statistically different between patients who switched to generics and patients who remained on brand. The average age was higher in the generic group. A higher percentage of patients in the generic group did not have OP visits in the baseline period and had lower AED costs. No statistically significant differences were found between the generic and brand groups for the percentage of patients with any IP or ED visits (27.3% vs 23.6%, respectively; P=.101), or OP visits (92.6% vs 95.2%, respectively; P=.030), and the mean number of OP visits per patient (9.49 vs 9.23, respectively; P=.653).

The total AED costs for the generic group were lower than the brand group ($2833.25 vs $3279.41, respectively; P=.001). For follow-up adjusted healthcare costs, a statistically significant decrease in the study’s AED costs ($937.84; P<.001) was found in patients who switched to generics versus patients who continued with brand drugs. No statistically significant differences, however, were found for total medical costs.

The researchers cited several study limitations. The follow-up data were limited to 60 days, so long-term results were not known. The study only included 4 AEDS; extrapolation to other AEDs or other classes was limited. Patients voluntarily switched to generic formulations; extrapolation to the general seizure population may have been limited.

In summary, the researchers stated that “step implementation provided overall value for UHC E&I and for patients who opted to switch to generics by decreasing AED costs without affecting medical utilization and costs compared to patients who opted to stay on brand formulations.”