Study finds no risk in shifting to generic AEDs.
The pharmacy benefits manager's analysis stems from questions over the last several years about generic AED drugs, specifically whether there is a higher risk of so-called breakthrough seizures or toxic side effects after patients are switched from a brand-name antiepileptic to a generic version.
Express Scripts says that its claims-based case-control study is the most comprehensive research to date of switching between A-rated AEDs. The PBM notes that its research was designed to address the methodological limitations of previous studies and that it uses the largest sample size over the longest time frame of any study to date. The results are slated to be published in the February issue of Current Medical Research and Opinion.
Concerns about switching between A-rated AEDs surfaced in the health care community after earlier findings suggested an association between antiepileptic drug switching, particularly to lower-cost generic medications, and seizure activity.
AEDs are considered "narrow therapeutic index" medications; therefore, it is thought that small deviations in blood concentrations can result in changes in the safety and effectiveness of the drug.
In November the Food and Drug Administration commissioned the National Institutes of Health to conduct studies to provide definitive evidence about this issue.
"Rigorous research methodology is fundamental to making the fight health care decisions," comments Express Scripts chief medical officer Steven Miller. "These results hold important implications for physicians, patients and plan sponsors as we all work toward optimizing health outcomes at the lowest cost.
"Given that many antiepileptic drugs are now available in lower-cost generic formulations, understanding the impact of switching is a critical question to answer."
By contrast, the Epilepsy Foundation last year announced results of survey data obtained from more than 1,000 consumers, who the foundation says reported a higher risk of seizures and side effects when they switched from one manufacturer's formulation of an AED to another.
"While most patients can safely switch their medications among different formulations of the same antiepileptic medication, the Epilepsy Foundation recommends that consent must be obtained from the individual with epilepsy and their physician before any such substitutions are made--to avoid potentially life-threatening seizures," the organization states.
"The cost savings in the less expensive medications may be lost when overall health costs and societal consequences are taken into account for those patients who experience breakthrough seizures or troublesome side effects when switched from their usual seizure medicine."
Similarly, the American Academy of Neurology opposes generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending physician's approval.
"The FDA has allowed for significant differences between name-brand and generic drugs. This variation can be highly problematic for patients with epilepsy," the academy says in a position paper. "Even minor differences in the composition of generic and name-brand anticonvulsant drugs for the treatment of epilepsy can result in breakthrough seizures."
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|Title Annotation:||Focus; A-rated antiepileptic drugs|
|Publication:||Chain Drug Review|
|Date:||Jan 18, 2010|
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