Duh Mei Sheng, Cahill Kevin E, Paradis Pierre Emmanuel, Cremieux Pierre Y, Greenberg Paul E
Analysis Group, Inc., 111 Huntington Avenue, Tenth Floor, Boston, MA 02199, USA.
Expert Opin Pharmacother. 2009 Oct;10(14):2317-28. doi: 10.1517/14656560903140525.
The US Food and Drug Administration (FDA) considers generic and branded drugs to be therapeutically equivalent if they are pharmaceutically equivalent and bioequivalent. The American Academy of Neurology (AAN) disagrees and opposes generic substitution of branded antiepileptic drugs (AEDs) without physician and patient approval due to the risk of loss of seizure control.
To review the evidence to date surrounding the economic impact of brand-to-generic substitutions of AEDs.
A systematic search of PubMed and MEDLINE was conducted; the bibliographies of key articles obtained from the search were used to identify additional sources.
RESULTS/CONCLUSION: Current literature suggests statistically higher overall healthcare costs during periods of generic AED use than during periods when branded AED are used, consistently demonstrated across different countries (Canada and the USA) and in both stable and unstable epilepsy patients, with more pronounced cost increases in patients receiving multiple generic versions. Brand-to-generic substitutions of AEDs do not necessarily reduce overall healthcare costs and may even increase them.
美国食品药品监督管理局（FDA）认为，如果仿制药和品牌药在药学上等效且生物等效，那么它们在治疗上也是等效的。美国神经病学学会（AAN）则持有不同意见，反对在未经医生和患者批准的情况下对品牌抗癫痫药物（AEDs）进行仿制药替代，因为存在癫痫控制丧失的风险。
回顾迄今为止有关AEDs从品牌药替换为仿制药所产生经济影响的证据。
对PubMed和MEDLINE进行了系统检索；利用检索获得的关键文章的参考文献来识别其他来源。
结果/结论：当前文献表明，在使用仿制药AEDs期间，总体医疗保健成本在统计学上高于使用品牌药AEDs的时期，这在不同国家（加拿大和美国）以及稳定和不稳定癫痫患者中均得到一致证明，在接受多种仿制药的患者中成本增加更为明显。AEDs从品牌药替换为仿制药不一定会降低总体医疗保健成本，甚至可能会增加成本。
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