Impact of evergreening on patients and health insurance: a meta analysis and reimbursement cost analysis of citalopram-escitalopram antidepressantsReportar como inadecuado

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BMC Medicine

, 10:142

First Online: 20 November 2012Received: 11 July 2012Accepted: 20 November 2012


Background-Evergreening- refers to the numerous strategies whereby owners of pharmaceutical products use patent laws and minor drug modifications to extend their monopoly privileges on the drug. We aimed to evaluate the impact of evergreening through the case study of the antidepressant citalopram and its chiral switch form escitalopram by evaluating treatment efficacy and acceptability for patients, as well as health insurance costs for society.

MethodsTo assess efficacy and acceptability, we performed meta-analyses for efficacy and acceptability. We compared direct evidence meta-analysis of results of head-to-head trials and indirect evidence adjusted indirect comparison of results of placebo-controlled trials. To assess health insurance costs, we analyzed individual reimbursement data from a representative sample of the French National Health Insurance Inter-regime Information System SNIIR-AM from 2003 to 2010, which allowed for projecting these results to the whole SNIIR-AM population 53 million people.

ResultsIn the meta-analysis of seven head-to-head trials 2,174 patients, efficacy was significantly better for escitalopram than citalopram combined odds ratio OR 1.60 95% confidence interval 1.05 to 2.46. However, for the adjusted indirect comparison of 10 citalopram and 12 escitalopram placebo-controlled trials, 2,984 and 3,777 patients respectively, efficacy was similar for the two drug forms combined indirect OR 1.03 0.82 to 1.30. Because of the discrepancy, we could not combine direct and indirect data test of inconsistency, P = 0.07. A similar discrepancy was found for treatment acceptability. The overall reimbursement cost burden for the citalopram, escitalopram and its generic forms was 120.6 million Euros in 2010, with 96.8 million Euros for escitalopram.

ConclusionsThe clinical benefit of escitalopram versus citalopram remains uncertain. In our case of evergreening, escitalopram represented a substantially high proportion of the overall reimbursement cost burden as compared with citalopram and the generic forms.

KeywordsEvergreening Meta-analysis Health Insurance Reimbursement Escitalopram Citalopram Chiral switch French health information system generic drugs AbbreviationsCIconfidence interval

DDDdefined daily dose

EGBEchantillon généraliste de bénéficiaires

MADRSMontgomery-Åsberg depression rating scale

NNTnumber needed to treat

ORodds ratio

RCTsrandomized controlled trials

SNIIR-AMFrench National Health Insurance Inter-regime Information System

Electronic supplementary materialThe online version of this article doi:10.1186-1741-7015-10-142 contains supplementary material, which is available to authorized users.

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Autor: Ali A Alkhafaji - Ludovic Trinquart - Gabriel Baron - Moïse Desvarieux - Philippe Ravaud


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