The manufacturer of agomelatine (Servier) has informed NICE that it would not be making an evidence submission for the appraisal of agomelatine for the treatment of major depressive episodes.

Servier drew attention to the fact that NICE guidelines for England and Wales recommend generic selective serotonin reuptake inhibitors (SSRIs) as first-line treatment followed by a different SSRI or a better tolerated newer-generation agent as second-line treatment. The manufacturer noted that the majority of the clinical trial evidence for agomelatine was as a first-line treatment and furthermore was not against the full range of comparators in the scope. The manufacturer stated that this precluded the development of an economic case that would address the NICE decision problem and maintain the requisite level of certainty.

NICE has therefore terminated this single technology appraisal.

TA231 Depression – agomelatine: guidance (PDF). NICE, 27 Jul 2011.