Background On 8 September 2015, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to conduct a supplementary assessment for Commission A15-16 (Vortioxetine – Benefit Assessment According to §35a Social Code Book (SGB) V).
In the dossier on vortioxetine for the assessment of the acute treatment of patients with moderate and severe major depressive episodes, the pharmaceutical company (hereinafter referred as “the company”) had presented an adjusted indirect comparison in comparison with the selective serotonin reuptake inhibitor (SSRI) citalopram using a common comparator placebo. The dossier assessment on vortioxetine showed that the results presented by the company were unsuitable for the assessment of the added benefit of vortioxetine. This was largely due to the fact that the company made an inadequate limitation of the study pool for the meta-analyses of the indirect comparison and did not consider the available evidence completely.
In its comment, the company submitted supplementary analyses on the indirect comparison, which went beyond the information provided in the dossier. Moreover, the company in its comments referred to a study of direct comparison of vortioxetine versus the SSRI escitalopram (study 318), which the company had not included in the dossier for the assessment of the added benefit. The G-BA commissioned IQWiG with the assessment of the additional data on the indirect comparison and of study 318.
The responsibility for the present assessment and the results of the assessment lies exclusively with IQWiG. The assessment is forwarded to the G-BA. The G-BA decides on the added benefit.
Keywords: Vortioxetine; Depressive Disorder; Benefit Assessment.
Copyright © 2015 by the Institute for Quality and Efficiency in Healthcare (IQWiG).