20 June 2019 - Independent appraisal committee votes that evidence is adequate to demonstrate clinical benefits of esketamine versus placebo, but concerns remain about the study criteria used to define treatment-resistant depression and the lack of longer-term data on esketamine’s safety and effectiveness.

The ICER today released a final evidence report and report-at-a-glance assessing the comparative clinical effectiveness and value of esketamine (Spravato, Janssen), a nasal spray approved by the FDA in March as a therapy for treatment-resistant depression (TRD). Esketamine is one of the two mirror-image molecules (enantiomers) that make up ketamine, an anesthetic that is commonly used off-label to treat TRD.

ICER’s report was reviewed at the May 2019 public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), one of ICER’s three independent evidence appraisal committees. During the meeting, the CEPAC found that the evidence demonstrated esketamine plus background antidepressant to be clinically superior to background antidepressant alone. The CEPAC members found the evidence to be insufficient to demonstrate a difference in net health benefit between esketamine and ketamine, transcranial magnetic stimulation, electroconvulsive therapy, or augmentation with olanzapine.

Read ICER Announcement