esketamine (Spravato)

following a full submission: 

esketamine (Spravato®) is accepted for use within NHSScotland.

Indication under review: In combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI), for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

In a phase III study in adults (aged 18 to 64 years) with treatment resistant depression, esketamine plus newly initiated antidepressant significantly reduced the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 4 compared with placebo plus newly initiated antidepressant. A significantly lower rate of relapse in patients who received esketamine plus antidepressant over placebo plus antidepressant was demonstrated in a further phase III study.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.