In its new draft guidance, National Institute for Health and Care Excellence (NICE) does not recommend the nasal spray medication for treatment-resistant depression.
Owing to uncertainties over the clinical efficacy and cost-effectiveness, NICE has not accepted esketamine (Spravato) with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor for treatment-resistant depression in adults previously unresponsive to two different antidepressants in the current episode.
Evidence from clinical trials showed that esketamine with an oral antidepressant did not relieve the symptoms of depression more effectively than placebo with an oral antidepressant. It has also not been directly compared with other regimens such as oral antidepressants with antipsychotics or lithium, oral antidepressants combined or other alternative treatments.
Additionally, the effect of discontinuation of esketamine is uncertain. It is not clearly understood whether any improvement in symptoms will be sustained after a course of treatment and whether quality of life will improve. NICE has also determined that cost-effectiveness estimates for esketamine are likely to be much higher than its cut-off for use within the NHS.