NICE Assessment for SPRAVATO®▼

Janssen was disappointed with the recent decision (27/5/22) by the National Institute for Health and Care Excellence (NICE) on their Final Appraisal Determination, in which SPRAVATO®(esketamine) nasal spray has not been recommended for use within its marketing authorisation, in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), for adults living with treatment-resistant major depressive disorder (TRD), who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

  • Esketamine nasal spray is the first antidepressant with a new mechanism of action in more than 30 years
  • Esketamine nasal spray was authorised for the treatment of adults with treatment-resistant major depressive disorder in Europe in December 2019
  • Its novel mechanism of action means it works differently than currently available therapies for major depressive disorder. Esketamine nasal spray is derived from part of the ketamine molecule but is appraised by health authorities as a distinct medication, due to differences in the efficacy and safety profile. As such, it is important these terms are not used interchangeably

We have worked hard with NICE and other stakeholders throughout the appraisal process to provide the clinical evidence and data to demonstrate esketamine nasal spray is a cost-effective treatment for use on the NHS. Therefore, we are deeply disappointed with the decision published by NICE,” commented Amanda Cunnington, Senior Director of Patient Access, Janssen-Cilag Limited. “In treatment-resistant major depressive disorder, there continues to be systemic issues in introducing innovative treatment options on the NHS, which we have tried to overcome. We remain steadfast in collaborating with stakeholders and are considering all options including an appeal, to enable access to this important treatment for people living with the condition.”

For the last thirty years we have been waiting for innovations in the field for the most serious and debilitating mental illnesses such as treatment-resistant major depressive disorder,” commented Marjorie Wallace, Chief Executive, SANE. “It is, therefore, a huge disappointment that NICE’s decision will prevent the most desperate patients from accessing esketamine nasal spray.

We have little in our armoury to combat treatment-resistant major depressive disorder and the real shame is that NICE are rejecting one of the very few innovations in treating this condition.

Marjorie Wallace, Chief Executive, SANE