The Scottish Medicines Consortium (SMC) have accepted Spravato (esketamine) nasal spray for use within NHS Scotland less than a week after NICE ruled not to recommend the drug for use on the NHS in England.
Specifically, the nasal spray is approved in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI), for adults 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.
The SMC advice is based on data from the robust Phase 3 clinical trial, including the TRANSFORM-2 trial which showed that in adults (aged 18 to 64 years) with treatment resistant depression, esketamine nasal spray plus newly initiated oral antidepressant significantly reduced the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 4 compared with placebo nasal spray plus newly initiated oral antidepressant.
“Janssen is pleased with the SMC’s swift decision to accept the use of esketamine nasal spray in eligible patients, and we applaud the SMC’s pragmatic approach and flexibility in reaching this positive recommendation,” said Amanda Cunnington, Director of Health Economics, Market Access, Reimbursement (HEMAR) & Patient Engagement and Government Affairs, Janssen-Cilag.
“We recognise this outcome results in a discrepancy in access between patients in Scotland and those in the rest of the UK and are currently working closely with NICE in the hope that patients will also be able to access esketamine nasal spray routinely in England, Wales and Northern Ireland.”