The Scottish Medicines Consortium (SMC) has accepted the use of esketamine (Spravato; Janssen) nasal spray for use within NHS Scotland for adults with treatment-resistant major depressive disorder.
This is in contrast to draft guidance published by the National Institute for Health and Care Excellence (NICE), which did not recommend the nasal spray medicine for treatment-resistant depression.
The spray — which is to be used in combination with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor in patients who have not responded to at least two different treatments with antidepressants — was accepted by the SMC on the basis of a phase III clinical trial.
The data showed that in adults aged 18 to 64 years with treatment resistant depression, esketamine nasal spray plus a newly initiated oral antidepressant significantly reduced the Montgomery-Ã…sberg depression rating scale total score from baseline to week four, compared with placebo nasal spray plus a newly initiated oral antidepressant.
NICE, which has now launched its second public consultation on its draft guidance, does not recommend the nasal spray for treatment-resistant depression.
In a release from NICE, it said that its independent technology appraisal committee understood there was “a real need” for new treatment options in this area. However, it said that although the evidence from clinical trials suggested esketamine was more effective than placebo, it was unclear how effective it was because of the way the trials were carried out.
The second consultation, which closes on 25 September 2020, was required because comments from the first consultation suggested esketamine may be used in the NHS for people who might have more severe depression than those in the trials.
The committee also concluded that the cost-effectiveness estimates for esketamine were much higher than what NICE normally considered a cost-effective use of NHS resources.
“Our independent committee very much recognises the priority of addressing mental health challenges for the NHS,” said Meindert Boysen, deputy chief executive and director of the centre for health technology evaluation at NICE.
“However, the introduction of esketamine into clinical practice in the NHS will be complex because the structure and delivery of services would need to be changed.”
She said that the NICE committee was not confident that the impact of these changes had been captured adequately, and would like to understand better what the consequences were of patients having repeated courses of esketamine.
“There is also uncertainty about whether improvement in symptoms and quality of life can be sustained, and we would like to hear from stakeholders about this,” she added.
Esketamine is derived from the schedule 2 drug, ketamine, and its administration must be supervised by a healthcare professional in a clinic.
David Taylor, director of pharmacy and pathology at the Maudsley Hospital, said there was “little doubt” that ketamine in its various formulations was “rapidly effective” in refractory depression, but that concerns remained about its long-term benefit, toxicity and the potential for diversion.
“The ongoing argument is about the cost-effectiveness of a specific licensed esketamine nasal spray (Spravato),” he added.
“NICE has yet to publish a final decision on this product and is going through a second consultation process, although it has now twice indicated that it will not be approving this product.”