NICE has launched a second public consultation on its draft guidance which does not recommend a nasal spray medicine for treatment-resistant depression.
Esketamine (also called Spravato and made by Janssen) is being considered by NICE for treating treatment-resistant depression in adults who have not responded to at least two different antidepressants.
NICE’s independent technology appraisal committee understood there is a real need for new treatment options for those with treatment-resistant depression.
Evidence from clinical trials suggests esketamine is more effective than placebo but it is unclear how effective it is because of the way the trials were carried out.
The committee concluded that the cost-effectiveness estimates for esketamine are much higher than what NICE normally considers a cost-effective use of NHS resources.
As esketamine is derived from a schedule 2 drug (ketamine), its administration must be supervised by a healthcare professional in a clinic.
Meindert Boysen, deputy chief executive and director of the centre for health technology evaluation at NICE, said: "There is a clear need for effective alternative treatment options for people with treatment-resistant depression.
“Our independent committee very much recognises the priority of addressing mental health challenges for the NHS.
"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.
"The committee is not confident that the impact of these changes has been captured adequately, and would like to understand better what the consequences are 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.”
A second consultation is required because comments from the first consultation suggested esketamine may be used in the NHS for people who might have more severe depression than people in the trials. And we hope to receive feedback on how our committee responded to comments received in the first consultation about the clinical and economic evidence.
During this period the company will also be able to consider it’s economic model, taking into account the committee’s conclusions in the appraisal consultation document.
The draft guidance is subject to consultation. Consultees and commentators can have their say via nice.org.uk until 25 September 2020.