In second draft guidance published this week, the National Institute for Health and Care Excellence (NICE) states it will not recommend Spravato (esketamine) nasal spray in combination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 (MDD).
In a statement released following the publication o the guidance, the Janssen Pharmaceutical Companies of Johnson & Johnson said it is “disappointed” with the decision.
“It is a real shame that this treatment will now need to go through a third appraisal committee and is extremely frustrating for clinicians and for patients living with treatment-resistant major depressive disorder who are in desperate need of an alternative treatment option,” said Amanda Cunnington, Director of Health Economics, Market Access & Reimbursement (HEMAR) and Advocacy, Janssen-Cilag Limited.
“It is important that Janssen and NICE work together along with other stakeholders to make sure that innovative treatments in mental health, such as esketamine nasal spray, are able to navigate the NICE appraisal process and, once approved, be used in clinical practice.
“There are real challenges in the way mental healthcare is considered that limits access and uptake of innovation, which contributes to the disparity between treatments for physical and mental health.”
Janssen believes that, based on the evidence submitted, esketamine nasal spray is a cost-effective use of National Health Service (NHS) resources.
Janssen is now seeking to address NICE’s concerns and is “confident” that based on further technical responses and additional discussions with NICE, a route can be found for esketamine nasal spray to be made available for eligible patients.