Janssen says it is disappointed with second draft guidance from the National Institute for Health and Care Excellence (NICE) rejecting NHS funds for its nasal depression spray Spravato (esketamine).
Following a second appraisal consultation, the Institute is not recommending use of the 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) who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.
According to NICE, clinical trials suggest that Spravato with an SSRI or SNRI may be more effective than placebo with an SSRI or SNRI, but it is unclear how effective Spravato is “because of the way the trials were done”.
Also, people who may have Spravato in the NHS might have more severe depression than people in the trials, and there are “problems with the economic model because it does not reflect how treatment-resistant depression is treated in the NHS or how long an episode of depression lasts”.
NICE also highlighted uncertainty about whether any improvements in symptoms continue after treatment stops and if this will improve someone’s quality of life, as well as the costs of repeated courses of treatment with Spravato.
Janssen, however, believes that based on the evidence submitted Spravato is a cost-effective use of NHS resources. The firm said it is seeking to address the 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”.
“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.”
The consultation on the second draft guidance is open until September 25, with final guidance is expected later this year.
