The National Institute of Health and Care Excellence today published a draft guidance for public consultation without recommending Johnson & Johnson's nasal spray medicine for treatment-resistant depression.
Janssen-Cilag, J&J's pharma unit, has issued a sharp reaction to the government body's decision stating that this "may potentially deny patients living with treatment-resistant major depressive disorder access to a much-needed new treatment option."
Esketamine (Spravato) with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor has not been recommended by NICE due to issues around cost-effectiveness.
NICE director Meindert Boysen said: "Introduction of esketamine into clinical practice in the NHS will be complex because the structure and delivery of services would need to be changed. Estimates of the costs of providing the clinical service for esketamine were highly uncertain, as are the costs of repeated courses of the drug.
"There is a lack of evidence comparing esketamine with all relevant comparators, and the committee concluded that the estimates of cost-effectiveness were likely to be much higher than what the NHS usually considers value for money.”
However, commenting on the draft guidance, Janssen said it was "deeply disappointed" at the decision but was committed to working closely with NICE throughout the subsequent stages of this appraisal.
Janssen-Cilag's Jennifer Lee said: “It is evident from this initial draft guidance that current NICE technology appraisal processes are not fit for purpose in terms of evaluating innovative technologies for complex mental health conditions, an area that is already under-researched and underfunded.
"This decision further reinforces the need for reform through the NICE Methods Review, to allow a new generation of innovative treatments to reach patients.”
The draft guidance is open for consultation until February 18, 2020. A second committee meeting is due to be scheduled in either March or April 2020, and final guidance is expected to be published following this meeting.
