The UK’s National Institute for Health and Care Excellence (NICE) has announced that it is not recommending the use of Janssen’s Spravato esketamine nasal spray for the treatment of treatment-resistant depression due to concerns about clinical benefits and cost effectiveness. NICE will accept comments on the draft guidance through its web site until February 18, 2020.
Spravato was approved by the European Commission in December 2019 and has been approved in the US since March 2019. Janssen has submitted supplemental applications in the US and in the EU seeking to expand the use of Spravato to patients with active suicidal ideation with intent.
NICE Director of the Centre for Health Technology Evaluation Meindert Boysen explained, “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.”
NICE also said that while clinical trials show that Spravato plus an oral antidepressant is more effective than placebo, there have been no studies directly comparing Spravato to other types of therapy, including “psychological therapies” and combinations of oral antidepressants with lithium, antipsychotics, or other antibiotics.
The draft guidance also says that “There is uncertainty about the effect of stopping esketamine treatment. It is unclear if any improvements in symptoms will be maintained after a course of treatment and whether this will improve someone’s quality of life. The costs of repeated courses of treatment with esketamine are unknown, as are the costs of providing the clinic service for esketamine.”
Read the NICE announcement.
Read the NICE draft guidance.
