NICE declines to look again at depression drug Spravato


Johnson & Johnson has slammed a decision by NICE not to carry out a new appraisal of its antidepressant Spravato, claiming it has “grave concern” about access to new mental health treatments through NHS England.

The UK agency declined to recommend NHS funding for Spravato (esketamine) nasal spray in 2020 – following its approval as an add-on therapy for people with serious depression who don’t respond to treatment with at least two oral antidepressant therapies – saying it was not convinced by the clinical data for the drug and believed it was not cost-effective.

In a statement, J&J said it has “reluctantly concluded it has exhausted all current viable avenues to gain patients access to Spravato,” which NICE’s 2020 appraisal noted has a list price of around £10,500 per course of therapy ahead of any discounts.

The company pointed out that Spravato is available in 20 other countries across Europe, including Ireland and crucially Scotland, creating a disparity in access to the drug within the UK, which mental health charity SANE has described as “a further blow for patients.”

J&J added that it hopes NICE will “prioritise adapting its appraisal methods so that all mental health treatments may be appropriately assessed in the future.”

NICE said in an update that the evidence received since its first appraisal “did not support the need for an update of the existing recommendation […] so, the guidance will remain unchanged unless or until NICE becomes aware of new substantive information to support reconsideration.”

Its earlier appraisal raised a number of issues with Spravato, including a lack of comparisons with other approaches used for treatment-resistant depression and little data on what happens after treatment with the drug is stopped.

A couple of weeks ago, J&J reported data from a new phase 4 study of Spravato that showed a statistically significant improvement in depressive symptoms after 4 weeks of treatment, measured using the MADRS total score, when compared to placebo, with improvements seen as early as 24 hours after the first dose.

That speed of onset has been held up as the main benefit for Spravato compared to other approaches to treatment-resistant depression, which often rely on sequentially trying different oral therapies that can take weeks to confer a benefit – if they are effective at all.

Globally, the take-up of Spravato was modest in the post-launch period, but has started to gather momentum of late, with sales last year rising 80% to $689 million. Another 72% increase to $225 million in the first quarter of the year puts the drug on course to achieve blockbuster status, with sales of $1 billion-plus for calendar 2024.