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NICE refuses to re-appraise J&J’s SPRAVATO for depression



Johnson & Johnson (J&J) has expressed that it is deeply disheartened with the decision by the UK’s National Institute for Health and Care Excellence (NICE) to not re-appraise SPRAVATO for treatment-resistant depression (TRD) in England and Wales.

NICE has decided against reappraising the guidance despite significant new evidence that further supports SPRAVATO (an esketamine nasal spray [NS]) as an effective treatment for TRD.

The company has now raised concerns about what the decision means for the availability of innovative mental health treatments.

The new evidence comes from J&J’s ESCAPE-TRD Phase IIIb, randomised, multi-centre, active-controlled trial, which demonstrated that the esketamine nasal spray was superior in achieving remission and remaining relapse free, compared with a relevant active comparator, quetiapine extended release (QXR), in patients with TRD.

The trial was conducted to address questions from the NICE committee, to further demonstrate the meaningful efficacy of the medicine, and to help support patient access.

Roz Bekker, Managing Director, Johnson & Johnson Innovative Medicine, UK & Ireland, stated: “Johnson & Johnson feel the decision to not re-appraise esketamine NS, denying the NICE Committee a chance to properly assess the new evidence, is a significant missed opportunity for patients living with TRD.”

Through its surveillance review, NICE failed to see how the ESCAPE-TRD Phase
IIIb clinical study results could change the Committees’ current guidance.

This means patients in England and Wales continue to miss out on a treatment accessed by patients in 20 countries across Europe, including Scotland and Ireland, where esketamine NS has received a positive assessment for TRD.

In Germany, the NICE equivalent Gemeinsamer Bundesausschuss (G-BA), a challenging appraisal committee, announced its positive assessment on 21 September 2023, gaining a considerable added benefit outcome compared to QXR, which is the second highest possible rating and the first ever psychiatry product to gain such a high outcome.

This was largely due to the significant results of the ESCAPE-TRD trial, meaning patients in Germany now have access to esketamine NS.

“For over eleven years, our company has strived to navigate systematic challenges to provide patients with a treatment that may improve their quality of life. We are disheartened that England and Wales are now outliers compared to their immediate neighbours and other European countries,” continued Bekker.

“We have grave concerns about what this decision may mean for the availability of future innovative mental health treatments, based on the current assessment criteria used by NICE. We hope that any future appraisal reforms will finally provide patients living in England and Wales access to new mental health treatment options.”

Marjorie Wallace CBE, Chief Executive of SANE, a leading UK mental health charity, commented: “The decision by NICE not to re-appraise esketamine nasal spray is a further blow for people suffering from depression who do not respond to existing medications, or other treatments, and for whom there have been no new treatments for over thirty years.

“The only way to have a positive impact on the lives of people affected by this debilitating condition is for those in a position to do so to develop innovative treatments and for these to be made available. Access to new treatments could transform the future and bring hope for patients and families.”

J&J has stated that it has reluctantly concluded it has exhausted all current viable avenues to gain patient access to esketamine NS given the surveillance decision, and after working collaboratively with NICE since the beginning of the appraisal process.

“We hope that NICE will prioritise adapting its appraisal methods and processes to give due consideration to depression treatments so that all mental health treatments may be appropriately assessed in the future, bringing more parity with physical health treatments to better serve patients. We will continue to work collaboratively with NICE and the broader system in the future,” the company stated.

“This outcome will come as a disappointment to many clinicians treating large numbers of patients with TRD who may potentially have benefitted from this treatment, as demonstrated by the ESCAPE-TRD trial,” stated Professor Allan Young, Director, Centre for Affective Disorders, Institute of Psychiatry, Psychology and Neuroscience, King’s College London.

“From the ESCAPE-TRD trial findings we saw that this treatment had a significant effect on patients living with TRD across both sub-groups, particularly for those who had three or more prior treatment failures. Furthermore, this decision sends a negative signal to those with compounds in development that could potentially treat mental health conditions in the future.”