NICE Gets Called Out on Insufficient Explanation Regarding Janssen Spravato Decision

An appeal panel has sided with Janssen against the final guidance from the UK’s National Institute for Health and Care Excellence (NICE), which did not recommend the company’s Spravato (esketamine) nasal spray for treatment-resistant depression.

The appeal panel concluded that NICE’s final appraisal document did not provide sufficient explanation on how uncertainties inherent in clinical trials to treat mental illness had been taken into account in reaching its decision. As a result, said the panel, NICE had failed to act fairly.

The panel asked the appraisal committee to reconvene to address this point and to explain which uncertainties in mental health-focused clinical trials were, in its opinion, potentially solvable and which were not.

Said NICE, the appeal panel believes this might help inform future clinical trial design for treatment-resistant depression.

The appraisal committee is expected to meet next month to discuss the finding from the appeal panel.