NICE’s decision to not re-appraise Spravato “gravely concerning,” says J&J

US healthcare giant Johnson & Johnson (NYSE: JNJ) says it has “grave concern” for the availability of future innovative mental health treatments in England, following a decision by National Institute for Health and Care Excellence (NICE) to not re-appraise Spravato (esketamine nasal spray) for treatment-resistant depression in England – despite it being available in 20 other countries across Europe, including Scotland and Ireland.

This decision by the medicines cost-effectiveness body, which was made despite significant new evidence demonstrating it as a possible effective treatment, is being called “a further blow for patients” by the UK wide mental health organization, SANE.

The ESCAPE-TRD study is a Phase IIIb, randomized, multicenter, active-controlled trial which demonstrated that esketamine NS 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, further demonstrate the meaningful efficacy of the medicine, and to help support patient access.