UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued draft guidance not to recommend Spravato (esketamine) nasal spray in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), for adults living with treatment-resistant major depressive disorder (TRD) who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.
Janssen, the Rx pharma unit of US healthcare giant Johnson & Johnson (NYSE: JNJ), says it is deeply disappointed by the recommendation set out within the Appraisal Consultation Document (ACD). The company remains determined to ensure patients living with TRD are able to access an important new treatment option, despite the challenges posed by a national mental health care environment where the pace of change is slow, and adoption of innovation has historically been limited.
In its draft guidance, the NICE says that there are questions about not only the price of the drug – which costs around £10,500 per course of therapy before any discounts – but also the clinical data provided for Spravato.
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