NICE knocks back Janssen’s Spravato nasal spray for the second time in treatment-resistant depression

pharmafile | September 3, 2020 | News story | Sales and Marketing Janssen, Spravato, depression, pharma 

NICE has opted to reject Janssen’s nasal spray Spravato (esketamine) for routine use on the NHS for treatment-resistant major depressive disorder (MDD), following the drug’s second appraisal consultation with the UK watchdog.

The US drug firm had been seeking recommendation in patients who have not responded to at least two different antidepressant therapies when Spravato is used in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI).

However, NICE remarked that, due to issues in clinical trial design, it was difficult to determine the drug’s true efficacy, despite provided data suggesting that it was more effective than placebo when combined with an SSRI or SNRI. This also made it difficult to accurately identify whether any benefits would continue after treatment was ceased, and for how long.

Furthermore, the economic models put forward in the application were argued by NICE to not be representative of how treatment-resistant depression is currently treated on the NHS.

Janssen voiced its disappointment following the decision, with Amanda Cunnington, Director of Health Economics, Market Access & Reimbursement (HEMAR) and Advocacy, commenting: “It is a real shame that this treatment will now need to go through a third appraisal committee and is extremely frustrating for clinicians and for patients living with treatment-resistant major depressive disorder who are in desperate need of an alternative treatment option.

“It is important that Janssen and NICE work together along with other stakeholders to make sure that innovative treatments in mental health, such as esketamine nasal spray, are able to navigate the NICE appraisal process and, once approved, be used in clinical practice,” she continued. “There are real challenges in the way mental healthcare is considered that limits access and uptake of innovation, which contributes to the disparity between treatments for physical and mental health.”

The company maintains that Spravato is a cost-effective use of NHS resources and “is confident that based on further technical responses and additional discussions with NICE, a route can be found for esketamine nasal spray to be made available for eligible patients”.

Matt Fellows

Related Content


Janssen submits sNDA to FDA for full approval of Balversa

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental …

FDA approves IMIDEX’s AI-powered device VisiRad XR

The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug …

Artiva Biotherapeutics announces FDA clearance of IND for AlloNK and Rituximab combo

On 16 August 2023, the US Food and Drug Administration (FDA) officially cleared Artiva Biotherapeutics’ …

Latest content