A row has broken out between National Health Service spending watchdogs and leading mental health doctors over the approval of a controversial ketamine-based antidepressant.
Spravato, a nasal spray also known as esketamine, was given the green light by the European Medicines Agency in December 2019 as a fast-acting treatment for depression patients who had not responded to at least two other standard medications.
The trials showed that the benefits of the drug, which is taken alongside standard antidepressants, were also long-lasting, with patients taking it nearly half as likely to relapse within a year as those taking antidepressants alone. .
But in May, the UK’s prescribing body, the National Institute for Health and Care Excellence (NICE), rejected Spravato, which costs up to £489 per dose. Concerns were raised that the drug had to be administered in hospital, as often as twice a week, to control patient reactions and minimize safety risks.
NHS spending watchdog NICE has rejected the use of the ketamine nasal spray Spravato (pictured), which costs just under £1,000 a week, to treat depression in NHS patients.
Esketamine is a high-potency form of ketamine, a powerful and addictive medical anesthetic that is often used by drug addicts because it can cause hallucinations.
NICE disputed the trial data, saying there was insufficient evidence of long-term benefit and offering the drug was unlikely to be an acceptable use of NHS resources.
Janssen, the pharmaceutical firm behind Spravato and a subsidiary of US pharmaceutical giant Johnson & Johnson, struck back, claiming that NICE acted unfairly and called the evaluation process “not fit for purpose”. In June, Janssen appealed the ruling and, in a move that surprised many, the company received backing from the Royal College of Psychiatrists.
In emails seen by The Mail on Sunday, the Royal College accused NICE of being “unreasonable” and said the snub “discriminates against patients suffering from mental disorders”. The bar, in terms of required evidence, had been set so high that it would prevent any medication for treatment-resistant depression from being approved, he added.
Last week, NICE announced that its evaluation committee will meet again in October to explain its rationale. Representing the Royal College in the audience will be Dr Rupert McShane, of the Oxford Health NHS Foundation Trust, who worked as an investigator on Spravato trials and served on Janssen’s advisory boards.
Dr John Read, Professor of Clinical Psychology at the University of East London, said he was alarmed by the Royal College’s intervention, claiming “it was siding with the woefully biased position of the pharmaceutical company rather than prioritizing the welfare and safety of the patient.
Depression affects around five per cent of adults in the UK, but a third of them find no relief from antidepressants, most commonly selective serotonin reuptake inhibitors (SSRIs), which work by increasing levels of the messenger serotonin chemical in the brain.
Esketamine, the active ingredient in Spravato, works differently from SSRIs by increasing levels of a substance called glutamate, which helps brain cells work better.
Scientists have long looked at the potential use of ketamine as an antidepressant, but studies show that stopping it after regular use can trigger withdrawal symptoms, such as anxiety and tremors. But because esketamine is more potent, smaller amounts are needed to have an effect on the brain.
This, advocates say, means side effects are limited. However, the European Medicines Agency identified the risks of the treatment, including “transient dissociatives”. [trance-like] perceptual disturbances, altered consciousness and increased blood pressure. Patients using Spravato have reported “feeling drunk.”
Depression affects around five per cent of adults in the UK, but a third of them find no relief from antidepressants, most commonly selective serotonin reuptake inhibitors (image presented by model)
Carmine Pariante, professor of biological psychiatry at King’s College London, said he supported the Royal College: “We know how this treatment works and there is evidence from clinical trials that it is effective in those who have not responded to any other antidepressants.” We are limited in what we can offer these patients. I’m surprised NICE didn’t see it as a positive step.”
However, Joanna Moncrieff, a professor of critical and social psychiatry at University College London, said: “Esketamine is expensive and the adverse effect profile is worrying.” I think the push comes mainly from the pharmaceutical company and psychiatrists who want to find a drug that solves problems that drugs can’t solve.”
A spokesman for the Royal College of Psychiatrists said: ‘We are disappointed with NICE’s decision. In relation to our resource, all the rules on declaration of conflicts were complied with.
‘The university will continue to work with NICE to ensure that patients with treatment-resistant depression can access as many treatment options as possible.
‘Based on our consultation process with members, the college believes that with the appropriate safeguards in place, [esketamine] would be an important new treatment option for NHS patients, but for now it will continue to be available only privately.
“It is vital that NICE’s decision does not prevent further research into the efficacy of esketamine in helping treatment-resistant depression.”
.
