A “ketamine-like” spray that reportedly boosts a depressive’s mood in just a few hours has not been given the green light for use in the NHS.
The National Institute for Health and Care and Excellence (NICE), which issues guidelines for the health service, claims there are too many uncertainties regarding the drug esketamine’s price relative to its benefits.
According to NICE, esketamine is an isomer of ketamine (which means it has the same molecular formula).
Ketamine is more commonly known as an illicit "party drug" and can make users high when used in elevated doses. It is also used as a painkiller by the NHS.
Esketamine is thought to be more potent than ketamine at relieving symptoms of depression in patients, according to John Hopkins Medicine.
As a regulated drug, esketamine is only given in controlled doses and is free of the contaminants that can make ketamine dangerous.
It is said to boost mood by targeting the chemical glutamate, which is also linked to learning and memory.
The spray, which gets absorbed into the bloodstream, costs around £10,000 ($12,994) for one course of treatment, the BBC reported.
NICE argues there is a lack of evidence of esketamine’s effectiveness, particularly when compared to conventional treatments.
The Food and Drug Administration (FDA) in the US approved the spray last year for treatment-resistant depression.
“A substantial number of individuals suffering from major depression fail to respond to two or more conventional antidepressants,” Dr Paul Keedwell, from Cardiff University, said.
Treatment-resistant depression is thought to affect up to 30% of people with major depressive disorder (MDD) in the UK, according to a paper in the journal BMC Psychiatry.
MDD - defined as remitting and relapsing symptoms that may persist between episodes - affects between 5% and 10% of people in “primary care settings” in the UK, NICE reported.
“Existing approaches to treatment resistance, including medication combinations, talking therapy or electroconvulsive therapy (ECT) often fail or are unacceptable,” Dr Keedwell said.
“New approaches are required to reduce the costs to society of protracted suffering, disability and chronic healthcare needs.
“The committee's objection to its use appears to be largely based on cost rather than lack of effectiveness.
“While it is an expensive treatment, the additional costs incurred with any promising new medication must be compared to the financial burden of persisting depression.
“Another consideration is the emerging evidence that ketamine rapidly quells suicidal thoughts - an effect that could not only reduce levels of self-harm but could also reduce dependence on costly emergency services and crisis admissions to hospital.”
Ketamine, which has also been used to treat depression, tends to act in hours, rather than the weeks or even months it takes “traditional” antidepressants, Dr Keedwell claims.
It is not a permanent fix, however, with prolonged therapy required.
“Research at Oxford over the past 10 years has not revealed any evidence of drug-seeking or dose escalation during long term treatment,” Dr Keedwell said.
“In someone who’s life is transformed by this drug, the big ethical question is when do you stop it, if ever?
“Concerns raised by the committee about the potential harms of halting its prescribing need to countered by the observation that many individuals are ‘dependent’ on drugs to keep them well - consider bipolar patients, diabetics, asthmatics and epilepsy sufferers.
“There is no evidence thus far of a ketamine withdrawal syndrome, only evidence of relapse of depression.”
Dr Sameer Jauhar - from King’s College London - called esketamine’s efficacy data “quite reasonable”, noting many will not want ECT, regardless of how effective it may be.
One expert, however, welcomed NICE’s decision, calling it “sensible”.
“Many psychiatrists have been concerned at the lack of evidence that esketamine is really a helpful treatment for depression,” Professor David Curits, from University College London, said.
“There are also unanswered questions about the extent to which it might cause unwanted effects and how it could be safely used in practice.
“On this occasion NICE is quite correct to wait for additional information, including the results from further research, rather than allowing esketamine to be used in routine clinical practice.”
Dr Jauhar added: “There will be similar compounds, with novel modes of action, becoming available over the coming years, and this patient group badly needs access to effective treatments, which will - in time- be evaluated by NICE.”
NICE is advising patients in England and Wales who are already on esketamine, for example as part of a trial, continue taking it. Scotland is yet to issue guidance.
The watchdog’s draft guidance is open for consultation until February 18, the BBC reported.
Editor’s note: This article was updated on January 29