A dispute has erupted between NHS budget watchdogs and leading mental health physicians over the authorization of a controversial antidepressant containing ketamine.
The European Medicines Agency approved Spravato, a nasal spray also known as esketamine, in December 2019 as a rapid-acting treatment for depression patients who had not reacted to at least two other conventional drugs.
Trials demonstrated that the benefits of the medicine, which is taken in conjunction with regular antidepressants, were also long-lasting, and that patients who took it were nearly half as likely to experience a relapse within a year as those taking antidepressants alone.
However, in May, the National Institute for Health and Care Excellence (NICE) in the United Kingdom rejected Spravato, which costs up to £489 per dose. Concerns were expressed about the drug’s requirement to be delivered in the hospital as frequently as twice a week to monitor patients’ reactions and reduce safety concerns.
Esketamine is a high-strength version of ketamine, a potent and addictive medical anesthetic that is frequently abused by drug addicts due to its hallucinogenic properties.
The National Institute for Health and Care Excellence (NICE) questioned the study findings, stating that there was insufficient evidence of long-term benefit and that administering the medication was “unlikely to be an acceptable use of NHS resources.”
Janssen, the manufacturer of Spravato and a subsidiary of the U.S. pharmaceutical giant Johnson & Johnson, retaliated by saying that NICE acted unfairly and labeling the evaluation process as “not fit for purpose.” In June, Janssen challenged the verdict, and in a move that surprised many, the Royal College of Psychiatrists supported the business.
In emails obtained by The Mail on Sunday, the Royal College accused NICE of being “irrational” and said that the rejection “discriminates against people with mental problems.” In terms of required evidence, the bar had been raised so high that no medicine for treatment-resistant depression could be licensed, the report noted.
NICE said this week that its evaluation group will reconvene in October to explain its reasoning. Dr. Rupert McShane from Oxford Health NHS Foundation Trust, who worked as a researcher in Spravato trials and has served on advisory boards for Janssen, will represent the Royal College during the hearing.
Professor of Clinical Psychology at the University of East London, Dr. John Read, was startled by the Royal College’s intervention, alleging that sided with the drug company’s ludicrously biassed viewpoint rather than prioritizing patient wellbeing and safety
Approximately five percent of adults in the United Kingdom suffer from depression, yet a third of them do not find treatment on antidepressants, most frequently selective serotonin reuptake inhibitors (SSRIs), which act by increasing serotonin levels in the brain.
Esketamine, the main ingredient in Spravato, differs from SSRIs in that it enhances the function of brain cells by boosting glutamate levels.
Scientists have examined ketamine’s potential use as an antidepressant for a long time, but studies indicate that discontinuing regular use can cause withdrawal symptoms, such as anxiety and tremors. However, because ketamine is more effective, lower doses are required to affect the brain.
According to proponents, this means that negative effects are minimal. Nonetheless, the European Medicines Agency recognized the dangers of treatment, such as “transient dissociative [trance-like] states, sensory problems, awareness disturbances, and elevated blood pressure.” Patients utilizing Spravato have experienced a “buzzed” sensation.
Professor of Biological Psychiatry at King’s College London Carmine Pariante expressed his support for the Royal College, stating, “We understand how this treatment works, and there is a clinical trial proved that it is useful for patients who have not responded to other antidepressants.” We have limited options for these patients. I’m surprised NICE did not view this as a positive development.
Professor of Critical and Social Psychiatry at University College London, Joanna Moncrieff, remarked, “Esketamine is pricey and the adverse impact profile is concerning.” I believe that the push for it is mostly coming from the pharmaceutical industry and psychiatrists who want to find a treatment to treat conditions that cannot be treated with drugs.
Royal College of Psychiatrists spokesman: ‘We are dissatisfied by NICE’s decision. Regarding our appeal, all rules for declaring conflicts of interest were followed.
The college will continue to collaborate with NICE to ensure that patients with depression that is resistant to therapy have access to as many treatment alternatives as possible.
‘Based on our engagement process with members, the college feels that, with the proper safeguards in place, [esketamine] would be an essential new therapy option for NHS patients; nonetheless, for the time being, it will continue to be provided exclusively privately.
NICE’s judgment must not impede future research into the efficacy of esketamine in treating depression resistant to therapy.
