A vial of generic, off-patent ketamine costs about five dollars and could provide a cost-effective solution for people with treatment-resistant depression.
The potential use of ketamine as a lifeline intervention for patients emerges from a recently concluded clinical trial in Sydney, Melbourne, Adelaide, the Gold Coast, and Otago, NZ.
The double-blind trial (meaning neither participants nor researchers were aware of who was administered treatments or placebos) resulted in 20% of patients entering remission from their symptoms, and a third of all participants experienced a minimum 50% reduction in symptoms.
Under examination was the effectiveness of affordable, non-patented ketamine as a therapeutic for those for have failed to respond to at least two standard depression treatments.
“Once you fail two standard treatments, it’s much harder to get well with subsequent treatments,” says the study’s lead author Professor Colleen Loo, from the Black Dog Institute and UNSW.
Ketamine is known as a party drug, however evidence has emerged recently that it may be a suitable treatment for specific mental health patients. Other psychoactive substances like psilocybin and MDMA have also been approved by Australia’s Therapeutic Goods Administration as administrable by approved psychiatrists.
The dosage of ketamine used in the clinical trial is, however, far lower than those reportedly used recreationally. The trial also administered dosages subcutaneously (a needle into the skin) to reduce time in clinic.
“The word ‘transformative’ is not inappropriate,” says study co-author Professor Paul Glue, a Professor of Psychological Medicine, University of Otago, NZ.
“Of the people we’ve had through our clinic, and this is probably consistent with other centres internationally, somewhere between two-thirds and three-quarters of people have either a good or complete response.”
But Glue, and the study’s other authors, note that while generic ketamine is cheap to get and subcutaneous dosage can cut time and skill required to deliver treatment, it’s that time in the clinic that will carry the greatest financial burden for patients.
Outcomes will rely on several treatments, potentially over years for some patients. And that’s where regulator support will likely be needed to improve accessibility.
Potential side effects, while well-tolerated among participants, primarily included feelings of sedation and light-headedness, which wore off after an hour. The necessity for monitoring adds more time in-clinic, which Loo says, will be the source of most hip-pocket burden for patients. There will also be the cost of setting up high-standard care programs.
“The main barrier [now] is the cost, because of the two hours of monitoring [in clinic],” she says.
“You do have increases in blood pressure, you might feel a bit dizzy, so you do need to have careful monitoring in a medical setting for two hours after each dose.
“The treatment cost at our centre is about $350 for the treatment session, and the drug costs about five dollars.
“At the moment, you have to pay out of pocket in Australia [for] the $350 per treatment session, because there is no Medicare item number. Because it’s a new treatment, it’s not recognised by the private health funds or Medicare.”
The cost is markedly lower than patented treatments – currently in the form of a nasal spray – which can be more than twice as expensive as generic alternatives when administered clinically.
Due to the complexity, it’s unlikely that general practitioners will be dosing out ketamine any time soon, though some pharmaceutical companies are developing slow-release forms of the drug that could one day be prescribed for home use.
In the meantime, while ketamine is currently approved in Australia as an anaesthetic and sedative, psychiatrists trained in the off-label administration of the drug may soon be able to administer the drug as an intervention to those patients for whom other treatments have been ineffective.
The Black Dog Institute, where Loo is based, offers specialised training to psychiatrists to understand administration protocols.
“[In] Australia, I think it [ketamine] is ready to be used off-label,” Loo says.
“But I think because of the complexity of the treatment, it really is something that should be managed by a psychiatrist, not in… improperly setup clinics… private rooms… general community clinics.
“It’s a very powerful treatment. Done well, it’s an amazing treatment, which has been transformative for many people.
“The vast majority get some benefit, but done without adequate information and skill, and the framework for monitoring and careful management, it could also harm people.”
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