Groundbreaking research on the off-patent drug for treatment resistant depression still isn’t enough to defeat the funding loophole.
In an Australian first, long-term safety and efficacy research of generic ketamine for treatment resistant depression (TRD) has been published.
Dr Clara Tuneu, a psychiatrist and researcher at Black Dog Institute, told Haematology Republic that they found efficacy sustained up to six months with no serious side effects.
“To our knowledge, no other studies have evaluated the efficacy of generic racemic ketamine beyond four weeks,” she said.
Retrospective patient data from 2021 to 2024 were collected from three Australian clinics that provide ketamine treatment for TRD. This included public, private and not for profit ketamine clinics.
Of the 65 participants, three quarters showed improvement in suicidality at six months and 44% responded to treatment at six months, with nearly one-third achieving remission.
Researchers found that depressive symptoms decreased during the first eight weeks of treatment, but the benefit was sustained over six months.
While the cohort was small, Dr Tuneu said the report filled a major gap in the literature and has provided important supporting evidence for clinical generic ketamine use.
“Formal research trials are typically done in a narrow framework, excluding many people who would be treated in a typical clinic – this data complements and confirms the evidence provided by formal research trials,” she said.
Dr Tuneu said the response and remission rates were similar to the KADS trial and that their overall findings were consistent with what had been observed in real-world clinical practice.
“The implications for clinical care are that this is effective and safe and a useful treatment,” Professor Colleen Loo, a researcher with UNSW and the Black Dog Institute, told HR.
She said the research was a world first in terms of ongoing treatment for six months using generic, off-patent ketamine in real-world clinics of Australia.
However, despite years of lobbying from researchers, there is currently no way forward for funding generic ketamine.
“Because the drug is generic and off patent, there is no commercial sponsor,” Professor Loo said.
“Without a commercial sponsor, no matter how much evidence you have that the drug works, it will never be listed by the TGA for the treatment of this condition.”
The Australian government has said in principle they support generic, effective drugs, but Professor Loo explained that the actual mechanism for getting these to people does not exist.
“The government realises that this would be a great way forward, but they have not done enough, or really anything, that actually facilitates this,” she said.
Medicare can only fund treatments which are listed by the TGA for that disorder, but treatments can only be listed by the TGA by a sponsor, she explained.
“The whole Medicare system was clearly designed with commercial pharma companies in mind,” she said.
Professor Loo explained that because a Medicare item number usually applies to a broad class of treatment and is not specific to one drug, no commercial sponsor stands to gain from going through the process of applying for Medicare funding.
A sponsor would likely spend hundreds of thousands of dollars and put together this complex application, but this would allow the cheaper forms of ketamine to be used instead of their product, she said.
“There’s not a lot of incentive there,” said Professor Loo.
She said that she, along with the Black Dog Institute and collaborators at the George Institute, have been approaching Medicare for two to three years to try to get funding.
“We have a generic, off patent, cheap drug that works extremely well but we cannot get this treatment funded publicly so that people can actually access it,” she said.
“It’s actually a travesty.”
While electroconvulsive therapy (ECT) is funded for lifelong maintenance treatment for TRD, all of Professor Loo’s patients who have had both treatments prefer ketamine.
“Ketamine doesn’t cause any memory problems, so that they’re actually more able to function,” she said.
Ketamine has fewer risks and side effects than ECT and does not require general anaesthetic.
“People should not be choosing ECT or ketamine based on affordability or because Medicare and private health funds fund one but not the other; it should be based on what makes clinical sense,” she said.
“Clinical treatment is being distorted by the funding framework, and the funding framework makes no sense whatsoever.
“It makes a lot more sense clinically for a person to have ketamine first and then, if you don’t respond, go to ECT.”
Ketamine is a cheaper alternative to ECT for the government and private health funds, but it costs a patient about $10,000 for six months of treatment.
“I would say the majority of the Australian population who would need this cannot afford it,” she said.
She said it’s been heartbreaking to see people who have been absolutely transformed by the treatment unable to afford to continue.
There were some ketamine clinics set up in the public sector, but resourcing was severely limited, she explained.
Some can provide up to six months of treatment, while others can only offer 12 treatments per person. Regardless of what a patient needs, they cannot be treated for longer.
For people with the most severe and difficult to treat depression, for whom ketamine is the best option, this means that they are well for six months and when the treatment stops, and they typically relapse a few weeks to months later, said Professor Loo.
“This is something that obviously needs to change, and other countries are ahead of us in this,” she said.
In the Netherlands, ketamine for TRD has already been funded by the government.
In the UK, an application from the Royal College of Psychiatrists is currently under consideration for NHS funding on the grounds that it is the only treatment to ever have been shown to be as effective as ECT.
