Groundbreaking research on the off-patent drug ketamine for treatment-resistant depression (TRD) has highlighted its long-term efficacy and safety. However, despite these promising findings, funding obstacles continue to hinder its accessibility in Australia.
In a pioneering study, researchers at the Black Dog Institute have published the first Australian research on the long-term use of generic ketamine for TRD. Dr. Clara Tuneu, a psychiatrist and researcher involved in the study, reported that the drug’s efficacy was sustained for up to six months without serious side effects. “To our knowledge, no other studies have evaluated the efficacy of generic racemic ketamine beyond four weeks,” she stated.
Study Findings and Clinical Implications
The study analyzed retrospective patient data from 2021 to 2024, collected from three Australian clinics offering ketamine treatment for TRD, encompassing public, private, and non-profit sectors. Of the 65 participants, 75% showed improvement in suicidality at six months, 44% responded to treatment, and nearly one-third achieved remission.
Dr. Tuneu emphasized that while the cohort was small, the study filled a significant gap in the literature, providing crucial evidence supporting the clinical use of generic ketamine. “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 noted.
Professor Colleen Loo, a researcher with UNSW and the Black Dog Institute, highlighted the study’s groundbreaking nature. “The implications for clinical care are that this is effective and safe and a useful treatment,” she told The Medical Republic.
The Funding Conundrum
Despite the positive outcomes, the path to funding generic ketamine remains blocked. Professor Loo explained that without a commercial sponsor, the drug cannot be listed by the Therapeutic Goods Administration (TGA) for TRD treatment. “Because the drug is generic and off-patent, there is no commercial sponsor,” she 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 expressed support for generic, effective drugs in principle, but the mechanism to facilitate their availability is lacking. “The government realizes that this would be a great way forward, but they have not done enough, or really anything, that actually facilitates this,” Professor Loo remarked.
Comparative Treatment and Economic Implications
Currently, Medicare can only fund treatments listed by the TGA, and obtaining such a listing requires a sponsor. “The whole Medicare system was clearly designed with commercial pharma companies in mind,” Professor Loo explained. She pointed out that a sponsor would need to invest significantly to apply for Medicare funding, but this would allow cheaper forms of ketamine to be used instead of their product.
While electroconvulsive therapy (ECT) is funded for lifelong maintenance treatment for TRD, Professor Loo noted that patients who have experienced both treatments prefer ketamine. “Ketamine doesn’t cause any memory problems, so that they’re actually more able to function,” she said, adding that ketamine has fewer risks and side effects than ECT and does not require general anesthesia.
“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,” Professor Loo emphasized.
Despite being a cheaper alternative to ECT, ketamine treatment costs patients about $10,000 for six months, making it inaccessible for many Australians. “I would say the majority of the Australian population who would need this cannot afford it,” Professor Loo lamented.
International Perspectives and Future Directions
Professor Loo expressed frustration over the lack of progress in securing funding, despite efforts by the Black Dog Institute and collaborators at the George Institute. “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 some public sector ketamine clinics exist, their resources are limited, often providing only up to six months of treatment. For patients with severe depression, this means a temporary improvement followed by a relapse once treatment ends.
Internationally, other countries are advancing in this area. The Netherlands has already funded ketamine for TRD, and the UK is considering an application for NHS funding. “This is something that obviously needs to change, and other countries are ahead of us in this,” Professor Loo stated.
The call for action is clear: without changes to the funding framework, many Australians will continue to be denied access to a potentially life-changing treatment.
