After being abused as a child, David spent decades searching for a treatment for his depression and anxiety. Like many people with treatment-resistant depression, he was cycled by psychiatrists through a variety of drugs and therapies, but David – who asked for only his first name to be used – said he remained “debilitated”.
Then in October 2021, at age 64, he began a fortnightly ketamine treatment – and it proved to be a “lifesaver”.
“I had a number of very significant bouts of suicidal ideation and I think without ketamine, I would have probably acted on those impulses at some stage,” David said.
However, the medication costs the retired veterinarian $14,000 a year, meaning he cannot afford to take holidays. Experts say many people cannot afford the therapy at all, despite a cheaper alternative being available.
An article published this month in the Australian and New Zealand Journal of Psychiatry (ANZJP) said patients with treatment-resistant depression are missing out on ketamine treatment because there are no commercial incentives to get the cheaper generic brand approved by the medicines regulator.
In 2021, Australia’s Therapeutics Goods Administration (TGA) approved Spravato, the patented ketamine nasal spray developed by Janssen Pharmaceuticals that costs between $600 and $900 a dose. Applications to have Spravato subsidised by the government under the Pharmaceutical Benefits Scheme have failed, leaving researchers looking for more affordable alternatives.
Generic, or racemic, ketamine, commonly used as an anaesthetic, is not approved for use in treatment-resistant depression. It is significantly cheaper, at $5 a dose, although patients receiving the drug outside clinical trials pay an additional $350 for the consultation and monitoring.
The lead author of the ANZJP article, Prof Anthony Rodgers from the George Institute at the University of New South Wales, said there is good evidence for racemic ketamine’s use in treatment-resistant depression.
But he said there is a lack of commercial incentives to run the large trials needed for the TGA to approve the drug for treatment-resistant depression. Drugs that already exist – like ketamine – cannot be patented, meaning it is hard for companies to make money from them. Spravato managed to get a patent because it was adapted into a nasal spray.
Rodgers said while it may seem that trialing a drug that already exists would be cheap, his paper said substantial investment and specialist skills are required for trials to be conducted appropriately and to navigate complicated registration processes.
The article said new regulations need to be introduced to incentivise drug companies and other private entities to conduct trials on older drugs for treating new conditions, such as offering extended periods of market exclusivity if the drug proves successful.
Market exclusivity would allow the company that trialled the drug to market it for a period of time without direct competition from other manufacturers creating cheaper, duplicated products. Companies could also be offered tax credits for research and development into exisiting drugs, the article said.
However, even if these measures were introduced, the article acknowledged the cost to patients for appointments to have the drug administered alongside psychotherapy may still be prohibitive. Patients require monitoring for at least two hours after receiving each dose of racemic ketamine and ongoing doses are needed for treatment to be effective.
Researchers supported by Australia’s peak body for psychiatrists have applied to have all methods of delivery and forms of ketamine, including the nasal spray and lower-cost injections, subsidised by Medicare.
A co-author of the ANZJP article, Prof Colleen Loo from the Black Dog Institute, said ketamine treatments should not be seen as a cure, with further research needed to understand whether the treatment’s effects are long-lasting.
Dr Adam Bayes, a psychiatrist at the Black Dog Institute who conducts clinical trials with ketamine in patients with mood disorders and was not an author of the article, highlighted the “huge” structural problems in accessing psychedelic treatments.
He said the expense means “a lot of people out there that have treatment-resistant depression” will be excluded from treatment.
“And often, because they’re depressed, they’re unemployed or they’ve had gaps in employment and they are often in a vulnerable financial situation,” Bayes said. “So there is a real need to address these issues.”