Ensuring the affordable becomes accessible-lessons from ketamine, a new treatment for severe depression.

The repurposing of generic racemic ketamine for severe depression has been delayed and uncoordinated for over 20 years due to insufficient commercial incentives, while a patented intranasal formulation (Spravato) gained widespread registration through substantial commercial investment. Spravato costs $600-$900 per dose compared to about $5 per dose for generic ketamine, and an annual government investment of approximately AUD$100 million in Australia was rejected twice, leaving the treatment largely inaccessible. Emerging evidence suggests generic ketamine is at least as effective as Spravato, but no comparative trials have been conducted. Without systemic reforms—including commercial incentives, public funding, reduced regulatory barriers, and coordinated international support—this pattern will repeat with new psychedelic treatments.

Study at a glance

Abstract

In this paper, the case study of ketamine as a new treatment for severe depression is used to outline the challenges of repurposing established medicines and we suggest potential solutions. The antidepressant effects of generic racemic ketamine were identified over 20 years ago, but there were insufficient incentives for commercial entities to pursue its registration, or support for non-commercial entities to fill this gap. As a result, the evaluation of generic ketamine was delayed, piecemeal, uncoordinated, and insufficient to gain approval. Meanwhile, substantial commercial investment enabled the widespread registration of a patented, intranasal s-enantiomeric ketamine formulation (Spravato®) for depression. However, Spravato is priced at $600-$900/dose compared to ~$5/dose for generic ketamine, and the ~AUD$100 million annual government investment requested in Australia (to cover drug costs alone) has been rejected twice, leaving this treatment largely inaccessible for Australian patients 2 years after Therapeutic Goods Administration approval. Moreover, emerging evidence indicates that generic racemic ketamine is at least as effective as Spravato, but no comparative trials were required for regulatory approval and have not been conducted. Without action, this story will repeat regularly in the next decade with a new wave of psychedelic-assisted psychotherapy treatments, for which the original off-patent molecules could be available at low-cost and reduce the overall cost of treatment. Several systemic reforms are required to ensure that affordable, effective options become accessible; these include commercial incentives, public and public-private funding schemes, reduced regulatory barriers and more coordinated international public funding schemes to support translational research.