Ensuring the affordable becomes accessible-lessons from ketamine, a new treatment for severe depression.
The Australian and New Zealand journal of psychiatry – February 01, 2024
Source: PubMed
Summary
Generic racemic ketamine, priced around $5 per dose, shows comparable antidepressant effects to the patented Spravato® at $600-$900 per dose. Despite its potential, generic ketamine's evaluation faced delays and lack of support, leaving it largely inaccessible in Australia even two years post-approval. With an annual investment request of AUD$100 million rejected twice, affordable treatment options remain elusive. Systemic reforms are necessary to facilitate access to low-cost treatments, especially as new psychedelic therapies emerge on the horizon.
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.