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

This commentary (2023) highlights the challenges in repurposing established medicines, using ketamine as a case study for treating severe depression. Generic ketamine’s efficacy was known for over two decades, but commercial disinterest and lack of support delayed its approval. Instead, a costly patented formulation, Spravato®, gained widespread acceptance despite emerging evidence of generic ketamine’s similar effectiveness. Systemic reforms are essential to prevent a repeat scenario with new psychedelic-assisted psychotherapy treatments, including commercial incentives, public funding, and reduced regulatory barriers.

Abstract of Ensuring the affordable becomes accessible-lessons from ketamine

“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.”

Authors: Anthony Rodgers, Dilara Bahceci, Christopher G. Davey, Mary Lou Chatterton, Nick Glozier, Malcolm Hopwood & Colleen Loo

Summary of Ensuring the affordable becomes accessible-lessons from ketamine