The parable of the TGA approval of esketamine (Spravato) in Australia: Part 2 - Submission for listing on the PBS.
William Lugg
Australasian Psychiatry July 8, 2025 DOI: 10.1177/10398562251358137 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Intervention | Esketamine |
| Topics | Esketamine |
| Keywords | Pbac Pbs Tga review Navigate approval Conditional approval Broader access |
| Key findings | The PBAC made a conditional recommendation for esketamine to be listed on the PBS despite lack of evidence for effectiveness beyond 1-2 weeks, potential for serious acute harms including suicide, and substantial financial costs. |
Abstract
ObjectivesTo review the available evidence, key deliberations, and potential influences behind the Pharmaceutical Benefits Advisory Committee's (PBAC's) conditional recommendation for esketamine to be listed on the Pharmaceutical Benefits Scheme (PBS).ConclusionsThis paper forms part 2 of the esketamine story in Australia-its handling by the Therapeutic Goods Administration (TGA) and, subsequently, the PBAC. Currently available high-quality evidence does not support esketamine as an effective treatment for depression beyond 1-2 weeks. The available data suggests potential for serious acute harms, including suicide. There is insufficient data regarding long-term harms, but data from animal and recreational settings is extremely concerning. Financial costs are estimated to be substantial. Despite these issues, in December 2024, the PBAC made a conditional recommendation for esketamine to be listed on the PBS. This paper explores the evidence, key deliberations and potential influences behind the PBAC's decision on esketamine and revisits related issues concerning the TGA.
Comparable studies
Other narrative reviews on esketamine, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Synthesizing the Evidence for Ketamine and Esketamine in Treatment-Resistant Depression: An International Expert Opinion on the Available Evidence and Implementation Adults with treatment-resistant depression | 2021 | Review | |
| Long-term safety of ketamine and esketamine in treatment of depression | 2022 | Review | |
| Ketamine, Esketamine, and Arketamine: Their Mechanisms of Action and Applications in the Treatment of Depression and Alleviation of Depressive Symptoms. | 2024 | Review | |
| The potential of ketamine for posttraumatic stress disorder: a review of clinical evidence. | 2023 | Review | |
| Variations in BDNF and Their Role in the Neurotrophic Antidepressant Mechanisms of Ketamine and Esketamine: A Review. Patients with depression | 2024 | Narrative review |
Citations in the library
Cites 7
- Do the dissociative side effects of ketamine mediate its antidepressant effects? Journal of Affective Disorders February 18, 2014
- Long-Term Safety and Maintenance of Response With Esketamine Nasal Spray in Participants With Treatment-Resistant Depression: Interim Results of the SUSTAIN-3 Study Neuropsychopharmacology May 12, 2023
- Brain Changes Associated With Long-Term Ketamine Abuse, A Systematic Review Frontiers in Neuroanatomy March 18, 2022
- Esketamine Treatment for Depression in Adults: A PRISMA Systematic Review and Meta-Analysis. American Journal of Psychiatry March 1, 2025
- Does the intensity of dissociation predict antidepressant effects 24 hours after infusion of racemic ketamine or esketamine in treatment-resistant depression? A secondary analysis from a randomized controlled trial Trends in Psychiatry and Psychotherapy May 27, 2025
and 2 more in the library