The parable of the TGA approval of esketamine (Spravato) in Australia: Part 2 - Submission for listing on the PBS.
Australasian psychiatry : bulletin of Royal Australian and New Zealand College of Psychiatrists July 8, 2025 William Lugg
Despite high-quality evidence showing esketamine is not an effective treatment for depression beyond one to two weeks and data suggesting serious acute harms including suicide, the Pharmaceutical Benefits Advisory Committee (PBAC) conditionally recommended listing esketamine on the Pharmaceutical Benefits Scheme (PBS) in December 2024. Long-term harms data is insufficient, but animal and recreational use data is extremely concerning, and financial costs are substantial. This paper reviews the evidence, key deliberations, and potential influences behind the PBAC's decision and revisits related issues concerning the Therapeutic Goods Administration (TGA).