The parable of the TGA approval of esketamine (Spravato) in Australia: Part 2 - Submission for listing on the PBS.

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.