Breaking a three-decade deadlock: New therapy PBS listed in depression

Johnson & Johnson Innovative Medicine has achieved a major milestone, securing Pharmaceutical Benefits Scheme (PBS) listing for its glutamate receptor modulator – the first new type of medicine for treatment-resistant depression (TRD) to be funded in three decades.

From 1 May, up to 30,000 Australians living with moderate to severe TRD who have not responded adequately to at least two different antidepressants will gain access to Spravato (esketamine) nasal spray, administered alongside a newly-initiated oral antidepressant.

Professor Ian Hickie AO, Co-Director of Health and Policy at the Brain and Mind Centre, University of Sydney, stated “For the first time, we have a government funded medicine specifically for people trapped in an acute depressive episode despite treatment with multiple antidepressants.”

While Spravato was registered by the Therapeutic Goods Administration (TGA) back in 2021, Johnson & Johnson has faced a series of setbacks through multiple PBAC submissions before finally achieving reimbursement.

Professor Hickie added, “Depression of this nature affects every aspect of a person’s life and can make it seem as though life is not worth living. When multiple treatment options have not delivered relief, that feeling can be compounded, leaving people with little hope.

“People with treatment-resistant depression have complex and often urgent mental healthcare needs. Affordable access to treatment is essential if we are to help them out of what is often a dark, deep and dangerous hole.”

Spravato will be available exclusively through certified treatment centres equipped to safely administer the therapy and closely monitor patients.

Professor Colleen Loo, Professor of Psychiatry at UNSW and the Black Dog Institute, said “Many will improve from depression, be able to function and return to work, as well as have quality of life. Next, we need Medicare to fund the cost of the treatment process [which is separate to the drug costs funded by the PBS]. This is critical for the treatment to be rolled out, not in a simplistic manner ‘just take this medication’ but in a best-practice model as a transformative treatment.”

Joana De Castro, Managing Director of Johnson & Johnson Innovative Medicine ANZ, described the PBS listing of Spravato as “long overdue”.

“Four years after TGA registration and following four funding submissions, we are pleased that Australians with treatment-resistant depression will at last have access to Spravato through the PBS,” she said.

Depression impacts one in seven Australians, with approximately one-third of individuals cycling through multiple antidepressant therapies without achieving meaningful relief – thus meeting the criteria for TRD. Compared to those with major depressive disorder, people living with TRD typically face more severe and prolonged depressive episodes, a higher incidence of suicidal thoughts, diminished capacity to experience joy, and an increased lifetime burden of depression.

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