Will real-world evidence be the key to securing PBS listing for J&J’s depression therapy?

Pharma News: Depression, a complex and often life-altering condition, stands as the leading cause of disability worldwide, impacting an estimated 280 million people. Despite its prevalence, treating depression remains a significant challenge.

“There are many effective treatments out there, but often they don’t work as well as we hope because they’re not matched well to the right individuals,” said Dr Alexis Whitton, a Research Fellow and Psychologist at The Black Dog Institute and UNSW.

The reasons behind the varying responses to antidepressants are not fully understood, leaving many patients struggling to find relief. The mental health system exacerbates this issue, being fragmented and under-resourced, which results in long wait times, high out-of-pocket costs, and difficulty in accessing appropriate care. Alarmingly, less than half of Australians who need mental health support are able to obtain it.

A real-world study funded by the Northern Sydney Local Health District aims to address some of these gaps. Titled Positioning of Esketamine Treatment (PoET) in the real-world management of depression, the study is led by Professor Gin Malhi, Head of the Academic Department of Psychiatry and Director of the CADE clinic at the Royal North Shore Hospital in Sydney.

The PoET study is set to investigate the efficacy of Spravato (esketamine) when added to ongoing antidepressant treatment, and to identify patient characteristics that may predict a positive therapeutic response in real-world practice.

Johnson & Johnson Innovative Medicine (previously Janssen) made a resubmission to the Pharmaceutical Benefits Advisory Committee (PBAC) for Spravato in treatment-resistant depression. During last year’s re-evaluation process, the PBAC raised concerns about the management of episodic treatment, the effects of treatment discontinuation in responders, and the potential extension of usage beyond the initially proposed 12-month period – issues that were not addressed in previous submissions.

Professor Colleen Loo from the Black Dog Institute and UNSW Sydney has also drawn attention to the potential off-label use of generic ketamine. She cited a recent systematic review and meta-analysis comparing the efficacy of generic ketamine and Spravato for treating depression.

As PoET study investigators explain, “Researchers have been investigating the antidepressant properties of ketamine for a long time. It is thought that ketamine, and its derivative, esketamine, help to treat depression for a number of reasons. However, it is not yet known which patients benefit most from esketamine when used in conjunction with conventional antidepressants.”

They further emphasised the unknowns, saying “We do not yet understand how the effect of esketamine is impacted by other treatments that a patient may be taking for their depression. Finally, it has not yet been investigated how patients with a partial response to an antidepressant will benefit from adding esketamine to their therapeutic regimen without switching to a new baseline antidepressant.”

The first participant in the PoET study was enrolled in October 2023, with the final data collection expected in September 2025. This study could provide critical insights that personalise depression treatment more effectively.

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