PBAC nods for J&J, AbbVie and Lundbeck

The December 2024 PBAC outcomes have delivered positive news for patients diagnosed with treatment resistant depression, schizophrenia, and immune-mediated inflammatory diseases.

In a win for for Johnson and Johnson Innovative Medicine (formally Janssen), the PBAC, after five resubmissions, has finally recommended funding for Spravato (esketamine) to treat treatment-resistant depression (TRD) in adults with major depressive disorder (MDD) who have not responded adequately to at least two different antidepressants.

The PBAC’s recommendation comes after a review of additional changes to restrictions and financial estimates that addressed concerns raised at the July 2024 meeting. The PBAC noted that consultations with the Royal Australian and New Zealand College of Psychiatrists (RANZCP) led to a revised restriction with more practical wording, better supporting the intended patient population. The committee also considered that the revised financial estimates provided a more reasonable basis for expenditure caps under the proposed Risk Sharing Arrangement.

The PBAC reiterated its previous consideration that, given the uncertainty with how Spravato would be used in practice – particularly in terms of use beyond 12 months and the extent of retreatment – it was appropriate for utilisation to be monitored following the PBS listing.

Spravato is currently funded through WorkCover and the Department of Veterans’ Affairs for eligible patients under an individual application process.

Joana De Castro, Managing Director, Johnson & Johnson Innovative Medicine Australia and New Zealand, said “We acknowledge the unmet clinical need for new treatment options for patients living with TRD, particularly given that there have been no new therapies in this area for over a decade. We are eager to advance to the next step in making SPRAVATO available for patients who need it.”

Meanwhile, Lundbeck’s Abilify Asimtufii – a long-acting, once-every-two-month injectable aripiprazole – has been recommended for the maintenance treatment of schizophrenia in patients who have been stabilised on the monthly formulation of aripiprazole. This recommendation comes after cost-effectiveness assessments, with the PBAC signalling that the long-acting formulation of Abilify Asimtufii could offer cost minimisation.

AbbVie’s Humira (adalimumab) secured PBAC recommendation for new listings to treat paediatric patients with enthesitis/spondylitis-related juvenile idiopathic arthritis (JIA) and chronic plaque psoriasis.

These add to the recommended changes to the current listings for Humira in moderate to severe ulcerative colitis, severe Crohn disease and JIA for paediatric patients to reflect current evidence and practice in managing these conditions. The PBAC acknowledged the comprehensive advice received from clinicians in rheumatology, gastroenterology and dermatology specialties.

The PBAC also recommended that these revised and new PBS listings for Humira be applied to its TGA-registered biosimilars.

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