DELGOCITINIB

The PBAC welcomed the consumer input received in relation to this submission. The input highlighted severe chronic hand eczema is an ongoing condition that causes pain and physical distress. The PBAC acknowledged the need for new and effective treatment options for patients, particularly as topical corticosteroid therapies have known adverse effects. 

At its November 2025 meeting, the PBAC recommended delgocitinib be listed on the PBS. At that time, it was concerned that the sponsor’s approach to justifying the requested price was unreliable. In particular, the estimates of benefits in the economic model did not reflect the clinical evidence in the submission. The model included multiple treatment cycles, although clinical evidence was available for only one cycle, and several inputs were based on insufficient data. The PBAC advised that a simpler analysis of benefits and costs over a single 16-week cycle of delgocitinib treatment would be adequate to determine an appropriate treatment cost per patient and recommended listing on that basis. The PBAC also noted that limits on the prescribable quantity and number of repeats would help prevent use outside the subsidised criteria, including use on other areas of the body, which could result in use beyond the cost-effective estimate.

The company that supplies delgocitinib did not agree with the PBAC’s conclusions at its November 2025 meeting, and made a new submission with a revised economic analysis seeking to address the concerns of the PBAC raised at its November 2025 meeting. The PBAC concluded the revised economic analysis lodged by the sponsor did not adequately address its previous concerns regarding cost-effectiveness and therefore did not provide a basis to vary the previous recommendation.

The PBAC noted that the submission did not contain new financial estimates, although claimed that listing delgocitinib on the PBS would result in significant cost savings due to the replacement of dupilumab. This claim was not accepted by the PBAC as it considered that the extent to which delgocitinib would replace dupilumab was likely to be small given the treatments have a different place in therapy. 

The PBAC provided further advice regarding the restriction, recommending that the maximum quantity be reduced to 1 with 1 repeat and that the restriction be split into three treatment phases to better reflect the intended pattern of use in clinical practice.

Sponsor's comment:
LEO Pharma remains committed to achieving a PBS listing for Anzupgo for Australians living with chronic hand eczema and we are working with the PBAC and the Department of Health, Disability and Ageing to that goal.