DUPILUMAB

The PBAC recommended the listing of dupilumab as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation (defined by the submission as blood eosinophil ≥ 300 cells/µL). In making this recommendation, the PBAC accepted that there was a persistent clinical need for treatment options in patients who continue to experience exacerbations while receiving treatment with triple inhaled therapy. 
The PBAC acknowledged the support for this listing from individuals who would like access to dupilumab, health care professionals and organisations. The PBAC noted comments describing the significant impact COPD had on the daily lives of patients, impacting their ability to work and socialise, which led to a decline in mental health. The PBAC noted the input highlighted the importance of additional treatment options to help manage impact of the disease on patients, reduce reliance on oral corticosteroids, and ultimately improve long-term health outcomes.
The PBAC considered that a price reduction was required for dupilumab to be considered cost-effective and that further revisions to the estimated costs were required. The PBAC considered that with these revisions, a risk sharing arrangement would address remaining uncertainty about the cost. The PBAC advised that if listed, the arrangement should include mepolizumab which the PBAC also considered at the March 2026 meeting for the treatment of the same population.
The PBAC noted that flow-on changes to all PBS-subsidised biological medicines listed for nasal polyps, uncontrolled severe allergic asthma, and uncontrolled severe asthma will be required to prevent use of more than one biologic at a time for these indications including uncontrolled COPD.