MEPOLIZUMAB

The PBAC recommended the listing of mepolizumab as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation (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 mepolizumab, health care professionals and organisations. The PBAC noted that comments highlighted that COPD exacerbations (i.e. sudden worsening of symptoms) significantly limited daily functioning, contributed to a reduced quality of life, and increased the likelihood of future exacerbations. Comments also highlighted the importance of additional treatment options to help manage the significant disease burden, reduce reliance on oral corticosteroids, and ultimately improve long-term outcomes.

Overall, the PBAC considered that the submission’s claim that mepolizumab was more effective compared to triple inhaled therapy alone was reasonable but that the evidence did not allow certainty about the extent to which the additional benefit would be realised. 

The PBAC considered that a price reduction was required for mepolizumab to be considered cost-effective and that further revisions to the estimated number of patients that would use mepolizumab were required. The PBAC considered that with these revisions, the remaining uncertainties related to the estimated costs of listing mepolizumab could be managed through an arrangement to manage financial risk. The PBAC advised that if listed, the arrangement should also include dupilumab, 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.