DupilumabDupixent

7.1 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 count (BEC) ≥ 300 cells/µL). The PBAC was satisfied that dupilumab provides, for some patients, a significant improvement in efficacy over triple inhaled therapy alone.PSD · Mar 2026

OFFICIAL Public Summary Document – March 2026 PBAC Meeting extended the time to first moderate/severe AECOPD compared to triple inhaled therapy alone. The PBAC considered that the incremental cost-effectiveness ratio (ICER) was high and uncertain, but that with revisions to the economic model and a price reduction dupilumab could be considered cost-effective.PSD · Mar 2026

6.38 The submission presented a stepped cost-effectiveness and cost-utility analysis comparing dupilumab + triple inhaled therapy with triple inhaled therapy alone in patients with uncontrolled COPD with type 2 inflammation.PSD · Mar 2026

OFFICIAL Public Summary Document – March 2026 PBAC Meeting Table 10: Summary of model structure, key inputs and rationale Component Summary Treatments Dupilumab + triple inhaled therapy vs triple inhaled therapy Time horizon 35 years (lifetime) in the model base case versus 1 year in pivotal clinical trials Outcomes Number of moderate exacerbations, number of severe exacerbations, LYs, QALYs Methods used to Year 1: decision tree based on health state …PSD · Mar 2026

6.33 The submission described dupilumab + triple inhaled therapy as superior in terms of effectiveness compared to triple inhaled therapy alone, in patients with uncontrolled COPD with type 2 inflammation. The Sub-Committees agreed with the evaluation that this claim was adequately supported by the evidence presented by the submission with respect to the primary outcome.PSD · Mar 2026

6.34 Dupilumab demonstrated a statistically significant improvement in pre-BD FEV 1 compared to placebo, and in health-related quality of life (HRQoL) compared to placebo, as measured by the change in SGRQ total score. Maintaining these improvements was dependent on continuing treatment with dupilumab. The submission did not discuss whether the change in pre-BD FEV was clinically 1 meaningful. The change in SGRQ did not meet the pre-specified MCID.PSD · Mar 2026

5.2 The PBAC noted and welcomed the input from medical organisations (2) and Consumer group/organisation (2) via the Consumer Comments facility on the PBS website. The comments from Australasian Society of Clinical Immunology and Allergy (ASCIA) expressed its support for this submission, highlighting that dupilumab significantly improves the health and quality of life for patients with chronic severe atopic dermatitis (eczema) and/or uncontrolled severe …PSD · Mar 2025

5.3 The PBAC noted input received from the National Paediatric Medicines Forum (NPMF) in support for the PBS listing of dupilumab PFP. The input outlined the effectiveness of dupilumab in treating severe uncontrolled asthma and atopic dermatitis in paediatric patients, reducing the need for excessive corticosteroids, often associated with negative long-term- adverse effects.PSD · Mar 2025