PBAC's latest decision on Fluticasone propionate with salmeterol: Recommended with restriction (2023). Considered for Treatment of asthma in patients aged 4 years or older; treatment of chronic obstructive pulmonary disease (COPD) in patients with severe COPD and a history of repeated exacerbations.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2023
Submissions
1
2023 → 2023
Eligible population
Adults and children aged 4 years or older with asthma, and adults with severe COPD (FEV1 <50% predicted normal) with a history of repeated exacerbations and significant symptoms despite regular beta-2 agonist therapy.
Therapy area
Respiratory
Line of therapy
Not applicable
Evidence base
Cost-minimisation
Primary endpoint
Cost-minimisation
Pivotal trial size
1,043 patients
Comparator
Seretide Accuhaler 250/50 and 500/50, Fluticasone Salmeterol Ciphaler, Pavtide Accuhaler
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis performed; no ICER calculated as drugs are bioequivalent with identical costs.