PBAC's latest decision on Indacaterol maleate: Not recommended (2010). Considered for long-term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD).
PBAC outcome
Not recommended
2010
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2010
Submissions
1
2010 → 2010
Eligible population
patients with chronic obstructive pulmonary disease (COPD)
Therapy area
Respiratory
Evidence base
RCT
Primary endpoint
trough FEV1 improvement
Key trials
Study 2335, Study 2331
Comparator
tiotropium
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis presented; no ICER calculated as equi-effective doses were assumed
Why PBAC said no
Reasons cited in the latest PSD: uncertainty about the clinical place of indacaterol in the treatment of COPD, concerns about the long-term safety of LABA without ICS therapy in COPD, absence of data on the comparative efficacy and safety of indacaterol and LABA/ICS combinations