PBAC's latest decision on Indacaterol + glycopyrronium: Recommended with restriction (2014). Considered for Once-daily maintenance dual bronchodilator treatment to relieve symptoms in patients with COPD currently on LABA or LAMA monotherapy who require additional relief from symptoms.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2014
Submissions
1
2014 → 2014
Eligible population
Patients with moderate to severe COPD currently on LABA or LAMA monotherapy requiring additional relief from symptoms.
Therapy area
Respiratory
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Surrogate
Pivotal trial size
193 patients
Key trials
BEACON, SHINE, SPARK, INTRUST1, INTRUST2
Comparator
indacaterol and glycopyrronium given concurrently; indacaterol plus tiotropium; LABA/ICS plus tiotropium
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.