PBAC's latest decision on Indacaterol with glycopyrronium: Recommended with restriction (2014). Considered for Once daily maintenance bronchodilation in patients with chronic obstructive pulmonary disease (COPD) who have been stabilised on a combination of a long acting muscarinic antagonist and long acting beta-2 agonist.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2014
Submissions
1
2014 → 2014
Eligible population
Adults with COPD who have been stabilised on a combination of a long acting muscarinic antagonist (LAMA) and long acting beta-2 agonist (LABA).
Therapy area
Respiratory
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
SHINE
Comparator
indacaterol 150 µg and glycopyrronium 50 µg given concurrently; indacaterol + tiotropium; LABA/ICS plus tiotropium; umeclidinium with vilanterol
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. Submission was on a cost-minimisation basis compared to the components given concomitantly.