script.reportAU
Respiratory

Aclidinium bromide plus eformoterol fumarate dihydrate

Brand: Brimica® Genuair®

PBAC's latest decision on Aclidinium bromide plus eformoterol fumarate dihydrate: Recommended with restriction (2015). Considered for Treatment of chronic obstructive pulmonary disease (COPD) in patients 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 2015
Submissions
1
2015 → 2015

Eligible population

Adults with moderate to severe COPD who have been stabilised on a combination of a long-acting muscarinic antagonist and long-acting beta-2 agonist.

Therapy area
Respiratory
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Trough FEV1
Pivotal trial size
1,254 patients
Key trials
ACLIFORM, AUGMENT, SHINE, ENLIGHTEN, Donohue (2013)
Comparator
glycopyrronium/indacaterol FDC and umeclidinium/vilanterol FDC
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis conducted; no ICER calculated by design.

Similar precedents

Open on full dashboard →