PBAC's latest decision on Tiotropium bromide plus olodaterol hydrochloride: 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
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2015
Submissions
1
2015 → 2015
Eligible population
Adults with moderate to severe COPD (FEV₁ <80%) 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
Not applicable
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
3,101 patients
Key trials
TONADO 1, TONADO 2, SHINE, SPARK, ARISE, Decramer 1, Decramer 2, ANHELTO 1, ANHELTO 2, Study 11, Study 12, Study 13, Study 14
Comparator
glycopyrronium/indacaterol FDC, umeclidinium/vilanterol FDC, tiotropium monotherapy, olodaterol monotherapy, and tiotropium plus olodaterol concurrent administration