PBAC's latest decision on Umeclidinium bromide and vilanterol trifenatate: Not recommended (2014). Considered for Treatment of chronic obstructive pulmonary disease (COPD) in adults where symptoms persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA) and/or long acting beta2 agonist (LABA), or in patients stabilised on a combination of LAMA and LABA in separate devices.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2014
Submissions
1
2014 → 2014
Eligible population
Adult patients with COPD where symptoms persist despite regular bronchodilator treatment with LAMA and/or LABA, or patients stabilised on combination LAMA and LABA in separate devices
Cost-minimisation analysis; no ICER calculated by design
Why PBAC said no
Reasons cited in the latest PSD: Absence of individual components (umeclidinium and vilanterol) on PBS is problematic for stepwise treatment; risks of inappropriate early combination therapy transition and potential double-dosing of LABAs; no superiority demonstrated over comparator on clinically relevant outcomes; concerns regarding safety profile with higher adverse event and serious adverse event rates in some trials; safety risks from potential prescribing errors and incorrect dosing of FDC products