PBAC's latest decision on Umeclidinium + vilanterol: Not recommended (2014). Considered for Long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) who have symptoms persisting despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA) and/or long acting beta-2 agonist (LABA), or who are stabilised on a combination of a LAMA and LABA.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
2
first 2014
Submissions
2
2014 → 2014
Eligible population
Adult patients with COPD who have symptoms persisting despite regular bronchodilator treatment with a LAMA and/or LABA, or who are stabilised on a combination of a LAMA and LABA in separate devices.
Therapy area
Respiratory
Line of therapy
Not applicable
Evidence base
Other
Economic model
Not modelled
ICER note
This is a minor submission for restriction amendment; no new economic evaluation was conducted.
Why PBAC said no
Reasons cited in the latest PSD: proposed restriction does not address PBAC concerns about patients initiating FDC before clinically appropriate, no new data presented to justify amending listing, magnitude of synergistic effects of LAMA and LABA combination remains unclear, restriction inconsistent with indacaterol/glycopyrronium listing, quality use of medicine concerns regarding proliferation of FDC treatments and use of FDC prior to patient trialling combination therapy via separate inhalers
Submission history
Jul 2014: Recommended with restriction · Authority Required