script.reportAU
Respiratory

Budesonide / glycopyrronium / formoterol

Brand: Breztri Aerosphere

PBAC's latest decision on Budesonide / glycopyrronium / formoterol: Recommended with restriction (2021). Considered for Maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate to very severe COPD who require treatment with a combination of an ICS, a LABA, and a LAMA.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2021
Submissions
1
2021 → 2021

Eligible population

Adults with moderate to very severe COPD who have experienced at least one severe exacerbation requiring hospitalisation, or two or more moderate exacerbations in the previous 12 months, despite regular bronchodilator therapy, or who have been stabilised on a combination of LAMA, LABA and ICS.

Therapy area
Respiratory
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Exacerbation rate
Pivotal trial size
8,509 patients
Key trials
ETHOS, KRONOS, IMPACT, TRIBUTE, TRILOGY
Comparator
fluticasone furoate / umeclidinium / vilanterol (FF/UMEC/VI; Trelegy Ellipta)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis conducted; no numeric ICER calculated by design.

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