PBAC's latest decision on Fluticasone furoate / umeclidinium / vilanterol: Recommended with restriction (2021). Considered for Maintenance treatment of severe asthma in adults who are not adequately controlled with a combination of inhaled corticosteroid and long-acting beta2 agonist.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2017
Submissions
3
2017 → 2021
Eligible population
Adults aged 18 years or over with severe asthma who remain uncontrolled on inhaled corticosteroid and long-acting beta2 agonist therapy despite correct inhaler technique and good adherence, and who have experienced at least one severe exacerbation requiring systemic corticosteroids in the previous 12 months.
Therapy area
Respiratory
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Trough FEV1
Key trials
CAPTAIN, TRIGGER, IRIDIUM, ARGON, PrimoTinA 1 & 2
Comparator
mometasone furoate/indacaterol/glycopyrronium (MF/IND/GLY) 136/114/46 mcg and high dose ICS/LABA + tiotropium
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.
Submission history
Dec 2017: Recommended with restriction · Authority Required
Mar 2019: Recommended with restriction · Authority Required
Nov 2021: Recommended with restriction · Authority Required