Beclometasone dipropionate with formoterol fumarate dihydrate and glycopyrronium
Brand: Trimbow
PBAC's latest decision on Beclometasone dipropionate with formoterol fumarate dihydrate and glycopyrronium: Recommended with restriction (2022). Considered for Maintenance treatment of severe asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta-2 agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2022
Submissions
1
2022 → 2022
Eligible population
Adults aged 18 years or over with severe asthma not adequately controlled with a maintenance combination of a long-acting beta-2 agonist and an inhaled corticosteroid who experienced at least one severe asthma exacerbation (requiring systemic corticosteroids) in the previous 12 months despite optimised asthma therapy and correct inhaler technique
Therapy area
Respiratory
Line of therapy
Any
Evidence base
RCT
Primary endpoint
FEV1, Exacerbation rate
Key trials
TRIMARAN, TRIGGER
Comparator
mometasone furoate with indacaterol and glycopyrronium (MF/IND/GLY)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design
Risk sharing
Risk-sharing arrangement in place — Medium dose BEC/FOR/GLY (100/6/10 μg) is part of a risk sharing arrangement (RSA) with other triple FDC products for the COPD indication