PBAC's latest decision on Fluticasone propionate with eformoterol fumarate: Recommended (2013). Considered for Regular maintenance treatment of asthma in patients whose asthma is not adequately controlled with inhaled corticosteroids alone or who require combination inhaled corticosteroid and long-acting beta-2 agonist therapy.
PBAC outcome
Recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2013
Submissions
1
2013 → 2013
Eligible population
Patients with asthma requiring maintenance treatment with combination inhaled corticosteroid and long-acting beta-2 agonist, including those not adequately controlled with inhaled corticosteroids alone or requiring combination therapy following oral corticosteroid use
Therapy area
Respiratory
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
FEV1
Pivotal trial size
1,280 patients
Key trials
FLT3501, FLT3502, FLT3503, FLT3505
Comparator
fluticasone with salmeterol pressurised metered dose inhaler
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis presented; PBAC did not accept the sponsor's proposed pricing methodology and instead based recommendation on equi-effective dosing with fluticasone/salmeterol MDI
Risk sharing
Risk-sharing arrangement in place — PBAC noted potential risk of off-label use in SMART and COPD indications and considered that this should be managed through pricing and/or risk share arrangements