PBAC's latest decision on Fluticasone furoate + vilanterol: Recommended with restriction (2014). Considered for Symptomatic treatment of chronic obstructive pulmonary disease (COPD) in patients with forced expiratory volume in 1 second (FEV₁) less than 50% of predicted normal and a history of repeated exacerbations with significant symptoms despite regular beta-agonist bronchodilator therapy.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2014
Submissions
1
2014 → 2014
Eligible population
Patients with COPD with FEV₁ less than 50% of predicted normal and a history of repeated exacerbations with significant symptoms despite regular beta-agonist bronchodilator therapy.
Cost-minimisation analysis; no ICER calculated. Submission was on a cost-minimisation basis comparing FF/VI 100/25 to FP/SAL 500/50.
Risk sharing
Risk-sharing arrangement in place — An agreed risk minimisation plan with the TGA to monitor cardiovascular safety through standard post-marketing surveillance mechanisms.