Fluticasone Furoate + Vilanterol
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.
Access path
- Jul 2014Recommended · restricted
vs fluticasone propionate/salmeterol (FP/SAL) 500/50
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the listing of fluticasone with vilanterol, in the form fluticasone furoate with vilanterol (as trifenatate), 100/25 as a restricted benefit for the treatment of COPD with a maximum quantity of one pack with five repeats.PSD · Jul 2014
7.2 The PBAC agreed that the main comparator is the existing ICS/LABA, FP/SAL 500/50 when used for the treatment of COPD.PSD · Jul 2014
6.14 The minor submission did not present a new economic analysis.PSD · Jul 2014
6.9 The March 2014 submission claimed that FF/VI 100/25 FDC is non-inferior in terms of comparative effectiveness over the FP/SAL 500/50 FDC in the treatment of COPD.PSD · Jul 2014
The PBAC considered that the submission’s claim with regard to comparative effectiveness was reasonable.PSD · Jul 2014
6.2 The PBAC noted that a letter was received from the Thoracic Society of Australia and New Zealand (TSANZ). This advice discussed the place in therapy of ICS/LABA FDCs in COPD (refer to paragraph 4.3).PSD · Mar 2014
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission was on a cost-minimisation basis comparing FF/VI 100/25 to FP/SAL 500/50.
The PBAC considered that the cost-effectiveness of fluticasone with vilanterol would be acceptable if it were cost-minimised against aclidinium, which was recommended for listing by PBAC in March 2014 for the same indication but at the lower price requested by the sponsor and which is, in turn, cost-minimised to the comparator via tiotropium. PBAC · 2014
Decision context
PopulationPatients 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.
Risk sharingAn agreed risk minimisation plan with the TGA to monitor cardiovascular safety through standard post-marketing surveillance mechanisms.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2014 | Recommended · restricted | fluticasone propionate/salmeterol (FP/SAL) 500/50 | — | RCT · Non-inferiority of effectiveness and safety |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to FEV₁ <50% (versus TGA's <70%) and requires "repeated exacerbations with significant symptoms" versus TGA's broader "exacerbation history."