Fluticasone Furoate / Vilanterol TrifenatateBreo Ellipta
Regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination product (long-acting beta-2 agonist and inhaled corticosteroid) is appropriate.
Decision on record
- Meeting Mar 2014 Not recommended Dry powder inhaler (DPI) Breo® Ellipta® GlaxoSmithKline Australia Pty Ltd Chronic Obstructive Pulmonary Disease (COPD) To request a Restricted Benefit General Schedule listing for the symptomatic treatment of chronic obstructive pulmonary disease (COPD), where FEV1 is less than 50% of predicted norm
Access path
- TGA registered · Breo Ellipta
TGA label narrower than the PBS population
- Mar 2014Recommended
vs fluticasone propionate/salmeterol (FP/SAL) fixed dose…
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended PBS listing of fluticasone furoate with vilanterol (dry powder inhaler) on a cost minimisation basis to fluticasone propionate with salmeterol (dry powder inhaler and metered dose inhaler).PSD · Mar 2014
7.2 The PBAC agreed that the restriction for FF/VI FDC should be consistent with the restrictions for the other ICS-LABA FDCs listed for asthma maintenance therapy, but that the PBS-subsidised use of FF/VI FDC should be additionally restricted to patients who are 12 years or older. This is consistent with the TGA approved product information and with the clinical trials presented in the submission.PSD · Mar 2014
6.13 Economic analysis was based on a cost minimisation comparing FF/VI FDC with FP/SAL FDC. 5PSD · Mar 2014
• FF/VI 100/25mcg once daily was equivalent to FP/SAL 250/50mcg (DPI) twice daily based on direct trial evidence (Trial HZA113091); andPSD · Mar 2014
6.12 The submission claimed the FF/VI FDC as non-inferior in terms of comparative effectiveness and non-inferior in terms of comparative safety over the FP/SAL FDC. The PBAC considered this claim was reasonable.PSD · Mar 2014
6.2 The PBAC noted there were no consumer comments on FF/VI FDC for the treatment of asthma.PSD · Mar 2014
Cost-effectiveness
Cost minimisation analysis; no ICER calculated by design
The submission used a market-based approach assuming substitution of fluticasone propionate /salmeterol (FP/SAL) and budesonide/eformoterol (BUD/FOR). PBAC · 2014
Decision context
PopulationAdults and adolescents aged 12 years and older with asthma who are symptomatic on inhaled corticosteroids with 'as needed' short-acting beta-2 agonist, or already on both an inhaled corticosteroid and a long-acting beta-2 agonist.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2014 | Recommended | fluticasone propionate/salmeterol (FP/SAL) fixed dose combination | — | RCT · PFS |
Clinical evidence
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients symptomatic on ICS monotherapy or already on ICS+LABA; TGA label includes all appropriate combination candidates.