Fluticasone Furoate / Umeclidinium / Vilanterol
Maintenance treatment of severe asthma in adults who are not adequately controlled with a combination of inhaled corticosteroid and long-acting beta2 agonist.
Decision on record
- Meeting Nov 2021 Recommended Severe asthma
Access path
- Dec 2017Recommended · restricted
vs fluticasone propionate 500 mcg/salmeterol 50 mcg FDC twice…
- Mar 2019Recommended · restricted
Comparator changed: fluticasone propionate 500 mcg/salmeterol 50 mcg FDC twice daily plus…
- Nov 2021Recommended · restricted
Comparator changed: dual therapy LAMA/LABA (UMEC 62.5mcg / VI 25mcg) → mometasone…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Authority Required (STREAMLINED) listing of fluticasone furoate (FF) with vilanterol (VI) and umeclidinium (UMEC) fixed dose combination (FDC) for maintenance therapy of severe asthma. The recommended listing was for one strength: FF/UMEC/VI 200/62.5/25 mcg.PSD · Nov 2021
The PBAC considered the claim of non-inferior effectiveness and safety to the FDC of mometasone furoate (MF) 136 mcg, with indacaterol (IND) 114 mcg and glycopyrronium (GLY) 46 mcg was reasonable. However, the PBAC considered for purposes of satisfying Section 101(3B) of the National Health Act 1953, any high dose inhaled corticosteroid (ICS) with long-acting beta2-agonist (LABA) + tiotropium (TIO) combination are relevant alternative therapies.PSD · Nov 2021
The submission presented a cost-minimisation analysis comparing FF/UMEC/VI 200/62.5/25 and MF/IND/GLY 136/114/46, the main comparator, and versus high dose ICS/LABA + TIO. The analysis assumed no additional costs or cost-offsets. The PBAC considered this was appropriate.PSD · Nov 2021
The submission proposed the following equi-effective doses based on the trial evidence presented: FF/UMEC/VI 200/62.5/25 one actuation daily = MF/IND/GLY 136/114/46 one actuation daily.PSD · Nov 2021
FF/UMEC/VI 200/62.5/25 has similar or comparable safety compared with MF/IND/GLY 136/114/46 as well as high dose ICS/LABA Source: Table 1, p16 of the submission.PSD · Nov 2021
ACQ-7: Asthma Control Questionnaire; AE: adverse event; AQLQ: Asthma Quality of Life Questionnaire; FDC: fixed dose combination; FEV1: forced expiratory volume in one second; FF: fluticasone furoate; GLY: glycopyrronium; ICS: inhaled corticosteroid; IND: indacaterol; LABA: long-acting beta2-adrenergic agonist; LAMA: long-acting muscarinic receptor antagonist; MF: mometasone furoate; SAE: serious adverse event; TIO: tiotropium; UMEC: umeclidinium VI: …PSD · Nov 2021
The PBAC noted and welcomed the input from health care professionals (1) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with FF/UMEC/VI including that single inhaler triple therapy provides a treatment option for ICS/LAMA/LABA therapy that is likely less costly and more convenient than mixing device types.PSD · Nov 2021
The pre-PBAC response proposed a risk sharing arrangement (RSA) as a mechanism to reduce the perceived risk of inappropriate prescribing to the PBS budget instead of an Authority Required (telephone/online) listing. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Nov 2021
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The submission presented a cost-minimisation analysis comparing FF/UMEC/VI 200/62.5/25 and MF/IND/GLY 136/114/46, the main comparator, and versus high dose ICS/LABA + TIO. The analysis assumed no additional costs or cost-offsets. The PBAC considered this was appropriate. PBAC · 2021
Decision context
PopulationAdults aged 18 years or over with severe asthma who remain uncontrolled on inhaled corticosteroid and long-acting beta2 agonist therapy despite correct inhaler technique and good adherence, and who have experienced at least one severe exacerbation requiring systemic corticosteroids in the previous 12 months.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2021 | Recommended · restricted | mometasone furoate/indacaterol/glycopyrronium (MF/IND/GLY) 136/114/46 mcg and high dose ICS/LABA + tiotropium | — | RCT · Trough FEV1 |
| Mar 2019 | Recommended · restricted | dual therapy LAMA/LABA (UMEC 62.5mcg / VI 25mcg) | — | RCT · Annual rate of exacerbations |
| Dec 2017 | Recommended · restricted | fluticasone propionate 500 mcg/salmeterol 50 mcg FDC twice daily plus tiotropium 18 mcg once daily; LAMA/LABA FDC combin | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ILLUMINATE | Ph 3 | 523 | Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 | completed |
| DB2116134 | Ph 3 | 717 | Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in… | completed |
Consumer voice
Healthcare professionals and organisations noted benefits of single inhaler triple therapy (FF/UMEC/VI) as a more convenient and potentially less costly option compared to mixed devices, while expressing concerns about the complexity and time-consuming nature of the PBS authority process for asthma compared to COPD.
single inhaler triple therapy provides a treatment option for ICS/LAMA/LABA therapy that is likely less costly and more convenient than mixing device types Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe asthma with recent exacerbation requiring systemic corticosteroids; TGA label covers all inadequately controlled asthma on ICS/LABA.