Fluticasone FuroateArnuity Ellipta
Recommended RespiratoryUnrestricted 💬 consumer voice
Maintenance treatment of asthma in children aged 5 to 11 years.
3
Submissions
2 resub
2015–19
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2019 Recommended Asthma
- Meeting Mar 2019 Recommended Chronic Obstructive Pulmonary Disease (COPD)
- Meeting Nov 2018 Not recommended Asthma
- Meeting Aug 2017 Recommended Indication not stated no PSD
- Meeting Mar 2017 Recommended Asthma
- Meeting Nov 2016 Not recommended Asthma and chronic obstructive pulmonary disease (COPD)
- Meeting Nov 2015 Recommended Asthma
- Meeting Jul 2014 Recommended fluticasone furoate 100 microgram/actuation + vilanterol trifenatate 25 microgram/actuation, fluticasone furoate 200 microgram/actuation + vilanterol trifenatate 25 microgram/actuation, Breo® Ellipta® GlaxoSmithKline Australia Pty Ltd New listing (Minor submission) Chronic obstructive pulmonary dise
Access path
- TGA registered · Arnuity Ellipta
TGA label narrower than the PBS population
- Nov 2015Recommended
vs fluticasone propionate
- Mar 2017Recommended
Evidence: RCT → Other
- Jul 2019Recommended
Comparator changed: fluticasone propionate → fluticasone propionate (FP) 100 mcg twice…
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the listing of fluticasone furoate (FF) 50 mcg on the General Schedule as an unrestricted benefit. The PBAC recommended that the listing be on a cost-minimisation basis to fluticasone propionate (FP) 100 mcg at equi-effective doses of FF 50 mcg once daily and FP 100 mcg twice daily.PSD · Jul 2019
7.2 The PBAC reiterated its previous advice that FP was the appropriate comparator.PSD · Jul 2019
Economic analysis
6.20 Based on the claim of non-inferior efficacy and safety of FF compared to FP, the equi- effective doses were stated to be FF 50 mcg once daily and FP 100 mcg twice daily.PSD · Jul 2019
6.21 The minor submission stated the calculation of equi-effective doses was based on a direct randomised trial where doses of all treatments were fixed and consistent with 9PSD · Jul 2019
Clinical claim
6.17 The submission claimed that FF 50 mcg once daily is non-inferior, in terms of both efficacy and safety, to FP 100 mcg administered twice daily in patients aged 5 to 11 years with asthma.PSD · Jul 2019
6.18 The PBAC had previously considered that the claim of non-inferior comparative effectiveness and safety compared to FP was reasonable for FF 100 mcg and 200 mcg presentations (paragraph 7.3, FF PSD, November 2015).PSD · Jul 2019
Consumer comments
6.2 The PBAC noted and welcomed the input from organisations (2) via the Consumer Comments facility on the PBS website. The comments described the benefits of treatment with FF 50 mcg including adherence advantages, reduced burden of disease for paediatric patients and fewer occasions of emergency health care utilisation, while also highlighting the importance of provider education to ensure that the product is prescribed, accessed and used appropriately …PSD · Jul 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated.
The PBAC recommended listing on a cost-minimisation basis to existing ICS monotherapy fluticasone, in the form of fluticasone propionate (FP). PBAC · 2019
Cost-effectiveness accepted ×2
Decision context
PopulationChildren aged 5 to 11 years with inadequately controlled asthma.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2019 | Recommended | fluticasone propionate (FP) 100 mcg twice daily | — | RCT · Change in morning peak expiratory flow (PEF) |
| Mar 2017 | Recommended | fluticasone propionate | — | Other · Other |
| Nov 2015 | Recommended | fluticasone propionate | — | RCT · FEV1 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| HZA106829 | Ph 3 | 587 | Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expir… | completed |
Consumer voice
Two consumer organisations noted benefits of FF 50 mcg treatment including improved adherence, reduced disease burden in paediatric patients, and fewer emergency care visits, while emphasizing the need for provider education on appropriate and safe use.
The comments described the benefits of treatment with FF 50 mcg including adherence advantages, reduced burden of disease for paediatric patients and fewer occasions of emergency health care utilisation Consumer comments · PSD
adherence advantagesreduced disease burdenreduced emergency healthcare utilisationaccess barrierstreatment safety
Similar precedents
Fluticasone Furoate / Vilanterol Trifenatate77%Fluticasone Propionate With Eformoterol Fumarate77%Fluticasone Propionate With Formoterol Fumarate Dihydrate74%Fluticasone Furoate / Umeclidinium / Vilanterol75%Mometasone Furoate With Indacaterol74%Fluticasone Propionate With Salmeterol69%Beclometasone With Formoterol67%Fluticasone Furoate + Vilanterol66%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts subsidy to children aged 5–11 years; TGA label includes all patients aged 5 years and over.