Aclidinium Bromide Plus Eformoterol Fumarate Dihydrate
Recommended · restricted RespiratoryAuthority Required
Treatment of chronic obstructive pulmonary disease (COPD) in patients stabilised on a combination of a long-acting muscarinic antagonist and long-acting beta-2 agonist.
1
Submissions
2015–15
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Jul 2015Recommended · restricted
vs glycopyrronium/indacaterol FDC and umeclidinium/vilanterol…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the listing of aclidinium/eformoterol FDC as an Authority required (STREAMLINED) benefit for the treatment of chronic obstructive pulmonary disease for patients already stabilised on concomitant LAMA and LABA therapy.PSD · Jul 2015
7.2 The PBAC recommended the listing on a cost-minimisation basis to the existing LAMA/LABA fixed dose combinations, umeclidinium/vilanterol and glycopyrronium/indacaterol. The equi-effective doses are considered to be aclidinium 340 microgram with eformoterol 12 microgram (twice daily), umeclidinium 10PSD · Jul 2015
Economic analysis
6.16 The submission presented a cost-minimisation analysis. The equi-effective doses were estimated as: aclidinium/eformoterol 340/12 µg twice daily; glycopyrronium/indacaterol 50/110 µg once daily; and umeclidinium/vilanterol 62.5/25 µg once daily.PSD · Jul 2015
The equi-effective doses were trial-based. This was appropriate.PSD · Jul 2015
Clinical claim
6.14 Comparison 1: versus glycopyrronium/indacaterol FDC Comparison 2: versus umeclidinium/vilanterol FDC The submission described aclidinium/eformoterol FDC as non-inferior in terms of comparative effectiveness and non-inferior in terms of comparative safety over glycopyrronium/indacaterol FDC and umeclidinium/vilanterol FDC. 7PSD · Jul 2015
6.15 Comparison 3a: versus aclidinium monotherapy Comparison 3b: versus eformoterol monotherapy The submission described aclidinium/eformoterol FDC as superior in terms of comparative effectiveness and non-inferior in terms of comparative safety over aclidinium monotherapy or eformoterol monotherapy.PSD · Jul 2015
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated by design.
The submission presented a cost-minimisation analysis. PSD · 2015
Decision context
PopulationAdults with moderate to severe COPD who have been stabilised on a combination of a long-acting muscarinic antagonist and long-acting beta-2 agonist.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2015 | Recommended · restricted | glycopyrronium/indacaterol FDC and umeclidinium/vilanterol FDC | — | RCT · Trough FEV1 |
Similar precedents
Aclidinium Bromide79%Umeclidinium + Vilanterol76%Indacaterol With Glycopyrronium75%Budesonide With Eformoterol Fumarate Dihydrate73%Budesonide With Glycopyrronium And Formoterol72%Indacaterol + Glycopyrronium72%Fluticasone Furoate + Vilanterol72%Beclometasone Dipropionate With Formoterol Fumarate Dihydrate And Glycopyrronium Bromide72%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients stabilised on LAMA plus LABA combination; TGA label permits any COPD patient.