Glycopyrronium BromideAxhidrox
Recommended RespiratoryRestrictedNot applicable line
COPD patients in combination with LAB/ICS (long-acting beta-2 agonist/inhaled corticosteroid), specifically salmeterol/fluticasone.
2
Submissions
1 resub
2013–15
On the record
—
ICER range
Not modelled
Cost basis
Decision on record
- Meeting Nov 2013 Recommended 50 microgram, powder for inhalation Seebri® Breezhaler® Novartis Pharmaceuticals Australia Pty Ltd Major submission Chronic obstructive pulmonary disease Restricted Benefit listing for the maintenance treatment of chronic obstructive pulmonary disease (COPD). s recommendation was based on a cost min
Access path
- TGA registered · Axhidrox
- Nov 2013Recommended · restricted
vs tiotropium
- Nov 2015Noted
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
3.1 The PBAC noted the the publication: Firth et al, Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study—a randomised controlled trial. (2015) Thorax.PSD · Nov 2015
3.2 The PBAC noted that publication reaffirmed the view of the Committee in November 2013 that glycopyrronium was non-inferior in regards to efficacy and safety with tiotropium.PSD · Nov 2015
Cost-effectiveness
No economic evaluation provided; this was a data submission to confirm comparative effectiveness and safety of an already-restricted listing.
The PBAC agreed that a cost-minimisation analysis was the correct approach based on the evidence presented. PBAC · 2013
Cost-effectiveness accepted
Decision context
PopulationPatients with COPD receiving combination therapy with salmeterol/fluticasone.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2015 | Noted | tiotropium | — | RCT · Lung function and health status |
| Nov 2013 | Recommended · restricted | tiotropium | — | RCT · FEV1 |