IndacaterolOnbrez Breezhaler
Deferred mixed outcome RespiratoryRestricted benefitLater-line line
treatment of chronic obstructive pulmonary disease (COPD)
1
Submissions
1 resub
2011–11
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
The committee reached more than one outcome for this medicine at its most recent sitting — different indications were decided differently. The header reflects the least favourable of them; all are listed below.
- Meeting Jul 2020 Deferred Asthma
- Meeting Jul 2020 Recommended Asthma
- Meeting Jul 2014 Recommended Ultibro Breezhaler 110/50® Novartis Pharmaceuticals Pty Ltd New listing (Minor submission) Chronic obstructive pulmonary disease. Restricted Benefit listing for once daily maintenance bronchodilation in patients with chronic obstructive pulmonary disease (COPD) currently on LABA or LAMA monotherapy
- Meeting Jul 2011 Recommended Chronic obstructive pulmonary disease (COPD)
- Meeting Nov 2010 Not recommended Chronic obstructive pulmonary disease (COPD)
Access path
- TGA registered · Onbrez Breezhaler
TGA label narrower than the PBS population
- Jul 2011Recommended · restricted
vs fluticasone with salmeterol
- PBS listing · Restricted benefit
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated
Surrogate endpointNo head-to-head trialIndirect comparison
Decision context
Populationpatients with moderate-to-severe chronic obstructive pulmonary disease
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2011 | Recommended · restricted | fluticasone with salmeterol | — | RCT · FEV1 trough |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to moderate-to-severe COPD patients in later-line treatment; TGA label covers all airflow limitation severity without line-of-therapy restriction.