Indacaterol MaleateOnbrez Breezhaler
long-term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD)
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 equal than the PBS population
- Nov 2010Not recommended
uncertainty about the clinical place of indacaterol in the treatment of COPD, concerns about the long-term safety of…
Cost-effectiveness
Cost-minimisation analysis presented; no ICER calculated as equi-effective doses were assumed
Decision context
Populationpatients with chronic obstructive pulmonary disease (COPD)
Why it was knocked back
- uncertainty about the clinical place of indacaterol in the treatment of COPD, concerns about the long-term safety of LABA without ICS therapy in COPD, absence of data on the comparative efficacy and safety of indacaterol and LABA/ICS combinations
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2010 | Not recommended | tiotropium | — | RCT · trough FEV1 improvement |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both describe long-term maintenance bronchodilator treatment for airflow limitation/bronchospasm in COPD patients without additional restrictions.