Aclidinium BromideBretaris Genuair inhaler
Recommended RespiratoryRestricted
Long-term maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
1
Submissions
2014–14
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2015 Recommended Chronic obstructive pulmonary disease
- Meeting Mar 2014 Recommended Bretaris® Genuair® A.Menarini Australia Pty Ltd Chronic Obstructive Pulmonary Disease (COPD) To request Restricted Benefit General Schedule listing for patients with chronic obstructive pulmonary disease (COPD). Based on the data provided, the PBAC accepted that treatment with aclidinium bromide res
Access path
- TGA registered · Bretaris Genuair inhaler
TGA label narrower than the PBS population
- Mar 2014Recommended · restricted
vs tiotropium
- PBS listing · Restricted
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis was used; no ICER calculated.
The PBAC considered that a cost-minimisation analysis was the correct approach based on the evidence presented. PBAC · 2014
Decision context
PopulationAdult patients with stable moderate to severe chronic obstructive pulmonary disease (COPD), including those using aclidinium bromide as monotherapy, in combination with a long-acting beta agonist (LABA), or in combination with a LABA and an inhaled corticosteroid (ICS).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2014 | Recommended · restricted | tiotropium | — | RCT · FEV1 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ATTAIN | Ph 3 | 828 | Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Se… | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to moderate to severe COPD, whereas TGA label covers all adult COPD patients without severity specification.