AmbrisentanAmbrisentan Viatris
Recommended RespiratoryAuthority Required
treatment of primary pulmonary hypertension (PPH) or pulmonary arterial hypertension secondary to connective tissue disease (PAH-CTD) in patients with WHO functional class III or IV severity
1
Submissions
2009–09
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Jul 2009 Recommended Pulmonary arterial hypertension
Access path
- TGA registered · Ambrisentan Viatris
TGA label narrower than the PBS population
- Jul 2009Recommended · restricted
vs bosentan
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
Cost minimisation analysis conducted; no ICER calculated as drugs claimed equi-effective
ICER uncertainCost-effectiveness accepted
Decision context
Populationpatients with primary pulmonary hypertension (PPH) or pulmonary arterial hypertension secondary to connective tissue disease (PAH-CTD) in patients with WHO functional class III or IV severity
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2009 | Recommended · restricted | bosentan | — | RCT · 6 Minute Walk Distance (6MWD) |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO functional class III or IV only; TGA label includes class II.