PBAC's latest decision on Ambrisentan: Recommended with restriction (2009). Considered for 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.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2009
Submissions
1
2009 → 2009
Eligible population
patients 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
Therapy area
Respiratory
Evidence base
RCT
Primary endpoint
6 Minute Walk Distance (6MWD)
Key trials
AMB320, AMB321, AC351, AC352
Comparator
bosentan
Economic model
Cost-minimisation
ICER note
Cost minimisation analysis conducted; no ICER calculated as drugs claimed equi-effective