PBAC's latest decision on Sitaxentan sodium: Recommended (2007). Considered for treatment of primary pulmonary arterial hypertension (PAH) in patients with NYHA/WHO Functional Class III symptoms and primary pulmonary hypertension associated with connective tissue disease.
PBAC outcome
Recommended
2007
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2007
Submissions
1
2007 → 2007
Eligible population
patients with NYHA/WHO Functional Class III symptoms and primary pulmonary hypertension associated with connective tissue disease
Therapy area
Cardiovascular
Line of therapy
Later-line
Evidence base
RCT, indirect meta-analysis
Primary endpoint
QoL (6MWD)
Key trials
STRIDE-2, Frost et al. (2005), Horn et al. (2004), Langleben et al. (2004), Oudix et al. (2006), Channick et al (2001), Rubin et al (2002), Denton et al (2006), Galie et al. (2003)
Comparator
bosentan
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis used; no ICER calculated. Drug cost/patient/year estimated at $45,000–$75,000 range, but this is a cost estimate, not an ICER (which requires an effectiveness denominator such as QALY or LY).