Sitaxentan Sodium
Recommended RespiratoryAuthority Required
Primary pulmonary arterial hypertension (PAH) in patients with NYHA/WHO Functional Class III symptoms and primary pulmonary hypertension associated with connective tissue disease.
2
Submissions
2007–07
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Jul 2007 Recommended Pulmonary arterial hypertension
Access path
- Jul 2007Recommended
Evidence: RCT, indirect meta-analysis → RCT
- Jul 2007Recommended
Evidence: RCT, indirect meta-analysis → RCT
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Drug cost/patient/year estimated at $45,000–$75,000.
The cost-minimisation approach taken by the submission was accepted as valid. PBAC · 2007
Decision context
PopulationPatients with primary pulmonary arterial hypertension (PAH) in NYHA/WHO Functional Class III or primary pulmonary hypertension associated with connective tissue disease.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2007 | Recommended | bosentan | — | RCT, indirect meta-analysis · QoL (6MWD) |
| Jul 2007 | Recommended | bosentan | — | RCT · 6MWD |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to primary PAH and PAH-CTD in later-line therapy; TGA label includes all PAH regardless of etiology or treatment line.