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Treprostinil Sodium

Recommended CardiovascularAuthority RequiredNot applicable line

Treatment of primary pulmonary arterial hypertension or pulmonary arterial hypertension associated with connective tissue disease, in patients with disease of WHO Functional Class III or IV severity.

2
Submissions
2005–05
On the record
ICER range
Cost-min
Cost basis

Access path

2 submissions · public record
  1. Nov 2005
    Recommended

    Evidence: RCT → Meta-analysis

  2. Nov 2005
    Recommended

    Evidence: RCT → Meta-analysis

  3. PBS listing · Authority Required
RecommendedDeferredNot recommended

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated

The choice of the cost-minimisation approach was considered valid by the PBAC. PBAC · 2005

Decision context

PopulationPatients with primary pulmonary arterial hypertension or pulmonary arterial hypertension associated with connective tissue disease, excluding congenital heart disease, chronic thromboembolic pulmonary hypertension, and portopulmonary hypertension, with WHO Functional Class III or IV severity.

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Nov 2005 Recommended bosentan RCT · 6-minute walk test, survival
Nov 2005 Recommended bosentan Meta-analysis · 6MWD

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to primary PAH or CTD-associated PAH; TGA label includes all PAH types without etiology specification.