Bosentan MonohydrateBosentan Cipla
Pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger's physiology in patients with WHO functional class III or IV symptoms.
Decision on record
- Meeting Mar 2008 Recommended Pulmonary Arterial Hypertension (PAH)
Access path
- TGA registered · Bosentan Cipla
TGA label narrower than the PBS population
- Mar 2008Recommended · restricted
vs standard care (supplemental oxygen, digitalis, diuretics…
- PBS listing · Restricted
Cost-effectiveness
ICER derived from previously accepted economic model for iPAH (2002), applied to current APAH-CHD indication. Original model estimated ICER at 15 years; lower range possible with continuation rules.
This original model estimated the ICER for iPAH at 15 years as between $45,000 and $75,000 (without continuation rules, or lower, but within the same range after continuation rules were added). PBAC · 2008
Decision context
PopulationPatients with pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger's physiology with WHO functional class III or IV symptoms.
Risk sharingConfidential Special Pricing Arrangement allowing rebate to PBS from first day of listing.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2008 | Recommended · restricted | standard care (supplemental oxygen, digitalis, diuretics, vasodilators, anticoagulants, or lung transplantation and repa | $45k–75k | RCT · Oxygen saturation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted subsidy to congenital shunts/Eisenmenger's only; TGA label includes idiopathic, familial, and scleroderma-associated PAH.