PBAC's latest decision on Bosentan monohydrate: Recommended with restriction (2008). Considered for Pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger's physiology in patients with WHO functional class III or IV symptoms.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
$75k/QALY
Range: $45k/QALY–$75k/QALY
Submissions
1
first 2008
Submissions
1
2008 → 2008
Eligible population
Patients with pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger's physiology with WHO functional class III or IV symptoms.
Therapy area
Cardiovascular
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Oxygen saturation
Pivotal trial size
52 patients
Key trials
BREATHE-5
Comparator
standard care (supplemental oxygen, digitalis, diuretics, vasodilators, anticoagulants, or lung transplantation and repair)
Economic model
CUA
ICER note
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.
Risk sharing
Risk-sharing arrangement in place — Confidential Special Pricing Arrangement allowing rebate to PBS from first day of listing.