PBAC's latest decision on Macitentan: Recommended with restriction (2014). Considered for Idiopathic pulmonary arterial hypertension (IPAH), PAH secondary to connective tissue disease (PAH-CTD), and PAH associated with congenital heart disease (PAH-CHD) in patients with WHO Functional Class III and IV severity.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2014
Submissions
1
2014 → 2014
Eligible population
Patients with WHO Functional Class III or IV idiopathic PAH (IPAH), PAH secondary to connective tissue disease (PAH-CTD), or PAH associated with congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) (PAH-CHD) who have not received prior PBS-subsidised treatment with a PAH agent, or who wish to recommence or switch to macitentan.
Therapy area
Cardiovascular
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Morbidity/mortality
Pivotal trial size
492 patients
Key trials
SERAPHIN, Study 351, BREATHE-1, EARLY, STRIDE-2
Comparator
bosentan
Economic model
Cost-minimisation
Eligible patients/year
10,000
ICER note
Cost-minimisation analysis was conducted; no ICER calculated as macitentan was demonstrated to be non-inferior to bosentan with equivalent drug costs.