PBAC's latest decision on Sotatercept: Recommended with restriction (2025). Considered for Add-on therapy for adult patients with Group 1 pulmonary arterial hypertension (PAH) WHO Functional Class II (with elevated NT-proBNP) or III who have been on stable PAH therapy for at least 90 days.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2025
Submissions
1
2025 → 2025
Eligible population
Adult patients with PAH WHO Functional Class II (with NT-proBNP ≥650 ng/L or BNP ≥200 ng/L) or WHO Functional Class III who have been on stable PAH therapy for at least 90 days, as add-on to dual, triple, or quadruple combination therapy.
Therapy area
Respiratory
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
ZENITH
Comparator
placebo (primary); selexipag (secondary)
Economic model
CUA
ICER note
ICER not stated in the public summary document. The document indicates an economic evaluation was performed but the specific ICER value is not disclosed.