PBAC's latest decision on Palopegteriparatide: Recommended with restriction (2025). Considered for Treatment of adult patients with chronic hypoparathyroidism who are inadequately controlled on conventional therapy (consisting of active vitamin D and calcium supplements).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2025
Submissions
2
2025 → 2025
Eligible population
Adult patients with chronic hypoparathyroidism (postsurgical, auto-immune, genetic, or idiopathic) who have been inadequately controlled on conventional therapy (calcitriol ≥0.5 mcg/day plus elemental calcium ≥800 mg/day for ≥12 weeks) and have evidence of inadequate control (serum calcium <2.0 mmol/L, or serum phosphate >1.5 mmol/L, or prior ER/urgent visits or hospitalisations for HPT in previous 6 months, or 24-hour urinary calcium >7 mmol/24 hours, or history of nephrolithiasis/nephrocalcinosis or eGFR <60 mL/min/1.73m²), with eGFR >30 mL/min/1.73m².
Therapy area
Endocrinology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
PaTHway
Comparator
conventional therapy (active vitamin D and calcium supplements)
Economic model
CUA
ICER note
The resubmission base case resulted in an ICER of $75,000 to <$95,000 per QALY. The PBAC previously (March 2025) considered cost-effective at $45,000 to <$55,000 per QALY; the sponsor did not fully implement PBAC's requested model revisions.
ICER (historical)
$75k/QALY–$95k/QALY in an earlier submission (2025) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Risk sharing
Risk-sharing arrangement in place — Risk sharing arrangement with a rebate for use above the expenditure caps.
Submission history
Mar 2025: Recommended with restriction · Authority Required