PBAC's latest decision on Trientine dihydrochloride: Recommended (2023). Considered for Chelation of elevated copper levels in patients with Wilson disease who are intolerant of penicillamine.
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
4
first 2021
Submissions
4
2021 → 2023
Eligible population
Patients with Wilson disease who are intolerant of penicillamine.
Therapy area
Metabolic
Line of therapy
Not applicable
Evidence base
Single-arm
Primary endpoint
Other
Pivotal trial size
102 patients
Key trials
Study 15-VIN-747, Study 17-VIN-0021
Comparator
Trientine Waymade (same active substance, strength, and formulation)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated as Dr.Reddy's proposed the same AEMP as Waymade and listing expected to be cost-neutral to Government.
ICER (historical)
$45k/QALY–$55k/QALY across 2 submissions (2022) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Nov 2021: Recommended with restriction · Authority Required
Mar 2022: Not recommended — ICER $55k/QALY
Mar 2022: Recommended with restriction · Authority Required — ICER $55k/QALY