PBAC's latest decision on Trientine tetrahydrochloride: Recommended with restriction (2022). Considered for Treatment of patients with Wilson Disease who are intolerant to D-penicillamine therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
3
first 2021
Submissions
3
2021 → 2022
Eligible population
Adults, adolescents and children aged 5 years and older with Wilson Disease who are intolerant to D-penicillamine therapy.
Therapy area
Rare disease
Line of therapy
Any
Evidence base
Single-arm
Primary endpoint
QALY
Key trials
CHELATE
Comparator
best supportive care
Economic model
CUA
ICER note
ICER range redacted; corresponds to $95,000 to <$115,000 per QALY in the revised base case (March 2022 resubmission).
ICER (historical)
$95k/QALY–$115k/QALY across 2 submissions (2022) — 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 (RSA) proposed with expenditure caps set below estimated PBS/RPBS costs; beyond the caps, a rebate would be applied.
Submission history
Nov 2021: Recommended with restriction · Authority Required
Mar 2022: Recommended with restriction · Authority Required — ICER $115k/QALY
Mar 2022: Recommended with restriction · Authority Required — ICER $115k/QALY