PBAC's latest decision on Ivosidenib: Recommended with restriction (2024). Considered for Treatment of locally advanced or metastatic cholangiocarcinoma in patients with an IDH1 R132 variant whose disease has progressed on at least one prior line of systemic therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$75k/QALY
Range: $55k/QALY–$75k/QALY
Submissions
2
first 2024
Submissions
2
2024 → 2024
Eligible population
Adult patients with locally advanced or metastatic cholangiocarcinoma with confirmed IDH1 R132 tier I variant who have disease progression following at least one line of systemic chemotherapy, with WHO performance status 2 or less.
Therapy area
Oncology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
OS
Key trials
ClarIDHy
Comparator
palliative care (primary); chemotherapy with FOLFOX or FOLFIRI (secondary)
Economic model
CUA
ICER note
ICER range stated in base case results: $55,000 to < $75,000 per QALY
Submission history
Jul 2024: Recommended with restriction · Authority Required
Nov 2024: Recommended with restriction · Authority Required — ICER $75k/QALY