PBAC's latest decision on Ruxolitinib: Recommended with restriction (2025). Considered for Treatment of adult patients with polycythaemia vera (PV) who are resistant to or intolerant of hydroxycarbamide (hydroxyurea).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
7
first 2013
PBS spend
$80M
16,972 scripts · 2024
Eligible population
Adult patients (18 years and over) with polycythaemia vera who are resistant to or intolerant of hydroxycarbamide/hydroxyurea.
Therapy area
Haematology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Response rate
Key trials
MAJIC, RESPONSE, RESPONSE-2
Comparator
best available therapy (BAT)
Economic model
CUA
ICER note
ICER values are redacted (marked with *** in the document); PBAC economic evaluation was conducted but commercial-in-confidence pricing details prevent explicit disclosure of numeric ICER.
ICER (historical)
$45k/QALY–$75k/QALY in an earlier submission (2013) — 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 — Special Pricing Arrangement (SPA) proposed with dispensed price for maximum quantity (DPMQ) $4,912.60 published price and confidential effective price.
PBS expenditure
The Australian government paid $80M in PBS benefits for Ruxolitinib in 2024 across 16,972 scripts, at $4,714 per script.
Submission history
Jul 2013: Not recommended · Authority Required — ICER $75k/QALY
Jul 2014: Deferred · Authority Required
Mar 2015: Deferred · Authority Required
Jul 2016: Recommended · Authority Required
Nov 2019: Recommended with restriction · Authority Required
Jul 2022: Recommended with restriction · Restricted
Mar 2025: Recommended with restriction · Authority Required