PBAC's latest decision on Tapentadol: Recommended with restriction (2013). Considered for Chronic severe disabling pain not responding to non-narcotic analgesics.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2011
Submissions
3
2011 → 2013
Eligible population
Adults with chronic severe disabling pain not responding to non-narcotic analgesics.
Therapy area
Pain
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Pain efficacy; gastrointestinal safety
Pivotal trial size
2,975 patients
Key trials
KF11, KF12, KF23, KF20
Comparator
oxycodone CR and tramadol SR
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.
ICER (historical)
$15k/QALY–$45k/QALY in an earlier submission (2012) — 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 — A revised Risk Share Arrangement (RSA) was agreed to be needed due to uncertainties in usage estimates and financial implications.
Submission history
Mar 2011: Not recommended
Mar 2012: Not recommended · Restricted benefit — ICER $45k/QALY
Nov 2013: Recommended with restriction · Restricted