PBAC's latest decision on Rifaximin: Not recommended (2019). Considered for Prevention of recurrence of hepatic encephalopathy where other treatments have failed or are contraindicated.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
4
first 2011
Submissions
4
2011 → 2019
Eligible population
Patients with prior episodes of hepatic encephalopathy, to be treated by or in consultation with a gastroenterologist or hepatologist, in combination with lactulose if tolerated.
Therapy area
Hepatology
Line of therapy
Not applicable
Evidence base
Other
Economic model
BIA only
ICER note
This is a minor submission (change to authority level only); no economic evaluation or ICER calculation was performed.
ICER (historical)
$15k/QALY–$45k/QALY across 3 submissions (2011–2012) — 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 — Rifaximin is listed with a Risk Sharing Arrangement including a two-tier subsidisation cap. Where Subsidisation Cap 1 is breached, 30% of Commonwealth expenditure above SC1 is reimbursed by sponsor. Where SC2 is breached, 60% of Commonwealth expenditure above SC2 is reimbursed.
Why PBAC said no
Reasons cited in the latest PSD: Current authority level is effective in managing risks of leakage beyond the treatment indication (IBS, travellers' diarrhoea) and potential for antimicrobial resistance development; telephone authority requirement is not administratively burdensome and is unlikely to prevent clinically appropriate prescribing.
Submission history
Nov 2011: Not recommended — ICER $75k/QALY
Jul 2012: Not recommended · Authority Required — ICER $45k/QALY
Nov 2012: Deferred · Authority Required — ICER $45k/QALY