RifaximinXIFAXAN
Prevention of recurrence of hepatic encephalopathy where other treatments have failed or are contraindicated.
Decisions on record
- Meeting Jul 2019 Not recommended Prevention of hepatic encephalopathy
- Meeting Apr 2013 Recommended Liver disease no PSD
- Meeting Nov 2012 Deferred Liver disease
- Meeting Jul 2012 Not recommended Prevention of the recurrence of hepatic encephalopathy (HE) where other treatments have failed or are contraindicated.
- Meeting Nov 2011 Not recommended Hepatic encephalopathy
Access path
- TGA registered · XIFAXAN
TGA label narrower than the PBS population
- Nov 2011Not recommended
high and very uncertain cost effectiveness, uncertainty about magnitude of treatment effect, model concerns including…
- ↻ resubmittedJul 2012Recommended
ICER dropped $75,000 → $45,000 (-40%)
- Jul 2012Not recommended
high uncertain and unacceptable cost effectiveness, uncertain efficacy beyond 6 months, magnitude of treatment effect…
- Nov 2012Deferred
Comparator changed: placebo as add-on therapy to lactulose → lactulose alone (with…
- Jul 2019Not recommended
Current authority level is effective in managing risks of leakage beyond the treatment indication (IBS, travellers'…
From the public summary
6.1 The PBAC did not recommend the requested change to the PBS listing of rifaximin to lower the authority level from Authority Required to Authority Required (STREAMLINED) for prevention of recurrent HE.PSD · Jul 2019
6.2 The PBAC recalled that it previously noted the potential for substantial leakage beyond the treatment of patients with recurrent HE into treatment of IBS and travellers’ diarrhoea (see paragraph 3.4). The PBAC also recalled expert advice expressing concerns about the potential for the development of AMR.PSD · Jul 2019
5.3 The minor submission claimed that the current Authority level impedes access to rifaximin for patients with liver disease and prior episodes of HE, and therefore requested a change to a STREAMLINED Authority to facilitate access and improve health outcomes for these patients and to reduce the time burden on prescribers (p8 of the submission).PSD · Jul 2019
5.4 To support this hypothesis, the submission presented a survey of 39 specialists (gastroenterologists/hepatologists) in Australia. The submission claimed that the results revealed : The time taken to obtain an authority approval code can be up to 10 minutes (mean = 5.5 minutes, median = 5 minutes).PSD · Jul 2019
5.14 Rifaximin is listed on the PBS in conjunction with a Risk Sharing Arrangement that includes a two-tier subsidisation cap. Where Subsidisation Cap (SC) 1 is breached, it 6PSD · Jul 2019
Cost-effectiveness
This is a minor submission (change to authority level only); no economic evaluation or ICER calculation was performed.
The PBAC rejected the submission for rifaximin on the basis of high, uncertain, and unacceptable cost effectiveness. PBAC · 2012
Decision context
PopulationPatients with prior episodes of hepatic encephalopathy, to be treated by or in consultation with a gastroenterologist or hepatologist, in combination with lactulose if tolerated.
Risk sharingRifaximin 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 it was knocked back
- 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
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2019 | Not recommended | — | — | Other |
| Nov 2012 | Deferred | lactulose alone (with placebo) | $15k–45k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
| Jul 2012 | Recommended | lactulose alone (with placebo) | $15k–45k | RCT · Time to first breakthrough overt hepatic encephalopathy episode |
| Jul 2012 | Not recommended | placebo as add-on therapy to lactulose | $15k–45k | RCT |
| Nov 2011 | Not recommended | lactulose alone (or placebo) | $45k–75k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
Consumer voice
One healthcare professional via the Consumer Comments facility supported a STREAMLINED Authority listing for rifaximin to make it easier for prescribers to appropriately prescribe the medication for patients with hepatic encephalopathy.
a STREAMLINED Authority listing would make it easier for prescribers to appropriately prescribe rifaximin for patients with HE. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to prior hepatic encephalopathy episodes and specialist oversight; adds mandatory lactulose coadministration requirement.