FebuxostatAdenuric tablets
Treatment of chronic gout in patients with a contraindication to, or intolerant of treatment with allopurinol.
Decisions on record
- Meeting Jul 2017 Not recommended Chronic gout
- Meeting Mar 2015 Recommended Second-line treatment of chronic symptomatic gout
- Meeting Mar 2014 Not recommended Adenuric® A.Menarini Australia Pty Ltd Gout To request Authority Required (STREAMLINED) General Schedule listing for the treatment of chronic gouty arthritis associated with hyperuricaemia. Sponsor Comment: Menarini is disappointed by the decision from the PBAC as there is a high clinical need and p
Access path
- TGA registered · Adenuric tablets
TGA label narrower than the PBS population
- Mar 2014Not recommended
Clinical data did not demonstrate superior effectiveness to allopurinol for patient-relevant outcomes (reduction in…
- ↻ resubmittedMar 2015Recommended · restricted
Comparator changed: allopurinol → probenecid
- Jul 2017Not recommended
paucity of evidence of efficacy and safety in allopurinol insufficient patients, risk of prescribing behaviour outside…
From the public summary
5.1 The PBAC did not recommend amending the current Authority Required listing of febuxostat to Authority Required (STREAMLINED) for treatment of chronic gout.PSD · Jul 2017
5.2 The Sponsor presented the utilisation of febuxostat in the first 18 months of listing, and claimed that the number of scripts used was lower than anticipated. The sponsor assumed that the current lower than expected utilisation of the drug was due to the Authority Required restriction.PSD · Jul 2017
6.19 The economic analysis presented was a cost-per-responder analysis (response defined as achievement of serum uric acid levels <357 µmol/l) of febuxostat compared with placebo and each of the three nominated comparators versus placebo.PSD · Mar 2015
6.20 The economic analysis was a simple decision tree analysis that considered drug treatment costs and the proportion of patients who reached sUA <357 µmol/L (responders). The table below summarises the model structure.PSD · Mar 2015
6.18 The re-submission appropriately did not make a formal clinical claim regarding the comparative efficacy and safety of febuxostat versus the relevant comparators for any of the populations for whom listing was sought. The re-submission asserted that ≤25% of subjects on allopurinol either cannot tolerate dose titration or cannot achieve sUA ≤357 µmol/L with maximal doses.PSD · Mar 2015
For more detail on PBAC’s view, see section 7 “PBAC outcome”.PSD · Mar 2015
6.33 The sponsor signalled its willingness to enter into a risk sharing agreement based on a patient cap and rebate.PSD · Mar 2015
Cost-effectiveness
Not modelled — minor submission requesting streamlined access to existing Authority Required listing; no new economic evaluation undertaken.
The PBAC considered that the advantage of a fast reduction in sUA did not translate into benefits over allopurinol for more clinically meaningful outcomes such as flare reduction, tophi resolution or health-related quality of life (HRQoL). PBAC · 2014
Decision context
PopulationAdults with chronic gout who have a contraindication to, or are intolerant of, allopurinol.
Risk sharingRisk Sharing Agreement in place to reduce risk of unexpected Commonwealth expenditure if febuxostat used beyond the recommended listing; expenditure cap based on conservative estimate of allopurinol-intolerant patients.
Why it was knocked back
- paucity of evidence of efficacy and safety in allopurinol insufficient patients, risk of prescribing behaviour outside of current PBS restriction, Authority Required restriction considered appropriate as useful signal regarding appropriate prescribing
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Not recommended | probenecid | — | Not applicable |
| Mar 2015 | Recommended · restricted | probenecid | — | RCT · Serum uric acid reduction |
| Mar 2014 | Not recommended | allopurinol | — | RCT · Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| APEX | Ph 3 | 1,072 | Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Decilite… | completed |
| FACT | Ph 3 | 760 | Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (m… | completed |
| EXCEL | Ph 3 | 1,086 | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1. | completed |
| CONFIRMS | Ph 3 | 2,269 | Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at… | completed |
| FOCUS | Ph 2 | 116 | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL… | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to allopurinol-intolerant/contraindicated patients; TGA label has no such treatment-history prerequisite.