RopiniroleAPPESE
Treatment of severe primary restless legs syndrome in patients who score ≥21 on the International Restless Legs Severity Scale (IRLS) and meet IRLSSG diagnostic criteria.
Access path
- TGA registered · APPESE
TGA label narrower than the PBS population
- Mar 2006Not recommended
uncertainty about the extent of clinical benefit, high placebo response rate, concerns about treatment effect size…
- Mar 2006Not recommended
uncertainty about the extent of clinical benefit, high placebo response rate, concerns about economic model…
Cost-effectiveness
The Committee had a number of concerns with respect of the economic model, including one about the questionnaire used to elucidate utilities that the PBAC considered likely to have biased all utility weights. PBAC · 2006
Decision context
PopulationPatients with severe primary restless legs syndrome (IRLS score ≥21) meeting IRLSSG diagnostic criteria (desire to move limbs with paraesthesias/dysaesthesias, motor restlessness, symptoms worse at rest with relief by activity, symptoms worse in evening/night)
Why it was knocked back
- uncertainty about the extent of clinical benefit, high placebo response rate, concerns about economic model (particularly utility weights and sensitivity to small changes), higher toxicity with ropinirole than placebo, unclear effect of dose reduction on efficacy
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2006 | Not recommended | placebo | $15k–45k | RCT · Other |
| Mar 2006 | Not recommended | placebo | $15k–45k | RCT · IRLS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe RLS (IRLS ≥21) with confirmed IRLSSG diagnostic criteria; TGA label covers all primary RLS without severity threshold.