PramipexoleSimpral
Recommended NeurologyAuthority Required
use in moderate to very severe, idiopathic Restless Legs Syndrome (RLS) in patients who meet certain criteria
1
Submissions
1 resub
2006–06
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2011 Recommended Parkinson disease no PSD
- Meeting Nov 2008 Recommended Alleviates the symptoms of Parkinson disease and of Restless Legs Syndrome
- Meeting Jul 2007 Not recommended The treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa. The symptomatic treatment of idiopathic Restless Legs Syndrome. no PSD
- Meeting Nov 2006 Not recommended Treatment for restless legs syndrome
- Meeting Jul 2004 Recommended Used for the treatment of Parkinson's disease no PSD
Access path
- TGA registered · Simpral
TGA label narrower than the PBS population
- Nov 2006Not recommended
uncertain clinical benefit, non-inferiority against cabergoline not substantiated, outcome measures not comparable…
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation approach attempted but not completed; no ICER calculated due to uncertain comparator cost-effectiveness
ICER uncertainEconomic model disputed
Decision context
Populationpatients with moderate to very severe, idiopathic Restless Legs Syndrome (RLS) who meet certain criteria
Why it was knocked back
- uncertain clinical benefit, non-inferiority against cabergoline not substantiated, outcome measures not comparable across trials, comparator cost-effectiveness not established for PBS purposes
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2006 | Not recommended | cabergoline | — | RCT | Single-arm · QoL |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to moderate-to-very severe idiopathic RLS; TGA label covers all symptomatic primary RLS regardless of severity.