Pramipexole HydrochlorideSimpral
monotherapy for idiopathic Parkinson disease in patients with motor disability and no evidence of cognitive impairment
Decisions on record
- Meeting Mar 2010 Recommended Parkinson disease no PSD
- Meeting Jul 2009 Recommended Parkinson disease
- Meeting Jul 2008 Not recommended Parkinson’s disease
Access path
- TGA registered · Simpral
TGA label narrower than the PBS population
- Nov 2006Not recommended
uncertain clinical benefit due to inability to substantiate non-inferiority versus cabergoline, comparator selection…
- ↻ resubmittedJul 2007Recommended
Comparator changed: cabergoline → levodopa/benserazide
- Jul 2007Recommended
Comparator changed: cabergoline → levodopa/benserazide
- Jul 2008Recommended
Comparator changed: levodopa/benserazide → cabergoline
- Nov 2008Recommended · restricted
Comparator changed: cabergoline → levodopa with benserazide
- Jul 2009Recommended · restricted
Comparator changed: levodopa with benserazide → cabergoline
- PBS listing · Restricted
From the public summary
In a double-blind, randomised, cross-over trial comparing pramipexole versus levodopa/benserazide, the periodic limb movement index (PLMI) was the primary outcome measure. There were no statistically significant differences between pramipexole and levodopa/benserazide treatment in PLMI in both the intention-to-treat (ITT) and per-protocol (PP) population.PSD · Jul 2007
primary outcome. There were no statistically significantly differences between pramipexole and levodopa/benserazide in any of the secondary outcomes.PSD · Jul 2007
Cost-effectiveness
Cost minimisation analysis presented; no ICER calculated by design.
The PBAC recommended the listing of pramipexole on the PBS on a cost minimisation basis compared with cabergoline. The PBAC accepted that pramipexole has similar effectiveness, with a different safety profile to cabergoline and the equi-effective doses are 2.77 mg pramipexole is equivalent to 2.90 mg cabergoline. PBAC · 2009
Decision context
Populationpatients with motor disability and no evidence of cognitive impairment due to idiopathic Parkinson disease
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2009 | Recommended · restricted | cabergoline | — | RCT, Meta-analysis · QoL, Safety |
| Nov 2008 | Recommended · restricted | levodopa with benserazide | — | RCT · Other |
| Jul 2008 | Recommended | cabergoline | — | RCT, Meta-analysis · change in UPDRS motor disability scale from baseline |
| Jul 2007 | Recommended | levodopa/benserazide | $15k–45k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
| Jul 2007 | Recommended | levodopa/benserazide | $15k–45k | RCT · PLMI |
| Nov 2006 | Not recommended | cabergoline | — | Meta-analysis · RLSRS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to severe RLS with baseline IRLSRS ≥21; TGA label covers all symptomatic primary RLS without severity threshold.