RotigotineNeupro
Recommended Neurology
Monotherapy or in combination with levodopa for the treatment of idiopathic Parkinson's disease from early stage to advanced disease.
1
Submissions
2008–08
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2008 Recommended Parkinson disease no PSD
- Meeting Mar 2008 Not recommended Parkinson’s disease
Access path
- TGA registered · Neupro
TGA label equal than the PBS population
- Mar 2008Recommended
vs cabergoline
- PBS listing
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis presented; no incremental cost-effectiveness ratio stated.
The equi-effective doses of rotigotine 7.6 mg daily and cabergoline 3.42 mg daily used in the cost-minimisation analysis were considered a likely underestimate favouring rotigotine. PBAC · 2008
ICER uncertainEconomic model disputed
Decision context
PopulationPatients with idiopathic Parkinson's disease from early stage to advanced disease, treated with rotigotine as monotherapy or in combination with levodopa.
Why it was knocked back
- comparison against levodopa in early Parkinson's disease not provided, claim of superior safety profile over cabergoline not substantiated, claimed cost offsets for monitoring safety of cabergoline unacceptable
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2008 | Recommended | cabergoline | — | RCT · Other |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| SP512 | Ph 3 | 217 | Number of Subjects With at Least One Adverse Event During This Open-label Extension Study | completed |
| SP513 | Ph 3 | 381 | Number of Subjects With at Least One Adverse Event During This Open-label Extension Study | completed |
| SP515 | Ph 3 | 395 | Number of Subjects With at Least One Adverse Event During This Open-label Extension Study | completed |
| SP650 | Ph 3 | 258 | Number of Subjects With at Least One Adverse Event During This Open-label Extension Study | completed |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both texts describe identical populations: idiopathic Parkinson's disease early to advanced stage, monotherapy or with levodopa.