RasagilineAKM Rasagiline
Parkinson disease as adjunctive therapy in patients being treated with levodopa-decarboxylase inhibitor combinations who are experiencing fluctuations in motor function due to end-of-dose effect.
Decisions on record
- Meeting Mar 2012 Recommended Parkinson Disease
- Meeting Jul 2011 Not recommended Parkinson disease
Access path
- TGA registered · AKM Rasagiline
TGA label narrower than the PBS population
- Jul 2011Recommended
vs entacapone (but PBAC considered it inappropriate…
- Mar 2012Recommended · restricted
Comparator changed: entacapone (but PBAC considered it inappropriate; selegiline should…
- Mar 2012Recommended · restricted
Comparator changed: entacapone (but PBAC considered it inappropriate; selegiline should…
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
The basis for the recommendation was cost-minimisation primarily against selegiline. PBAC · 2012
Decision context
PopulationPatients with Parkinson disease experiencing motor fluctuations due to end-of-dose effect who are being treated with levodopa-decarboxylase inhibitor combinations
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2012 | Recommended · restricted | selegiline (primary), entacapone (secondary) | — | RCT, cost-minimisation · QoL, change in mean total daily OFF time, Total UPDRS score in ON state |
| Mar 2012 | Recommended · restricted | mixed comparator of selegiline and entacapone | — | RCT |
| Jul 2011 | Recommended | entacapone (but PBAC considered it inappropriate; selegiline should have been included) | — | RCT · QoL, other (no specific endpoint stated) |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adjunctive therapy with motor fluctuations/end-of-dose effect; TGA label includes monotherapy and broader adjunctive use.