Memantine HydrochlorideAPO-MEMANTINE
Treatment of moderately severe Alzheimer's disease in patients with baseline (Standardised) Mini-Mental State Examination ((S)MMSE) score of 10-14.
Decisions on record
- Meeting Nov 2009 Recommended Alzheimer disease no PSD
- Meeting Mar 2008 Recommended Alzheimer’s disease
Access path
- TGA registered · APO-MEMANTINE
TGA label narrower than the PBS population
- Mar 2007Not recommended
Insufficient comprehensive MMSE data for memantine; uncertain comparative effectiveness versus donepezil; no evidence…
- Mar 2007Not recommended
insufficient MMSE data for requested population, inability to demonstrate memantine improves MMSE by clinically…
- ↻ resubmittedMar 2008Recommended · restricted
Comparator changed: donepezil → donepezil, galantamine, rivastigmine
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis based on indirect meta-analysis; no ICER presented
A modelled economic evaluation was not presented. This was appropriate. PSD · 2007
Decision context
PopulationAdults with moderately severe Alzheimer's disease with baseline (Standardised) Mini-Mental State Examination ((S)MMSE) score of 10-14
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2008 | Recommended · restricted | donepezil, galantamine, rivastigmine | — | Meta-analysis · Cognitive and functional outcomes (MMSE, ADAS-COG, activities of daily living) |
| Mar 2007 | Not recommended | donepezil | — | RCT, cost-minimisation analysis |
| Mar 2007 | Not recommended | donepezil | — | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to moderately severe only and added specific (S)MMSE score range 10-14 threshold.