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RivastigmineExelon Patch

Recommended NeurologyAuthority RequiredNot applicable line

Treatment of mild to moderately severe Alzheimer-type dementia. This submission seeks listing of an additional patch strength (13.3 mg/24 hours) to provide an additional dosing option for patients with this condition.

1
Submissions
1 resub
2015–15
On the record
—
ICER range
Not modelled
Cost basis

Decisions on record

5 decisions
  • Meeting Jul 2015 Recommended Dementia
  • Meeting Mar 2008 Recommended Alzheimer’s disease no PSD
  • Meeting Jun 2002 Recommended Alzheimer's drug no PSD
  • Meeting Dec 2001 Recommended A drug to treat mild to moderate Alzheimer's disease no PSD
  • Meeting Jun 2001 Recommended Alzheimer's disease drug no PSD

Access path

1 submission · public record
  1. TGA registered · Exelon Patch

    TGA label narrower than the PBS population

  2. Jul 2015
    Recommended
  3. PBS listing · Authority Required
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC recommended the listing of rivastigmine (13.3 milligrams/24 hours patch) for the treatment of mild to moderately severe Alzheimer disease, under the same conditions as current PBS-listed strengths.PSD · Jul 2015
7.2 The PBAC was satisfied that rivastigmine (13.3 milligrams/24 hours patch) would provide patient treatment options given the persisting clinical need for treatments of mild to moderately severe Alzheimer disease.PSD · Jul 2015
Economic analysis
6.6 As a minor submission, there is no economic comparison presented. 2PSD · Jul 2015

Cost-effectiveness

Minor submission; no economic comparison presented

As a minor submission, there is no economic comparison presented. PSD · 2015

Decision context

PopulationPatients with mild to moderately severe Alzheimer-type dementia with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, confirmed by or in consultation with a specialist/consultant physician.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Jul 2015 Recommended — — RCT · Other

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Regulatory · TGA

Label narrower than PBS population — PBAC restricts to mild-moderately severe (excluding severe) with MMSE/SMMSE ≥10, whereas TGA label includes all severity levels.

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