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Benztropine Mesylate

Recommended NeurologyUnrestrictedNot applicable line

Emergency treatment of acute dystonic reactions.

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

Decision on record

1 decision
  • Meeting Nov 2015 Recommended Acute dystonic reactions

Access path

1 submission · public record
  1. Nov 2015
    Recommended
  2. PBS listing · Unrestricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
4.1 The PBAC recommended listing of the proposed alternative brand of benztropine injection with the greater maximum quantity of 1 pack of 10 ampoules.PSD · Nov 2015
4.2 The PBAC noted that this recommendation re-affirmed the Committee’s advice to the Minister in November 2013, following a similar request due to supply issues.PSD · Nov 2015

Cost-effectiveness

No economic evaluation performed; minor submission for alternative brand listing due to supply issues.

Decision context

PopulationPatients requiring emergency treatment of acute dystonic reactions.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Nov 2015 Recommended Other

Similar precedents

By decision profile

Regulatory · TGA

Label equal than PBS population — Both TGA label and PBAC recommendation specify emergency treatment of acute dystonic reactions with no population restrictions.