← The record

FlucloxacillinDBL Flucloxacillin Sodium

Recommended Infectious diseaseUnrestrictedNot applicable line

Supply of flucloxacillin 1 g injection in a 10 vial pack to address ongoing shortage of the 5 vial pack size on the Australian market.

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

Decision on record

1 decision
  • Meeting Nov 2015 Recommended Beta-lactam antibacterials

Access path

1 submission · public record
  1. TGA registered · DBL Flucloxacillin Sodium

    TGA label equal than the PBS population

  2. Nov 2015
    Recommended
  3. PBS listing · Unrestricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
3.1 The PBAC recommended listing of the proposed alternative pack size of flucloxacillin 1 g injection to maintain supply on the PBS in light of an ongoing shortage of the 5 vial pack size in the Australian market.PSD · Nov 2015
3.2 The PBAC recommended that listing should be under same conditions as the currently available 5 vial pack size of flucloxacillin 1 g. Outcome: RecommendedPSD · Nov 2015

Cost-effectiveness

not-modelled — this is a minor submission for an alternative pack size, not a new formulation or clinical evaluation

Decision context

PopulationPatients requiring flucloxacillin 1 g injection (same indication as existing 5 vial pack size)

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Nov 2015 Recommended Cost-minimisation

Similar precedents

By decision profile

Regulatory · TGA

Label equal than PBS population — PBAC recommendation covers same indication as TGA label—patients requiring flucloxacillin 1 g injection, differing only in pack size.