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Cefuroxime AxetilAL-CEFUROXIME

Recommended Infectious diseaseUnrestrictedNot applicable line

Treatment of mild to moderately severe infections caused by sensitive bacteria, including tonsillitis, pharyngitis, and acute bacterial otitis media.

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

Decision on record

1 decision
  • Meeting Mar 2009 Recommended Antibiotic no PSD

Access path

1 submission · public record
  1. TGA registered · AL-CEFUROXIME

    TGA label narrower 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
4.1 The PBAC recommended the listing of a new pack size of 20 for the currently listed pharmaceutical item cefuroxime, tablet 250 mg (as axetil).PSD · Nov 2015
4.2 The PBAC recommended the listing of a new pharmaceutical item cefuroxime, powder for oral suspension 125 mg (as axetil) per 5 mL, 100 mL.PSD · Nov 2015

Cost-effectiveness

Not modelled; minor submission (formulation and pack size change only).

The PBAC noted a small net cost to the PBS as a consequence of the reduction in repeat scripts which patients will no longer require because of the larger presentation for both tablets and suspension. PBAC · 2015
Cost-effectiveness accepted

Decision context

PopulationPatients requiring treatment for mild to moderately severe infections caused by sensitive bacteria; specific subgroup consideration for paediatric patients 3 months to 12 years of age for the suspension formulation.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Nov 2015 Recommended Cost-minimisation · Cost-minimisation

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to mild-to-moderately severe infections caused by sensitive bacteria; TGA label includes bronchitis and other infections without severity or sensitivity qualifiers.