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Benzathine Benzylpenicillin

Recommended Infectious diseaseUnrestrictedNot applicable line

Treatment of infections due to penicillin-sensitive micro-organisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. The new strength (0.6 million units) is indicated for accurate administration of paediatric doses in young children.

1
Submissions
2019–19
On the record
—
ICER range
Not modelled
Cost basis

Decisions on record

2 decisions
  • Meeting May 2019 Recommended Antibacterial no PSD
  • Meeting Mar 2019 Recommended Treatment of infections

Access path

1 submission · public record
  1. Mar 2019
    Recommended
  2. PBS listing · Unrestricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
5.1 The PBAC recommended the unrestricted General Schedule listing of a new additional strength of benzathine benzylpenicillin (0.6 million units, 517 mg in 1.17 mL pre-filled syringe, Bicillin L-A®) at an equivalent price per unit to the currently listed strength.PSD · Mar 2019
5.2 The PBAC noted that the new strength contains half the active ingredient of the currently listed strength (0.6 million units compared to 1.2 million units), which is within the TGA-approved dosage for young children: 0.3 million to 0.6 million units per injection. The submission stated the new strength of benzathine benzylpenicillin allows accurate administration of paediatric doses and will reduce wastage.PSD · Mar 2019

Cost-effectiveness

Minor submission — formulation/strength addition with no new clinical trials or economic model. Cost-minimisation analysis only (estimated cost saving to Commonwealth).

Decision context

PopulationYoung children requiring penicillin therapy; specifically those for whom the 0.6 million unit dose (half the currently listed 1.2 million unit strength) is appropriate, within the TGA-approved paediatric dosage range of 0.3 to 0.6 million units per injection.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Mar 2019 Recommended — — Cost-minimisation

Similar precedents

By decision profile
Cefuroxime Axetil66%Flucloxacillin62%Adrenaline (Epinephrine)61%Bimekizumab60%Mercaptopurine60%Insulin Lispro59%Methylphenidate Hydrochloride59%Pneumococcal Polysaccharide Conjugate Vaccine, 13-Valent58%

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to young children requiring the 0.6 million unit dose within TGA paediatric range; TGA label permits broader dosing.