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Pertussis Vaccine-Acellular, Combined With Diphtheria And Tetanus Toxoids (Dtap)

Recommended VaccinesUnrestrictedNot applicable line

Prevention of pertussis as an 18-month booster dose in infants.

1
Submissions
1 resub
2015–15
On the record
ICER range
Cost-min
Cost basis

Access path

1 submission · public record
  1. Jul 2015
    Recommended

    vs DTPa (Infanrix) as an 18-month booster

  2. PBS listing · Unrestricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC recommended including the 18-month booster of the Pertussis Vaccine- Acellular, combined with Diphtheria and Tetanus Toxoids (Adsorbed) (Tripacel, DTaP) vaccine on the National Immunisation Program (NIP) for the prevention of pertussis on the basis of cost-minimisation to the 18-month booster of the combined diphtheria, tetanus and acellular pertussis (Infanrix, DTPa) vaccine recommended at the November 2014 PBAC meeting for inclusion on the …PSD · Jul 2015
7.2 The PBAC noted that this would be the second pertussis-containing vaccine recommended at the 18-month time point for inclusion on the NIP. The PBAC agreed with the Australian Technical Advisory Group on Immunisation that the reintroduction of an 18-month DTPa booster onto the NIP is necessary from a public health perspective, as an additional measure to improve control of pertussis in Australia.PSD · Jul 2015
Economic analysis
6.16 The economic evaluation was a cost-minimisation analysis.PSD · Jul 2015
6.17 The equi-effective doses were estimated as 1 x 0.5 mL dose of DTaP for 1 x 0.5 mL dose of DTPa.PSD · Jul 2015
Clinical claim
6.14 The submission described the 18-month DTaP booster as non-inferior in terms of comparative effectiveness and safety over 18 months DTPa booster. This claim appears adequately supported, though the claim of efficacy is based on surrogate immunogenicity outcomes and the primary data is both under-powered and likely not adjusted for multiple comparisons.PSD · Jul 2015
6.15 The ESC also noted that there were differences between the recommended NIP schedule and the trials presented as supporting evidence, including variable co- administration of Hib/IPV/HepB, use of a 7-valent pneumococcal vaccine, a mixture of oral and inactivated polio vaccine and the absence of influenza or meningococcal vaccine in the presented trials.PSD · Jul 2015

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated by design.

The listing was requested on a cost minimisation basis compared to Infanrix (DTPa), recommended as an 18-month booster at the November 2014 PBAC meeting. PSD · 2015

Decision context

PopulationInfants aged approximately 18 months requiring a booster dose of pertussis vaccine combined with diphtheria and tetanus toxoids.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Jul 2015 Recommended DTPa (Infanrix) as an 18-month booster RCT · Immunogenicity

Similar precedents

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