Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis And Haemophilus Influenzae Type B Conjugate Vaccine
Recommended VaccinesUnrestrictedFirst-line line 💬 consumer voice
Primary vaccination course in infants at 2, 4 and 6 months of age, and catch-up immunisation in children less than 10 years of age who have not previously received DTPa-HB-IPV-Hib vaccination.
1
Submissions
2022–22
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Mar 2022 Recommended Prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b
Access path
- Mar 2022Recommended
vs Infanrix Hexa (DTPa-HB-IPV-Hib)
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
The PBAC recommended that diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b conjugate vaccine (DTPa-HB-IPV-Hib, Vaxelis) be a designated vaccine for the purposes of the National Health Act 1953, for the primary vaccination series against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b at 2, 4 and 6 months of age.PSD · Mar 2022
The PBAC considered that the nominated comparator, Infanrix Hexa, was appropriate noting it is currently the only hexavalent vaccine supplied on the NIP.PSD · Mar 2022
Economic analysis
The submission used a cost-minimisation approach (CMA) comparing Vaxelis with Infanrix Hexa when used as a three-dose primary vaccination series in infants. The equi-effective doses were based on the recommended dosing regimens outlined in the relevant Product Information documents, which are the same as the doses used in the included clinical trials: 3 x 0.5 mL doses of Vaxelis = 3 x 0.5 mL doses of Infanrix Hexa.PSD · Mar 2022
The submission used a proxy price of $ in the CMA as the assumed NIP list price of Infanrix Hexa, which is the current market price of Infanrix Hexa provided by the Royal Children’s Hospital Melbourne. The results of the CMA are summarised in Table 7.PSD · Mar 2022
Clinical claim
The submission claimed that it concurred with the ATAGI pre-submission advice that:PSD · Mar 2022
• Vaxelis is a safe and suitable alternative to Infanrix Hexa for use as primary immunisation at 2, 4 and 6 months of age, in accordance with the current NIP schedule, provided that a DTPa/Hib booster is provided at 18 months of age;PSD · Mar 2022
Consumer comments
The PBAC noted and welcomed the input from organisations (2) via the Consumer Comments facility on the PBS website. The comments from the Global Healthy Living Foundation Australia (GLHF Australia) noted that reducing the vaccination burden in terms of number of injections with a hexavalent vaccine such as Vaxelis may in turn increase vaccine uptake and increase completion of vaccine series.PSD · Mar 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
Decision context
PopulationInfants aged around 2, 4 and 6 months of age receiving a three-dose primary series, and children less than 10 years of age who have not previously received DTPa-HB-IPV-Hib vaccination receiving catch-up doses.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended | Infanrix Hexa (DTPa-HB-IPV-Hib) | — | RCT · Immunogenicity |
Consumer voice
Two consumer organisations provided input supporting Vaxelis, noting that a hexavalent vaccine could reduce injection burden and increase vaccine uptake, while prefilled syringes may reduce vaccination anxiety and provide particular benefits for Aboriginal and Torres Strait Islander children at higher risk of Hib disease.
reducing the vaccination burden in terms of number of injections with a hexavalent vaccine such as Vaxelis may in turn increase vaccine uptake and increase completion of vaccine series Consumer comments · PSD
treatment burdenvaccine uptakeaccess barriersanxiety reductionhealth equity
Similar precedents
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