Pneumococcal Conjugate Vaccine, 20-Valent
Prevention of pneumococcal disease caused by Streptococcus pneumoniae in paediatric populations including infants aged 12 months or younger and children with NIP-funded risk conditions.
Decision on record
- Meeting Nov 2023 Recommended Prevention of pneumococcal disease (paediatric populations)
Access path
- Nov 2023Recommended
vs 13-valent pneumococcal conjugate vaccine (13vPCV) and…
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended that 20-valent pneumococcal conjugate vaccine (20vPCV; Prevenar 20®) be a designated vaccine for the purposes of the National Health Act 1953, for the prevention of pneumococcal disease in the following paediatric populations:PSD · Nov 2023
• Children aged 12 months or younger in NSW, VIC, ACT, and TAS and non Indigenous children aged 12 months or younger in QLD, NT, WA and SA (2+1 schedule).PSD · Nov 2023
6.53 The submission presented a cost-minimisation approach (CMA) based on the claim of equivalent effectiveness and safety compared with 13vPCV and 15vPCV. A CMA was consistent with the clinical claim of non-inferior effectiveness compared to 13vPCV and 15vPCV for shared serotypes and similar safety to 13vPCV.PSD · Nov 2023
6.54 The submission presented the CMA based on the nationally negotiated price for 13vPCV of $ per dose. Table 14 presents the results of the cost-minimisation approach presented in the submission.PSD · Nov 2023
6.43 The submission claimed that in the paediatric populations who are currently eligible for funded 13vPCV under the NIP, 20vPCV has equivalent immunogenicity, and by extrapolation efficacy, against IPD, pneumococcal pneumonia and otitis media, for the shared serotypes with 13vPCV and 15vPCV but is superior for the additional serotypes contained in 20vPCV and not in 13vPCV or 15vPCV.PSD · Nov 2023
6.44 The claim of non-inferior effectiveness was based on comparative immunogenicity data, where non-inferiority was not proven for all serotypes. The ATAGI Advice to the PBAC stated ‘that the clinical significance of missing some non-inferiority criteria is unknown. However, the use of a bridge to a bridge also raises concerns regarding the potential for downward drift, and whether the immunological/clinical relationship will still hold for 20vPCV.PSD · Nov 2023
6.3 The Immunisation Foundation of Australia (IFA) expressed its strong support for the NIP listing of 20vPCV for the current NIP paediatric populations. The IFA noted that 20vPCV provided additional coverage to circulating pneumococcal stereotypes in Australia.PSD · Nov 2023
6.72 The submission did not propose a risk-sharing arrangement. 32PSD · Nov 2023
Cost-effectiveness
Cost-minimisation approach used; no ICER calculated by design
Decision context
PopulationChildren aged 12 months or younger in NSW, VIC, ACT, and TAS and non-Indigenous children aged 12 months or younger in QLD, NT, WA and SA (2+1 schedule); Aboriginal and Torres Strait Islander children aged 12 months or younger in QLD, NT, WA and SA (3+1 schedule); children aged 12 months or younger with NIP-funded risk conditions (3+1 schedule); children aged more than 12 months with NIP-funded risk conditions (single dose)
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended | 13-valent pneumococcal conjugate vaccine (13vPCV) and 15-valent pneumococcal conjugate vaccine (15vPCV) | — | RCT · Other |
Consumer voice
The Immunisation Foundation of Australia expressed strong support for NIP listing of 20vPCV, noting it would provide additional coverage to circulating pneumococcal serotypes in Australia and reduce disease burden. A parent advocate statement highlighted the loss of a family member to a pneumococcal serotype not covered by currently available PCVs.
20vPCV provided additional coverage to circulating pneumococcal stereotypes in Australia. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to paediatric populations aged ≤12 months, whereas TGA label includes adults aged ≥18 years.