Pneumococcal Polysaccharide Conjugate Vaccine, 13-Valent
Prevention of pneumococcal disease (community-acquired pneumonia and invasive pneumococcal disease) in children aged ≥5 to <15 years at increased risk, individuals aged ≥15 to <65 years at increased risk, and Indigenous adults aged ≥25 years.
Access path
- 2010Recommended
vs Synflorix (10-valent vaccine)
- Jul 2010Recommended
Comparator changed: Synflorix (10-valent vaccine) → Synflorix (10-valent vaccine, 3+1…
- Nov 2018Not recommended
Comparator changed: Synflorix (10-valent vaccine, 3+1 schedule) → 23-valent pneumococcal…
From the public summary
7.1 The PBAC decided not to recommend a change to the circumstances under which 13vPCV is available as a designated vaccine for the NIP. Specifically, the PBAC decided not to recommend vaccination of individuals with an at-risk condition (aged ≥5 to <65 years) and Indigenous adults (aged ≥25 years) on the basis of unacceptably high and uncertain estimated ICERs.PSD · Nov 2018
7.2 The PBAC noted the advice from ATAGI that the current funding arrangements though the NIP and PBS for 23vPPV in at-risk populations are complicated, varying by age and Indigenous status. ATAGI expressed a “strong desire to simplify the current recommendations and funding arrangements while ensuring optimal protection for those at increased risk of pneumococcal disease” (post-submission advice, p1).PSD · Nov 2018
6.21 The economic evaluations presented were a cost-effectiveness analysis (CEA) and cost-utility analysis (CUA). The submission presented two versions of the model: one for at-risk individuals aged ≥5 to <65 years, the other for Indigenous adults aged ≥25 years. Health benefits were reported as life years (LYs) and quality-adjusted life years (QALYs) gained.PSD · Nov 2018
Outcomes LYs and QALYs gained Methods used to generate results Cohort expected value analysis Health states Alive (no meningitis cx), Alive (with meningitis cx), Dead Events modelled IPD (bacteraemia; meningitis), Hospital treated CAP, GP treated CAP Cycle length 1 year, half cycle correction applied At risk population: aged ≥5 to <65 years:PSD · Nov 2018
Safety: Equivalent to 23vPPV in terms of treatment emergent adverse events (TEAEs) and serious AEs (SAEs).PSD · Nov 2018
Source: Table 1.1.1 p19 and p203 of the submission and p1 of the PSCR.PSD · Nov 2018
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. The submission was based on cost-effectiveness compared with 23vPPV, but the PBAC's outcome section does not provide a numeric ICER.
Decision context
PopulationChildren aged ≥5 to <15 years at increased risk of pneumococcal disease; individuals aged ≥15 to <65 years with at-risk conditions; and Indigenous adults aged ≥25 years regardless of risk status.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2018 | Not recommended | 23-valent pneumococcal polysaccharide vaccine (23vPPV) | — | RCT · Surrogate |
| Jul 2010 | Recommended | Synflorix (10-valent vaccine, 3+1 schedule) | — | RCT · surrogate outcome measures (IgG responders, GMC, OPA responders, GMT) |
| 2010 | Recommended | Synflorix (10-valent vaccine) | — | RCT · surrogate outcome measures (IgG responders, GMC, OPA responders, GMT) |
Consumer voice
Seqirus, the sponsor of 23vPPV, submitted a consumer comment questioning the timing of the 13vPCV submission in relation to the upcoming cost-effectiveness review of 23vPPV on the NIP for older adults.
Seqirus questioned the timing of the submission for 13vPCV in the context of the upcoming cost-effectiveness review of 23vPPV on the NIP for older adults Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to children aged ≥5–<15 years at increased risk; TGA label includes all children aged 6 weeks to 17 years.