Pneumococcal Conjugate Vaccine, 13-Valent
Prevention of pneumococcal disease (community-acquired pneumonia and invasive pneumococcal disease) in pneumococcal vaccine-naive non-Indigenous adults aged 65 years and over, and pneumococcal vaccine-naive Indigenous adults aged 50 years and over.
Access path
- Mar 2015Not recommended
vs 23-valent pneumococcal polysaccharide vaccine (23vPPV) for…
- ↻ resubmittedJul 2015Recommended
Comparator changed: 23-valent pneumococcal polysaccharide vaccine (23vPPV) for primary…
- Jul 2016Recommended
Listing: Not applicable → Restricted
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended a change to the circumstances under which 13vPCV is made available as a designated vaccine for the NIP for the prevention of pneumococcal pneumonia and IPD in adults on the basis of cost-effectiveness compared with 23vPPV.PSD · Jul 2016
7.2 The PBAC recalled that it previously recommended 13vPCV on a cost minimisation basis to 23vPPV. At that time it recommended that a single dose of 13vPCV be made available to pneumococcal vaccine naïve non-Indigenous adults aged 65 years and over and to pneumococcal vaccine naïve Indigenous adults aged 50 years and over.PSD · Jul 2016
6.20 The model structure was the same as that presented in the July 2015 submission.PSD · Jul 2016
The key inputs that were changed were 13vPCV cost (reduced), CAP incidence (reduced), proportion of CAP due to 13vPCV serotypes (reduced) and duration of protection with 23vPPV (reduced).PSD · Jul 2016
6.14 The submission described 13vPCV as: superior in terms of comparative effectiveness for the prevention of VT-CAP over 23vPPV; equivalent to 23vPPV in terms of comparative effectiveness for the prevention of IPD; and equivalent to 23vPPV in terms of comparative safety.PSD · Jul 2016
6.15 At the March 2015 meeting, while noting the limitations in the available evidence for 23vPPV, the PBAC considered that 13vPCV is likely to be superior to 23vPPV in terms of prevention of VT CAP, although the magnitude of superiority was unclear.PSD · Jul 2016
6.2 The PBAC noted and welcomed the input from individuals (3) and an organisation (1) via the Consumer Comments facility on the PBS website. The comments described the debilitating symptoms of pneumonia. The PBAC noted the advice received from the Lung Foundation Australia clarifying the health burden of pneumonia and the need for further awareness of the benefit of pneumococcal vaccination in older Australians and other high risk populations.PSD · Jul 2016
6.40 The submission acknowledged that a Risk Share Arrangement may be required; however, no specific details were provided.PSD · Jul 2016
Cost-effectiveness
Cost-minimisation analysis; PBAC recommended 13vPCV on basis of cost-minimisation to 23vPPV at July 2015 meeting. Current submission (July 2016) sought to demonstrate cost-effectiveness but economic model details are incomplete in the provided text; ICER values not stated in excerpt.
The minor re-submission presented a cost-effectiveness analysis against 23vPPV. PSD · 2015
Decision context
PopulationPneumococcal vaccine-naive non-Indigenous adults aged 65 years and over, and pneumococcal vaccine-naive Indigenous adults aged 50 years and over.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2016 | Recommended | 23-valent pneumococcal polysaccharide vaccine (23vPPV) | — | RCT · Vaccine-type pneumococcal community-acquired pneumonia and vaccine-type invasive pneumococcal disease |
| Jul 2015 | Recommended | 23-valent pneumococcal polysaccharide vaccine (23vPPV) | — | RCT · Prevention of vaccine-type pneumonia |
| Mar 2015 | Not recommended | 23-valent pneumococcal polysaccharide vaccine (23vPPV) for primary program; no vaccine for catch-up program | — | RCT · Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CAPiTA | Ph 4 | 84,496 | Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pne… | completed |
Consumer voice
Three individuals and the Lung Foundation Australia provided input describing the debilitating symptoms of pneumonia and emphasizing the need for greater awareness of pneumococcal vaccination benefits in older Australians and high-risk populations.
The comments described the debilitating symptoms of pneumonia. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to vaccine-naive adults and raised non-Indigenous threshold from 50 to 65 years.