Rotavirus Vaccine, Live, Oral Liquid, Pentavalent
Recommended ImmunologyUnrestricted
Vaccination of all infants at 2, 4 and 6 months of age to prevent rotavirus gastroenteritis
2
Submissions
2 resub
2006–06
On the record
$15k–75k
ICER range
2 sourced ICERs · 2006
ICER stated
Cost basis
Access path
- 2006Not recommended
uncertain cost-effectiveness at the price requested; uncertain QALY gains from quality of life impacts of a temporary…
- ↻ resubmittedNov 2006Recommended
ICER dropped $45,000 → $15,000 (-67%)
- PBS listing · Unrestricted
RecommendedDeferredNot recommended
Cost-effectiveness
Revised ICER excluding work loss costs was <$15,000 per QALY gained; original submission was $45,000–$75,000
The PBAC noted the following matters were outstanding from that meeting: • The sponsor’s treatment of QALY gains. • The impact of the death rates applied in the model of the cost-effectiveness results. • Inclusion of production gains. • Inclusion of cost of administration of an oral vaccination. • Whether the impact of nosocomial infections should be included in the model – this latter factor was raised by the PBAC as a (then un-estimated but claimed) benefit of the vaccine, which required more accurate estimation. PBAC · 2006
ICER uncertain ×2ICER / price too highEconomic model disputed
Decision context
PopulationInfants at 2, 4 and 6 months of age
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2006 | Recommended | standard medical management without rotavirus vaccination | $15k | Registry | Other (systematic reviews) |
| 2006 | Not recommended | standard medical management without rotavirus vaccination | $45k–75k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other (QALY) |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted subsidy to infants aged 2, 4, and 6 months; TGA label permits broader age use.