Human Papillomavirus (Hpv) Types 16/18 Vaccine
Recommended VaccinesRestrictedNot applicable line
Prophylactic vaccination of females aged 12-13 years against cervical cancer and precancerous lesions associated with HPV-16 and HPV-18, using a 2-dose regimen instead of the previously listed 3-dose regimen.
1
Submissions
1 resub
2015–15
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Nov 2015Recommended
vs Cervarix 3-dose and Gardasil 3-dose
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the current listing on the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) for Human papillomavirus (HPV) Vaccine (Cervarix) for the vaccination of a female who is at least 12 years old but less than 14 years of age to be changed from three doses to two doses.PSD · Nov 2015
7.2 The PBAC noted that the equi-effective doses were estimated as Cervarix 2 x 0.5 mL (at 0 and 5-12 months) and Cervarix 3 x 0.5mL (at 0, 1 and 6 months), while the course cost proposed in the submission was $''''''''''''''' per 2-dose vaccination course.PSD · Nov 2015
Economic analysis
6.24 The submission presented two separate economic evaluations. A cost-minimisation analysis comparing 2-dose Cervarix with 3-dose Cervarix under the assumption of non-inferiority. A partial cost-effectiveness analysis comparing Cervarix 2-dose and Gardasil 3-dose, with the clinical claim of non-inferiority with respect to effectiveness of HPV-16 and HPV-18 strains and inferiority with respect to HPV-6 and HPV-11 strains.PSD · Nov 2015
6.25 The equi-effective doses were estimated as Cervarix 2 x 0.5 mL (at 0 and 5-12 months) and Cervarix 3 x 0.5mL (at 0, 1 and 6 months). The course cost proposed in the submission is $''''''''''''''' per 2-dose vaccination course.PSD · Nov 2015
Clinical claim
6.21 The PBAC considered that the claim of non-inferiority in terms of comparative effectiveness and non-inferiority in terms of comparative safety of 2-dose Cervarix over 3-dose Cervarix was adequately supported.PSD · Nov 2015
6.22 The PBAC considered that the claim of non-inferiority in terms of comparative effectiveness and non-inferiority in terms of comparative safety of 2-dose Cervarix over 3-dose Gardasil was adequately supported in HPV-16 and HPV-18 strains.PSD · Nov 2015
Cost-effectiveness
Cost-minimisation analysis used for Cervarix 2-dose vs Cervarix 3-dose; partial cost-effectiveness analysis for Cervarix 2-dose vs Gardasil 3-dose. No numeric ICER stated in the public text.
The cost-minimisation analysis included vaccine costs only (excluding administration costs and adverse events), which is conservative. PSD · 2015
ICER uncertainEconomic model disputed
Decision context
PopulationFemales aged 12-13 years (with some supportive immunogenicity data in 9-14 year olds and 15-25 year olds) receiving a 2-dose HPV-16/18 vaccine regimen for prevention of cervical cancer and precancerous lesions.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2015 | Recommended | Cervarix 3-dose and Gardasil 3-dose | — | RCT · Immunogenicity (GMT, seroconversion) |
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