Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Recommended · restricted Other
prevention of human papillomavirus (HPV) in males aged 12 to 13 years and a catch-up program over 2 years for Year 9 males
2
Submissions
1 resub
2006–11
On the record
$15k–45k
ICER range
2 sourced ICERs · 2006–2011
ICER stated
Cost basis
Access path
- 2006Recommended · restricted
vs standard medical management, which in Australia includes…
- Mar 2011Recommended · restricted
Comparator changed: standard medical management, which in Australia includes the…
- PBS listing
RecommendedDeferredNot recommended
From the public summary
Economic analysis
The first main clinical uncertainty relates to the demonstration of any treatment effect in males beyond condyloma. The claim for a treatment effect on anal cancer relies on a subgroup of Protocol 20 of men who have sex with men, and so the submission relies on an inference that the treatment effect in this subgroup can be generalised to the Australian male population on the basis of a constant relative treatment effect (i.e., “vaccine efficacy” in the …PSD · Mar 2011
PBAC noted that the composite outcome was driven by condylomata, and the trial was underpowered to conclude any effect on PIN independent of other external genital lesions.PSD · Mar 2011
Cost-effectiveness
PBAC rejected the submitted base case as overly optimistic. The PBAC considered that a more likely incremental ratio might be in the range of $15,000–$45,000 per extra QALY gained, excluding penile cancer and HPV-related oropharyngeal cancer.
The PBAC considered the following main points in relation to the application. • The magnitude of the per patient clinical benefit for this vaccine is small across the vaccinated population overall and in most cases, the overall benefits for cervical cancer prevention will take a long time (modelling occurs over a lifetime to 85 years of age) to be realised. PBAC · 2006
ICER uncertainICER / price too highEconomic model disputedPrice cut / RSA neededCost-effectiveness accepted
Decision context
Populationmales aged 12 to 13 years and a catch-up program for Year 9 males
Why it was knocked back
- Clinical uncertainty regarding treatment effect in males beyond condyloma; uncertainty translating vaccine effect on AIN/PIN to cancer rates (retrospective evidence weaker than cervical cancer data); uncertain HPV attributable fractions for anal and other cancers; potential waning vaccine efficacy (serotype 18 after 3 years); uncertain herd immunity assumptions; projected increasing cancer incidence rates; acute adverse effects from vaccine injection; uncertainty regarding male vaccine uptake (80% assumed, higher than girls' 70% completion rate)
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2011 | Recommended · restricted | placebo (no vaccination) in males; secondary comparator: female-only vaccination | $15k–45k | RCT |
| 2006 | Recommended · restricted | standard medical management, which in Australia includes the operation of the National Cervical Screening Program (NCSP) | $16k–44k | RCT |
Similar precedents
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine89%Human Papillomavirus (Types 16 And 18) Recombinant, As04 Adjuvanted Vaccine82%Human Papillomavirus (Hpv) Types 16/18 Vaccine78%Human Papillomavirus 9-Valent Vaccine77%Zoster Virus Vaccine Live (Oka/Merk)69%Human Rotavirus Vaccine68%Varicella Zoster Virus Recombinant Vaccine65%Zoster Virus Vaccine Live65%