Human Papillomavirus (Types 16 And 18) Recombinant, As04 Adjuvanted Vaccine
Prophylactic vaccination of 12 and 13 year old girls (with a two-year catch up program for girls and women aged 13-26) against cervical cancer and precancerous lesions associated with HPV-16 and HPV-18.
Access path
- Jul 2007Recommended
Comparator changed: quadrivalent human papillomavirus types 6, 11, 16 and 18 vaccine…
- Jul 2007Recommended
Comparator changed: quadrivalent human papillomavirus types 6, 11, 16 and 18 vaccine…
- Nov 2007Recommended
Comparator changed: Gardasil (human papillomavirus types 6, 11, 16 and 18 vaccine) →…
- Nov 2007Recommended
Comparator changed: Gardasil (human papillomavirus types 6, 11, 16 and 18 vaccine) →…
- PBS listing · Restricted
Cost-effectiveness
Cost-saving in the range $45,000-$75,000 per QALY foregone compared to comparator; ICER not explicitly stated as a conventional threshold value.
The PBAC accepted that most of the assumptions in the economic model favoured Gardasil, and given that all other assumptions did not favour Cervarix and there is a recognised need for more than one vaccine to be available in the event of supply shortages, the PBAC was prepared to accept that Cervarix is acceptably cost-effective at the new price and thus recommended the inclusion of Cervarix in the National Immunisation Program. PBAC · 2007
Decision context
PopulationGirls aged 12 and 13 years (with two-year catch-up for girls and women aged 13-26)
Risk sharingGSK willing to develop an appropriate risk sharing arrangement to address uncertainties. PBAC recommended that GSK provide the same contribution towards the national cervical screening program as Gardasil sponsor and maintain a register of vaccinated persons. Risk-sharing agreement should include conditions concerning possible re-vaccination if vaccine efficacy wanes.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2007 | Recommended | Gardasil | $45k–75k | RCT |
| Nov 2007 | Recommended | Gardasil | — | Other |
| Jul 2007 | Recommended | quadrivalent human papillomavirus types 6, 11, 16 and 18 vaccine (Gardasil) | — | RCT |
| Jul 2007 | Recommended | Gardasil (human papillomavirus types 6, 11, 16 and 18 vaccine) | — | RCT · CIN2+ |