← The record

Human Papillomavirus (Types 16 And 18) Recombinant, As04 Adjuvanted Vaccine

Recommended VaccinesRestrictedNot applicable line

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.

4
Submissions
2 resub
2007–07
On the record
$45k–75k
ICER range
1 sourced ICER · 2007
Redacted
Cost basis
risk sharing

Access path

4 submissions · public record
  1. Jul 2007
    Recommended

    Comparator changed: quadrivalent human papillomavirus types 6, 11, 16 and 18 vaccine…

  2. Jul 2007
    Recommended

    Comparator changed: quadrivalent human papillomavirus types 6, 11, 16 and 18 vaccine…

  3. Nov 2007
    Recommended

    Comparator changed: Gardasil (human papillomavirus types 6, 11, 16 and 18 vaccine) →…

  4. Nov 2007
    Recommended

    Comparator changed: Gardasil (human papillomavirus types 6, 11, 16 and 18 vaccine) →…

  5. PBS listing · Restricted
RecommendedDeferredNot recommended

Cost-effectiveness

1 sourced ICER · 2007

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
ICER / price too highEconomic model disputed

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

4 entries
DecidedOutcomeComparatorICEREvidence
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+

Similar precedents

By decision profile