Human Papillomavirus 9-Valent Vaccine
Prevention of HPV-related infection and disease in females and males aged 9-25 years as part of the National Immunisation Program, with single-dose schedule for immunocompetent individuals and three-dose schedule for immunocompromised individuals.
Decision on record
- Meeting Jul 2017 Recommended Prevention of human papilloma virus (HPV)
Access path
- Jul 2017Recommended
vs 3-dose quadrivalent HPV vaccine (4vHPV)
- Dec 2022Recommended · restricted
Comparator changed: 3-dose quadrivalent HPV vaccine (4vHPV) → 2 or 3 doses of HPV vaccine
- PBS listing · Restricted
From the public summary
5.1 The PBAC recommended a change to the circumstances under which the human papillomavirus 9-valent (9vHPV) vaccine is made available as a designated vaccine for the purposes of the National Health Act 1953 based on a request for advice that was initiated by the Chief Medical Officer of the Department of Health and Aged Care.PSD · Dec 2022
5.2 The PBAC noted the advice of ATAGI regarding the likely non-inferior efficacy of a single dose of 9vHPV vaccine compared to two doses in immunocompetent adolescents aligned with recommendations made by the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) and the United Kingdom’s Joint Committee on Vaccination and Immunisation (JCVI).PSD · Dec 2022
4.12 The PBAC recalled in July 2017 that the cost effectiveness of 9vHPV was acceptable on the basis of the range of ICERs calculated by the evaluation (of $35,000 to < $45,000 per QALY gained, assuming the same price per dose for 4vHPV as for the 3-dose schedule (of $/dose)) and the sponsor (of $0 to < $5,000 per QALY gained (which assumed $/dose)) (paragraph 7.15, human papillomavirus 9-valent vaccine (Gardasil 9) Public Summary Document, July 2017 PBAC …PSD · Dec 2022
4.13 No new economic evaluation was provided with this submission.PSD · Dec 2022
4.10 The submission described that in the immunocompetent population, one dose of HPV vaccine is non-inferior to two or three dose of vaccine in terms of efficacy, with fewer mild-moderate short term adverse events.PSD · Dec 2022
4.11 The PBAC considered that based on the clinical and immunogencicity evidence available, it is likely that a single dose of 9vHPV vaccine is non-inferior in terms of efficacy as compared with a two dose schedule in non-immunocompromised individuals, and at least as comparable if not more so, in terms of safety (a singlePSD · Dec 2022
6.50 The submission noted that the current 4vHPV vaccine RSA covers the potential of a fourth booster dose being needed to maintain lifelong protection. The submission stated that the sponsor had no objection to these same provisions for a fourth booster dose continuing for the 9vHPV vaccine.PSD · Jul 2017
6.51 The evaluation noted that it was unclear whether the proposed RSA would also cover a third booster dose to address the risk that the efficacy of a 2-dose 9vHPV vaccine schedule may wane more quickly than a 3-dose 9vHPV vaccine schedule, in addition to the current RSA for a fourth booster dose.PSD · Jul 2017
Cost-effectiveness
This is a vaccine policy variation (single dose vs multi-dose schedule) with no economic evaluation presented; cost-effectiveness analysis was not required as the submission was a clinical/immunological assessment of schedule change.
Decision context
PopulationFemales and males aged 9-25 years eligible for HPV vaccination in the National Immunisation Program; immunocompetent individuals for single-dose schedule, immunocompromised individuals for three-dose schedule.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Dec 2022 | Recommended · restricted | 2 or 3 doses of HPV vaccine | — | RCT | Registry · Surrogate |
| Jul 2017 | Recommended | 3-dose quadrivalent HPV vaccine (4vHPV) | — | RCT · Efficacy against HPV types 6, 11, 16, 18, 31, 33, 45, 52, 58-related cervical intraepithelial neoplasias (CIN2/3) |
Consumer voice
One individual expressed concern that if 9vHPV is not recommended for listing, Australians will have to continue using a potentially less effective vaccine.
if 9vHPV is not recommended for listing, Australians will have to continue to use a potentially less effective vaccine Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ages 9-25 years and National Immunisation Program eligibility; TGA label allows any age with two or three dose schedules.