PBAC's latest decision on Human papillomavirus 9-valent vaccine: Recommended with restriction (2022). Considered for 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.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
2
first 2017
Submissions
2
2017 → 2022
Eligible population
Females 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.
Therapy area
Vaccines
Line of therapy
Not applicable
Evidence base
RCT | Registry
Primary endpoint
Surrogate
Pivotal trial size
760 patients
Key trials
KEN SHE trial, IARC trial (India), Brotherton et al. (Australian cohort), CVT trial, DoRIS trial
Comparator
2 or 3 doses of HPV vaccine
Economic model
Not modelled
ICER note
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.
Submission history
Jul 2017: Recommended with restriction · Restricted
Dec 2022: Recommended with restriction · Restricted