Gardasil for boys gets PBAC green light

CSL Ltd’s revised bid to have adolescent males vaccinated with Gardasil under the National Immunisation Program (NIP) has been accepted.

Minutes from the November meeting of the Pharmaceutical Benefits Advisory Committee (PBAC) released today show it now supports the move towards a “gender neutral program” involving the HPV vaccine.

The recommendation to government is for the NIP’s Gardasil vaccination program to be extended to include boys aged 12–13 years, plus a catch-up program over two years for males in Year 9.

CSL first applied for boys to also be given the cancer and genital wart-preventing vaccine in a submission made in November 2010, but this was rejected on economic grounds by the PBAC in March this year.

Pricing factors are understood to have been tweaked in CSL’s revised submission.

“The PBAC recommended extension of the NIP listing of quadrivalent human papillomavirus… recombinant vaccine… to include ongoing administration to males approximately 12 to 13 years of age in a school-based program,” the body said in minutes released on its website early on Friday.

“And for two catch-up cohorts for all males in the two year groups above the ongoing cohort, delivered over two years for Year 9 males”.

The PBAC also noted the extension should proceed “on the basis of acceptable cost effectiveness compared with female-only vaccination”.

The decision comes after the US Advisory Committee on Immunization Practices (ACIP), in late October, recommended in favour of the “routine use” of a quadrivalent HPV vaccine in boys aged 11–12 years.

Gardasil protects against genital warts and oncogenic strains (6, 11, 16 and 18) of HPV and is currently available on private script for boys and men aged 9–26 years.

A CSL spokeswoman welcomed the PBAC’s decision and said the revised submission “addressed the uncertainties previously identified by PBAC and took into account the differential disease burden in males and females”.

“The PBAC recommendation is a very important first step towards the implementation of a gender neutral HPV vaccination program,” the spokeswoman said.

“The government has due process to follow which CSL will work through as appropriate.”

Gardasil vaccination offers protection against genital warts, and also anal and penile cancer in men.

It is approved for women aged 9–45 years and funded for adolescent girls where it is primarily seen as offering protection against cervical cancer.

Comment was being sought from CSL Ltd.