The Pharmaceutical Benefits Advisory Committee (PBAC) has rejected a submission to add the human papillomavirus (HPV) vaccine Gardasil to the Pharmaceutical Benefits Scheme (PBS) for use in males.

Gardasil is currently only available on the PBS for girls through the National Immunisation Program (NIP) to combat cervical cancer.

Last year, drug maker CSL applied to add Gardasil for boys to the NIP, which would reduce HPV-caused penile, head and neck cancers in men generally, and anal cancers in gay men.

The PBAC “rejected the submission because of unacceptably high and uncertain cost-effectiveness”, according to the published outcomes of its March meeting.

The Kirby Institute’s Professor Basil Donovan, who called for Gardasil to be given to boys last year, said, as it was the first time CSL had made an application, it was “quite predictable” they had been knocked back.

“They usually reject everything on first approach,” Donovan told the Star Observer. “I have no doubt CSL will make another submission.”
Donovan thought CSL’s case would be strengthened by new American research into Gardasil and anal cancers and pre-cancerous anal conditions.

But with the federal Government refusing to add 13 drugs already approved by the PBAC to the PBS, Donovan could not say he was confident that Gardasil for boys would be added to the NIP.

“You can’t be confident of anything in this world. Even things that have been approved by the PBAC, the federal Government is deciding not to fund,” Donovan said.

Australian Federation of AIDS Organisations (AFAO) executive director Don Baxter, another supporter of the vaccine being given to boys, told Star Observer that it wasn’t time to panic yet.

“The PBAC’s role is to get the best possible price so there’s usually a bit of back and forth with applications to get a lower price or different package,” Baxter said.

However, AFAO was concerned about Cabinet taking a larger role in deciding which drugs went on the PBS. This could delay the process when and if the PBAC approved the drug for boys.

“The way it’s playing out, I think, is giving some cause for concern,” Baxter said. “AFAO will keep a close eye on this.”

“CSL believes extending HPV vaccination to males is an important public health initiative and we are committed to working with the PBAC to secure a positive recommendation for the NIP,” a CSL spokeswoman told the Star Observer.

“We are currently working on a resubmission and aim to submit in the coming months.”

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