10/28/11: UPDATE - This story has been revised and updated with additional information.
ATLANTA – Boys aged 11-12 years routinely should be given the quadrivalent human papillomavirus vaccine, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommended.
The recommendation for boys aged 11-12 years to receive three doses of the vaccine is identical to the one currently in place for girls, except that it does not mention the other, bivalent HPV vaccine, which is not licensed for males. The vote was unanimous with one abstention, despite concerns voiced by several committee members about cost-effectiveness of the vaccine’s use in males. The vaccine becomes less cost-effective in males the more its coverage among females increases, the CDC’s Dr. Lauri Markowitz said.
The American Academy of Pediatrics Committee on Infectious Disease had previously voted for the same recommendation, Dr. Michael T. Brady, the AAP liaison to ACIP, said in an interview. The American Academy of Family Practice is expected to endorse it as well, said Dr. James Loehr, the AAFP liaison. The vote “made sense, and could possibly help with vaccination of females since now there won’t be a gender difference,” he noted.
Although routine vaccination of girls aged 11-12 years has been shown to be cost-effective in most scenarios, there is more uncertainty in cost-effectiveness estimates in women and in males. Routine HPV vaccination of boys at age 12 years could be cost-effective, particularly when female coverage is less than 50%. Those estimates range from $24,000 to $62,000 per quality-adjusted life-year (QALY) in published studies. In 2010, coverage rates in females were 49% for one dose and 32% for all three doses, Dr. Markowitz reported.
First-year costs of giving the vaccine to boys aged 11-12 years is estimated at $136,000,000, assuming an 11% probability of initiating the series and a 70% probability of completing it – somewhat lower than the uptake seen in females – at a cost of $119/dose, she said.
Some committee members voiced concern about whether cost-effectiveness estimates for males would become less favorable if vaccination rates increase in females beginning in 2012, when the proportion of girls who receive all three HPV vaccine doses by their 13th birthday will be a HEDIS (Healthcare Effectiveness Data and Information Set) measure.
Estimated costs per QALY also differed between calculations that included only diseases for which the vaccine is indicated (cervical disease, vulvar/vaginal disease, genital warts, and anal cancer) and those that also included prevention of other HPV-related conditions for which the vaccine isn’t indicated, including recurrent respiratory papillomatosis, oropharyngeal cancer, and penile cancer.
In all, most of the cost-effectiveness benefit obtained from routinely giving the vaccine to boys aged 11-12 years came from the prevention of cervical cancer in female partners, and prevention of oropharyngeal cancer in both males and females, Dr. Markowitz said.
The committee also recommended the vaccine’s use for catch-up in males aged 13-21 years who have not been previously vaccinated or who have not completed the three-dose series. Males aged 22-26 years also “may be vaccinated.” This vote was split, 8-5, with several members expressing concern that this recommendation is not harmonized with the uniform recommendation for females aged 9-26 years. Again, the different age cutoff was chosen due to cost-effectiveness considerations. However, the committee did vote to recommend the vaccine for males through age 26 years who have sex with other males and for those who are HIV-infected. For all males who have sex with males, the vaccine is cost-effective at less than $50,000/QALY.
In a joint interview, Dr. Brady and Dr. Loehr both commented that the relatively recent inclusion of cost-effectiveness considerations in the making of vaccine policy is a major shift from the past and now often overshadows other relevant information.
“It’s a huge concern, and it’s something the ACIP is wrestling with, how to incorporate cost-effectiveness data into decision-making. … I’m not sure there’s been clear guidance as to how the cost-effectiveness data is supposed to be applied,” said Dr. Loehr of Cayuga Family Medicine, Ithaca, N.Y.
Indeed, Dr. Brady pointed out that many older vaccines, such as those that prevent polio and Haemophilus influenzae type B, are cost saving because they prevent more costs than they actually cost. But, the licensure of the pneumococcal conjugate vaccine in 2000 began the shift. “As soon as Prevnar came, that changed the thought process. … Now there is cost, and the question is whether it’s a cost we feel is reasonable.”
“A lot of people believe that ACIP should only determine if something is appropriate and someone else should be responsible for the cost issues, because these are scientists, not economists,” said Dr. Brady, chair of the department of pediatrics, Ohio State University, Columbus.