IDSA 2011: HPV Vaccination in Males

BOSTON, MA—Routine vaccination against human papillomavirus (HPV) has been recommended for adolescent females since 2006, but so far has not been actively recommended for males. As part of a mini-symposium at the IDSA annual meeting bearing the cheeky title of “Hot Topics in Sexually Transmitted Infections,” Kevin Ault, MD, associate professor of obstetrics and gynecology at the Emory University School of Medicine and an investigator at the Emory Vaccine Center, reviewed the pros and cons of recommending the HPV vaccine for males, with an emphasis on whether the benefits of vaccination would outweigh the costs. (To listen to an interview HCPLive conducted with Ault at the meeting, click here.)

In 2010, Ault explained, the Advisory Committee on Immunization Practices (ACIP), an independent expert advisory board that makes recommendations on vaccine policy to the Centers for Disease Control and Prevention, issued a “permissive” recommendation for males 9-26 to receive the HPV vaccine for prevention of genital warts. (This meant that the vaccine was permitted, but not recommended as routine.) This Tuesday, the ACIP will consider making a routine recommendation that males receive the HPV vaccine.

Ault explained that there are approximately 6 million new HPV infections per year, with at least 20 million people currently infected in the US. HPV infection is generally asymptomatic, though it can cause several serious diseases. The prevalence of genital warts, the most easily recognized sign of HPV, was approximately 3.7 million in 2003. Between 2004 and 2007, there were an average of 20,903 cancers of the cervix, vagina, vulva, oropharynx, and anus and rectum in women. Of these, 17,610 were HPV associated, and 14,720 were associated with the most common HPV strains, 16 and 18. In males during the same period, there were an average of 11,553 cases of cancer of the penis, oropharynx, and anus and rectum, 7,490 of which were HPV associated, and 7,080 HPV 16/18 associated.

Arguments in favor of vaccinating males against HPV, Ault said, include offering direct protection to men and increasing herd protection to women against HPV-related cancers and genital warts. Arguments against include the fact that most HPV-related cancers occur in females, the vaccine’s relatively high cost, and a lack of data on the bivalent vaccine (Cervarix) in males.

The generally accepted definition of a cost-effective treatment is one that costs less than $100,000 per quality-adjusted life year (QALY). For the sake of comparison, Ault explained that the MMR, polio, and several other vaccines save more money than they cost, while the influenza vaccine costs $10,000 per QALY. The meningococcal vaccine is a bit expensive at $120,000 per QALY, and the adolescent female quadrivalent vaccine (Gardasil) costs less than $50,000 per QALY. (In an interview with HCPLive, Ault explained his sense of why the meningococcal vaccine is recommended despite its high cost: “I think that’s such a devastating disease and happens in such a young, healthy population that that kind of overrode the concerns about the cost of the vaccine.”)

It turns out that the HPV vaccine for males is more cost-effective the lower the coverage is of females with the vaccine—and, so far, coverage of females has been disappointingly low. The National Immunization Survey—Teen found that in 2010 just 32% of girls 13-17 had received the full three-dose sequence of the vaccine. According to data presented by Ault, at this level of female coverage, giving males the HPV vaccine costs just over $50,000 per QALY. If female coverage were to rise to 50%, however, then covering males would cease to be cost-effective, coming in at almost $150,000 per QALY.