ACIP to vote Tuesday on new HPV vaccine recommendation for males

Two years after declining to endorse routine use of Gardasil in males, the CDC's Advisory Committee on Immunization Practices is scheduled to vote tomorrow on a revised recommendation that would support vaccination of males with the vaccine for protection against genital warts and other HPV-related diseases.

Gardasil has been licensed for the prevention of genital warts in males since October 2009; an expanded indication in December 2010 added prevention of anal cancer in both sexes to its approved uses.

In late 2010, we wrote about the status of recommendations regarding Gardasil in males (among other policy and ethical issues related to HPV vaccination) in a paper published in the American Journal of Public Health -- "HPV Vaccination's Second Act: Promotion, Competition, Compulsion". The paper argued that the decision not to endorse routine male vaccination be reconsidered, particularly as additional evidence became available. Here's part of what we wrote:

"Arguments in favor of the broad use of Gardasil among males can be made in terms of direct and indirect benefits. The clearest direct benefit involves genital wart protection, for which the vaccine appears to be highly effective. However, the high cost of the vaccine and the nonfatal nature of genital warts lead to highly unfavorable cost-effectiveness analyses when modeling large-scale vaccination of males for this purpose.

A second class of direct benefits to males involves protection against several anogenital cancers and a respiratory condition caused by the HPV types included in the vaccine. Whereas these benefits are widely believed to exist, the FDA approval of Gardasil for males does not include these indications. Obtaining data sufficient to do so will be difficult, because the conditions are relatively rare and lack the ‘‘precursor lesions’’ of cervical cancer that facilitated approval of the vaccines for females. Including these additional presumed benefits results in cost-effectiveness figures generally accepted as representing a worthwhile investment of health
care resources.

The indirect benefit of male HPV vaccination is the additional reduction in cervical cancer incidence that would result from targeting a reservoir for the virus. Once again, economic modeling of male vaccination efforts for this additional objective remains unfavorable, suggesting that concentrated attention to vaccinating females is a superior strategy for cervical cancer prevention. However, encouraging both genders to receive the vaccine not only appeals to fairness but also simplifies promotional efforts made by the medical community. It would also symbolize the shared responsibility of men and women in the prevention of cervical cancer
and other sexually transmitted infections.

In October 2009, the ACIP opted against a routine recommendation for male HPV vaccination. As explained in their published guidance, this decision was based on cost-effectiveness data considering only the licensed indication for genital wart prevention. The committee instead adopted a ‘‘permissive use’’ statement that says little beyond acknowledging that the vaccine is available for those who want it. This decision and its consequences for vaccine availability and affordability likely mean that male HPV vaccination will be a rarity for the foreseeable future.

Prominent voices in the public health and vaccination communities have expressed their disappointment with the panel’s recommendation. Public attention to the disparate messages regarding male and female HPV vaccination should cause this important question of ethics and public health to be reopened and discussed far more broadly than it has been thus far.

Amid limited health care resources, concerns over the total costs of broad HPV vaccination programs are well-founded. As our ability to model the financial and medical impact of health policy options grows, so too does the influence of such analyses among policymakers and third-party payers. Among the questions worthy of discussion on this topic is how well even the most sophisticated economic modeling can reflect the values and priorities of communities in improving public health."

You can read the full paper, including references and discussion of additional topics in HPV vaccine ethics and policy, at the AJPH website.