Male Immunization with Gardasil Not Deemed Cost Effective

By: Drucilla Dyess
Published: Friday, 23 October 2009

Although Gardasil has been proven to protect against two strains of the human papillomavirus (HPV) that cause cervical cancer, as well as two additional strains that cause genital warts, the Advisory Committee on Immunization Practices has voted against its use as a routine immunization for boys and men. However, the committee did vote, almost unanimously, to allow doctors to recommend the vaccine be given to males to reduce their likelihood of acquiring genital warts.

HPV is a sexually transmitted pathogen that is believed to cause approximately 70 percent of all cervical cancers. In addition, HPV has been associated with more rare forms of cancer of the throat, genitals and anus, as well as genital warts. Studies have found Gardasil not only to be safe, but also to be nearly 100 percent effective in preventing pre-cancerous cervical lesions from the four HPV strains that it targets. In addition, findings have shown that Gardasil is far more effective in females when given before they become sexually active.

Since first being approved by the U.S. Food and Drug Administration (FDA) in 2006 for use in females, the issue of whether or not to use Gardasil for males has been strongly debated. Advocates for use of Gardasil as a routine immunization among males believe that widespread use of the vaccine may reduce cervical cancer rates, since males commonly transmit HPV to females.

Although in early October the FDA approved the Gardasil vaccine for use among males aged 9 through 26, results of a study conducted in the same month revealed that immunization among males was not cost effective, as costs would outweigh the health benefit of the vaccine. Now, the results of the final vote by the Advisory Committee on Immunization Practices reported to the U.S. Centers for Disease Control and Prevention (CDC) has apparently put this issue to rest. The vaccine will not be approved for boys as part of the childhood immunization schedule.

The pivotal study published in the British Medical Journal made a comparison between a female-only vaccination program and a co-ed vaccination program. Researchers from the Harvard School of Public Health performed the analysis. According to lead researcher Jane Kim, an assistant professor of health decision science, “This study found that while vaccine coverage and efficacy are high in girls, including boys in an HPV vaccination program generally exceeds what the U.S. typically considers good value for money.”

The basis of a good value was deemed as having cost-effectiveness ratios ranging from $50,000 to $100,000 per quality-adjusted life year, or the cost of the vaccine versus the number of added years someone would gain by getting the vaccine. By assuming lifelong protection among 75 percent coverage, the routine vaccination of girls who were 12 years of age was found to be a good value at less than $50,000 per quality adjusted life year. However, by adding boys of the same age, the cost-effectiveness ratio was increased to over $100,000 per quality adjusted life year.

Currently, the CDC recommends Gardasil for girls ages 11 and 12, and for women ages 13 to 26, who have not been vaccinated for the prevention cervical cancer. The disease claims 4,000 female lives annually in the United State alone.