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Gardasil For Boys May Not Be Cost-Effective

Oct 9, 2009 | Parker Waichman Alonso LLP

Just as U.S. regulators are set to decide on approving Gardasil for boys and young men, a new study is questioning the cost-effectiveness of HPV vaccination for that group. The study appeared online today in The British Medical Journal.

According to a press release from Harvard School of Public Health (HSPH),  researchers there found that if  HPV vaccine coverage and efficacy are high in girls, a universal recommendation to vaccinate young boys is unlikely to provide comparatively good value for resources, compared with vaccinating girls only.

To reach that conclusion, the researchers looked at computer-based disease models to simulate the course of HPV-related diseases in the U.S. population over time. The analysis looked at the vaccine's potential benefits on a comprehensive set of HPV-related conditions among females and males, including cervical and non-cervical HPV-related cancers, genital warts and juvenile onset recurrent respiratory papillomatosis, a rare but severe respiratory condition usually diagnosed in infancy that may be related to a mother's infection with genital warts.

The results showed that, assuming 75% vaccination coverage and lifelong vaccine protection against cervical disease, routine HPV vaccination of 12-year-old girls was associated with a cost-effectiveness ratio of $40,310 per quality-adjusted life year (QALY).  Including boys in the vaccination program had a cost-effectiveness ratio of $290,290 per QALY when compared to vaccinating girls only.

QALY is  a health metric used to reflect both the excess mortality and reduced quality of life associated with disease. In the U.S., interventions with cost-effectiveness ratios below $50,000 or $100,000 per QALY are informally considered good value for the money.

The results were robust across a range of alternative scenarios, such as changes in screening practice, decreased vaccine efficacy in boys, shorter duration of vaccine protection, and the inclusion of other HPV-related outcomes noted above. The authors acknowledged, however, that there are many uncertain factors that can influence the findings.

The U.S. Food & Drug Administration (FDA) is currently considering whether or not Gardasil, the HPV vaccine marketed by Merck & Co. should be approved for boys and young men. Last month, an FDA advisory panel had recommended that it be approved for boys and young men aged 9 to 26 for protection against genital warts caused by HPV.  In the U.S., Gardasil is currently only approved for use in girls and young women.