HPV vaccine coverage debated

Despite benefits, males pay in full

By Deborah Kotz
Globe Staff / July 23, 2011

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When Gardasil, the vaccine that protects against the virus that causes cervical cancer, was approved for boys and young men in 2009, the US Centers for Disease Control and Prevention declined to recommend it after considering its cost, efficacy, and safety. Some insurance companies took that as a reason to avoid coverage for males.

The vaccine had initially been shown to protect males from genital warts, but public health specialists considered most of the benefits to be altruistic: Young men who are protected against the sexually transmitted human papillomavirus (HPV) would not be able to infect young women.

New research, though, suggests that Gardasil also protects against anal cancer - thought to be caused by HPV, too - which occurs predominantly in women and gay men. Thus, young gay men could get potentially lifesaving benefits from the vaccine. But some insurance companies still refuse to cover the nearly $400 cost of the three shots required for full protection.

An estimated 5,260 Americans - 2,000 men and 3,260 women - are diagnosed with anal cancer every year, and more than 700 die of the disease annually, according to the National Cancer Institute. (Cervical cancer occurs in 12,000 women and causes 4,000 deaths a year.)

Clinical trial data submitted to the US Food and Drug Administration by manufacturer Merck found that Gardasil was 78 percent effective in preventing precancerous lesions in the anus in vaccinated men who had sex with other men.

Bennett Klein, a senior attorney at the Boston-based Gay & Lesbian Advocates & Defenders, said in an interview that he was informed by pediatricians that some parents were not getting coverage for their sons’ immunization.

In May, Klein sent letters to both Blue Cross Blue Shield of Massachusetts and Neighborhood Health Plan asking them to provide coverage for boys, as well as girls. “They’re preventing young gay men from having access to prevention for a very serious disease,’’ Klein said.

Both insurers said they covered the vaccine only for girls and women up to age 26, based on recommendations from the CDC. The agency says males “may get HPV vaccine,’’ but does not recommend it.

That distinction, though, has not stopped other insurers, including Tufts Health Plan, Harvard Pilgrim, and MassHealth, which serves the state’s Medicaid patients, from providing coverage for boys.

In a letter responding to Klein, Neighborhood Health Plan said it would change its policy and provide coverage for HPV vaccination for all age-eligible boys and young men “to provide equal care to our gay/bisexual population.’’

Blue Cross Blue Shield, the state’s largest insurer, told Klein that it was sticking with its policy, but would change it if the CDC decides to recommend vaccination in males. An agency advisory committee is slated to meet in the fall to discuss the issue.

“Our vaccination policy is pretty straightforward,’’ said Jay McQuaide, a Blue Cross Blue Shield spokesman. “We decided it based on one criteria, whether it’s recommended by the CDC.’’

But Dr. Carole Allen, director of pediatrics at Harvard Vanguard, said that is not good enough. “I’ve had parents in my practice who said, ‘I want my son to have this vaccine because I want him to be a responsible citizen, gay or straight,’ ’’ she said, “and it isn’t fair that Blue Cross isn’t covering it.’’

Allen said that far fewer parents seek out HPV vaccination for their boys than their girls and that doctors are part of the problem. “We don’t always remember to mention it, but if I have any inkling that one of my male patients is gay, I make sure to bring up the immunization with the parents, without, of course, outing the child.’’

Jane Kim, a health policy analyst at Harvard School of Public Health, said it is reasonable for insurance firms to follow the CDC’s lead to determine coverage, but she added that the agency does not always take the right approach on recommendations.

Vaccinated boys can also help lower the rates of circulating HPV, providing community immunity to girls who are not vaccinated, Only 25 percent of teenage girls in the United States have received all three shots.

While anal cancer is fairly rare, the subgroup of men who have sex with other men are at the highest risk, especially those who are HIV positive, said Kim, who has studied the use of Gardasil in males.

“Since we don’t always know who that subgroup is,’’ she added, “maybe the best way to ensure protection is to offer the vaccine to all boys.’’

Parents and those considering Gardasil vaccination should be aware of side effects, including fainting - which the FDA says is “common’’ in teens and sometimes causes serious head injuries - pain at the injection site, headache, nausea, and fever. The FDA has also received reports of a few deaths in girls following vaccination, but it is uncertain whether the fatalities were related to immunization.

Deborah Kotz can be reached at