Questions abound about implementing the HPV vaccine

February 2007

The FDA’s approval of the first human papillomavirus vaccine, and another in the pipeline, brings many unanswered questions and concerns about the challenges to be faced during implementation of the vaccine as a standard practice.

HPV is one of the most common STDs in the United States and is a major cause of cervical cancer. There are about 100 strains of HPV, some of which are associated with genital warts, whereas others are linked to cervical cancer. More than 50% of all women will get HPV at some time in their life, most of whom will not know it because of asymptomatic strains.

Last June, the FDA approved Gardasil (Merck) for females aged 9 to 26 years. Gardasil prevents the most common types of HPV, strains 6, 11, 16 and 18, the four that cause about 70% of cervical cancer and 90% of genital warts. It is administered intramuscularly at three doses: The first dose is followed by a second dose two months later and then a third six months after the first dose. The CDC also recommended catch-up vaccination for those aged 13 to 26 years. Research thus far indicated that vaccination lasts for at least five years, and that the vaccine cannot treat HPV that is already present.

“The general results of efficacy studies are that this vaccine prevents getting HPV infection, but it does not treat HPV infection that’s already evident,” said Anne Schuchat, MD, director of the National Immunization Program at the CDC. “That’s one of the reasons we recommend giving the vaccine to young girls before they’ve actually ever been exposed to the virus.”

Schuchat and several other experts gathered during an “Ask the experts” Webcast to discuss the HPV vaccine and answer questions such as who should receive it and at what age, who will pay for it, what is the best way to ensure access to the vaccine and what are the current challenges.

Potential challenges

The Advisory Committee on Immunization Practices recommended routine vaccination for girls aged 11 to 12 years and catch-up vaccination of all girls and women aged 9 to 26. Schuchat said the ACIP made age recommendations based on various scientific data of immune response, antibody levels, effectiveness and safety information, and a review of sexual behavior.

“This vaccine will work best if given before you have the onset of sexual activity, and that varies in everybody,” she said. “At a population level, by targeting girls 11 to 12, we should be able to reach almost everyone before sexual activity.”

Some have questioned incorporating the HPV vaccine as a routine part of the infant immunization schedule, but the experts argued that studies to date do not indicate for how long the HPV vaccine will protect.

Financing options is another area where concerns have arisen. The vaccine costs $120 a dose, $360 for the series, not including administration fee, and financing differs for girls younger than 18, said Alina Salganicoff, PhD, vice president and director of the Women’s Health Policy at the Kaiser Family Foundation.

Co-pays and deductibles will also affect affordability. Salganicoff discussed the Vaccines for Children program, a federal entitlement program that covers children who are on Medicaid, American Indian, Native Alaskan or uninsured, and those under-insured children seeking care at Federally Qualified Health Centers or Rural Health Centers.

Several states have also considered taking their own initiative on providing this vaccine by introducing legislation that would require a mandate for 11- and 12-year-olds to get the vaccine, according to Salganicoff. New Hampshire and South Dakota have already arranged programs to provide Gardasil free of charge to girls. (For more on vaccine finance issues, see our round table.)

Fewer financing options are available for women aged 19 to 26, 29% of whom are uninsured. Salganicoff said that Medicaid, private and individual insurance typically covers HPV vaccination, and state coverage will vary by location, but “not all plans are covering the vaccine in this older age group.” Merck has a vaccine assistance program targeted to those who are low-income and uninsured.

There are also supply issues that still need to be addressed. Many physicians do not want to order excess supplies of the vaccine because they are unsure how many patients will come in to receive it. Cost is high and reimbursement rates also vary. According to Schuchat, the manufacturer said the supply is ample and there are mechanisms for the private and public sector to access the vaccine.

Renee Jenkins, MD, professor and chair of the department of pediatrics and child health at Howard University College of Medicine, discussed the importance of HPV education among the public and medical professionals.

According to studies, about 40% of U.S. women have heard of HPV, and only 20% of these women know it is associated with cervical cancer.

Therefore, the education of providers and the general public about HPV and cancer prevention is critically important, Jenkins said, and should also incorporate sexual behavior messages.

“That’s why I think it’s so exciting to have this vaccine,” she said. “It’s all part of the package and opportunity to bring up these issues of risk for the STD, as well as the conversations we’re now having about cancer risk. We need to look at each opportunity to be able to get that message in.”

Researchers plan to evaluate a HPV vaccine for boys and men.

At the time of the recommendations, the evidence base did not extend to boys, according to Schuchat. Merck is currently in the process of studying the vaccine in men. Future studies include further evaluation of the duration of protection and whether a booster might be needed at a later time. Another challenge is how to nationally track immunization coverage and ensure that access is provided for all girls and women regardless of ethnicity and economic status.

For more information:

• To view the Webcast from Jan. 10, 2007, visit: www.kaisernetwork.org/health_cast/hcast_index.cfm?display=detail&hc=2010.