HPV vaccine, with nod from FDA, is first one approved to prevent cervical cancer
ARHP, Planned Parenthood team up to deliver provider education
With approval from the Food and Drug Administration (FDA) and a recommendation from the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) in hand, providers are poised to offer the first vaccine specifically designed to prevent cervical cancer.
The FDA in June approved quadrivalent HPV vaccine (Gardasil, Merck & Co.; Whitehouse Station, NJ). The vaccine targets four types of human papillomaviruses (HPVs): types 6, 11, 16, and 18. HPV types 16 and 18 and others, known as "high-risk" HPV types, may cause abnormal Pap tests and cervical cancer in women, as well as a number of other cancers in the vulva, vagina, anus, or penis. While other risk factors may come into play, being infected with a high-risk type HPV appears to be a necessary factor for cervical cancer development.1
The CDC estimates about 20 million people are infected with HPV.1 About half of sexually active men and women acquire genital HPV infection at some point in their lives.
The ACIP recommendation is a powerful endorsement for the use of the vaccine, says Amy Middleman, MD, MPH, MSEd, an adolescent medicine specialist at Texas Children's Hospital and associate professor of pediatrics with Baylor College of Medicine, both in Houston. Professional societies, such as the Society for Adolescent Medicine, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and the American Academy of Family Physicians, are poised to issue guidance on use of the vaccine, she says. Studies have shown that providers place a great deal of importance on such professional organizations' statements and recommendations.2-4
How to use vaccine?
According to the ACIP recommendation, three doses of the new vaccine should routinely be given to girls when they are ages 11 to 12; however, the vaccination series can be started as early as age 9 at the discretion of the health care provider. Females ages 13-26 also may receive the vaccine if they have not received it at a younger age, according to the ACIP recommendation. The vaccine is most effective when it is given before people are infected with HPV.
The FDA indication for use of the vaccine is for girls and women ages 9-26. In an information sheet prepared by the agency, it advises that it is best to administer the shot before the start of sexual activity.5
The vaccine comes as a $360 series of three shots; the second dose is given two months after the first injection, with the third dose given six months after the initial injection. ACIP voted to add the HPV vaccine to the coverage list for the Vaccines for Children program, which pays for immunizations for uninsured and underinsured children. A 2003 analysis indicated that vaccination of girls against high-risk HPV subtypes would be cost-effective.5
Will private insurance companies cover the vaccination series? According to a 2005 survey conducted by America's Health Insurance Plans, most health insurance plans said they include most or all of the ACIP recommended vaccines in their benefits for children, adolescents, and adults.6 Most indicated an ability to act on new ACIP recommendations within three months of release, with health maintenance organizations being able to reimburse more quickly than preferred provider organizations.6
Put shot into practice
The vaccine is very safe, according to Daron Ferris, MD, professor in the departments of family medicine and OB/GYN at the Medical College of Georgia in Augusta and an investigator in the Gardasil trial. Research of the vaccine showed only minor problems; some people had a slight fever, while others had redness or irritation on their skin where they got the shot, he notes.7
Although the new vaccine represents a major advance in the prevention of genital HPV and cervical cancer, it does not replace other prevention strategies, such as cervical cancer screening for women or protective sexual behaviors, public health officials emphasize. Women should continue to get Pap tests as a safeguard against cervical cancer, they note.
How should providers integrate vaccinations into their practices? Use standing orders, screening tools, reminder systems, and registries whenever possible to increase vaccination, says Middleman.
"I think that if providers are willing to take some brief period of time to become involved in the immunization registry, in the long run, as immunization schedules become more complex and the number of providers administering vaccines grows, those systems can end up saving a great deal of time and increasing compliance significantly," says Middleman.
Patient and provider resources for family planning providers are being developed through a joint partnership of the Association of Reproductive Health Professionals (ARHP) and the Planned Parenthood Federation of America, reports Wayne Shields, ARHP president and CEO. The two groups are developing a clinical education program, "Comprehensive HPV Services: Prevention, Screening, and Treatment," that will offer continuing medical education modules and associated materials and tools to targeted practitioners in the field. The program will include live sessions, web casts, and a CD-ROM. Patient materials will be developed in English and Spanish, says Shields. The groups are aiming to launch the program in the first quarter of 2007. Providers who are interested in the program should contact ARHP to be added to a preregistration list, says Shields.
References
1. Centers for Disease Control and Prevention. Genital HPV Infection. Fact sheet. Accessed at: www.cdc.gov/std/HPV/STDFact-HPV.htm.
2. Raley JC, Followwill KA, Zimet GD, et al. Gynecologists' attitudes regarding human papilloma virus vaccination: A survey of Fellows of the American College of Obstetricians and Gynecologists. Infect Dis Obstet Gynecol 2004; 12:127-133.
3. Kahn JA, Zimet GD, Bernstein DI, et al. Pediatricians' intention to administer human papillomavirus vaccine: The role of practice characteristics, knowledge, and attitudes. J Adolesc Health 2005; 37:502-510.
4. Daley MF, Crane LA, Beaty BL, et al. National survey of pediatrician knowledge and attitudes regarding human papillomavirus vaccination. Presented at the 2006 National Immunization Conference. Atlanta; March 2006.
5. Sanders GD, Taira AV. Cost-effectiveness of a potential vaccine for human papillomavirus. Emerg Infect Dis 2003; 9:37-48.
6. American Social Health Organization. FAQs about Cervical Cancer/HPV Vaccine Access in the U.S. Accessed at: www.ashastd.org/pdfs/FAQ_HPV_0606.pdf.
7. Villa LL, Costa RL, Petta CA, et al. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 viruslike particle vaccine in young women: A randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncology 2005; 6:271-278.
Resources
- To access an on-line version of the Food and Drug Administration information sheet on HPV and immunization, go to www.fda.gov/womens/getthefacts/hpv.html.
- The Centers for Disease Control and Prevention (CDC) offers several clinician resources on HPV and immunization. Visit the agency's Sexually Transmitted Diseases web page, www.cdc.gov/std. Click on "HPV and HPV Vaccine" for information prepared for health care providers and look at "HPV Vaccine Questions and Answers" for information geared to patients. On this same page, check out the replay of the CDC's National Center for HIV, STD, and TB Prevention, National Center for Chronic Disease Prevention and Health Promotion, and the National Immunization Program netconference program, "Human Papillomavirus (HPV), Cervical Cancer, and HPV Vaccine and Recommendations." Slides from the netconference also are available at the site.
- The CDC's National Immunization Program web site, www.cdc.gov/nip, offers information on immunization registries. On the left side of the page, under "NIP sub-sites," click on "Immunization Registries." Provider resources include information on privacy and confidentiality, as well as information for patients.
- Access the Gardasil prescribing information and the patient production information at the Gardasil product web site, www.gardasil.com.
- To be added to a preregistration list for the "Comprehensive HPV Services: Prevention, Screening, and Treatment" program under development by the Association of Reproductive Health Professionals and Planned Parenthood Federation of America, contact ARHP at [email protected].
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