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HPV, cervical cancer, and the new vaccine

A number of issues surround the large-scale administration of a new vaccine to treat cervical cancer, and while this report relates to the United States, it has relevance in other countries as well.

The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States, with about 6.2 million cases diagnosed annually. [1] There are more than 100 strains of HPV, and more than 30 of these strains can infect the genitals. Although most HPV infections are benign, HPV has been found to be associated with cervical cancer and genital warts. In June 2006, a new vaccine produced by Merck called Gardasil, that protects against certain strains of HPV, was approved by the U.S. Food and Drug Administration (FDA) for use in girls and women ages 9 to 26. While this advance has the potential to improve the health of millions of women, policymakers and health professionals will need to address many issues to assure the large scale administration of this new vaccine including: public and provider education, health care financing, parental consent and confidentiality, and access to care.

The basics: HPV and cervical cancer

HPV is an STI that can be transmitted through genital contact without intercourse. Most HPV infections are asymptomatic and will typically resolve themselves. Certain strains, however, can have serious clinical consequences, including genital warts and cervical cancer. HPV infection is associated with the vast majority of cases of cervical cancer.

In 2005, there were 500,000 new cases of cervical cancer worldwide, and 260,000 women died of cervical cancer. The overwhelming majority of these women were in developing countries, where cervical cancer screening programs and infrastructures for prevention, diagnoses, and treatment are weak. [2] In the United States, the cervical cancer incidence rate is much lower. It is estimated that there will be 9,710 cases of invasive cervical cancer and approximately 3,700 deaths from cervical cancer in the United States in 2006. [3] This lower rate is attributable to the success of the widespread use of the Papanicolaou (Pap) test, which detects changes in cervical tissue, and is a major tool in screening for early identification of cervical cancer.

If detected early, cervical cancer is highly treatable. In the United States, it is recommended that women receive Pap tests at least once every three years. However, many women still do not receive Pap tests at the recommended frequency. In particular, Asian/Pacific Islander women have significantly lower rates of Pap tests than women of other races. Cervical cancer incidence and mortality are approximately 1.5 times higher among African American and Latina women, compared to White women. [4] Researchers have postulated several reasons for these disparities, including fear, cost, lack of physician referral, and cultural issues. [5]

The HPV vaccine

Following the FDA approval of the Gardasil vaccine, the federal Advisory Committee on Immunization Practices (ACIP), a committee of the Centres for Disease Control and Prevention (CDC), recommended the new vaccine be administered routinely to girls 11 to 12 years of age. Use at a health provider's discretion was also recommended for girls and women between the ages of 9 to 26. [6] These recommendations were designed to encourage vaccination before initiation of sexual activity, and were based on data from clinical trials demonstrating a greater immune response in girls ages 10 to 15 compared to young women ages 16 to 25. [7]

Gardasil prevents infection of four strains of HPV—two strains (16, 18) that cause 70% of cervical cancer cases and two strains (6, 11) that cause 90% of genital warts cases. It does not protect against all types of cervical cancer-causing HPV. Therefore, regular Pap tests remain a critical tool for early detection of precancerous cells. [8] Gardasil should be administered in three doses over six months. Presently, there is only enough research to show vaccine effectiveness for 5 years. Further research will determine whether booster shots are needed. Furthermore, clinical trials were conducted in 9- to 26-year-old females, so effectiveness is only known for this age group, not for older women or males. [9]

Vaccine implementation and costs

Health care professionals follow ACIP recommendations closely. Health care professional associations often base their own policies on these recommendations. [10] After ACIP makes its recommendations, each state decides whether the vaccine should be required for entry into childcare or school. [11] There are no federal laws that mandate vaccination; thus, mandatory vaccination laws will vary from state to state. Currently, legal exemptions to vaccination based on medical, religious, or philosophical grounds also vary from state to state. [12] Some groups have already expressed opposition to mandatory vaccination for entry into school. [13] In addition, most vaccines r
equire parental consent. It is not yet clear how states and providers will handle consent issues, particularly with women ages 18 and under who do not need consent for STI preventive services or treatment.

Another major hurdle will be the price of the vaccine. Merck has said that the list price of the vaccine will be $360 for the three doses, making it one of the costliest vaccines on the market. Private insurance companies usually cover ACIP-recommended vaccines, so most insured individuals will likely have coverage, although it is still too soon to tell. The Vaccines for Children (VFC) program, a federal entitlement program, covers the cost for children under age 19 who are uninsured, on Medicaid, Alaska Natives, or American Indians. [14]

However, for women 19 and older, the policies are different. Under Medicaid—the primary form of coverage for low-income women—vaccines are considered an "optional" benefit, which means that each state decides whether it will be a covered service. Some states also have public health programs in place that provide free or low-cost vaccines to those whose health insurance plan does not cover vaccines. [15] For uninsured women, Merck has announced that it will establish an assistance program to provide free vaccines, including Gardasil, to uninsured and low-income adults ages 19 and older who visit private practices that already provide Merck vaccines. The details of the program have not yet been released. [16] [17] Many uninsured women in this age group rely on publi
cly funded clinics and health centres, not physicians in private practice.

Public acceptability

Numerous studies have evaluated acceptability and attitudes regarding the use of the HPV vaccine. Acceptability among gynaecologists and physicians is generally high, depending on factors such as a patient's gender, age, and sexual history, as well as efficacy of the vaccine. [18] [19] A review of research regarding STI and HPV vaccine acceptability also indicates that health care providers and professional health organizations play a large part in a parent's decision to vaccinate his or her child. Parents are more likely to follow the recommendations and information put forth by health care providers, and health care providers are more apt to follow a professional health organization's endorsement of a vaccine. ref=http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=16310137&query_hl=4&itool=pubmed_docsum target=_blank>[20] Thus, health care providers will likely play a pivotal role in relaying information about HPV and HPV immunization in order to ensure the targeted population is vaccinated.

The approval of the new vaccine holds great promise for millions of women. Not only can it greatly reduce deaths attributable to cervical cancer, but it also has the potential to reduce the economic and emotional burdens that women experience when they face an abnormal Pap smear that requires further testing and treatment. The key to the success of this new vaccine will be in how policymakers, health care providers, parents, and women and girls respond to make sure that all those who can benefit from this new technology have access to it.

Discussion questions

• What are the major implementation challenges in the administration of this new vaccine? How can policymakers intervene to improve access to the vaccine?

• What regulations and policies are needed to allow low-income and underinsured individuals to gain greater access to vaccinations at both the state and federal level? What options would be needed to improve access for uninsured women ages 19 to 26?

• What are the barriers to making this vaccine mandatory? How could these barriers be addressed?

• What else can be done to decrease cervical cancer incidence and mortality rates? What can be done to address racial and ethnic disparities in terms of access to screenings?

Article courtesy of the Kaiser Family Foundation

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