STD Quarterly

Family planning providers get in gear to offer new HPV vaccine to young women

Vaccine addition to federal immunization program broadens access

Access to Gardasil (Merck & Co., Whitehouse Station, NJ) continues to expand as the shot has been added to the federal Vaccines for Children (VFC) program for young women ages 9 to 18. The program is administered at the national level by the Centers for Disease Control and Prevention (CDC) through its National Immunization Program.

"The Vaccines for Children Program provides a tremendous safety net for the most impoverished and for special vulnerable groups in the country," explains Anne Schuchat, MD, director of the CDC's National Center for Immunization and Respiratory Diseases. Any young woman who is eligible for the Vaccines for Children program will have access to the vaccine, she notes.

WellPoint in Indianapolis, America's largest health insurer, announced that it would cover costs for the new vaccine following regulatory approval and recommendation for vaccine use by the CDC's Advisory Committee on Immunization program (ACIP) in June 2006. While Merck reports more than 95 insurance plans have decided to reimburse costs for Gardasil, cost has been a factor for patients without insurance coverage. At $120 a dose, plus provider charges, a full three-shot series can run $400 to $500.1

Program adds coverage

To further broaden access to the vaccine, Merck has initiated a new patient assistance program. Currently available in private physicians' offices, the program allows Gardasil and other proprietary vaccines to be provided free of charge to those ages 19 and older who are uninsured and who are unable to afford vaccines.

Patients may be eligible for the program if all three of the following conditions apply:

  • United States resident, age 19 or older;
  • no health insurance coverage (examples of coverage include private insurance, health maintenance organization, preferred provider organization, college health plan, Medicaid, veterans' assistance, or any other social service agency support);
  • household income less than $19,600 for individuals, $26,400 for couples, or $40,000 for a family of four.

Individuals who do not meet these criteria still may qualify for the vaccine program if the patient has special circumstances of financial and medical hardship. Upper-income limit for exceptional patients is $39,200 for individuals, $52,800 for couples, and $80,000 for a family of four.

Merck will use the following criteria to determine licensed prescriber participation:

  • stocks Merck vaccines;
  • does not purchase vaccines for Merck Vaccine Patient Assistance Program-eligible population with government funds;
  • willing to screen applications according to Merck's eligibility criteria and to work with Merck's vendor to process applicants;
  • willing to accept potential auditing to participate in the program and that no vaccine administration fee is provided by Merck;
  • willing to keep individual immunization records.

Will nonprofit clinics be eligible to participate in the program? The answer is a qualified "yes." Practices that are wholly owned and operated by the government are not eligible for the program at this time, states the corporate web site.

A nonprofit organization, the Partnership to End Cervical Cancer, is advocating to make cervical cancer vaccines part of routine preventive health care for American women. More than 20 member organizations, including the American College of Obstetricians and Gynecologists (ACOG) and the Planned Parenthood Federation of America, have joined the organization, which is focused on educating women about cervical cancer and encouraging the public health network, providers, and policy-makers to take action to make sure women have access to vaccines against the disease. GlaxoSmithKline of Research Triangle Park, NC, plans to seek regulatory approval in 2007 for its HPV vaccine, Cervarix. The bivalent vaccine is formulated to strike HPV types 16 and 18.

Help put use of the vaccine into practice in your facility: Look to new clinical recommendations released from ACOG.2 The new committee opinion offers general information about the vaccine and provides guidance on proper administration, precautions, and contraindications.

Obstetrician-gynecologists should be proactive in educating patients about the vaccine so that as many women as possible are able to take advantage of it, says Douglas Laube, MD, MEd, ACOG president Providers must be prepared to administer the vaccine and to answer patient and parent questions that will arise, he notes.

While use of the vaccine is important, recommendations for cervical cytology screening remain unchanged, the ACOG guidelines emphasize. Pap screening should begin within three years of sexual intercourse (or by age 21) and then annually until age 30. After age 30, most women can continue annual testing or can choose to be tested every two to three years after three consecutive negative Pap tests, the guidance notes.2

While the Gardasil vaccine protects against human papillomavirus (HPV) types 6, 11, 16, and 18, there are additional HPV strains that can cause cervical cancer. Pap testing can detect abnormal cervical cells caused by other HPV strains not covered by the vaccine, the guidance states.

Who should get shots?

Gardasil is a ready-to-use, three-dose, intramuscular vaccine. According to its prescribing information, it should be administered in three intramuscular injections in the upper arm or upper thigh over six months.3 The recommended dosing schedule is to give the first dose, followed by the second dose two months after the initial injection, with the third dose administered six months after the initial dose.

While the Food and Drug Administration has approved the vaccine for girls and women ages 9 to 26, ACIP recommendations advise that vaccine administration begin between the ages 11 and 12. Vaccination also is recommended for women up to age 26, regardless of sexual activity.

Women who previously have had abnormal cervical cytology, genital warts, or precancerous lesions can be vaccinated. Those with suppressed immune systems also can be vaccinated, although the protection may be less than those with normal immune function.

Advise patients that the HPV vaccine is not a treatment for current HPV infection or genital warts. Women who are undergoing treatment for HPV-related symptoms such as cervical cytology abnormalities or genital warts should continue taking their prescribed medication while going through the immunization process.

While Gardasil has not been shown to have a harmful effect on pregnancy, it is not recommended that pregnant women be vaccinated with the drug. If a woman discovers she is pregnant during the vaccine schedule, she should delay finishing the series until after she gives birth. Women who are breast-feeding can receive the vaccine, the prescribing information states.3

Reproductive health professionals have played a vital role in preventing morbidity and mortality from HPV-related disease through the provision of education, prevention, and treatment, states Evan Myers, MD, MPH, associate professor of OB/GYN at Duke University Medical Center in Durham in a recent published editorial on vaccination.4 Providers can continue such efforts by offering vaccination to appropriate populations, continuing to educate patients on other effective methods for prevention of HPV-related diseases, and advocating for policies to ensure maximum access and coverage, he states.

References

  1. Stein R. Vaccine for girls raises thorny issues. Washington Post; Nov. 7, 2006: HE01.
  2. Committee on Adolescent Health Care; ACOG Working Group on Immunization. ACOG Committee Opinion No. 344: Human papillomavirus vaccination. Obstet Gynecol 2006; 108(3 Pt 1):699-705.
  3. Merck & Co. Gardasil [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]. October 2006.
  4. Myers ER. HPV vaccines: Now that they're here, how do we maximize their benefit? Contraception 2006; 74:277-279.

Resource

To learn more about Merck & Co. Vaccine Patient Assistance Program, go to the corporate web site, www.merck.com. Click on "Patient Assistance Program," then under the subheading "Merck Vaccine Patient Assistance Program," click on "Learn More." Application forms in English and Spanish are available. Licensed prescribers and their office personnel also can call (800) 293-3881 to obtain enrollment applications for patients and to request additional information about the program.