Gardasil approved for use in males — Cervarix gets OK for use in females
Both recommended for Vaccines for Children coverage
Two new actions from the Food and Drug Administration (FDA) will impact your practice. The agency has given the nod to use of the Merck & Co. quadrivalent vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men ages 9-26. The FDA also has approved the GlaxoSmithKline Cervarix bivalent vaccine for use in the prevention of cervical precancers and cervical cancer associated with oncogenic HPV types 16 and 18 for use in girls and young women ages 10-25.
Gardasil currently is approved for use in girls and women ages 9-26 for the prevention of cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types 6 and 11. Cervarix is the second vaccine approved for HPV prevention in women.
Cervarix now joins Gardasil as the second of two vaccines recommended by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) for prevention of cervical cancer in females. The recommendation was issued at the committee's October 2009 meeting.
ACIP did not call for routine use of Gardasil in males. Instead, it voted to approve the statement "the quadrivalent HPV vaccine may be given to males aged 9 through 26 years to reduce their likelihood of acquiring genital warts."1 This "permissive use" guidance means that Gardasil may be given to males ages 9-26 to reduce the likelihood of acquiring genital warts at the discretion of the patient's health care provider.
Cervarix and Gardasil earned the committee's recommendation for coverage under the Vaccines for Children (VFC) program, which pays for uninsured and underinsured children through age 18. The ACIP recommendations do not result in requirements for vaccine administration by individual states or coverage by insurance companies; however, state health authorities and private insurers typically follow the committee's guidance.
Extend use to males
Nearly 17,000 new cases of genital HPV infection, of any type, occur each day in U.S. males and females, says Anna Giuliano, PhD, professor of medicine and epidemiology at the University of South Florida and a program leader in the Risk Assessment, Detection, and Intervention program at Moffitt Cancer Center in Tampa. While most of the infections clear on their own, it is estimated that 1 million people in the United States will develop genital warts, which can cause discomfort and be distressing, observes Giuliano. While some resolve without treatment, warts recur in at least one-quarter of cases that require care.
Gardasil helps protect against the four types of HPV (6, 11, 16, and 18) that cause the most disease. It is estimated that HPV types 16 and 18 account for 70% of cervical and vaginal cancer cases and up to half of vulvar cancer cases; types 6 and 11 cause about 90% of all genital warts cases.
To address any funding challenges that might impede access to vaccination for those not in the VFC-eligible age range, Merck will extend its assistance program to cover uninsured males ages 19-26. The program, established in 2008, provides Gardasil free of charge to women of similar ages who meet the program criteria.
Merck plans to extend its Gardasil patient rebate and dose replacement programs to eligible privately insured males with partial or no coverage. The rebate program enables those qualifying people ages 19-26 with private insurance whose out-of-pocket costs are more than $30 to receive a rebate from Merck for up to a maximum of $130 per dose. The dose replacement program provides a limited number of replacement doses of the vaccine to eligible health care providers who learn after giving the vaccine to a qualifying patient that no reimbursement is available from their private insurance.
Public health officials are weighing the cost-effectiveness of administering Gardasil in men. Results of a just-published analysis state that given currently available information, including boys in an HPV vaccination program "generally exceeds conventional thresholds of good value for money, even under favorable conditions of vaccine protection and health benefits."2 Information from such cost-benefit analyses led the committee to issue "permissive" use guidance rather than recommendation for routine use.3
Cervarix is expected to be commercially available in the United States in late 2009, say company officials. It is administered to young women in a three-dose schedule that should be completed within six months of the initial dose. The most common local adverse reactions and general adverse events reported in clinical trial participants were pain, redness, and swelling at the injection site; fatigue; headache; joint and muscle ache; and gastrointestinal symptoms.
Public health officials are weighing the evidence when it comes to determining the use of the two available HPV vaccine options in women. At the June 2009 ACIP meeting, research presented from a comparative trial of Gardasil and Cervarix indicates the bivalent vaccine does produce higher titers than the quadrivalent vaccine.4 Both vaccines produce titers that are substantially higher than those after natural infection; the implications of this, in terms of differences in duration of protection, are unclear, note officials.4
At its October 2009 meeting, ACIP members recommended routine vaccination of females ages 11 or 12 with three doses of HPV vaccine for prevention of cervical cancer. The quadrivalent vaccine is recommended for prevention of cervical cancer and genital warts.1
The FDA approval of a vaccine such as Cervarix is an important development in the prevention of cervical cancer, says Levi Downs, MD, MS, FACOG, assistant professor in the Department of Obstetrics, Gynecology, and Women's Health at the University of Minnesota.
"The treatment of cervical precancers and cancer can be devastating for women and their families," says Downs, who served as a clinical trial investigator for Cervarix. "It's important for a vaccine to help reduce the need for the invasive procedures often used to treat cervical precancers and cancers."
References
- Centers for Disease Control and Prevention. CDC's Advisory Committee on Immunization Practices Meeting. ACIP Meeting Notes. Press release. Oct. 21, 2009.
- Kim JJ, Goldie SJ. Cost-effectiveness analysis of including boys in a human papillomavirus vaccination programme in the United States. Br Med J 2009. Doi: 10.1136/bmj.b3884.
- Randall T, Pettypiece S. Merck cancer vaccine may not win routine use in boys. Bloomberg News; Oct. 21, 2009. Accessed at www.bloomberg.com/apps/news?pid=20601103&sid=azRbLuBh8lwo#.
- Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices. Summary report. June 24-26, 2009. Atlanta. Accessed at www.cdc.gov/vaccines/recs/acip/downloads/min-jun09.pdf.
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