What is the latest on the vaccine to prevent HPV infections, cervical cancer and genital warts?
A year ago, the introduction of the human papillomavirus (HPV) vaccine was being hailed as a major public health success story. Merck's Gardasil, shown to prevent two HPV strains responsible for 70% of cervical cancer cases (as well as two other strains tied to nearly all cases of genital warts), was approved by the Food and Drug Administration (FDA) in June 2006 and was soon recommended by the government for all girls aged 11?12; a "catch-up" campaign was also advised for young women aged 13?26. A second vaccine, Cervarix, was submitted to the FDA in April 2007 by GlaxoSmithKline and could be approved early in 2008.
At the start of 2007, legislators in half the states introduced proposals to require HPV immunization for school attendance, (1) a tactic that has been widely credited for achieving near-universal use of other vaccines. Yet, these proposals were derailed by opposition from an unlikely combination of supporters of parental rights; opponents of vaccines in general, drug company critics, communities of color, and public health advocates. Many in the latter group argued for a slower approach, supporting voluntary vaccination while educating the public and monitoring the vaccine's safety as it is rolled out to millions of Americans.
Clinics have a role
The nation's 7,500 family planning clinics are well positioned to help under this new scenario, both in terms of providing voluntary HPV vaccination?particularly to the older, catch-up population?and educating women about HPV, cervical cancer and the benefits of the vaccine. Nearly four in 10 of women 15?24 who obtain sexually transmitted disease testing or treatment services do so at one of these clinics. (2) Many of these young women have no interaction with the health care system apart from their clinic visits.
More specifically, family planning clinics are a key source of care for black and
Cost is a factor
At about $300 per patient, even with Merck's discount for clinics, the HPV vaccine is extraordinarily expensive for a vaccine. To meet this cost, clinics will have to cobble together money from a range of public and private funding sources. The Vaccines for Children (VFC) program provides free vaccines to children through age 18 who are uninsured, underinsured or have public coverage such as Medicaid. Medicaid itself covers the vaccine for women ages 19?20 and through age 26 in roughly half the states (at the states' option). Several states have also allocated millions of their own dollars to cover vaccine provision and education. (Ironically, the Title X family planning program may not play a major role, both because its funding is limited and because in some states, laws requiring parental consent for vaccination will interfere. Title X?supported services must be provided confidentially to all clients, including minors.)
In the private sector, a major source of funding will be private health insurance. Merck estimates that 94% of individuals with private coverage are in plans covering the vaccine,(4) and three states?Colorado, Nevada and New Mexico?have already enacted laws mandating such coverage.(1) Yet, reimbursement by private plans has been reportedly low compared to high up-front costs for providers.
Merck itself has established a patient assistance program to reimburse providers for that up-front cost for vaccines provided to uninsured, low-income adults. However, health department clinics and other government-run agencies are not eligible, and providers that are eligible are reimbursed quarterly, requiring another source of funding to tide them over.
What lies ahead?
Beyond the financial challenges, clinics wishing to provide the vaccine must decide which populations to target, secure quality training for their staff, design appropriate counseling and service protocols, and explore reconfiguring their hours and venues, and find ways to bring in potential clients. In some states, VFC participation requires providers to offer all of the vaccines required for adolescents and young adults, not merely the HPV vaccine, and it entails costly procedures related to vaccine refrigeration. The vaccine's unusual regimen?three shots in six months?means that clinics must ensure that women return for subsequent shots when they would not otherwise visit. And with continuing controversy, whatever its validity, over the HPV vaccine's safety, efficacy and link to sexual behavior, rigorous informed consent protocols will be especially salient.
These are serious challenges, but if they can be overcome, family planning clinics can prove themselves anew to be a central cog in the nation's public health system and help reduce long-standing racial, ethnic and socioeconomic disparities in cervical cancer incidence and mortality.
By Adam Sonfield
Senior Public Policy Associate
1. Guttmacher Institute.
2. Gold RB. Challenges and opportunities for
To appear in the upcoming issue of the newsletter: Contraceptive Technology Update
Key Words: HPV (human papillomavirus) vaccine, Gardasil, family planning clinics, infections, cervical cancer, genital warts, costs, Merck, private health insurance